Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2005, 36620-36640 [05-12525]

Download as PDF 36620 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 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 government agencies. 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 one year. Individuals and States are not included in the definition of a small entity; therefore, this requirement does not apply. 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 Metropolitan Statistical Area and has fewer than 100 beds. The Unfunded Mandates Reform Act of 1995 requires that agencies prepare an assessment of anticipated costs and benefits before publishing any notice that may result in an annual expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $110 million or more (adjusted each year for inflation) in any one year. Since participation in the SCHIP program on the part of States is voluntary, any payments and expenditures States make or incur on behalf of the program that are not reimbursed by the Federal government are made voluntarily. This notice will not create an unfunded mandate on States, tribal, or local governments because it merely notifies States of their SCHIP allotment for FY 2006. Therefore, we are not required to perform an assessment of the costs and benefits of this notice. Low-income children will benefit from payments under SCHIP through increased opportunities for health insurance coverage. We believe this notice will have an overall positive impact by informing States, the District of Columbia, and U.S. Territories and Commonwealths of the extent to which they are permitted to expend funds under their child health plans using their FY 2006 allotments. Under Executive Order 13132, we are required to adhere to certain criteria regarding Federalism. We have reviewed this notice and determined that it does not significantly affect States’ rights, roles, and responsibilities because it does not set forth any new policies. VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this notice will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. (Section 1102 of the Social Security Act (42 U.S.C. 1302)) (Catalog of Federal Domestic Assistance Program No. 93.767, State Children’s Health Insurance Program) Dated: April 29, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. Dated: May 11, 2005. Michael O. Leavitt, Secretary. [FR Doc. 05–12521 Filed 6–23–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9028–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2005 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2005 through March 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, for the first time, this notice PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may have a specific information need and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing information contact persons to answer general questions concerning these items. Copies are not available through the contact persons. (See Section III of this notice for how to obtain listed material.) Questions concerning items in Addendum III may be addressed to Timothy Jennings, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786–2134. Questions concerning Medicare NCDs in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1– 09–06, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786–0261. Questions concerning FDA-approved Category B IDE numbers listed in Addendum VI may be addressed to John Manlove, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, S3–26–10, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786– 6877. Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Jim Wickliffe, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5–14–03, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786–4596. Questions concerning Medicareapproved carotid stent facilities may be addressed to Rana A. Hogarth, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1– E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 09–06, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786–2112; or to Sarah J. McClain, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1–09–06, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786– 2994. Questions concerning all other information may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare & Medicaid Services, C5–14–03, 7500 Security Boulevard, Baltimore, MD 21244–1850, or you can call (410) 786–6954. SUPPLEMENTARY INFORMATION: I. Program Issuances The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million Medicaid recipients. Administration of the two programs involves (1) furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently. Section 1871(c)(1) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3month time frame. VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 II. How To Use the Addenda This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, NCDs, and FDA-approved IDEs published during the subject quarter to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals may wish to review Table I of our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring information on the Medicare NCD Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may wish to review the August 21, 1989, publication (54 FR 34555). Those interested in the revised process used in making NCDs under the Medicare program may review the September 26, 2003, publication (68 FR 55634). To aid the reader, we have organized and divided this current listing into eight addenda: • Addendum I lists the publication dates of the most recent quarterly listings of program issuances. • Addendum II identifies previous Federal Register documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda. • Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manuals. • Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register during the quarter covered by this notice. For each item, we list the— Æ Date published; Æ Federal Register citation; Æ Parts of the Code of Federal Regulations (CFR) that have changed (if applicable); Æ Agency file code number; and Æ Title of the regulation. • Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. • Addendum VI includes listings of the FDA-approved IDE categorizations, PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 36621 using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number. • Addendum VII includes listings of all approval numbers from the Office of Management and Budget (OMB) for collections of information in CMS regulations in title 42; title 45, subchapter C; and title 20 of the CFR. • Addendum VIII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS’s standards for performing carotid artery stenting for high risk patients. III. How To Obtain Listed Material A. Manuals Those wishing to subscribe to program manuals should contact either the Government Printing Office (GPO) or the National Technical Information Service (NTIS) at the following addresses: Superintendent of Documents, Government Printing Office, ATTN: New Orders, P.O. Box 371954, Pittsburgh, PA 15250–7954, Telephone (202) 512–1800, Fax number (202) 512– 2250 (for credit card orders); or National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487–4630. In addition, individual manual transmittals and Program Memoranda listed in this notice can be purchased from NTIS. Interested parties should identify the transmittal(s) they want. GPO or NTIS can give complete details on how to obtain the publications they sell. Additionally, most manuals are available at the following Internet address: https://cms.hhs.gov/manuals/ default.asp. B. Regulations and Notices Regulations and notices are published in the daily Federal Register. Interested individuals may purchase individual copies or subscribe to the Federal Register by contacting the GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) E:\FR\FM\24JNN1.SGM 24JNN1 36622 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is https://www.gpoaccess.gov/fr/ index.html, by using local WAIS client software, or by telnet to swais.gpoaccess.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512–1661; type swais, then log in as guest (no password required). C. Rulings We publish rulings on an infrequent basis. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is https://cms.hhs.gov/rulings. D. CMS’ Compact Disk-Read Only Memory (CD–ROM) Our laws, regulations, and manuals are also available on CD–ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717– 139–00000–3. The following material is on the CD–ROM disk: • Titles XI, XVIII, and XIX of the Act. • CMS-related regulations. • CMS manuals and monthly revisions. • CMS program memoranda. The titles of the Compilation of the Social Security Laws are current as of January 1, 1999. (Updated titles of the Social Security Laws are available on the Internet at https://www.ssa.gov/ OP_Home/ssact/comp–toc.htm.) The remaining portions of CD–ROM are updated on a monthly basis. Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD–ROM. We intend to re-visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD–ROM. Any cost report forms incorporated in the manuals are included on the CD– ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk. IV. How To Review Listed Material Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare NCD publication titled ‘‘Implantable Automatic Defibrillators,’’ use CMS–Pub. 100–03, Transmittal No. 29. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance, Program No. 93.774, Medicare— Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: June 20, 2005. Jacquelyn White, Director, Office of Strategic Operations and Regulatory Affairs. Addendum I This addendum lists the publication dates of the most recent quarterly listings of program issuances. December 27, 2002 (67 FR 79109). March 28, 2003 (68 FR 15196). June 27, 2003 (68 FR 38359). September 26, 2003 (68 FR 55618). December 24, 2003 (68 FR 74590). March 26, 2004 (69 FR 15837). June 25, 2004 (69 FR 35634). September 24, 2004 (69 FR 57312). December 30, 2004 (69 FR 78428). February 25, 2005 (70 FR 9338). Addendum II—Description of Manuals, Memoranda, and CMS Rulings An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM (now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468. ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS [January Through March 2005] Transmittal No. Manual/subject/publication No. Medicare General Information (CMS Pub. 100–01) 15 .................. 16 .................. 17 .................. 18 .................. 19 .................. VerDate jul<14>2003 Review of Contractor Implementation of Change Requests (Replacement for expired CR 944). Review of Contractor Implementation of Change Requests. CR Implementation Report—Summary Page. CR Implementation Report—Details Page. CR Implementation Report—Sample Cover Letter/ Attestation Statement. Standard Terminology for Claims Processing Systems. This Transmittal rescinded and replaced Transmittal 15. Billing for Blood and Blood Products Under the Hospital Outpatient Prospective Payment System. Items Subject to Blood Deductibles. Blood. Revisions to Chapter 5, Section 50 of Publication 100–01 in the Internet Only. Manual to Clarify Current Policy. Home Health Agency Defined. Arrangements by Home Health Agencies. 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 36623 ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. Rehabilitation Centers. Medicare Benefit Policy (CMS Pub. 100–02) 29 .................. 30 .................. Telehealth Originating Site Facility Fee Payment Amount Update. Policy for Repair and Replacement of Durable Medical Equipment. Medicare National Coverage Determinations (CMS Pub. 100–03) 27 .................. 28 .................. 29 .................. 30 .................. Infusion Pumps: C-Peptide Levels As A Criterion for Use. Update of Laboratory NCDs to Reference New Screening Benefits. Blood Glucose Testing. Lipid Testing. Implantable Automatic Defibrillators. Coverage of Colorectal Anti-Cancer Drugs Included in Clinical Trials. Anti-Cancer Chemotherapy for Colorectal Cancer (Effective January 28, 2005). Medicare Claims Processing (CMS Pub. 100–04) 423 ................ 424 ................ 425 ................ 426 ................ 427 ................ 428 ................ 429 ................ 430 ................ 431 ................ 432 ................ 433 ................ 434 ................ 435 ................ 436 ................ 437 ................ 438 ................ 439 ................ 440 ................ VerDate jul<14>2003 January 2005 Update of the Hospital Outpatient Prospective Payment System: Summary of Payment Policy Changes. Implementation of the Annual Desk Review Program for Hospital Wage Data: Cost Reporting Periods Beginning on or After October 1, 2001, Through September 30, 2002 (FY 2006 Wage Index). Section 630 of the Medicare Modernization Act allows for the Reimbursement for Ambulance Services Provided by Indian Health Service/Tribal Hospitals, Including Critical Access Hospitals, Which Manage and Operate Hospital-Based Ambulances. General Coverage and Payment Policies. Indian Health Service/Tribal Billing. Modification to Reporting of Diagnosis Codes for Screening Mammography Claims. Healthcare Common Procedure Coding System and Diagnosis Codes for Mammography Services. Revision of Change Request 2928: Implementation of Payment Safeguards for Home Health Prospective Payment System Claims Failing to Report Prior Hospitalizations. Adjustments of Episode Payment—Hospitalization Within 14 Days of Start of Care. Update to Billing Requirements for FDG-Positron Emission Tomography Scans For Use in the Differential Diagnosis of Alzheimer’s Disease and Fronto-Temporal Dementia and Update to the Fiscal Intermediaries Billing Requirements for Special Payment Procedures for All Positron Emission Tomography Scan. Claims for Services Performed in a Critical Access Hospital. Billing Instructions. Coverage for Positron Emission Tomography Scans for Dementia and Neurodegenerative Disease. Change to the Common Working File Skilled Nursing Facility Consolidated Billing Edits for Critical Access Hospitals That Have Elected Method II Payment Option and Bill Physician Services to Their Fiscal Intermediaries. Physician’s Services and Other Professional Services Excluded From Part A PPS Payment and the Consolidated Billing Requirement. Mandatory Assignment for Medicare Modernization Act § 630 Claims. Other Part B Services. Durable Medical Equipment Regional Carrier Drugs. Claims Processing Requirements for Medicare Modernization Act § 630. Claims Processing for Durable Medical Equipment Prosthetic, Orthotics & Supplies and Durable Medical Equipment Regional Carrier Drugs. Enrollment for Durable Medical Equipment Prosthetic, Orthotics & Supplies and Durable Medical Equipment Regional Carrier Drugs. Enrollment and Billing for Clinical Laboratory and Ambulance Services and Part B Drugs. Claims Submission and Processing for Clinical Laboratory and Ambulance Services and Part B Drugs. Updated Skilled Nursing Facility No Pay File for April 2005. Adding an Indicator to the National Claims History to Indicate That Durable Medical Regional Carriers, Carriers, and Fiscal Intermediaries Have Reviewed a Potentially Duplicate Claim. Detection of Duplicate Claims. Issued to a specific audience, not posted to the Internet/Intranet due to the Sensitivity of Instruction. Addition of Clinical Laboratory Improvement Act Edits to Certain Health Care Procedure Coding System Codes for Mohs Surgery. This Transmittal has been rescinded and replaced by Transmittal 450. Remittance Advice Remark Code and Claim Adjustment Reason Code Update. Revisions and Corrections to the Medicare Claims Processing Manual, Chapter 6, Section 30 and Various Sections in Chapter 15. Billing Skilled Nursing Facility Prospective Payment System Services General Coverage and Payment Policies. Air Ambulance for Deceased Beneficiary. General Billing Guidelines for Intermediaries and Carriers. Intermediary Guidelines. Fiscal Intermediary Standard Paper Remittance Advice Changes. Modification to the Fiscal Intermediary Standard System Regarding Ambulance Services Billed on 18x and 21x Types of Bill. Updating the Common Working File Editing for Pap Smear (Q0091) and Adding a New Low Risk Diagnosis Code (V72.31) for Pap Smear and Pelvic Examination. 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 36624 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. 441 ................ 442 ................ 443 ................ 444 ................ 445 ................ 446 ................ 447 ................ 448 ................ 449 ................ 450 ................ 451 452 453 454 ................ ................ ................ ................ 455 ................ 456 ................ 457 ................ 458 ................ 459 ................ 460 ................ 461 ................ VerDate jul<14>2003 Healthcare Common Procedure Coding System Codes for Billing. Diagnoses Codes. Payment Method. Revenue Codes and Healthcare Common Procedure Coding System Codes for Billing. Medicare Summary Notice Messages. Remittance Advice Codes. Viable Medicare Systems Changes to Durable Medical Equipment Regional Carrier Processing of Method II Home Dialysis Claims. Hospital Outpatient Prospective Payment System: Use of Modifiers -52, -73 and -74 for Reduced or Discontinued Services Use of Modifiers. Use of Modifiers for Discontinued Services. This Transmittal is rescinded and replaced by Transmittal 505. Further Information Related to Inpatient Psychiatric Facility Prospective Payment System Payment to Providers/Suppliers Qualified to Bill Medicare for Prosthetics and Certain Custom-Fabricated Orthotics. Provider Billing for Prosthetics and Orthotic Services. Diabetes Screening Tests. Common Working File Editing for Method Selection on Durable Medical Equipment Regional Carrier Claims for EPO and Aranesp Epoetin Alfa Furnished to Home Patients. Darbepoetin Alfa Furnished to Home Patients. Timeframe for Continued Execution of Crossover Agreements and Update on the Transition to the National Coordination of Benefits Agreement Program Crossover Claims Requirements. Fiscal Intermediaries Requirements. Durable Medical Equipment Regional Carrier Requirements. Consolidation of the Claims Crossover Process. Electronic Transmission - General Requirements. ANSI X12N 837 Coordination of Benefit Transaction Fee Collection. Medigap Electronic Claims Transfer Agreements. Intermediary Crossover Claim Requirements. Carrier/Durable Medical Equipment Regional Carrier Crossover Claims Requirements. April Quarterly Update to 2005 Annual Update of Healthcare Common Procedure Coding System Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement Enforcement of Mandatory Electronic Submission of Medicare Claims Failure To Furnish Information Medicare Summary Notice Message. Falta De Information Sometida Medicare Summary Notice Message Enforcement. April 2005 Quarterly Fee Schedule Update for Durable Medical Equipment, Prosthetics, Orhtotics, and Supplies. New Remittance Advice Message for Referred Clinical Diagnostic/ Purchased Diagnostic Service Duplicate Claims. Instructions for Downloading the Medicare Zip Code File. Definitions of Electronic and Paper Claims. Payment Ceiling Standards. This transmittal is rescinded and replaced by Transmittal 509. Independent Laboratory Billing for the Technical Component of Physician. Pathology Services Furnished to Hospital Patients (Supplemental to Change Request 3467) Diabetes Screening Tests. Healthcare Common Procedure Coding System Coding for Diabetes Screening. Carrier Billing Requirements. Modifier Requirements for Pre-Diabetes. Fiscal Intermediary Billing Requirements. Diagnosis Code Reporting. Medicare Summary Notices. Remittance Advice Remark Codes. Claims Adjustment Reason Codes. Hospice Physician Recertification Requirements. Data Required on Claim to Fiscal Intermediaries. Full Replacement of Change Request 3427, Transmittal 342, Issued on October 29, 2004—Change to the Common Working File Skilled Nursing Facility. Consolidated Billing Edits for Ambulance Transports to or From a Diagnostic or Therapeutic Site. Ambulance Services. Skilled Nursing Facility Billing. Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. Processing Durable Medical Equipment, Orthotics, Prosthetics, Drugs, and Surgical Dressings Claims for Indian Health Services and Tribally Owned and Operated Hospitals or Hospital Based Facilities Including Critical Access. Hospital. Other Part B Services. Prosthetics and Orthotics. Prosthetic Devices. Surgical Dressings and Splints and Casts. Drugs Dispensed by IHS Hospital-Based or Freestanding Facilities. Claims Processing for Durable Medical Equipment Prosthetics, Orthotics & Supplies. 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 36625 ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. 462 ................ 463 ................ 464 ................ 465 ................ 466 ................ 467 ................ 468 ................ 469 ................ 470 ................ 471 ................ 472 ................ 473 474 475 476 477 ................ ................ ................ ................ ................ 478 ................ 479 ................ 480 ................ 481 ................ 482 ................ 483 ................ 484 ................ VerDate jul<14>2003 Enrollment for Durable Medical Equipment Prosthetics, Orthotics & Supplies. Claims Submission for Durable Medical Equipment Prosthetics, Orthotics & Supplies. Durable Medical Equipment Regional Carrier Only—Dispensing Fees for Immunosuppressive Drugs. Update to 100–04 and Therapy Code Lists. Healthcare Common Procedure Coding System Coding Requirement. Part B Outpatient Rehabilitation and Comprehensive Outpatient Rehabilitation Facility Services—General. Discipline Specific Outpatient Rehabilitation Modifiers—All Claims. The Financial Limitation. Reporting of Service Units With HCPCS—Form CMS–1500 and Form CMS–1450. Implementation of the Abstract File for Purchased Diagnostic. Test/Interpretations (Supplemental to CR 3481). Payment Jurisdiction Among Local Carriers for Services Paid Under the Physician Fee Schedule and Anesthesia Services. Payment Jurisdiction for Purchased Services. Payment to Physician or Other Supplier for Purchased Diagnostic Tests—Claims Submitted to Carriers. Payment to Supplier of Diagnostic Tests for Purchased Interpretations. Billing Requirements for Physician Services in Method II Critical Access Hospitals. Payment for Inpatient Services Furnished by a Critical Access Hospital. Special Rules for Critical Access Hospital Outpatient Billing. Billing and Payment in a Physician Scarcity Area. Quarterly Update to Correct Coding Initiative Edits, Version 11.1, Effective April 1, 2005. Modifications to Duplicate Editing for Dispensing/Supply Fee Codes for Oral Anti-Cancer, Oral Anti-Emetic, Immunosuppressive and Inhalation Drugs. Appeals Transition—Benefits, Improvement & Protection Act Section 521. Appeals. New Waived Tests—April 1, 2005. Standardization of Fiscal Intermediary Use of Group and Claim Adjustment. Reason Codes and Calculation and Balancing of TS2 and TS3 Segment. Data Elements. This Transmittal is rescinded and replaced by Transmittal 513. Revisions to Payment for Services Provided Under a Contractual Arrangement—Carrier Claims Only. Exceptions to Assignment of Provider’s Right to Payment—Claims Submitted to Fiscal Intermediaries and Carriers. Payment for Services Provided Under a Contractual Arrangement—Carrier Claims Only. Use of 12X Type of Bill for Billing Vaccines and Their Administration Bills Submitted to Fiscal Intermediaries. Coordination of Benefits Agreement Detailed Error Report Notification Process. 1st Update to the 2005 Medicare Physician Fee Schedule Database. Type of Service Corrections. New Case-Mix Adjusted End-Stage Renal Disease Composite Payment Rates And New Composite Rate Exceptions Window for Pediatric End-Stage Renal Disease Facilities. Outpatient Provider-Specific File. Calculation of Case-Mix Adjustment Composite Rate. Required Information for In-Facility Claims Paid Under the Composite Rate. Clarification of the Verification Process to be Used to Determine If the Inpatient Rehabilitation Facility Meets the Inpatient Rehabilitation Classification Criteria Verification Process To Be Used To Determine If the Inpatient Rehabilitation Facility Met the Classification Criteria. Update to the Healthcare Provider Taxonomy Codes Version 5.0. April 2005 Quarterly Average Sale Price Medicare Part B Drug Pricing File, Effective April 1, 2005, and New January 2005 Quarterly Average Sale Price File. Updated Manual Instructions for the Medicare Claims Processing Manual, Chapter 10. General Guidelines for Processing Home Health Agency Claims. Effect of Election of Medicare Advantage Organization and Eligibility Changes on Home Health Prospective Payment System Episodes. General Guidance on Line Item Billing Under the Home Health Prospective Payment System. Request for Anticipated Payment. Home Health Prospective Payment System Claims. Special Billing Situations Involving Outcome & Assessment Information Set Assessments. Medical and Other Health Services Not Covered Under the Plan of Care (Bill Type 34X). Manualization of Payment Change for Diagnostic Mammography and Diagnostic Computer Aided Detection. Screening Mammography Services. Computer Aided Design Billing Charts. Payment for Screening Mammography Services Provided Prior to January 1, 2002. Payment for Screening Mammography Services Provided On and After January 1, 2002. Outpatient Hospital Mammography Payment Table. Payment for Computer Add-On Diagnostic and Screening Mammograms for Fiscal Intermediaries and Carriers. Mammograms Performed With New Technologies. Hospital Partial Hospitalization Services Billing Requirements. Special Partial Hospitalization Billing Requirements for Hospitals, Community Mental Health Centers, and Critical Access Hospitals. Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers. New Remittance Advice Message for Referred Clinical Diagnostic/Purchased Diagnostic Service Duplicate Claims. 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 36626 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. 485 ................ Calculating Payment-to-Cost Ratios for Purposes of Determining Transitional Corridor Payments Under the Outpatient Prospective Payment System. Manualization of Carrier Claims Processing Instructions for Stem Cell Transplantation. Stem Cell Transplantation. General. Healthcare Common Procedure Coding System and Diagnosis Coding. Non-Covered Conditions. Edits. Suggested Medicare Summary Notice and Remittance Advice Messages. Medicare Qualifying Clinical Trials. Chapter 32, Section 69.0—Qualifying Clinical Trials. This Transmittal has been rescinded and replaced by Transmittal 497. Correction to Healthcare Common Procedure Coding System Code A4217. Payment of Durable Medical Equipment Prosthetics, Orthotics & Supplies Items Based on Modifiers. Claims Status Code/Claims Status Category Code Update. Health Care Claims Status Category Codes and Health Care Claims Status Codes for Use With Health Care Claims Status Request and Response ASC X12N 276/277. Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. Adding an Indicator to the National Claims History to Indicate That Durable Medical Equipment Regional Carrier, Carriers and Fiscal Intermediaries Have Reviewed a Potentially Duplicate Claim. Detection of Duplicate Claims. Revision to Chapter 1, and Removal of Section 70 from Chapter 25 of the Medicare Claims Processing Manual. Inpatient Billing From Hospitals and Skilled Nursing Facilities. Submitting Bills in Sequence for a Continuous Inpatient Stay or Course of Treatment. Intermediary Processing of No-Payment Bills. Time Limitations for Filing Provider Claims to Fiscal Intermediaries. Statement of Intent. Filing Request for Payment to Carriers—Medicare Part B. Fiscal Intermediary Consistency Edits. Patient is a Member of a Medicare Advantage Organization for Only a Portion of the Billing Period. Late Charges. Inpatient Part A Hospital Adjustment Bills. April 2005 Outpatient Prospective Payment System Code Editor Specifications Version 6.1. Inpatient Psychiatric Facility Prospective Payment System—Further Clarifications. Billing for Blood and Blood Products Under the Hospital Outpatient Prospective Payment System. When a Provider Paid Under the Outpatient Prospective Payment System Does Not Purchase the Blood or Blood Products That It Procures From a Community Blood Bank, or When a Provider Paid Under the Outpatient Prospective Payment System Does Not Assess a Charge for Blood or Blood Products Supplied by the Provider’s Own Blood Bank Other Than Blood Processing and Storage. When a Provider Paid Under the Outpatient Prospective Payment System Purchases Blood or Blood Products from a Community Blood Bank or When a Provider Paid Under the Outpatient Prospective Payment System Assesses a Charge for Blood or Blood Products Collected by Its Own Blood Bank That Reflects More Than Blood Processing and Storage. Billing for Autologous Blood (Including Salvaged Blood) and Directed Donor Blood. Billing for Split Unit of Blood. Billing for Irradiation of Blood Products. Billing for Frozen and Thawed Blood and Blood Products. Billing for Unused Blood. Billing for Transfusion Services. Billing for Pheresis and Apheresis Services. Correct Coding Initiative Edits. Blood Products and Drugs Classified in Separate Average Projected Costs for Hospital Outpatients. Billing for Implantable Automatic Defibrillators for Beneficiaries in a Medicare Advantage Plan and Use of the Quarterly Refund Modifier to Identify Patient Registry Participation. Billing of the Diagnosis and Treatment of Peripheral Neuropathy With Loss of Protective Sensation in People With Diabetes. General Billing Requirements. Applicable Healthcare Common Procedure Coding System Codes. Diagnosis Codes. Payment. Applicable Revenue Codes. Editing Instructions for Fiscal Intermediaries. Common Working File General Information. Common Working File Utilization Edits. 2005 Scheduled Release for April Updates to Software Programs and Pricing/Coding Files. Changes to the Laboratory National Coverage Determination Edit. Software for April 2005. Bone Mass Measurements—Procedure Coding. New Contrast Agents Healthcare Common Procedure Coding System Codes. April Update to the Medicare Non-Outpatient Prospective Payment Systems. Outpatient Code Editor Specification Version 20.2. Update to Pub 100–04, Chapter 12, Section 200 of the Internet Only Manual. 486 ................ 487 ................ 488 ................ 489 ................ 490 ................ 491 ................ 492 ................ 493 ................ 494 ................ 495 ................ 496 ................ 497 ................ 498 ................ 499 ................ 500 ................ 501 ................ 502 ................ 503 ................ 504 ................ VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 36627 ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. 505 ................ 506 507 508 509 ................ ................ ................ ................ 510 511 512 513 514 ................ ................ ................ ................ ................ Allergy Testing and Immunotherapy. Unprocessable Unassigned Form CMS–1500 Claims. Incomplete or Invalid Claims Processing Terminology. Updated Manual Instructions for Item 24G (Days or Units), Chapter 26. New Healthcare Common Procedure Coding System for Intravenous Immune Globulin. This Transmittal is rescinded and replaced by Transmittal 514. Number of Drug Pricing Files That Must Be Maintained Online for Medicare—Durable Medical Equipment Regional Carriers Only. Online Pricing Files for Average Sales Price. Update to Fiscal Year 2005 Pricer for IPPS Hospitals. Type of Service Corrections. Coverage of Colorectal Anti-Cancer Drugs Included in Clinical Trials. Infusion Pumps: C-Peptide Levels As a Criterion for Use. April 2005 Update of the Hospital Outpatient Prospective Payment System: Summary of Payment Policy Changes. Medicare Secondary Payer (CMS Pub. 100–05) 23 .................. 24 .................. 25 .................. 26 .................. 27 .................. Modification to Online Medicare Secondary Payer Questionnaire. Admission Questions to Ask Medicare Beneficiaries. Issued to a specific audience, not posted to Internet/Intranet, due to Sensitivity of Instruction. Update Medicare Secondary Payer Manual Publication 100–05 to reflect Statutory Changes included in the Medicare Modernization Act. General Provisions. Conditional Primary Medicare Benefits. When Conditional Primary Medicare Benefits May Be Paid. When Medicare Secondary Benefits Are Payable and Not Payable. Definitions. Beneficiary’s Rights and Responsibility. Statutory Provisions. No-Fault Insurance. Situations in Which Medicare Secondary Payer Billing Applies. Incorrect Group Health Plan Primary Payments. General Policy. Conditional Primary Medicare Benefits. Conditional Medicare Payment. Medicare Right of Recovery. Conflicting Claims by Medicare and Medicaid. Third Party Payer Refund Requests Served on Medicare. General Operational Instructions. Conditional Primary Medicare Benefits. Existence of Overpayment. Clarification for Change Request (CR) 3267. General Policy. Updates to the Electronic Correspondence Referral System User Guide v8.0 and Quick Reference Card v8.0. Coordination of Benefits Contractor Electronic Correspondence Referral System. Providing Written Documents to the Coordination of Benefits Contractor. Medicare Financial Management (CMS Pub. 100–06) 55 .................. 56 .................. 57 .................. 58 .................. 59 .................. 60 .................. VerDate jul<14>2003 Reporting Appeals Redetermination Information on Forms CMS–2591 and 2590. Revision to Balancing Requirement on Form 5, Line 10, of the Contractor. Reporting of Operational and Workload Data. Revised Reporting Requirements for Contractor Reporting of Operational Workload Data Health Professional Shortage Area Quarterly Report. Issued to specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. Notice of New Interest Rate for Medicare Overpayments and Underpayments. Revised instructions on contractor procedures for provider audit and the Provider. Statistical & Reimbursement Report. Submission of Cost Report Data to CMS. Desk Review Exceptions Resolution Process. Definition of Field Audits. Purpose of Field Audits. Establishing the Objective/Scope of the Field Audit. Audit Confirmation Letter. Entrance Conference. Tests of Internal Control. Designing Tests/Sampling. Pre-Exit Conference. Finalization of Audit Adjustments. Exit Conference. 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 36628 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. 61 .................. 62 .................. 63 .................. 64 .................. 65 .................. 66 .................. Medicare Cost Report and All Related Documents. Qualifications. Internal Quality Control. Final Settlement of the Cost Report. Audit Responsibility When Provider Changes Contractors. Audits of Home Offices. Standards for Issuance of an Audit Report for a Home Office. Provider Permanent File. Contractor Responsibility in Suspected Fraud or Abuse Cases. New Location Code Interstate Commerce Commission, Status Code AR and Modified Intent Letter for Unfiled Cost Reports Only. Recovery of Overpayment Due to Overdue Cost Report. Provider Overpayment Recovery System User Manual. List of Status Codes. Content of Demand Letters-Fiscal Intermediary Serviced Providers. Timeframe for Continued Execution of Crossover Agreements and Updated on the Transition to the National Coordination of Benefits Agreement Program. Coordination of Medicare and Complementary Insurance Programs. Notice of New Interest Rate for Medicare Overpayments and Underpayments. For Fiscal Intermediaries, a New Provider Type 80, Status Code CH, and Method of Recoupment Codes. For Carriers and Durable Medical Equipment. Regional Carriers Status Code 2. Provider Overpayment Reporting System User Manual. List of Status Codes. Physician/Supplier Overpayment Reporting System User Manual. Revised Reporting Requirements for Contractor Reporting of Operational Workload Data Physician Scarcity Area Quarterly Report (CMS Form—1565F, CROWD Form6). Completing Physician Scarcity Area Quarterly Report Form CMS 1565F, CROWD Form 6. Physician Scarcity Area Quarterly Report, Line Descriptors. Error Descriptors. Checking Reports. Chapter 7, Internal Control Requirements Update. Federal Managers’ Financial Integrity Act of 1982. Federal Managers Financial Integrity Act and the CMS Medicare Contractor Contract. Chief Financial Officers Act of 1990. Office of Management & Budget Circular A–123. General Accounting Office Standards for Internal Controls in the Federal Government. Fundamental Concepts. Control Activities. Monitoring. Risk Assessment. Internal Control Objectives. Fiscal Year 2005 Medicare Control Objectives. Policies and Procedures. Control Activities. Testing Methods. Documentation and Working Papers. Requirements. Certification Statement. Executive Summary. Certification Package for Internal Controls Report of Material Weaknesses. Certification Package for Internal Controls Report of Reportable Conditions. Definitions and Examples of Reportable Conditions and Material Weaknesses. Material Weaknesses Identified During the Fiscal Year. Corrective Action Plans. Submission, Review, and Approval of Corrective Action Plans. Corrective Action Plan Reports. CMS Finding Numbers. Initial Corrective Action Plan Report. Quarterly Corrective Action Plan Report. Entering Data: Initial or Quarterly Corrective Action Plan Report. Medicare State Operations Manual (CMS Pub. 100–07) 00 .................. None Medicare Program Integrity (CMS Pub. 100–08)) 93 .................. VerDate jul<14>2003 This Transmittal has been rescinded and replaced by Transmittal 102. 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 36629 ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. 94 .................. Informing Beneficiaries About Which Local Medical Review Policy and/or Local Coverage Determination and/or National Coverage. Determination Is Associated With Their Claim Denial. Prepayment Edits. Change in Provider Enrollment Appeals Process. Administrative Appeals. Consent Settlements. Postpayment Review Case Selection. Location of Postpayment Reviews. Re-adjudication of Claims. Calculation of the Correct Payment Amount and Subsequent Over/Underpayment. Notification of Provider(s) or Supplier(s) and Beneficiaries of the Postpayment Review Results. Provider(s) or Supplier(s) Rebuttal(s) of Findings. Evaluation of the Effectiveness of Postpayment Review and Next Steps. Consent Settlement Instructions. Background on Consent Settlement. Opportunity to Submit Additional Information Before Consent Settlement Offer. Consent Settlement Offer. Election to Proceed to Statistical Sampling for Overpayment Estimation. Acceptance of Consent Settlement Offer. Consent Settlement Budget and Performance Requirements for Medicare Contractors. Provider Enrollment and Inpatient Rehabilitation Facility (IRF) Compliance Reviews. Psychotherapy Notes. Additional Documentation Requests During Prepayment or Postpayment Medical Review. Program Integrity Manual Modification—Changes Waivers Approved by the Regional Office by Replacing Regional Office With Central Office. Contractor Medical Director. Benefit Integrity Security Requirements. The Carrier Advisory Committee. Review of Documentation During Medical Review. Additional Documentation Requests During Prepayment or Postpayment Medical Review. Documentation in the Patient’s Medical Records. Benefit Integrity Personal Information Manager Revisions. Sources of Data for Program Safeguard Contractors. Procedural Requirements. Benefit Integrity Security Requirements. Requests for Information From Outside Organizations. Program Safeguard Contractor and Medicare Contractor Coordination With Other Program. Safeguard Contractors and Medicare Contractors. Complaint Screening. Types of Fraud Alerts. Alert Specifications. Editorial Requirements. Coordination. Distribution of Alerts. Information Not Captured in the Fraud Investigation Database. Initial Entry Requirements for Investigations. Designated Program Safe Guard and Medicare Contractor Background Investigation. Unit Staff and the Fraud Investigation Database. Affiliated Contractor and Program Safeguard Contractor Coordination on Voluntary Refunds. Referral of Cases to the Office of the Inspector General/Office of Investigations. Referral to State Agencies or Other Organizations. Civil Monetary Penalties Delegated to Office of the Inspector General. Annual Deceased-Beneficiary Postpayment Review. Vulnerability Report. Medical Review of Rural Air Ambulance Services. ‘‘Reasonable’’ Requests. Emergency Medical Services Protocols. Prohibited Air Ambulance Relationships. Reasonable and Necessary Services. Definition of Rural Air Ambulance Services. Discontinuation of Medical Review Reports—The Medicare Status Report. Report of Benefit Savings, Medicare Focused Medical Review Status Report, and Focused Medical Review Report. Requirement that Medicare Carrier System Not Allow the Re-review of Previously Denied Claims. Contractor Administrative Budget & Financial Management II Reporting for Medical Review Activities. The Medically Unbelievable Edits. Inclusion of Interventional Pain Management Specialists on Carrier Advisory Committee Membership Physicians. 95 .................. 96 .................. 97 .................. 98 .................. 99 .................. 100 ................ 101 ................ 102 ................ 103 ................ 104 ................ 105 ................ 106 ................ VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 36630 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices ADDENDUM III.—MEDICARE AND MEDICAID MANUAL INSTRUCTIONS—Continued [January Through March 2005] Transmittal No. Manual/subject/publication No. Medicare Contractor Beneficiary and Provider Communications (CMS Pub. 100–09) 08 .................. Medicare Beneficiary Call Centers Will Begin Offering Preventive Services Information. Promote Medicare Preventive Services. Medicare Managed Care (CMS Pub. 100–16) 65 .................. Surveys, Contracting Strategy, and Appeals. Medicare Business Partners Systems Security (CMS Pub. 100–17) 00 .................. None. Demonstrations (CMS Pub. 100–19) 15 16 17 18 19 20 .................. .................. .................. .................. .................. .................. 21 .................. Issued to a specific audience, not posted to Internet/Intranet due to the Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to the Sensitivity of Instruction. Demonstration Project for Medical Adult Day-Care Services. Demonstration Project to Clarify the Definition of Homebound, the Home Health Independence Demonstration. Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. Full Replacement of CR 3220, Method of Reimbursement for Inpatient Services for Rural Hospital Participating Under Demonstration Authorized by Section 410A of the Medicard Modernization Act, CR 3220 Is Rescinded. Full Replacement of CR 3639, Expansion of Coverage for Chiropractic Services Demonstration. One Time Notification (CMS Pub. 100–20) 134 ................ 135 ................ 136 ................ 137 ................ 138 ................ 139 140 141 142 143 ................ ................ ................ ................ ................ 144 ................ 145 ................ 146 ................ Revisions to January 2005 Quarterly Average Sales Price Medicare Part B Drug Pricing File. Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing. Medlearn Matters Article Related to the Flu Demonstration. Instruction to Contractors Regarding Aged, Pre-settlement Cases and Inter-Contractor Notices. Production of Provider Flat Files, Including Taxpayer Identification Numbers, From the Fiscal Intermediary Standard System, Financial Master Files. Update to the Evaluation Plan for the CD-Rom Initiative Used in the Mailing of 2005 Annual Participation Enrollment Material. Revisions to January 2005 Quarterly Average Sales Price Medicare Part B Drug Pricing File. Shared System and Common Working File Renovation of Override Code Process (Phase 3). This Transmittal Is Rescinded and Will Not Be Replaced at this Time. Shared System Maintainer Hours to Begin Work and Analysis on the Implementation of the National Provider Identifier—FOR ANALYSIS ONLY. Debt Collection Improvement Act Backlog Non-Medicare Secondary Payor Collections From February 1998 to September 2004. Frequent Hemodialysis Network Payment Changes for Approved Clinical Trial Costs. Appeals Transition—BIPA Section 521 Appeals. ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER JANUARY THROUGH MARCH 2005 Publication date FR Vol. 70 page No. CFR parts affected File code Title of regulation State Children’s Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2002. Medicare Program; Establishment of the Medicare Advantage Program. Medicare Program; Medicare Prescription Drug Benefit. Medicare Program; Meeting of the Medicare Coverage Advisory Committee—March 29, 2005. Medicare Program; Meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services. Medicare Program; Demonstration of Coverage of Chiropractic Services Under Medicare. Medicare Program; Re-Chartering of the Advisory Panel on Medicare Education (APME) and Notice of the APME Meeting—February 24, 2005. Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates, Policy Changes, and Clarification. January 19, 2005 ....... 3036 ............................................. CMS–2230–NC ...... January 28, 2005 ....... 4588 417 and 422 ....................... CMS–4069–F ......... January 28, 2005 ....... 4194 CMS–4068–F ......... January 28, 2005 ....... 4133 400, 403, 411, 417, and 423. ............................................. January 28, 2005 ....... 4132 ............................................. CMS–5033–N2 ...... January 28, 2005 ....... 4130 ............................................. CMS–5037–N ........ January 28, 2005 ....... 4129 ............................................. CMS–4079–N ........ February 3, 2005 ....... 5724 412 ..................................... CMS–1483–P ........ VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00074 CMS–3150–N ........ Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices 36631 ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER JANUARY THROUGH MARCH 2005— Continued Publication date FR Vol. 70 page No. CFR parts affected File code Title of regulation Medicare Program; E-Prescribing and the Prescription Drug Program. Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants. Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs). Medicare Program; Meeting of the Practicing Physicians Advisory Council—March 7, 2005. Medicare Program; Monthly Payment Amounts for Oxygen and Oxygen Equipment for 2005, in Accordance with Section 302(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Medicare Program; Quality Improvement Organization Contracts: Solicitation of Statements of Interest From In-State Organizations—Alaska, Hawaii, Idaho, Maine, South Carolina, Vermont, and Wyoming. Medicare Program; Meeting of the Advisory Panel on Medicare Education—March 22, 2005. Medicare Program; Part D Reinsurance Payment Demonstration. Medicare Program; Changes in Geographical Boundaries of Durable Medical Equipment Regional Service Areas. Medicare Program; Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic Laboratory Services. Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2004. Medicare and Medicaid Programs; Solicitation of Proposals for the Private, For-Profit Demonstration Project for the Program of All-Inclusive Care for the Elderly (PACE); Cancellation of Withdrawal. Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups. Medicare Program; Durable Medical Equipment Regional Carrier Service Areas and Related Matters. Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B. Medicare Program; Meeting of Advisory Panel on Medicare Education—March 22, 2005: Location Change. Medicare Program; Changes to the Medicare Claims Appeal Procedures. Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting and Announcement of Members. Medicare Program; Establishment of the Medicare Advantage Program; Interpretation. Medicare Program; Medicare Prescription Drug Benefit; Interpretation. Medicare Program; Recognition of NAIC Model Standards for Regulation of Medicare Supplemental Insurance. Medicare Program; Meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services. February 4, 2005 ....... 6526 423 ..................................... CMS–0011–P ........ February 4, 2005 ....... 6184 CMS–3818–P ........ February 4, 2005 ....... 6140 400, 405, 410, 412, 413, 414, 488, and 494. 405, 482, and 488 .............. February 4, 2005 ....... 6086 413, 441, 486, and 498 ...... CMS–3064–P ........ February 4, 2005 ....... 6014 ............................................. CMS–1366–N ........ February 4, 2005 ....... 6013 ............................................. CMS–1299–N ........ February 4, 2005 ....... 6012 ............................................. CMS–3155—N ....... February 25, 2005 ..... 9362 ............................................. CMS–4089–N ........ February 25, 2005 ..... 9360 ............................................. CMS–4088–N ........ February 25, 2005 ..... 9358 ............................................. CMS–1219–N ........ February 25, 2005 ..... 9355 ............................................. CMS–3119–FN ...... February 25, 2005 ..... 9338 ............................................. CMS–9025–N ........ February 25, 2005 ..... 9337 ............................................. CMS–5011–WN2 ... February 25, 2005 ..... 9336 ............................................. CMS–1296–N ........ February 25, 2005 ..... 9232 421 ..................................... CMS–1219–F ......... March 4, 2005 ............ 10746 414 ..................................... CMS–1325–P ........ March 4, 2005 ............ 10645 ............................................. CMS–4089–N2 ...... March 8, 2005 ............ 11420 401 and 405 ....................... CMS–4064–IFC ..... March 11, 2005 .......... 12691 ............................................. CMS–1269–N3 ...... March 21, 2005 .......... 13401 417 and 422 ....................... CMS–4069–F2 ....... March 21, 2005 .......... 13397 CMS–4068–F2 ....... March 25, 2005 .......... 15394 400, 403, 411, 417, and 423. ............................................. March 5, 2005 ............ 15343 ............................................. CMS–5033–N3 ...... VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00075 CMS–3835–P ........ CMS–4080–N ........ Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 36632 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices ADDENDUM IV.—REGULATION DOCUMENTS PUBLISHED IN THE FEDERAL REGISTER JANUARY THROUGH MARCH 2005— Continued Publication date FR Vol. 70 page No. CFR parts affected File code Title of regulation Medicare Program; Meeting of the Medicare Coverage Advisory Committee—May 24, 2005. Medicare Program; Public Meetings in Calendar Year 2005 for All New Public Requests for Revisions to the Healthcare Common Procedures Coding System (HCPS) Coding and Payment Determinations. Medicare Program; Disapproval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers. Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Community Health Accreditation Program (CHAP) for Home Health Agencies. Medicare and Medicaid Programs; Recognition of the American Osteopathic Association (AOA) for Continued Approval of Deeming Authority for Hospitals. Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Home Health Agencies. Procedures for Non-Privacy Administrative Simplification Complaints Under the Health Insurance Portability and Accountability Act of 1996. Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatibility and Immunogentics as a CLIA Accreditation Organization. Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations. Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs); Extension of Comment Period. Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants; Extension of Comment Period. Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Amendment. March 25, 2005 .......... 15341 ............................................. CMS–3151–N ........ March 25, 2005 .......... 15340 ............................................. CMS–1297–N ........ March 25, 2005 .......... 15337 ............................................. CMS–3112–FN ...... March 25, 2005 .......... 15335 ............................................. CMS–2256–FN ...... March 25, 2005 .......... 15333 ............................................. CMS–2208—FN ..... March 25, 2005 .......... 15331 ............................................. CMS–2204–FN ...... March 25, 2005 .......... 15329 ............................................. CMS–0014–N ........ March 25, 2005 .......... 15324 ............................................. CMS–2211–N ........ March 25, 2005 .......... 15266 482 ..................................... CMS–3122–P ........ March 25, 2005 .......... 15265 413, 441, 486, and 498 ...... CMS–3064–N ........ March 25, 2005 .......... 15264 405, 482, and 488 .............. CMS–3835–N ........ March 25, 2005 .......... 15229 403, 416, 418, 460, 482, 483, and 485. CMS–3145–IFC ..... Addendum V.—National Coverage Determinations [January Through March 2005] A national coverage determination (NCD) is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title, or determination with respect to the amount of payment made for a particular item or service so covered. We include below all of the NCDs that were issued during the quarter covered by this notice. The entries below include information concerning completed decisions as well as sections on program and decision memoranda, which also announce pending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by the section of the NCDM in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site at https:// cms.hhs.gov/coverage. NATIONAL COVERAGE DETERMINATIONS [January Through March 2005] Title NCDM section TN No. Infusion Pumps: C-Peptide Levels as a Criterion for Use ............................. Update of Laboratory NCDs to Reference New Screening Benefits ............. Implantable Automatic Defibrillators ............................................................... 280.14 .............. 190.20/190.23 .. 20.4 .................. R27NCD ....... R28NCD ....... R29NCD ....... VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Issue date 02/04/05 02/11/05 03/04/05 Effective date 12/17/04 01/01/05 01/27/05 36633 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices NATIONAL COVERAGE DETERMINATIONS—Continued [January Through March 2005] Title NCDM section TN No. Anti-Cancer Chemotherapy for Colorectal Cancer ........................................ 110.17 .............. R30NCD ....... Addendum VI. FDA-Approved Category B IDEs [January Through March 2005] Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the Federal Register notice published on April 21, 1997 (62 FR 19328). The following list includes all Category B IDEs approved by FDA during the first quarter, January through March 2005. OMB control Nos. Category G030069. G040051. G040161. G040166. G040195. G040196. G040218. G040219. G040224. G040227. G040228. G040230. G040232. G040233. G050001. G050004. G050009. G050011. G050018. G050019. G050021. IDE 03/29/05 Effective date 01/28/05 Category G050022. G050024. G050026. G050029. G050034. G050038. G050043. G050045. Addendum VII.—Approval Numbers for Collections of Information Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget: Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 0938–0008 0938–0022 0938–0023 0938–0025 0938–0027 0938–0033 0938–0035 0938–0037 0938–0041 0938–0042 0938–0045 0938–0046 0938–0050 0938–0062 .... .... .... .... .... .... .... .... .... .... .... .... .... .... 0938–0065 0938–0074 0938–0080 0938–0086 0938–0101 0938–0102 0938–0107 0938–0146 0938–0147 0938–0151 0938–0155 0938–0170 0938–0193 0938–0202 0938–0214 0938–0236 0938–0242 0938–0245 0938–0246 0938–0251 0938–0266 0938–0267 0938–0269 0938–0270 0938–0272 .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... VerDate jul<14>2003 IDE Issue date 414.40, 424.32, 424.44 413.20, 413.24, 413.106 424.103 406.28, 407.27 486.100–486.110 405.807 407.40 413.20, 413.24 408.6, 408.22 410.40, 424.124 405.711 405.2133 413.20, 413.24 431.151, 435.1009, 440.220, 440.250, 442.1, 442.10–442.16, 442.30, 442.40, 442.42, 442.100–442.119, 483.400–483.480, 488.332, 488.400, 498.3–498.5 485.701–485.729 491.1–491.11 406.7, 406.13 420.200–420.206, 455.100–455.106 430.30 413.20, 413.24 413.20, 413.24 431.800–431.865 431.800–431.865, 493.1405, 493.1411, 493.1417, 493.1423, 493.1443, 493.1449, 493.1455 493.1461, 493.1469, 493.1483, 493.1489 405.2470 493.1269–493.1285 430.10–430.20, 440.167 413.17, 413.20 411.25, 489.2, 489.20 413.20, 413.24 442.30, 488.26 407.10, 407.11 431.800–431.865 406.7 416.41, 416.47, 416.48, 416.83 410.65, 485.56, 485.58, 485.60, 485.64, 485.66 412.116, 412.632, 413.64, 413.350, 484.245 405.376 440.180, 441.300–441.305 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 36634 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices OMB control Nos. Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 0938–0273 0938–0279 0938–0287 0938–0296 0938–0301 0938–0302 0938–0313 0938–0328 .... .... .... .... .... .... .... .... 0938–0334 0938–0338 0938–0354 0938–0355 0938–0357 0938–0358 0938–0359 0938–0360 0938–0365 0938–0372 0938–0378 0938–0379 0938–0382 0938–0386 0938–0391 0938–0426 0938–0429 0938–0443 0938–0444 0938–0445 0938–0447 0938–0448 0938–0449 0938–0454 0938–0456 0938–0463 0938–0467 0938–0469 0938–0470 0938–0477 0938–0484 0938–0501 0938–0502 0938–0512 0938–0526 0938–0534 0938–0544 0938–0564 0938–0565 0938–0566 0938–0573 0938–0578 0938–0581 0938–0599 0938–0600 0938–0610 0938–0612 .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 0938–0618 0938–0653 0938–0657 0938–0658 0938–0667 0938–0679 0938–0685 0938–0686 0938–0688 0938–0690 0938–0691 0938–0692 0938–0701 0938–0702 0938–0703 .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... VerDate jul<14>2003 485.701–485.729 424.5 447.31 413.170, 413.184 413.20, 413.24 418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100 489.11, 489.20 482.12, 482.13, 482.21, 482.22, 482.27, 482.30, 482.41, 482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66, 485.618, 485.631 491.9, 491.10 486.104, 486.106, 486.110 441.60 442.30, 488.26 409.40–409.50, 410.36, 410.170, 411.4–411.15, 421.100, 424.22, 484.18, 489.21 412.20–412.30 412.40–412.52 488.60 484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52 414.330 482.60–482.62 442.30, 488.26 442.30, 488.26 405.2100–405.2171 488.18, 488.26, 488.28 476.104, 476.105, 476.116, 476.134 447.53 473.18, 473.34, 473.36, 473.42 1004.40, 1004.50, 1004.60, 1004.70 412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78 405.2133 405.2133, 45 CFR 5, 5b; 20 CFR parts 401, 422E 440.180, 441.300–441.310 424.20 412.105 413.20, 413.24, 413.106 431.17, 431.306, 435.910, 435.920, 435.940–435.960 417.126, 422.502, 422.516 417.143, 417.800–417.840, 422.6 412.92 424.123 406.15 433.138 486.304, 486.306, 486.307 475.102, 475.103, 475.104, 475.105, 475.106 410.38, 424.5 493.1–493.2001 411.32 411.20–411.206 411.404, 411.406, 411.408 412.230, 412.256 447.534 493.1–493.2001 493.1–493.2001 405.371, 405.378, 413.20 417.436, 417.801, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102 493.801, 493.803, 493.1232, 493.1233, 493.1234, 493.1235, 493.1236, 493.1239, 493.1241, 493.1242, 493.1249, 493.1251, 493.1252, 493.1253, 493.1254, 493.1255, 493.1256, 493.1261, 493.1262, 493.1263, 493.1269, 493.1273, 493.1274, 493.1278, 493.1283, 493.1289, 493.1291, 493.1299 433.68, 433.74, 447.272 493.1771, 493.1773, 493.1777 405.2110, 405.2112 405.2110, 405.2112 482.12, 488.18, 489.20, 489.24 410.38 410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12 493.551–493.557 486.304, 486.306, 486.307, 486.310, 486.316, 486.318, 486.325 488.4–488.9, 488.201 412.106 466.78, 489.20, 489.27 422.152 45 CFR 146.111, 146.115, 146.117, 146.150, 146.152, 146.160, 146.180 45 CFR 148.120, 148.124, 148.126, 148.128 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices OMB control Nos. Approved CFR Sections in Title 42, Title 45, and Title 20 (Note: Sections in Title 45 are preceded by ‘‘45 CFR,’’ and sections in Title 20 are preceded by ‘‘20 CFR’’) 0938–0714 0938–0717 0938–0721 0938–0723 0938–0730 0938–0732 0938–0734 0938–0739 0938–0742 0938–0749 0938–0753 0938–0754 0938–0758 0938–0760 0938–0761 0938–0763 0938–0770 0938–0778 0938–0779 0938–0781 0938–0786 0938–0787 0938–0790 .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 0938–0792 0938–0798 0938–0802 0938–0818 0938–0829 0938–0832 0938–0833 0938–0841 .... .... .... .... .... .... .... .... 0938–0842 0938–0846 0938–0857 0938–0860 0938–0866 0938–0872 0938–0873 0938–0874 0938–0878 0938–0883 0938–0884 0938–0887 0938–0897 0938–0907 0938–0910 0938–0911 0938–0916 0938–0920 .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... .... 0938–0921 0938–0931 0938–0933 0938–0934 0938–0936 0938–0940 0938–0944 .... .... .... .... .... .... .... 411.370–411.389 424.57 410.33 421.300–421.318 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24 417.126, 417.470 45 CFR 5b 413.337, 413.343, 424.32, 483.20 422.300–422.312 424.57 422.000–422.700 441.151, 441.152 413.20, 413.24 Part 484 subpart E, 484.55 484.11, 484.20 422.1–422.10, 422.50–422.80, 422.100–422.132, 422.300–422.312, 422.400–422.404, 422.560–422.622 410.2 422.64, 422.111 417.126, 417.470, 422.64, 422.210 411.404–411.406, 484.10 438.352, 438.360, 438.362, 438.364 406.28, 407.27 460.12, 460.22, 460.26, 460.30, 460.32, 460.52, 460.60, 460.70, 460.71, 460.72, 460.74, 460.80, 460.82, 460.98, 460.102, 460.104, 460.106, 460.110, 460.112, 460.116, 460.118, 460.120, 460.122, 460.124, 460.132, 460.152, 460.156, 460.160, 460.164, 460.168, 460.172, 460.190, 460.196, 460.200, 460.202, 460.204, 460.208, 460.210 491.8, 491.11 413.24, 413.65, 419.42 419.43 410.141, 410.142, 410.143, 410.144, 410.145, 410.146, 414.63 422.568 Parts 489 and 491 483.350–483.376 431.636, 457.50, 457.60, 457.70, 457.340, 457.350, 457.431, 457.440, 457.525, 457.560, 457.570, 457.740, 457.750, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180 412.23, 412.604, 412.606, 412.608, 412.610, 412.614, 412.618, 412.626, 413.64 411.352–411.361 Part 419 Part 419 45 CFR part 162 413.337, 483.20 422.152 45 CFR parts 160 and 162 Part 422 subpart F & G 45 CFR parts 160 and 164 405.940 45 CFR 148.316, 148.318, 148.320 412.22, 412.533 412.230, 412.304, 413.65 422.620, 422.624, 422.626 426.400, 426.500 483.16 438.6, 438.8, 438.10, 438.12, 438.50, 438.56, 438.102, 438.114, 438.202, 438.206, 438.207, 438.240, 438.242, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416, 438.710, 438.722, 438.724, 438.810 414.804 45 CFR part 142.408, 162.408, and 162.406 438.50 403.766 423 484 and 488 422.250, 422.252, 422.254, 422.256, 422.258, 422.262, 422.264, 422.266, 422.270, 422.300, 422.304, 422.306, 422.310, 422.312, 422.314, 422.316, 422.318, 422.320, 422.322, 422.324, 423.251, 423.258, 423.265, 423.272, 423.286, 423.293, 423.301, 423.308, 423.315, 423.322, 423.329, 423.336, 423.343, 423.346, 423.350 Addendum VIII—Medicare-Approved Carotid Stent Facilities (January Through March 2005) On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid VerDate jul<14>2003 36635 19:06 Jun 23, 2005 Jkt 205001 artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 460.100, 460.154, 457.810, 438.402, 422.308, 423.279, created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. E:\FR\FM\24JNN1.SGM 24JNN1 36636 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices Facility Provider No. 1. Advocate Christ Medical Center, 4440 West 95th Street, Oak Lawn, IL 60453 ................................................ 2. Advocate Lutheran General Hospital, 1775 Dempster Street, Park Ridge, IL 60068 ........................................ 3. Aiken Regional Medical Centers, 302 University Parkway, P.O. Drawer 1117, Aiken, SC 29802–1117 .......... 4. Akron General Medical Center, 400 Wabash Avenue, Akron, OH 44266 ......................................................... 5. Albany Medical Center Hospital, 43 New Scotland Avenue, Albany, NY 12208 ............................................... 6. Alexian Brothers Medical Center, 800 W. Biesterfied Road, Elk Grove Village, IL 60007 ................................ 7. Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA 15212–4772 .......................................... 8. Arizona Heart Hospital, 1930 E. Thomas Road, Phoenix, AZ 85016 ................................................................ 9. Aspirus Wausau Hospital, Inc, 333 Pine Ridge Boulevard, Wausau, WI 54401 ............................................... 10. Aurora Sinai Medical Center, 945 N. 12th Street, Milwaukee, WI 53201 ........................................................ 11. Avera Heart Hospital of South Dakota, 4500 West 69th Street, Sioux Falls, SD 57108 ................................. 12. Bakersfield Heart Hospital, 3001 Sillect Avenue, Bakersfield, CA 93308 ........................................................ 13. Bakersfield Memorial Hospital, 420 34th Street, Bakersfield, CA 93301 ......................................................... 14. The Baldwin County Eastern Shore Health Care Authority, d/b/a Thomas Hospital, 750 Morphy Avenue, Fairhope, AL 36532 ............................................................................................................................................. 15. Banner Good Samaritan Medical Center, 1111 E. McDowell Road, Phoenix, AZ 85006 ............................... 16. Baptist Hospital East, 4000 Kresge Way, Louisville, KY 40207 ....................................................................... 17. Baptist Hospital of East Tennessee, 137 Blount Avenue, Knoxville, TN 37920 .............................................. 18. Baptist Hospital-Pensacola, 1000 West Moreno Street, Post Office Box 17500, Pensacola, FL 32522–7500 19. Baptist Medical Center, 1225 North State Street, Jackson, MS 39202 ........................................................... 20. Baptist Medical Center South, 2105 East South Boulevard, P.O. Box 11010, Montgomery, AL 36111–0010 21. Baptist Memorial Hospital, 6019 Walnut Grove Road, Memphis, TN 38120 ................................................... 22. Baptist Memorial Hospital-DeSoto, 7601 Southcrest Parkway, Southaven, MS 38671 ................................... 23. Baptist Montclair Medical Center, 800 Montclair Road, Birmingham, AL 35213 ............................................. 24. Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, St. Louis, MO 63110 ....................................... 25. Bay Medical Center, 615 North Bonita Avenue, Panama City, FL 32401 ....................................................... 26. Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199 ........................................................... 27. Benefis Healthcare, 1101 26th Street South, Great Falls, MT 59405 .............................................................. 28. Bethesda Hospital, 10500 Montgomery Road, Cincinnati, OH 45242–9508 ................................................... 29. Blanchard Valley Regional Health Center, 145 West Wallace Street, Findlay, OH 45840 .............................. 30. Borgess Medical Center, 1521 Gull Road, Kalamazoo, MI 49048 ................................................................... 31. Bon Secours St. Mary’s Hospital, 5801 Bremo Road, Richmond, VA 23226 .................................................. 32. Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115 .......................................................... 33. Caritas St. Elizabeth’s Medical Center, 736 Cambridge Street, Boston, MA 02135–2997 .............................. 34. Cascade Healthcare Community, Dba: St Charles Medical Center Bend, 2500 NE. Neff Road, Bend, OR 97701 ................................................................................................................................................................... 35. Central Baptist Hospital, 1740 Nicholasville Road, Lexington, KY 40503 ........................................................ 36. Central Dupage Hospital, 25 North Winfield Road, Winfield, IL 60190 ............................................................ 37. Central Georgia Health Systems, dba The Medical Center of Central Georgia, 777 Hemlock Street, Macon, GA 31208 ............................................................................................................................................................. 38. Charleston Area Medical Center, 3200 MacCorkle Avenue, SE, Charleston, WV 25304 ............................... 39. Charlotte Regional Medical Center, 809 East Marion Avenue, Punta Gorda, FL 33950 ................................. 40. [The] Christ Hospital, 2139 Auburn Avenue, Cincinnati, OH 45219 ................................................................. 41. Christiana Care Health Services, 4755 Ogletown-Stanton Road, P.O. Box 6001, Newark, DE 19718–6001 42. CHRISTUS St. Frances Cabrini Hospital, 3330 Masonic Drive, Alexandria, LA 71301 .................................. 43. CJW Medical Center, Chippenham Hospital, 7101 Jahnke Road, Richmond, VA 23225 ............................... 44. Clarian Health Partners, Inc, I–65 at 21st Street, P.O. Box 1367, Indianapolis, IN 46206–1367 ................... 45. Clear Lake Regional Medical Center, 500 Medical Center Blvd, Webster, TX 77598 ..................................... 46. The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195 ............................................... 47. College Station Medical Center, 1604 Rock Prairie Road, College Station, TX 77845 ................................... 48. Community Health Partners, 3700 Kolbe Road, Lorain, OH 44053–1697 ....................................................... 49. Dartmouth Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756 ................................. 50. Deaconess Medical Center, PO Box 248, Spokane, WA 99210–0248 ............................................................ 51. Doylestown Hospital, 595 West State Street, Doylestown, PA 18901 ............................................................. 52. Eastern Maine Medical Center, 489 State Street, P.O. Box 404, Bangor, ME 04402–404 ............................. 53. El Camino Hospital, 2500 Grant Road, P.O. Box 7025, Mountain View, CA 94039–7025 ............................. 54. Eliza Coffee Memorial Hospital, P.O. Box 818, Florence, AL 35631 ............................................................... 55. EMH Regional Medical Center, 630 East River Street, Elyria, OH 44035 ....................................................... 56. Emory Crawford Long Hospital, 550 Peachtree Street, NE, Atlanta, GA 30308–2225 ................................... 57. Emory University Hospital, 1364 Clifton Road, NE, Atlanta, GA 30322 ........................................................... 58. Erlanger Health System, 975 East Third Street, Chattanooga, TN 37403 ....................................................... 59. Evanston Hospital, 2650 Ridge Avenue, Evanston, IL 60201 .......................................................................... 60. Exempla St. Joseph Hospital, 1835 Franklin Street, Denver, CO 80218–1191 ............................................... 61. Fletcher Allen Health Care, Medical Center Campus, 111 Colchester Avenue, Burlington, VT 05401–1473 62. Forsyth Medical Center, 3333 Silas Creek Parkway, Winston Salem, NC 27103 ........................................... 63. Fort Sanders Regional Medical Center, 1901 W. Clinch Avenue, Knoxville, TN 37916–2398 ........................ 64. Fort Walton Beach Medical Center, 1000 Mar Walt Drive, Fort Walton Beach, FL 32547 ............................. 65. Fresno Heart Hospital, 15 E. Audubon Drive, Fresno, CA 93720 .................................................................... 66. Fountain Valley Regional Hospital and Medical Center, 17100 Euclid Street, P.O. Box 8010, Fountain Valley, CA 92708 ...................................................................................................................................................... 67. Galichia Heart Hospital, 2610 N. Woodlawn, Wichita, KS 67220–2729 .......................................................... 68. Geisinger Medical Center, 100 North Academy Avenue, Danville, PA 17822 ................................................. 69. Geisinger Wyoming Valley Medical Center, 1000 East Mountain Boulevard, Wilkes-Barre, PA 18711 .......... 70. Good Samaritan Hospital, 1225 Wilshire Boulevard, Los Angeles, CA 90017 ................................................ VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Effective date 140208 140223 420082 360027 330013 140258 390050 030102 520030 520064 430095 050724 050036 05/03/2005 05/05/2005 05/10/2005 05/16/2005 05/16/2005 04/18/2005 05/11/2005 04/18/2005 05/10/2005 05/03/2005 05/05/2005 05/25/2005 05/23/2005 010100 030002 180130 440019 100093 250102 010023 440048 250141 010104 260032 100026 220077 270012 360179 360095 020117 490059 220110 220036 04/07/2005 05/23/2005 04/12/2005 04/12/2005 04/27/2005 05/05/2005 04/20/2005 04/18/2005 05/05/2005 04/26/2005 05/05/2005 05/23/2005 05/16/2005 05/26/2005 05/05/2005 05/26/2005 04/12/2005 04/01/2005 05/16/2005 04/26/2005 380040 180103 140242 05/03/2005 04/27/2005 05/26/2005 110107 510022 100047 360163 080001 190019 490112 150056 450617 360180 450299 360172 300003 500044 390203 200033 050308 010006 360145 110078 110010 440104 140010 060009 470003 340014 440125 100223 050732 05/11/2005 04/27/2005 05/11/2005 05/26/2005 05/23/2005 04/18/2005 05/03/2005 05/23/2005 04/01/2005 04/12/2005 05/25/2005 05/23/2005 04/27/2005 05/10/2005 04/27/2005 04/18/2005 05/10/2005 05/05/2005 05/23/2005 05/16/2005 04/04/2005 05/23/2005 03/30/2005 05/10/2005 05/26/2005 04/20/2005 05/11/2005 04/14/2005 04/26/2005 050570 170192 390006 390270 050471 04/26/2005 05/16/2005 05/05/2005 05/05/2005 04/12/2005 36637 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices Facility Provider No. 71. Good Samaritan Hospital, 2425 Samaritan Drive, San Jose, CA 95124 ......................................................... 72. Good Samaritan Hospital, 255 Lafayette Avenue, Suffern, NY 10901 ............................................................ 73. Good Samaritan Hospital, 2222 Philadelphia Drive, Dayton, OH 45406–1891 ............................................... 74. Good Samaritan Hospital, 375 Dixmyth Avenue, Cincinnati, OH 45220–489 .................................................. 75. Grandview Hospital and Medical Center, 405 Grand Avenue, Dayton, OH 45405 ......................................... 76. Greater Baltimore Medical Center, 6701 N. Charles Street, Baltimore, MD 21204 ......................................... 77. Hackensack University Medical Center, 30 Prospect Avenue, Hackensack, NJ 07601 .................................. 78. Hahnemann University Hospital/Tenet, 230 N. Broad Street, Mailstop 119, Philadelphia, PA 19102–1192 .. 79. Hamot Medical Center, 201 State Street, Erie, PA 16550 ............................................................................... 80. Harbor-UCLA Medical Center, 1000 West Carson Street, Torrance, CA 90502 ............................................. 81. Harper-Hutzel Hospital, 3990 John R Street, Detroit, MI 48201 ...................................................................... 82. Harris Methodist Fort Worth Hospital, 1301 Pennsylvania Avenue, Fort Worth, TX 76104 ............................ 83. Harris Methodist HEB, 1600 Hospital Parkway, Bedford, TX 76022 ................................................................ 84. Hartford Hospital, 80 Seymour Street, P.O. Box 5037, Hartford, CT 06102–5037 .......................................... 85. Hays Medical Center, 2220 Canterbury Road, Hays, KS 67601 ..................................................................... 86. Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415–1829 ..................................... 87. Hialeah Hospital, 651 East 25th Street, Hialeah, FL 33013 ............................................................................. 88. High Point Regional Health System, 601 North Elm Street, P.O. Box HP–5, High Point, NC 27261 ............. 89. Hillcrest Hospital, 6780 Mayfield Road, Mayfield Hts., OH 44124 ................................................................... 90. Hoag Memorial Hospital Presbyterian, One Hoag Drive, Newport Beach, CA 92663 ..................................... 91. Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104 .............................. 92. Hunterdon Medical Center, 2100 Wescott Drive, Flemington, NJ 08822 ......................................................... 93. Huntington Hospital, 100 W. California Boulevard, P.O. Box 7013, Pasadena, CA 91109–7013 ................... 94. Iowa Methodist Medical Center, 1200 Pleasant Street, Des Moines, IA 50309 .............................................. 95. Irvine Regional Hospital & Medical Center, 16200 Sand Canyon Avenue, Irvine, CA 92618 ......................... 96. Jewish Hospital, 200 Abraham Flexner Way, Louisville, KY 40202 ................................................................. 97. John Muir Medical Center, 1601 Ygnacio Valley Road, Walnut Creek, CA 94598–3194 ............................... 98. Jupiter Medical Center, 1210 S. Old Dixie Hwy, Jupiter, FL 33458 ................................................................. 99. Kaleida Health, Millard Fillmore Hospital, 3 Gates Circle, Buffalo, NY 14209 ................................................. 100. Kansas Heart Hospital, 3601 N. Webb Road, Wichita, KS 67226 ................................................................. 101. Kent Hospital, 455 Toll Gate Road, Warwick, RI 02886 ................................................................................ 102. Kettering Medical Center, 3535 Southern Blvd, Kettering, OH 45429 ........................................................... 103. King’s Daughters Medical Center, 2201 Lexington Avenue, Ashland, KY 41101 .......................................... 104. Lakeland Hospital, 1234 Napier Avenue, St. Joseph, Mi 49085 .................................................................... 105. Lakeland Regional Medical Center, 1324 Lakeland Hills Boulevard, Lakeland, FL 33805 ........................... 106. Lakeview Regional Medical Center, 95 E. Fairway Drive, Covington, LA 70433 .......................................... 107. Lawnwood Medical Center, Inc, d/b/a Lawnwood Regional Medical Center and Heart Institute, 1700 South 23rd Street, Fort Pierce, FL 34950 ........................................................................................................... 108. LDS Hospital, 8th Avenue and C Street, Salt Lake City, UT 84143 .............................................................. 109. Lee’s Summit Hospital, 530 NW. Murray Road, Lee’s Summit, MO 64081 ................................................... 110. Lenox Hill Hospital, 100 East 77 Street, New York, NY 10021 ...................................................................... 111. Los Alamitos Medical Center, 3751 Katella Avenue, Los Alamitos, CA 90720 ............................................. 112. Los Robles Hospital and Medical Center, 215 West Janss Road, Thousand Oaks, CA 91360 ................... 113. Louisiana Heart Hospital, 64030 Louisiana Highway 434, Lacombe, LA 70445 ........................................... 114. Lourdes Vascular Center, Lourdes Hospital, 1530 Lone Oak Road, Paducah, KY 42003 ............................ 115. Loyola University Medical Center, 2160 South First Avenue, Maywood, IL 60153 ....................................... 116. Lutheran Hospital of Indiana, 7950 West Jefferson Boulevard, Fort Wayne, IN 46804 ................................ 117. Maricopa Integrated Health System, Maricopa Medical Center, Cardiac Catheterization Laboratory, 2601 E. Roosevelt, Phoenix, AZ 85008 ........................................................................................................................ 118. Martha Jefferson Hospital, 459 Locust Avenue, Charlottesville, VA 22902 ................................................... 119. Mary Greeley Medical Center, 1111 Duff Avenue, Ames, IA 50010 .............................................................. 120. Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114 ........................................................... 121. Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ 85054 ......................................................... 122. Medical Center of Plano, 3901 West 15th Street, Plano, TX 75075 .............................................................. 123. Medical College of Ohio, 3000 Arlington Avenue, Toledo, OH 43614 ........................................................... 124. Medical University of South Carolina Hospital Authority, 169 Ashley Avenue, PO Box 250347, Charleston, SC 29425 ............................................................................................................................................................. 125. Memorial Hospital Jacksonville, 3625 University Boulevard, South, Jacksonville, FL 32216 ........................ 126. Memorial Medical Center, 2700 Napoleon Ave, New Orleans, LA 70115 ..................................................... 127. Mercy Health Center, 4300 West Memorial Road, Oklahoma City, OK 73120–8304 ................................... 128. Mercy Hospital, 500 E. Market Street, Iowa City, IA 52245 ........................................................................... 129. Mercy Hospital Fairfield, 3000 Mack Road, Fairfield, OH 45014 ................................................................... 130. Mercy Hospital and Medical Center, 2525 South Michigan Avenue, Chicago, IL 60616 .............................. 131. Mercy Medical Center, 701 10th Street SE, Cedar Rapids, IA 52403 ........................................................... 132. Mercy Medical Center, 1111 6th Avenue, Des Moines, IA 50314 ................................................................. 133. Mercy Medical Center, 301 St. Paul Place, Baltimore, MD 21202 ................................................................. 134. Methodist Hospital, 300 West Huntington Drive, P.O. Box 60016, Arcadia, CA 91066–6016 ...................... 135. Methodist Medical Center of Oak Ridge, 990 Oak Ridge Turnpike, Oak Ridge, TN 37830 .......................... 136. Mid Michigan Medical Center-Midland, 4005 Orchard Drive, Midland, MI 48670 .......................................... 137. Missouri Baptist Medical Center, 3015 N. Ballas Road, St. Louis, MO 63131 .............................................. 138. Morton Plant Hospital, 300 Pinellas Street, Clearwater, FL 33756 ................................................................ 139. Moses H. Cone Memorial Hospital, 1200 N. Elm Street, Greensboro, NC 27401 ........................................ 140. Mount Carmel St. Ann’s Hospital, 500 South Cleveland Avenue, Westerville, OH 43081–8998 .................. 141. Mount Diablo Medical Center, 2540 East Street, PO Box 4110, Concord, CA 94524–4110 ........................ VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Effective date 050380 330158 360052 360134 360133 210044 310001 390290 390063 050376 230104 450135 450639 070025 170013 240004 100053 340004 360230 050224 390111 310005 050438 160082 050693 180040 050180 100253 330005 170186 410009 360079 180009 230021 100157 190177 04/12/2005 04/27/2005 05/25/2005 04/18/2005 05/05/2005 05/11/2005 04/27/2005 05/10/2005 05/05/2005 04/12/2005 04/19/2005 04/20/2005 05/16/2005 05/23/2005 05/23/2005 05/16/2005 05/05/2005 05/16/2005 05/16/2005 04/04/2005 05/23/2005 04/12/2005 05/05/2005 04/18/2005 05/10/2005 04/12/2005 05/10/2005 04/20/2005 05/03/2005 05/23/2005 04/20/2005 05/05/2005 05/23/2005 04/04/2005 05/25/2005 05/03/2005 100246 460010 260190 330119 050551 050549 190250 180102 140276 150017 04/20/2005 04/20/2005 05/17/2005 05/16/2005 05/23/2005 05/16/2005 04/01/2005 03/30/2005 05/05/2005 04/18/2005 032595 490077 160030 220071 030103 450651 360048 05/23/2005 04/07/2005 03/30/2005 05/03/2005 05/23/2005 05/16/2005 04/27/2005 420004 100179 190135 370013 160029 360056 140158 160079 160083 210008 050238 440034 230222 260108 100127 340091 360012 050496 05/26/2005 04/27/2005 05/16/2005 04/12/2005 05/05/2005 05/17/2005 05/05/2005 04/07/2005 04/12/2005 05/25/2005 04/12/2005 05/03/2005 05/10/2005 05/23/2005 05/16/2005 04/18/2005 05/25/2005 05/10/2005 36638 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices Facility Provider No. 142. [The] Mount Sinai Hospital, 1 Gustave L. Levy Place, New York, NY 10029 ................................................ 143. Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL 33140 ...................................................... 144. Mountain View Regional Medical Center, 4311 E. Lohman Avenue, Las Cruces, NM 88011 ...................... 145. Munroe Regional Medical Center, 1500 SW. 1st Avenue, Ocala, FL 34474 ................................................. 146. New York Presbyterian Hospital, 161 Ft. Washington Avenue, HIP1412, New York, NY 10032 .................. 147. Norman Regional Hospital, 901 North Porter, Box 1308, Norman, OK 73070–1308 .................................... 148. North Austin Medical Center, 12221 MoPac Expressway North, Austin, TX 78758 ...................................... 149. North Florida Regional Medical Center, 6500 Newberry Road, Gainesville, FL 32605 ................................. 150. North Memorial Health Care, 3300 Oakdale Avenue North, Robbinsdale, MN 55422 .................................. 151. North Oakland Medical Centers, 461 W. Huron Street, Pontiac, MI 48341–1651 ......................................... 152. Northeast Methodist Hospital, 12412 Judson Road, Live Oak, TX 78233 ..................................................... 153. Northwestern Memorial Hospital, 251 East Huron Street, Chicago, IL 60611 ............................................... 154. Norton Healthcare, P.O. Box 35070, Louisville, KY 40232–5070 .................................................................. 155. Ochsner Clinic Foundation, Department of Cardiology, 1514 Jefferson Highway, New Orleans, LA 70121– 2483 ..................................................................................................................................................................... 156. Ohio State University, University Medical Center, 452 West 10th Avenue, Columbus, OH 43210 ............... 157. Oklahoma Heart Hospital, 4050 West Memorial Road, Oklahoma City, OK 73120 ...................................... 158. Orlando Regional Healthcare System, Inc, 1414 Kuhl Avenue, Orlando, FL 32806 ..................................... 159. [The] Ortenzio Heart Center and Holy Spirit, 503 North 21st Street, Camp Hill, PA 17011–2288 ................ 160. OSF Saint Francis Medical Center, 530 NE. Glen Oak Avenue, Peoria, IL 61637 ....................................... 161. Our Lady of Bellefonte Hospital, St. Christopher Drive, Ashland, KY 41101 ................................................. 162. Our Lady of Lourdes Medical Center, 1600 Haddon Avenue, Camden, NJ 08103 ....................................... 163. Our Lady of Lourdes Regional Medical Center, 611 St. Landry Street, Lafayette, LA 70506 ....................... 164. Palomar Medical Center, 555 East Valley Parkway, Escondido, CA 92025 .................................................. 165. Parkwest Medical Center, 9352 Park West Boulevard, Knoxville, TN 37923 ................................................ 166. Parkview Hospital, 2200 Randallia Drive, Fort Wayne, IN 46805 .................................................................. 167. Parma Community General Hospital, 7007 Powers Boulevard, Parma, OH 44129–5495 ............................ 168. Phoenix Baptist Hospital, Cardiac Catheterization Laboratory/Interventional Radiology Suite, 2000 West Bethany Home Road, Phoenix, AZ 85015 .......................................................................................................... 169. Phoenix Memorial Hospital, Cardiac Catheterization Laboratory/Interventional Radiology Suite, 1201 South 7th Avenue, Phoenix, AZ 85007 ............................................................................................................... 170. Pinnacle Health Hospitals, 111 South Front Street, Harrisburg, PA 17101 ................................................... 171. Plaza Medical Center of Fort Worth, 900 Eighth Avenue, Fort Worth, TX 76104 ......................................... 172. Pomerado Hospital, 15615 Pomerado Road, Poway, CA 92064 ................................................................... 173. Presbyterian Hospital of Dallas, 8200 Walnut Hill Lane, Dallas, TX 75231–4496 ......................................... 174. Princeton Baptist Medical Center, 701 Princeton Avenue, SW, Birmingham, AL 35211–1399 ..................... 175. Provena Saint Joseph Hospital, 77 North Airlite Street, Elgin, IL 60123–4912 ............................................. 176. Providence Portland Medical Center, 4805 Northeast Glisan Street, Portland, OR 97213–2967 ................. 177. Providence St. Vincent Medical Center, 9205 S.W. Barnes Road, Portland, OR 97225 .............................. 178. Rapid City Regional Hospital, 353 Fairmont Boulevard, Rapid City, SD 57701 ............................................ 179. Rapides Regional Medical Center, Box 30101, 211 Fourth Street, Alexandria, LA 71301–8454 ................. 180. Research Medical Center, 2316 East Meyer Boulevard, Kansas City, MO 64132 ........................................ 181. Resurrection Medical Center, 7435 West Talcott, Chicago, Illinois 60631 .................................................... 182. Riverside Methodist Hospital, 3535 Olentangy River Road, Columbus, OH 43214 ...................................... 183. Robert Packer Hospital, One Guthrie Square, Sayre, PA 18840–1698 ......................................................... 184. Rogue Valley Medical Center, 2825 East Barnett Road, Medford, OR 97504 .............................................. 185. Rush University Medical Center, 1725 West Harrison Street, Suite 364, Chicago, IL 60612–3824 ............. 186. Sacred Heart Health System, 5151 N. Ninth Avenue, P.O. Box 2700, Pensacola, FL 32513 ...................... 187. Sacred Heart Medical Center, Oregon Heart & Vascular Institute, 1255 Hilyard Street, P.O. Box 10905, Eugene, OR 97440 .............................................................................................................................................. 188. Saint Joseph Health Center, 1000 Carondelet Drive, Kansas City, MO 64114 ............................................. 189. Saint Joseph Medical Center, Twelfth and Walnut Streets, P.O. Box 316, Reading, PA 19603–316 .......... 190. Saint Louis University Hospital, 3635 Vista at Grand Boulevard, P.O. Box 15250, St. Louis, MO 63110 .... 191. Saint Luke’s Hospital of Kansas City, 4401 Wornall Road, Kansas City, MO 64111 .................................... 192. Saint Raphael Healthcare System, 1450 Chapel Street, New Haven, CT 06511 ......................................... 193. Saints Memorial Medical Center, 1 Hospital Drive, Lowell, MA 01852–1389 ................................................ 194. Samaritan Hospital, 310 South Limestone Street, Lexington, KY 40508 ....................................................... 195. Seton Medical Center, 1900 Sullivan Avenue, Daly City, CA 94015 ............................................................. 196. Shady Grove Adventist Hospital, 9901 Medical Center Drive, Rockville, MD 20850 .................................... 197. Shands Jacksonville Medical Center, 655 West Eighth Street, Jacksonville, FL 32209 ............................... 198. Shawnee Mission Medical Center, 9100 W. 74th Street, Shawnee Mission, KS 66204 ............................... 199. Sierra Medical Center, 1625 Medical Center Drive, El Paso, TX 79902 ....................................................... 200. Sinai-Grace Hospital, 6071 W. Outer Drive, Detroit, MI 48235 ...................................................................... 201. Sioux Valley Hospital USD Medical Center, 1305 W. 18th Street, Sioux Falls, SD 57117–5039 ................. 202. Skyline Medical Center, 3441 Dickerson Pike, Nashville, TN 37207 ............................................................. 203. South Austin Hospital, 901 W. Ben White, Austin, TX 78704 ........................................................................ 204. Southern Baptist Hospital of Florida, Inc., d/b/a Baptist Medical Center, 800 Prudential Drive, Jacksonville, FL 32207 ...................................................................................................................................................... 205. Southern Maryland Hospital Center, 7503 Surratts Road, Clinton, MD 20735 .............................................. 206. Southwest Washington Medical Center, P.O. Box 1600, Vancouver, WA 98668 .......................................... 207. Spectrum Health Hospital, 100 Michigan Street NE, Grand Rapids, MI 49503 ............................................. 208. SSM St. Joseph Health Center, 300 First Capitol Drive, St. Charles, MO 63301 ......................................... 209. St. Anthony’s Hospital, 1200 7th Avenue North, St. Petersburg, FL 33705 .................................................. 210. St. Bernardine Medical Center, 2101 N. Waterman Avenue, San Bernardino, CA 92404–4836 .................. VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Effective date 330024 100034 320085 100062 330101 370008 450809 100204 240001 230013 450388 140281 180088 05/26/2005 04/07/2005 04/26/2005 05/23/2005 05/05/2005 05/23/2005 04/12/2005 04/19/2005 05/26/2005 05/03/2005 05/11/2005 04/26/2005 05/03/2005 190036 360085 370215 100006 390004 140067 180036 310029 190102 050115 440173 150021 360041 04/12/2005 05/05/2005 05/23/2005 05/23/2005 04/27/2005 04/27/2005 05/26/2005 05/05/2005 05/03/2005 05/10/2005 05/05/2005 05/11/2005 05/05/2005 030030 04/01/2005 030106 390067 450672 050636 450462 010103 140217 380061 380004 430077 190026 260027 140117 360006 390079 380018 140119 100025 05/16/2005 05/23/2005 05/23/2005 05/10/2005 05/10/2005 04/12/2005 05/11/2005 05/16/2005 05/16/2005 05/26/2005 05/23/2005 05/23/2005 04/12/2005 04/20/2005 04/18/2005 05/05/2005 04/20/2005 05/05/2005 380033 260085 390096 260105 260138 070001 220082 180007 050289 210057 100001 170104 450668 230024 430027 440006 450713 05/26/2005 05/16/2005 04/01/2005 05/17/2005 04/27/2005 05/05/2005 04/27/2005 05/17/2005 05/05/2005 04/20/2005 05/26/2005 05/16/2005 05/16/2005 04/19/2005 04/19/2005 04/07/2005 04/12/2005 100088 520054 500050 230038 260005 100067 050129 05/05/2005 05/26/2005 05/26/2005 04/18/2005 04/26/2005 04/19/2005 05/05/2005 36639 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices Facility Provider No. 211. St. David’s Medical Center, 919 East 32nd Street 78705, P.O. Box 4039, Austin, TX 78765–4039 ............ 212. St. Elizabeth Medical Center, South Unit, 1 Medical Village Drive, Edgewood, KY 41017 ........................... 213. St. Francis Hospital and Health Center, 12935 S. Gregory Street, Blue Island, IL 60406 ............................ 214. St. Francis Hospital & Health Centers, 1600 Albany Street, Beech Grove, IN 46107 ................................... 215. St. John Hospital and Medical Center, 22151 Moross Road, Detroit, MI 48236 ........................................... 216. St John’s Hospital, 800 East Carpenter Street, Springfield, IL 62769 ........................................................... 217. St. John’s Regional Medical Center, 2727 McClelland Boulevard, Joplin, MO 64804–1694 ........................ 218. St. John West Shore Hospital, 29000 Center Ridge Road, Westlake, OH 44145 ......................................... 219. St. Joseph Medical Center, Heart Institute, 7601 Osler Drive, Towson, MD 21204–7582 ............................ 220. St. Joseph Mercy Hospital, 5301 E. Huron River Drive, P.O. Box 995, Ann Arbor, MI 48106 ..................... 221. St. Joseph Regional Medical Center, 5000 West Chambers Street, Milwaukee, WI 53210–1688 ............... 222. St. Joseph’s Medical Center, 1800 N. California Street, Stockton, CA 95204 ............................................... 223. St. Joseph’s Mercy Health Center, 300 Werner Street, Hot Springs, AR 71903 ........................................... 224. St. Joseph’s Wayne Hospital, 224 Hamburg Turnpike, Wayne, NJ 07470 .................................................... 225. St. Luke’s, 915 East First Street, Duluth, MN 55805 ...................................................................................... 226. St. Lukes Episcopal Hospital, 6720 Bertner Avenue, Houston, TX 77030 .................................................... 227. St. Luke’s Hospital, 1026 A Avenue NE, P.O. Box 3026, Cedar Rapids, IA 52406–3026 ............................ 228. St. Luke’s Medical Center, 2900 W. Oklahoma Avenue, P.O. Box 2901, Milwaukee, WI 53201–2901 ....... 229. St. Luke’s-Roosevelt Hospital Center, 1000 Tenth Avenue, New York, NY 10019 ....................................... 230. St. Mary’s Hospital and Medical Center, 2635 North Seventh Street, P.O. Box 1628, Grand Junction, CO 81501 ................................................................................................................................................................... 231. St Mary’s Medical Center, 407 East Third Street, Duluth, MN 55805 ............................................................ 232. St. Mary’s Medical Center, 3700 Washington Avenue, Evansville, IN 47740–001 ........................................ 233. St. Patrick Hospital and Health Sciences Center, 500 West Broadway, Missoula, MT 59802 ...................... 234. St. Thomas Hospital, 4220 Harding Road, Nashville, TN 37205 ................................................................... 235. Strong Memorial Hospital, 601 Elmwood Avenue, Box 679, Rochester, NY 14642 ...................................... 236. Swedish American Hospital, 1401 East State Street, Rockford, IL 61104 ..................................................... 237. Swedish Medical Center, 501 East Hampden Ave, Englewood, CO 80113 .................................................. 238. Swedish Medical Center-First Hill Campus, 747 Broadway, Seattle, WA 98122 ........................................... 239. Swedish Medical Center-Providence Campus, 747 Broadway, Seattle, WA 98122 ...................................... 240. Tallahassee Memorial, 1300 Miccosukee Road, Tallahassee, FL 32308 ...................................................... 241. Terrebonne General Medical Center, 8166 Main Street, Houma, LA 70360 ................................................. 242. Texan Heart Hospital, 6700 IH–10 West, San Antonio, TX 78201 ................................................................ 243. Town and Country Hospital, 6001 Webb Road, Tampa, FL 33615–3241 ..................................................... 244. UC Davis Cardiac Cath Lab/UC Davis Medical Center, 2315 Stockton Boulevard, Sacramento, CA 95817 245. Union Hospital, 1606 North Seventh Street, Terre Haute, IN 47804–2780 ................................................... 246. Union Memorial Hospital, 201 East University Parkway, Baltimore, MD 21218–2895 .................................. 247. United Regional Health Care System, Eleventh Street Campus, 1600 Eleventh Street, Wichita Falls, TX 76301 ................................................................................................................................................................... 248. University of Alabama Hospital, 619 South 19th Street, Birmingham, AL 35233 .......................................... 249. University Health System, 1520 Cherokee Trail, Suite 200, Knoxville, TN 37920–2205 ............................... 250. University Health System, 4502 Medical Drive, San Antonio, TX 78229 ....................................................... 251. University of Kentucky Hospital, 800 Rose Street, Lexington, KY 40536–0293 ............................................ 252. University of Louisville Hospital, 530 South Jackson Street, Louisville, KY 40202 ....................................... 253. University of Pennsylvania Medical Center-Presbyterian, 39th and Market Streets, Philadelphia, PA 19104 ................................................................................................................................................................... 254. UPMC Presbyterian Shadyside, 200 Lothrop Street, Pittsburgh, PA 15213 .................................................. 255. Utah Valley Regional Medical Center, 1034 North 500 West, Provo, Utah 84605 ........................................ 256. The Valley Hospital, 223 N. Van Dien Avenue, Ridgewood, NJ 07450–2736 ............................................... 257. Vassar Brothers Medical Center, 45 Reade Place, Poughkeepsie, NY 12601 .............................................. 258. Washoe Medical Center, 75 Pringle Way, Reno, NV 89502 .......................................................................... 259. Washington Hospital Center, 110 Irving Street, NW., Washington, DC 20010 .............................................. 260. Wellmont Holston Valley Medical Center, Holston Valley Vascular Institute, 130 W. Ravine Road, Kingsport, TN 37660 ..................................................................................................................................................... 261. Wentworth-Douglass Hospital, 789 Central Avenue, Dover, NH 03820 ........................................................ 262. West Allis Memorial Hospital, 8901 West Lincoln Avenue, West Allis, WI 53227 ......................................... 263. Westchester Medical Center, 95 Grasslands Road, Valhalla, NY 10595 ...................................................... 264. Western Baptist Hospital, 2501 Kentucky Avenue, Paduach, KY 42003–3200 ............................................. 265. Western Medical Center-Santa Ana, 1001 North Tustin Avenue, Santa Ana, CA 92705 ............................. 266. William Beaumont Hospital, 3601 W. 13 Mile Road, Royal Oak, MI 48073 .................................................. 267. Willis Knighton Bossier, 2400 Hospital Drive, Bossier City, LA 71111 .......................................................... 268. Willis Knighton Medical Center, 2600 Greenwood Road, Shreveport, LA 71103 .......................................... 269. Winchester Medical Center, P.O. Box 3340, Winchester, VA 22604–2540 ................................................... 270. The Wisconsin Heart Hospital, LLC, 10000 West Blue Mound Road, Wauwatosa, WI 53226 ..................... 271. Wyoming Valley Health Care System, 575 North River Street, Wilkes Barre, PA 18764 ............................. 272. York Hospital, 15 Hospital Drive, York, ME 03909 ......................................................................................... VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Effective date 450431 180035 140118 150033 230165 140053 260001 360123 210007 230156 520136 050084 040026 310116 240047 450193 160045 520138 330046 05/05/2005 04/26/2005 05/11/2005 04/01/2005 04/27/2005 05/10/2005 04/19/2005 05/03/2005 05/17/2005 05/16/2005 05/10/2005 05/17/2005 05/26/2005 03/30/2005 04/19/2005 03/30/2005 05/10/2005 04/18/2005 05/23/2005 060023 240002 150100 270014 440082 330285 140228 060034 500027 500025 100135 190008 450878 100255 050599 150023 210024 04/20/2005 05/16/2005 05/17/2005 04/12/2005 04/19/2005 04/19/2005 05/03/2005 05/16/2005 05/17/2005 05/23/2005 05/16/2005 04/20/2005 05/26/2005 05/05/2005 04/19/2005 04/27/2005 04/07/2005 450010 010033 440015 450213 180067 180141 05/16/2005 05/26/2005 05/26/2005 04/27/2005 05/16/2005 05/05/2005 390223 390164 460001 310012 330023 290001 090011 04/01/2005 05/03/2005 05/26/2005 04/20/2005 05/05/2005 04/27/2005 05/16/2005 440017 300018 520139 330234 180104 050746 230130 190236 190111 490005 520199 390137 200020 05/16/2005 05/10/2005 05/26/2005 05/16/2005 05/05/2005 05/25/2005 05/10/2005 04/27/2005 04/27/2005 05/16/2005 05/05/2005 04/26/2005 04/14/2005 36640 Federal Register / Vol. 70, No. 121 / Friday, June 24, 2005 / Notices [FR Doc. 05–12525 Filed 6–23–05; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1480–N] RIN 0938–AN92 Medicare Program; Inpatient Rehabilitation Facility Compliance Criteria Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: SUMMARY: In accordance with the provisions of the Consolidated Appropriations Act of 2005, this notice announces the Secretary’s determination that the requirements for classification as an inpatient rehabilitation facility (IRF) specified in § 412.23(b)(2) are not inconsistent with a report that the Government Accountability Office (GAO) issued concerning classification of a facility as an IRF. DATES: Effective Date: This notice is effective on June 24, 2005. FOR FURTHER INFORMATION CONTACT: Pete Diaz, (410) 786–1235. SUPPLEMENTARY INFORMATION: I. Background A. Classification as an Inpatient Rehabilitation Facility Under § 412.23(b)(2) Sections 1886(d)(1)(B) and 1886(d)(1)(B)(ii) of the Social Security Act (the Act) give the Secretary the discretion to define a rehabilitation hospital and unit. A freestanding rehabilitation hospital and a rehabilitation unit of an acute care hospital are collectively referred to as an inpatient rehabilitation facility (IRF), and are paid under the IRF prospective payment system (PPS). Under the current regulations at 42 CFR 412.1(b)(2), a hospital or unit of a hospital, must first be deemed excluded from the diagnosis-related group (DRG)based inpatient prospective payment system (IPPS) to be paid under the IRF PPS. A facility must meet the applicable requirements in subpart B of part 412. Secondly, the excluded hospital or unit of the hospital must meet the conditions for payment under the IRF PPS at § 412.604. See § 412.23(b). Moreover, a provider, among other requirements, must be in compliance with the criteria VerDate jul<14>2003 19:06 Jun 23, 2005 Jkt 205001 specified in § 412.23(b)(2) in order to be classified as an IRF, see § 412.604(b). On May 7, 2004, we published a final rule in the Federal Register (69 FR 25752) that responded to public comments on the September 9, 2003 proposed rule (68 FR 26786), and revised the criteria for being classified as an IRF including the criteria at § 412.23(b)(2). The changes in the final rule were effective for cost reporting periods beginning on or after July 1, 2004. Under § 412.23(b)(2), a specific percentage, noted below, of an IRF’s total inpatient population must meet at least one of the following medical conditions: (1) Stroke. (2) Spinal cord injury. (3) Congenital deformity. (4) Amputation. (5) Major multiple trauma. (6) Fracture of femur (hip fracture). (7) Brain injury. (8) Neurological disorders, including multiple sclerosis, motor neuron diseases, polyneuropathy, muscular dystrophy, and Parkinson’s disease. (9) Burns. (10) Active, polyarticular rheumatoid arthritis, psoriatic arthritis, and seronegative arthropathies resulting in significant functional impairment of ambulation and other activities of daily living that have not improved after an appropriate, aggressive, and sustained course of outpatient therapy services or services in other less intensive rehabilitation settings immediately preceding the inpatient rehabilitation admission or that result from a systemic disease activation immediately before admission, but have the potential to improve with more intensive rehabilitation. (11) Systemic vasculidities with joint inflammation, resulting in significant functional impairment of ambulation and other activities of daily living that have not improved after an appropriate, aggressive, and sustained course of outpatient therapy services or services in other less intensive rehabilitation settings immediately preceding the inpatient rehabilitation admission or that result from a systemic disease activation immediately before admission, but have the potential to improve with more intensive rehabilitation. (12) Severe or advanced osteoarthritis (osteoarthrosis or degenerative joint disease) involving two or more major weight bearing joints (elbow, shoulders, hips, or knees, but not counting a joint with a prosthesis) with joint deformity and substantial loss of range of motion, atrophy of muscles surrounding the joint, significant functional impairment PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 of ambulation and other activities of daily living that have not improved after the patient has participated in an appropriate, aggressive, and sustained course of outpatient therapy services or services in other less intensive rehabilitation settings immediately preceding the inpatient rehabilitation admission but have the potential to improve with more intensive rehabilitation. (A joint replaced by a prosthesis no longer is considered to have osteoarthritis, or other arthritis, even though this condition was the reason for the joint replacement.) (13) Knee or hip joint replacement, or both, during an acute hospitalization immediately preceding the inpatient rehabilitation stay and also meets one or more of the following specific criteria: (i) The patient underwent bilateral knee or bilateral hip joint replacement surgery during the acute hospital admission immediately preceding the IRF admission. (ii) The patient is extremely obese with a Body Mass Index of at least 50 at the time of admission to the IRF. (iii) The patient is age 85 or older at the time of admission to the IRF. The percentage of an IRF’s inpatient population that must meet at least one of the above medical conditions is determined by the IRF’s cost reporting period. The following are the percentages of an IRF’s inpatient population that must meet at least one of the medical conditions specified above: For cost reporting periods beginning on or after July 1, 2004, and before July 1, 2005, the compliance threshold will be 50 percent of the IRF’s total inpatient population. For cost reporting periods beginning on or after July 1, 2005, and before July 1, 2006, the compliance threshold will be 60 percent of the IRF’s total inpatient population. For cost reporting periods beginning on or after July 1, 2006 and before July 1, 2007, the compliance threshold will be 65 percent of the IRF’s total inpatient population. Furthermore, for those cost reporting periods beginning before July 1, 2007, the regulations also permit certain comorbidities, as defined in § 412.602, to be counted towards the applicable inpatient population percentage, if certain requirements are met as specified in § 412.23(b)(2)(i). For cost reporting periods beginning on or after July 1, 2007, patient comorbidity as described in § 412.23(b)(2)(i) is not included in the inpatient population that counts toward the compliance threshold percentage. For cost reporting periods beginning on or after July 1, 2007, the compliance E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 70, Number 121 (Friday, June 24, 2005)]
[Notices]
[Pages 36620-36640]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12525]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9028-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2005

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice lists CMS manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published from January 2005 through March 2005, relating to the 
Medicare and Medicaid programs. This notice provides information on 
national coverage determinations (NCDs) affecting specific medical and 
health care services under Medicare. Additionally, this notice 
identifies certain devices with investigational device exemption (IDE) 
numbers approved by the Food and Drug Administration (FDA) that 
potentially may be covered under Medicare. This notice also includes 
listings of all approval numbers from the Office of Management and 
Budget for collections of information in CMS regulations. Finally, for 
the first time, this notice includes a list of Medicare-approved 
carotid stent facilities.
    Section 1871(c) of the Social Security Act requires that we publish 
a list of Medicare issuances in the Federal Register at least every 3 
months. Although we are not mandated to do so by statute, for the sake 
of completeness of the listing, and to foster more open and transparent 
collaboration efforts, we are also including all Medicaid issuances and 
Medicare and Medicaid substantive and interpretive regulations 
(proposed and final) published during this 3-month time frame.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may have a specific information need and not be able to determine 
from the listed information whether the issuance or regulation would 
fulfill that need. Consequently, we are providing information contact 
persons to answer general questions concerning these items. Copies are 
not available through the contact persons. (See Section III of this 
notice for how to obtain listed material.)
    Questions concerning items in Addendum III may be addressed to 
Timothy Jennings, Office of Strategic Operations and Regulatory 
Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 
786-2134.
    Questions concerning Medicare NCDs in Addendum V may be addressed 
to Patricia Brocato-Simons, Office of Clinical Standards and Quality, 
Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.
    Questions concerning FDA-approved Category B IDE numbers listed in 
Addendum VI may be addressed to John Manlove, Office of Clinical 
Standards and Quality, Centers for Medicare & Medicaid Services, S3-26-
10, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call 
(410) 786-6877.
    Questions concerning approval numbers for collections of 
information in Addendum VII may be addressed to Jim Wickliffe, Office 
of Strategic Operations and Regulatory Affairs, Regulations Development 
and Issuances Group, Centers for Medicare & Medicaid Services, C5-14-
03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call 
(410) 786-4596.
    Questions concerning Medicare-approved carotid stent facilities may 
be addressed to Rana A. Hogarth, Office of Clinical Standards and 
Quality, Centers for Medicare & Medicaid Services, C1-

[[Page 36621]]

09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can 
call (410) 786-2112; or to Sarah J. McClain, Office of Clinical 
Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-
06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call 
(410) 786-2994.
    Questions concerning all other information may be addressed to 
Gwendolyn Johnson, Office of Strategic Operations and Regulatory 
Affairs, Regulations Development Group, Centers for Medicare & Medicaid 
Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-6954.

SUPPLEMENTARY INFORMATION: 

I. Program Issuances

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs. These programs 
pay for health care and related services for 39 million Medicare 
beneficiaries and 35 million Medicaid recipients. Administration of the 
two programs involves (1) furnishing information to Medicare 
beneficiaries and Medicaid recipients, health care providers, and the 
public and (2) maintaining effective communications with regional 
offices, State governments, State Medicaid agencies, State survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, and others. To implement the various 
statutes on which the programs are based, we issue regulations under 
the authority granted to the Secretary of the Department of Health and 
Human Services under sections 1102, 1871, 1902, and related provisions 
of the Social Security Act (the Act). We also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    Section 1871(c)(1) of the Act requires that we publish a list of 
all Medicare manual instructions, interpretive rules, statements of 
policy, and guidelines of general applicability not issued as 
regulations at least every 3 months in the Federal Register. We 
published our first notice June 9, 1988 (53 FR 21730). Although we are 
not mandated to do so by statute, for the sake of completeness of the 
listing of operational and policy statements, and to foster more open 
and transparent collaboration, we are continuing our practice of 
including Medicare substantive and interpretive regulations (proposed 
and final) published during the respective 3-month time frame.

II. How To Use the Addenda

    This notice is organized so that a reader may review the subjects 
of manual issuances, memoranda, substantive and interpretive 
regulations, NCDs, and FDA-approved IDEs published during the subject 
quarter to determine whether any are of particular interest. We expect 
this notice to be used in concert with previously published notices. 
Those unfamiliar with a description of our Medicare manuals may wish to 
review Table I of our first three notices (53 FR 21730, 53 FR 36891, 
and 53 FR 50577) published in 1988, and the notice published March 31, 
1993 (58 FR 16837). Those desiring information on the Medicare NCD 
Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may 
wish to review the August 21, 1989, publication (54 FR 34555). Those 
interested in the revised process used in making NCDs under the 
Medicare program may review the September 26, 2003, publication (68 FR 
55634).
    To aid the reader, we have organized and divided this current 
listing into eight addenda:
     Addendum I lists the publication dates of the most recent 
quarterly listings of program issuances.
     Addendum II identifies previous Federal Register documents 
that contain a description of all previously published CMS Medicare and 
Medicaid manuals and memoranda.
     Addendum III lists a unique CMS transmittal number for 
each instruction in our manuals or Program Memoranda and its subject 
matter. A transmittal may consist of a single or multiple 
instruction(s). Often, it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
     Addendum IV lists all substantive and interpretive 
Medicare and Medicaid regulations and general notices published in the 
Federal Register during the quarter covered by this notice. For each 
item, we list the--
    [cir] Date published;
    [cir] Federal Register citation;
    [cir] Parts of the Code of Federal Regulations (CFR) that have 
changed (if applicable);
    [cir] Agency file code number; and
    [cir] Title of the regulation.
     Addendum V includes completed NCDs, or reconsiderations of 
completed NCDs, from the quarter covered by this notice. Completed 
decisions are identified by the section of the NCDM in which the 
decision appears, the title, the date the publication was issued, and 
the effective date of the decision.
     Addendum VI includes listings of the FDA-approved IDE 
categorizations, using the IDE numbers the FDA assigns. The listings 
are organized according to the categories to which the device numbers 
are assigned (that is, Category A or Category B), and identified by the 
IDE number.
     Addendum VII includes listings of all approval numbers 
from the Office of Management and Budget (OMB) for collections of 
information in CMS regulations in title 42; title 45, subchapter C; and 
title 20 of the CFR.
     Addendum VIII includes listings of Medicare-approved 
carotid stent facilities. All facilities listed meet CMS's standards 
for performing carotid artery stenting for high risk patients.

III. How To Obtain Listed Material

A. Manuals

    Those wishing to subscribe to program manuals should contact either 
the Government Printing Office (GPO) or the National Technical 
Information Service (NTIS) at the following addresses:
    Superintendent of Documents, Government Printing Office, ATTN: New 
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202) 
512-1800, Fax number (202) 512-2250 (for credit card orders); or
    National Technical Information Service, Department of Commerce, 
5825 Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.
    In addition, individual manual transmittals and Program Memoranda 
listed in this notice can be purchased from NTIS. Interested parties 
should identify the transmittal(s) they want. GPO or NTIS can give 
complete details on how to obtain the publications they sell. 
Additionally, most manuals are available at the following Internet 
address: https://cms.hhs.gov/manuals/default.asp.

B. Regulations and Notices

    Regulations and notices are published in the daily Federal 
Register. Interested individuals may purchase individual copies or 
subscribe to the Federal Register by contacting the GPO at the address 
given above. When ordering individual copies, it is necessary to cite 
either the date of publication or the volume number and page number.
    The Federal Register is also available on 24x microfiche and as an 
online database through GPO Access. The online database is updated by 6 
a.m. each day the Federal Register is published. The database includes 
both text and graphics from Volume 59, Number 1 (January 2, 1994) 
forward. Free public access is available on a Wide Area Information 
Server (WAIS)

[[Page 36622]]

through the Internet and via asynchronous dial-in. Internet users can 
access the database by using the World Wide Web; the Superintendent of 
Documents home page address is https://www.gpoaccess.gov/fr/, 
by using local WAIS client software, or by telnet to 
swais.gpoaccess.gov, then log in as guest (no password required). Dial-
in users should use communications software and modem to call (202) 
512-1661; type swais, then log in as guest (no password required).

C. Rulings

    We publish rulings on an infrequent basis. Interested individuals 
can obtain copies from the nearest CMS Regional Office or review them 
at the nearest regional depository library. We have, on occasion, 
published rulings in the Federal Register. Rulings, beginning with 
those released in 1995, are available online, through the CMS Home 
Page. The Internet address is https://cms.hhs.gov/rulings.

D. CMS' Compact Disk-Read Only Memory (CD-ROM)

    Our laws, regulations, and manuals are also available on CD-ROM and 
may be purchased from GPO or NTIS on a subscription or single copy 
basis. The Superintendent of Documents list ID is HCLRM, and the stock 
number is 717-139-00000-3. The following material is on the CD-ROM 
disk:
     Titles XI, XVIII, and XIX of the Act.
     CMS-related regulations.
     CMS manuals and monthly revisions.
     CMS program memoranda.
    The titles of the Compilation of the Social Security Laws are 
current as of January 1, 1999. (Updated titles of the Social Security 
Laws are available on the Internet at https://www.ssa.gov/OP_Home/
ssact/comp-toc.htm.) The remaining portions of CD-ROM are updated on a 
monthly basis.
    Because of complaints about the unreadability of the Appendices 
(Interpretive Guidelines) in the State Operations Manual (SOM), as of 
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future and, with the aid of newer 
technology, we may again be able to include the appendices on CD-ROM.
    Any cost report forms incorporated in the manuals are included on 
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the 
reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

    Transmittals or Program Memoranda can be reviewed at a local 
Federal Depository Library (FDL). Under the FDL program, government 
publications are sent to approximately 1,400 designated libraries 
throughout the United States. Some FDLs may have arrangements to 
transfer material to a local library not designated as an FDL. Contact 
any library to locate the nearest FDL.
    In addition, individuals may contact regional depository libraries 
that receive and retain at least one copy of most Federal Government 
publications, either in printed or microfilm form, for use by the 
general public. These libraries provide reference services and 
interlibrary loans; however, they are not sales outlets. Individuals 
may obtain information about the location of the nearest regional 
depository library from any library. For each CMS publication listed in 
Addendum III, CMS publication and transmittal numbers are shown. To 
help FDLs locate the materials, use the CMS publication and transmittal 
numbers. For example, to find the Medicare NCD publication titled 
``Implantable Automatic Defibrillators,'' use CMS-Pub. 100-03, 
Transmittal No. 29.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714, 
Medical Assistance Program)
    Dated: June 20, 2005.
Jacquelyn White,
Director, Office of Strategic Operations and Regulatory Affairs.

Addendum I

    This addendum lists the publication dates of the most recent 
quarterly listings of program issuances.

December 27, 2002 (67 FR 79109).
March 28, 2003 (68 FR 15196).
June 27, 2003 (68 FR 38359).
September 26, 2003 (68 FR 55618).
December 24, 2003 (68 FR 74590).
March 26, 2004 (69 FR 15837).
June 25, 2004 (69 FR 35634).
September 24, 2004 (69 FR 57312).
December 30, 2004 (69 FR 78428).
February 25, 2005 (70 FR 9338).

Addendum II--Description of Manuals, Memoranda, and CMS Rulings

    An extensive descriptive listing of Medicare manuals and memoranda 
was published on June 9, 1988, at 53 FR 21730 and supplemented on 
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 
50577. Also, a complete description of the former CIM (now the NCDM) 
was published on August 21, 1989, at 54 FR 34555. A brief description 
of the various Medicaid manuals and memoranda that we maintain was 
published on October 16, 1992, at 57 FR 47468.

        Addendum III.--Medicare and Medicaid Manual Instructions
                      [January Through March 2005]
------------------------------------------------------------------------
    Transmittal No.               Manual/subject/publication No.
------------------------------------------------------------------------
             Medicare General Information (CMS Pub. 100-01)
------------------------------------------------------------------------
 15....................  Review of Contractor Implementation of Change
                          Requests (Replacement for expired CR 944).
                         Review of Contractor Implementation of Change
                          Requests.
                         CR Implementation Report--Summary Page.
                         CR Implementation Report--Details Page.
                         CR Implementation Report--Sample Cover Letter/
                          Attestation Statement.
16.....................  Standard Terminology for Claims Processing
                          Systems.
17.....................  This Transmittal rescinded and replaced
                          Transmittal 15.
18.....................  Billing for Blood and Blood Products Under the
                          Hospital Outpatient Prospective Payment
                          System.
                         Items Subject to Blood Deductibles.
                         Blood.
19.....................  Revisions to Chapter 5, Section 50 of
                          Publication 100-01 in the Internet Only.
                         Manual to Clarify Current Policy.
                         Home Health Agency Defined.
                         Arrangements by Home Health Agencies.

[[Page 36623]]

 
                         Rehabilitation Centers.
------------------------------------------------------------------------
                Medicare Benefit Policy (CMS Pub. 100-02)
------------------------------------------------------------------------
 29....................  Telehealth Originating Site Facility Fee
                          Payment Amount Update.
30.....................  Policy for Repair and Replacement of Durable
                          Medical Equipment.
------------------------------------------------------------------------
       Medicare National Coverage Determinations (CMS Pub. 100-03)
------------------------------------------------------------------------
 27....................  Infusion Pumps: C-Peptide Levels As A Criterion
                          for Use.
28.....................  Update of Laboratory NCDs to Reference New
                          Screening Benefits.
                         Blood Glucose Testing.
                         Lipid Testing.
29.....................  Implantable Automatic Defibrillators.
30.....................  Coverage of Colorectal Anti-Cancer Drugs
                          Included in Clinical Trials.
                         Anti-Cancer Chemotherapy for Colorectal Cancer
                          (Effective January 28, 2005).
------------------------------------------------------------------------
               Medicare Claims Processing (CMS Pub. 100-04)
------------------------------------------------------------------------
 423...................  January 2005 Update of the Hospital Outpatient
                          Prospective Payment System: Summary of Payment
                          Policy Changes.
424....................  Implementation of the Annual Desk Review
                          Program for Hospital Wage Data: Cost Reporting
                          Periods Beginning on or After October 1, 2001,
                          Through September 30, 2002 (FY 2006 Wage
                          Index).
425....................  Section 630 of the Medicare Modernization Act
                          allows for the Reimbursement for Ambulance
                          Services Provided by Indian Health Service/
                          Tribal Hospitals, Including Critical Access
                          Hospitals, Which Manage and Operate Hospital-
                          Based Ambulances.
                         General Coverage and Payment Policies.
                         Indian Health Service/Tribal Billing.
426....................  Modification to Reporting of Diagnosis Codes
                          for Screening Mammography Claims.
                         Healthcare Common Procedure Coding System and
                          Diagnosis Codes for Mammography Services.
427....................  Revision of Change Request 2928: Implementation
                          of Payment Safeguards for Home Health
                          Prospective Payment System Claims Failing to
                          Report Prior Hospitalizations.
                         Adjustments of Episode Payment--Hospitalization
                          Within 14 Days of Start of Care.
428....................  Update to Billing Requirements for FDG-Positron
                          Emission Tomography Scans For Use in the
                          Differential Diagnosis of Alzheimer's Disease
                          and Fronto-Temporal Dementia and Update to the
                          Fiscal Intermediaries Billing Requirements for
                          Special Payment Procedures for All Positron
                          Emission Tomography Scan.
                         Claims for Services Performed in a Critical
                          Access Hospital.
                         Billing Instructions.
                         Coverage for Positron Emission Tomography Scans
                          for Dementia and Neurodegenerative Disease.
429....................  Change to the Common Working File Skilled
                          Nursing Facility Consolidated Billing Edits
                          for Critical Access Hospitals That Have
                          Elected Method II Payment Option and Bill
                          Physician Services to Their Fiscal
                          Intermediaries.
                         Physician's Services and Other Professional
                          Services Excluded From Part A PPS Payment and
                          the Consolidated Billing Requirement.
430....................  Mandatory Assignment for Medicare Modernization
                          Act Sec.   630 Claims.
                         Other Part B Services.
                         Durable Medical Equipment Regional Carrier
                          Drugs.
                         Claims Processing Requirements for Medicare
                          Modernization Act Sec.   630.
                         Claims Processing for Durable Medical Equipment
                          Prosthetic, Orthotics & Supplies and Durable
                          Medical Equipment Regional Carrier Drugs.
                         Enrollment for Durable Medical Equipment
                          Prosthetic, Orthotics & Supplies and Durable
                          Medical Equipment Regional Carrier Drugs.
                         Enrollment and Billing for Clinical Laboratory
                          and Ambulance Services and Part B Drugs.
                         Claims Submission and Processing for Clinical
                          Laboratory and Ambulance Services and Part B
                          Drugs.
431....................  Updated Skilled Nursing Facility No Pay File
                          for April 2005.
432....................  Adding an Indicator to the National Claims
                          History to Indicate That Durable Medical
                          Regional Carriers, Carriers, and Fiscal
                          Intermediaries Have Reviewed a Potentially
                          Duplicate Claim.
                         Detection of Duplicate Claims.
433....................  Issued to a specific audience, not posted to
                          the Internet/Intranet due to the Sensitivity
                          of Instruction.
434....................  Addition of Clinical Laboratory Improvement Act
                          Edits to Certain Health Care Procedure Coding
                          System Codes for Mohs Surgery.
435....................  This Transmittal has been rescinded and
                          replaced by Transmittal 450.
436....................  Remittance Advice Remark Code and Claim
                          Adjustment Reason Code Update.
437....................  Revisions and Corrections to the Medicare
                          Claims Processing Manual, Chapter 6, Section
                          30 and Various Sections in Chapter 15.
                         Billing Skilled Nursing Facility Prospective
                          Payment System Services General Coverage and
                          Payment Policies.
                         Air Ambulance for Deceased Beneficiary.
                         General Billing Guidelines for Intermediaries
                          and Carriers.
                         Intermediary Guidelines.
438....................  Fiscal Intermediary Standard Paper Remittance
                          Advice Changes.
439....................  Modification to the Fiscal Intermediary
                          Standard System Regarding Ambulance Services
                          Billed on 18x and 21x Types of Bill.
440....................  Updating the Common Working File Editing for
                          Pap Smear (Q0091) and Adding a New Low Risk
                          Diagnosis Code (V72.31) for Pap Smear and
                          Pelvic Examination.

[[Page 36624]]

 
                         Healthcare Common Procedure Coding System Codes
                          for Billing.
                         Diagnoses Codes.
                         Payment Method.
                         Revenue Codes and Healthcare Common Procedure
                          Coding System Codes for Billing.
                         Medicare Summary Notice Messages.
                         Remittance Advice Codes.
441....................  Viable Medicare Systems Changes to Durable
                          Medical Equipment Regional Carrier Processing
                          of Method II Home Dialysis Claims.
442....................  Hospital Outpatient Prospective Payment System:
                          Use of Modifiers -52, -73 and -74 for Reduced
                          or Discontinued Services
                         Use of Modifiers.
                         Use of Modifiers for Discontinued Services.
443....................  This Transmittal is rescinded and replaced by
                          Transmittal 505.
444....................  Further Information Related to Inpatient
                          Psychiatric Facility Prospective Payment
                          System
445....................  Payment to Providers/Suppliers Qualified to
                          Bill Medicare for Prosthetics and Certain
                          Custom-Fabricated Orthotics.
                         Provider Billing for Prosthetics and Orthotic
                          Services.
446....................  Diabetes Screening Tests.
447....................  Common Working File Editing for Method
                          Selection on Durable Medical Equipment
                          Regional Carrier Claims for EPO and Aranesp
                         Epoetin Alfa Furnished to Home Patients.
                         Darbepoetin Alfa Furnished to Home Patients.
448....................  Timeframe for Continued Execution of Crossover
                          Agreements and Update on the Transition to the
                          National Coordination of Benefits Agreement
                          Program
                         Crossover Claims Requirements.
                         Fiscal Intermediaries Requirements.
                         Durable Medical Equipment Regional Carrier
                          Requirements.
                         Consolidation of the Claims Crossover Process.
                         Electronic Transmission - General Requirements.
                         ANSI X12N 837 Coordination of Benefit
                          Transaction Fee Collection.
                         Medigap Electronic Claims Transfer Agreements.
                         Intermediary Crossover Claim Requirements.
                         Carrier/Durable Medical Equipment Regional
                          Carrier Crossover Claims Requirements.
449....................  April Quarterly Update to 2005 Annual Update of
                          Healthcare Common Procedure Coding System
                          Codes Used for Skilled Nursing Facility
                          Consolidated Billing Enforcement
450....................  Enforcement of Mandatory Electronic Submission
                          of Medicare Claims
                         Failure To Furnish Information Medicare Summary
                          Notice Message.
                         Falta De Information Sometida Medicare Summary
                          Notice Message Enforcement.
451....................  April 2005 Quarterly Fee Schedule Update for
                          Durable Medical Equipment, Prosthetics,
                          Orhtotics, and Supplies.
452....................  New Remittance Advice Message for Referred
                          Clinical Diagnostic/ Purchased Diagnostic
                          Service Duplicate Claims.
453....................  Instructions for Downloading the Medicare Zip
                          Code File.
454....................  Definitions of Electronic and Paper Claims.
                         Payment Ceiling Standards.
455....................  This transmittal is rescinded and replaced by
                          Transmittal 509.
456....................  Independent Laboratory Billing for the
                          Technical Component of Physician.
                         Pathology Services Furnished to Hospital
                          Patients (Supplemental to Change Request 3467)
457....................  Diabetes Screening Tests.
                         Healthcare Common Procedure Coding System
                          Coding for Diabetes Screening.
                         Carrier Billing Requirements.
                         Modifier Requirements for Pre-Diabetes.
                         Fiscal Intermediary Billing Requirements.
                         Diagnosis Code Reporting.
                         Medicare Summary Notices.
                         Remittance Advice Remark Codes.
                         Claims Adjustment Reason Codes.
458....................  Hospice Physician Recertification Requirements.
                         Data Required on Claim to Fiscal
                          Intermediaries.
459....................  Full Replacement of Change Request 3427,
                          Transmittal 342, Issued on October 29, 2004--
                          Change to the Common Working File Skilled
                          Nursing Facility.
                         Consolidated Billing Edits for Ambulance
                          Transports to or From a Diagnostic or
                          Therapeutic Site.
                         Ambulance Services.
                         Skilled Nursing Facility Billing.
460....................  Issued to a specific audience, not posted to
                          Internet/Intranet due to Confidentiality of
                          Instruction.
461....................  Processing Durable Medical Equipment,
                          Orthotics, Prosthetics, Drugs, and Surgical
                          Dressings Claims for Indian Health Services
                          and Tribally Owned and Operated Hospitals or
                          Hospital Based Facilities Including Critical
                          Access.
                         Hospital.
                         Other Part B Services.
                         Prosthetics and Orthotics.
                         Prosthetic Devices.
                         Surgical Dressings and Splints and Casts.
                         Drugs Dispensed by IHS Hospital-Based or
                          Freestanding Facilities.
                         Claims Processing for Durable Medical Equipment
                          Prosthetics, Orthotics & Supplies.

[[Page 36625]]

 
                         Enrollment for Durable Medical Equipment
                          Prosthetics, Orthotics & Supplies.
                         Claims Submission for Durable Medical Equipment
                          Prosthetics, Orthotics & Supplies.
462....................  Durable Medical Equipment Regional Carrier
                          Only--Dispensing Fees for Immunosuppressive
                          Drugs.
463....................  Update to 100-04 and Therapy Code Lists.
                         Healthcare Common Procedure Coding System
                          Coding Requirement.
                         Part B Outpatient Rehabilitation and
                          Comprehensive Outpatient Rehabilitation
                          Facility Services--General.
                         Discipline Specific Outpatient Rehabilitation
                          Modifiers--All Claims.
                         The Financial Limitation.
                         Reporting of Service Units With HCPCS--Form CMS-
                          1500 and Form CMS-1450.
464....................  Implementation of the Abstract File for
                          Purchased Diagnostic.
                         Test/Interpretations (Supplemental to CR 3481).
                         Payment Jurisdiction Among Local Carriers for
                          Services Paid Under the Physician Fee Schedule
                          and Anesthesia Services.
                         Payment Jurisdiction for Purchased Services.
                         Payment to Physician or Other Supplier for
                          Purchased Diagnostic Tests--Claims Submitted
                          to Carriers.
                         Payment to Supplier of Diagnostic Tests for
                          Purchased Interpretations.
465....................  Billing Requirements for Physician Services in
                          Method II Critical Access Hospitals.
                         Payment for Inpatient Services Furnished by a
                          Critical Access Hospital.
                         Special Rules for Critical Access Hospital
                          Outpatient Billing.
                         Billing and Payment in a Physician Scarcity
                          Area.
466....................  Quarterly Update to Correct Coding Initiative
                          Edits, Version 11.1, Effective April 1, 2005.
467....................  Modifications to Duplicate Editing for
                          Dispensing/Supply Fee Codes for Oral Anti-
                          Cancer, Oral Anti-Emetic, Immunosuppressive
                          and Inhalation Drugs.
468....................  Appeals Transition--Benefits, Improvement &
                          Protection Act Section 521.
                         Appeals.
469....................  New Waived Tests--April 1, 2005.
470....................  Standardization of Fiscal Intermediary Use of
                          Group and Claim Adjustment.
                         Reason Codes and Calculation and Balancing of
                          TS2 and TS3 Segment.
                         Data Elements.
471....................  This Transmittal is rescinded and replaced by
                          Transmittal 513.
472....................  Revisions to Payment for Services Provided
                          Under a Contractual Arrangement--Carrier
                          Claims Only.
                         Exceptions to Assignment of Provider's Right to
                          Payment--Claims Submitted to Fiscal
                          Intermediaries and Carriers.
                         Payment for Services Provided Under a
                          Contractual Arrangement--Carrier Claims Only.
473....................  Use of 12X Type of Bill for Billing Vaccines
                          and Their Administration Bills Submitted to
                          Fiscal Intermediaries.
474....................  Coordination of Benefits Agreement Detailed
                          Error Report Notification Process.
475....................  1st Update to the 2005 Medicare Physician Fee
                          Schedule Database.
476....................  Type of Service Corrections.
477....................  New Case-Mix Adjusted End-Stage Renal Disease
                          Composite Payment Rates And New Composite Rate
                          Exceptions Window for Pediatric End-Stage
                          Renal Disease Facilities.
                         Outpatient Provider-Specific File.
                         Calculation of Case-Mix Adjustment Composite
                          Rate.
                         Required Information for In-Facility Claims
                          Paid Under the Composite Rate.
478....................  Clarification of the Verification Process to be
                          Used to Determine If the Inpatient
                          Rehabilitation Facility Meets the Inpatient
                          Rehabilitation Classification Criteria
                          Verification Process To Be Used To Determine
                          If the Inpatient Rehabilitation Facility Met
                          the Classification Criteria.
479....................  Update to the Healthcare Provider Taxonomy
                          Codes Version 5.0.
480....................  April 2005 Quarterly Average Sale Price
                          Medicare Part B Drug Pricing File, Effective
                          April 1, 2005, and New January 2005 Quarterly
                          Average Sale Price File.
481....................  Updated Manual Instructions for the Medicare
                          Claims Processing Manual, Chapter 10.
                         General Guidelines for Processing Home Health
                          Agency Claims.
                         Effect of Election of Medicare Advantage
                          Organization and Eligibility Changes on Home
                          Health Prospective Payment System Episodes.
                         General Guidance on Line Item Billing Under the
                          Home Health Prospective Payment System.
                         Request for Anticipated Payment.
                         Home Health Prospective Payment System Claims.
                         Special Billing Situations Involving Outcome &
                          Assessment Information Set Assessments.
                         Medical and Other Health Services Not Covered
                          Under the Plan of Care (Bill Type 34X).
482....................  Manualization of Payment Change for Diagnostic
                          Mammography and Diagnostic Computer Aided
                          Detection.
                         Screening Mammography Services.
                         Computer Aided Design Billing Charts.
                         Payment for Screening Mammography Services
                          Provided Prior to January 1, 2002.
                         Payment for Screening Mammography Services
                          Provided On and After January 1, 2002.
                         Outpatient Hospital Mammography Payment Table.
                         Payment for Computer Add-On Diagnostic and
                          Screening Mammograms for Fiscal Intermediaries
                          and Carriers.
                         Mammograms Performed With New Technologies.
483....................  Hospital Partial Hospitalization Services
                          Billing Requirements.
                         Special Partial Hospitalization Billing
                          Requirements for Hospitals, Community Mental
                          Health Centers, and Critical Access Hospitals.
                         Bill Review for Partial Hospitalization
                          Services Provided in Community Mental Health
                          Centers.
484....................  New Remittance Advice Message for Referred
                          Clinical Diagnostic/Purchased Diagnostic
                          Service Duplicate Claims.

[[Page 36626]]

 
485....................  Calculating Payment-to-Cost Ratios for Purposes
                          of Determining Transitional Corridor Payments
                          Under the Outpatient Prospective Payment
                          System.
486....................  Manualization of Carrier Claims Processing
                          Instructions for Stem Cell Transplantation.
                         Stem Cell Transplantation.
                         General.
                         Healthcare Common Procedure Coding System and
                          Diagnosis Coding.
                         Non-Covered Conditions.
                         Edits.
                         Suggested Medicare Summary Notice and
                          Remittance Advice Messages.
487....................  Medicare Qualifying Clinical Trials.
                         Chapter 32, Section 69.0--Qualifying Clinical
                          Trials.
488....................  This Transmittal has been rescinded and
                          replaced by Transmittal 497.
489....................  Correction to Healthcare Common Procedure
                          Coding System Code A4217.
                         Payment of Durable Medical Equipment
                          Prosthetics, Orthotics & Supplies Items Based
                          on Modifiers.
490....................  Claims Status Code/Claims Status Category Code
                          Update.
                         Health Care Claims Status Category Codes and
                          Health Care Claims Status Codes for Use With
                          Health Care Claims Status Request and Response
                          ASC X12N 276/277.
491....................  Issued to a specific audience, not posted to
                          Internet/Intranet due to Confidentiality of
                          Instruction.
492....................  Adding an Indicator to the National Claims
                          History to Indicate That Durable Medical
                          Equipment Regional Carrier, Carriers and
                          Fiscal Intermediaries Have Reviewed a
                          Potentially Duplicate Claim.
                         Detection of Duplicate Claims.
493....................  Revision to Chapter 1, and Removal of Section
                          70 from Chapter 25 of the Medicare Claims
                          Processing Manual.
                         Inpatient Billing From Hospitals and Skilled
                          Nursing Facilities.
                         Submitting Bills in Sequence for a Continuous
                          Inpatient Stay or Course of Treatment.
                         Intermediary Processing of No-Payment Bills.
                         Time Limitations for Filing Provider Claims to
                          Fiscal Intermediaries.
                         Statement of Intent.
                         Filing Request for Payment to Carriers--
                          Medicare Part B.
                         Fiscal Intermediary Consistency Edits.
                         Patient is a Member of a Medicare Advantage
                          Organization for Only a Portion of the Billing
                          Period.
                         Late Charges.
                         Inpatient Part A Hospital Adjustment Bills.
494....................  April 2005 Outpatient Prospective Payment
                          System Code Editor Specifications Version 6.1.
495....................  Inpatient Psychiatric Facility Prospective
                          Payment System--Further Clarifications.
496....................  Billing for Blood and Blood Products Under the
                          Hospital Outpatient Prospective Payment
                          System.
                         When a Provider Paid Under the Outpatient
                          Prospective Payment System Does Not Purchase
                          the Blood or Blood Products That It Procures
                          From a Community Blood Bank, or When a
                          Provider Paid Under the Outpatient Prospective
                          Payment System Does Not Assess a Charge for
                          Blood or Blood Products Supplied by the
                          Provider's Own Blood Bank Other Than Blood
                          Processing and Storage.
                         When a Provider Paid Under the Outpatient
                          Prospective Payment System Purchases Blood or
                          Blood Products from a Community Blood Bank or
                          When a Provider Paid Under the Outpatient
                          Prospective Payment System Assesses a Charge
                          for Blood or Blood Products Collected by Its
                          Own Blood Bank That Reflects More Than Blood
                          Processing and Storage.
                         Billing for Autologous Blood (Including
                          Salvaged Blood) and Directed Donor Blood.
                         Billing for Split Unit of Blood.
                         Billing for Irradiation of Blood Products.
                         Billing for Frozen and Thawed Blood and Blood
                          Products.
                         Billing for Unused Blood.
                         Billing for Transfusion Services.
                         Billing for Pheresis and Apheresis Services.
                         Correct Coding Initiative Edits.
                         Blood Products and Drugs Classified in Separate
                          Average Projected Costs for Hospital
                          Outpatients.
497....................  Billing for Implantable Automatic
                          Defibrillators for Beneficiaries in a Medicare
                          Advantage Plan and Use of the Quarterly Refund
                          Modifier to Identify Patient Registry
                          Participation.
498....................  Billing of the Diagnosis and Treatment of
                          Peripheral Neuropathy With Loss of Protective
                          Sensation in People With Diabetes.
                         General Billing Requirements.
                         Applicable Healthcare Common Procedure Coding
                          System Codes.
                         Diagnosis Codes.
                         Payment.
                         Applicable Revenue Codes.
                         Editing Instructions for Fiscal Intermediaries.
                         Common Working File General Information.
                         Common Working File Utilization Edits.
499....................  2005 Scheduled Release for April Updates to
                          Software Programs and Pricing/Coding Files.
500....................  Changes to the Laboratory National Coverage
                          Determination Edit.
                         Software for April 2005.
501....................  Bone Mass Measurements--Procedure Coding.
502....................  New Contrast Agents Healthcare Common Procedure
                          Coding System Codes.
503....................  April Update to the Medicare Non-Outpatient
                          Prospective Payment Systems.
                         Outpatient Code Editor Specification Version
                          20.2.
504....................  Update to Pub 100-04, Chapter 12, Section 200
                          of the Internet Only Manual.

[[Page 36627]]

 
                         Allergy Testing and Immunotherapy.
505....................  Unprocessable Unassigned Form CMS-1500 Claims.
                         Incomplete or Invalid Claims Processing
                          Terminology.
506....................  Updated Manual Instructions for Item 24G (Days
                          or Units), Chapter 26.
507....................  New Healthcare Common Procedure Coding System
                          for Intravenous Immune Globulin.
508....................  This Transmittal is rescinded and replaced by
                          Transmittal 514.
509....................  Number of Drug Pricing Files That Must Be
                          Maintained Online for Medicare--Durable
                          Medical Equipment Regional Carriers Only.
                         Online Pricing Files for Average Sales Price.
510....................  Update to Fiscal Year 2005 Pricer for IPPS
                          Hospitals.
511....................  Type of Service Corrections.
512....................  Coverage of Colorectal Anti-Cancer Drugs
                          Included in Clinical Trials.
513....................  Infusion Pumps: C-Peptide Levels As a Criterion
                          for Use.
514....................  April 2005 Update of the Hospital Outpatient
                          Prospective Payment System: Summary of Payment
                          Policy Changes.
------------------------------------------------------------------------
                Medicare Secondary Payer (CMS Pub. 100-05)
------------------------------------------------------------------------
 23....................  Modification to Online Medicare Secondary Payer
                          Questionnaire.
                         Admission Questions to Ask Medicare
                          Beneficiaries.
24.....................  Issued to a specific audience, not posted to
                          Internet/Intranet, due to Sensitivity of
                          Instruction.
25.....................  Update Medicare Secondary Payer Manual
                          Publication 100-05 to reflect Statutory
                          Changes included in the Medicare Modernization
                          Act.
                         General Provisions.
                         Conditional Primary Medicare Benefits.
                         When Conditional Primary Medicare Benefits May
                          Be Paid.
                         When Medicare Secondary Benefits Are Payable
                          and Not Payable.
                         Definitions.
                         Beneficiary's Rights and Responsibility.
                         Statutory Provisions.
                         No-Fault Insurance.
                         Situations in Which Medicare Secondary Payer
                          Billing Applies.
                         Incorrect Group Health Plan Primary Payments.
                         General Policy.
                         Conditional Primary Medicare Benefits.
                         Conditional Medicare Payment.
                         Medicare Right of Recovery.
                         Conflicting Claims by Medicare and Medicaid.
                         Third Party Payer Refund Requests Served on
                          Medicare.
                         General Operational Instructions.
                         Conditional Primary Medicare Benefits.
                         Existence of Overpayment.
26.....................  Clarification for Change Request (CR) 3267.
                         General Policy.
27.....................  Updates to the Electronic Correspondence
                          Referral System User Guide v8.0 and Quick
                          Reference Card v8.0.
                         Coordination of Benefits Contractor Electronic
                          Correspondence Referral System.
                         Providing Written Documents to the Coordination
                          of Benefits Contractor.
------------------------------------------------------------------------
             Medicare Financial Management (CMS Pub. 100-06)
------------------------------------------------------------------------
 55....................  Reporting Appeals Redetermination Information
                          on Forms CMS-2591 and 2590.
56.....................  Revision to Balancing Requirement on Form 5,
                          Line 10, of the Contractor.
                         Reporting of Operational and Workload Data.
57.....................  Revised Reporting Requirements for Contractor
                          Reporting of Operational Workload Data Health
                          Professional Shortage Area Quarterly Report.
58.....................  Issued to specific audience, not posted to
                          Internet/Intranet due to Sensitivity of
                          Instruction.
59.....................  Notice of New Interest Rate for Medicare
                          Overpayments and Underpayments.
60.....................  Revised instructions on contractor procedures
                          for provider audit and the Provider.
                         Statistical & Reimbursement Report.
                         Submission of Cost Report Data to CMS.
                         Desk Review Exceptions Resolution Process.
                         Definition of Field Audits.
                         Purpose of Field Audits.
                         Establishing the Objective/Scope of the Field
                          Audit.
                         Audit Confirmation Letter.
                         Entrance Conference.
                         Tests of Internal Control.
                         Designing Tests/Sampling.
                         Pre-Exit Conference.
                         Finalization of Audit Adjustments.
                         Exit Conference.

[[Page 36628]]

 
                         Medicare Cost Report and All Related Documents.
                         Qualifications.
                         Internal Quality Control.
                         Final Settlement of the Cost Report.
                         Audit Responsibility When Provider Changes
                          Contractors.
                         Audits of Home Offices.
                         Standards for Issuance of an Audit Report for a
                          Home Office.
                         Provider Permanent File.
                         Contractor Responsibility in Suspected Fraud or
                          Abuse Cases.
61.....................  New Location Code Interstate Commerce
                          Commission, Status Code AR and Modified Intent
                          Letter for Unfiled Cost Reports Only.
                         Recovery of Overpayment Due to Overdue Cost
                          Report.
                         Provider Overpayment Recovery System User
                          Manual.
                         List of Status Codes.
                         Content of Demand Letters-Fiscal Intermediary
                          Serviced Providers.
62.....................  Timeframe for Continued Execution of Crossover
                          Agreements and Updated on the Transition to
                          the National Coordination of Benefits
                          Agreement Program.
                         Coordination of Medicare and Complementary
                          Insurance Programs.
63.....................  Notice of New Interest Rate for Medicare
                          Overpayments and Underpayments.
64.....................  For Fiscal Intermediaries, a New Provider Type
                          80, Status Code CH, and Method of Recoupment
                          Codes. For Carriers and Durable Medical
                          Equipment.
                         Regional Carriers Status Code 2.
                         Provider Overpayment Reporting System User
                          Manual.
                         List of Status Codes.
                         Physician/Supplier Overpayment Reporting System
                          User Manual.
65.....................  Revised Reporting Requirements for Contractor
                          Reporting of Operational Workload Data
                          Physician Scarcity Area Quarterly Report (CMS
                          Form--1565F, CROWD Form6).
                         Completing Physician Scarcity Area Quarterly
                          Report Form CMS 1565F, CROWD Form 6.
                         Physician Scarcity Area Quarterly Report, Line
                          Descriptors.
                         Error Descriptors.
                         Checking Reports.
66.....................  Chapter 7, Internal Control Requirements
                          Update.
                         Federal Managers' Financial Integrity Act of
                          1982.
                         Federal Managers Financial Integrity Act and
                          the CMS Medicare Contractor Contract.
                         Chief Financial Officers Act of 1990.
                         Office of Management & Budget Circular A-123.
                         General Accounting Office Standards for
                          Internal Controls in the Federal Government.
                         Fundamental Concepts.
                         Control Activities.
                         Monitoring.
                         Risk Assessment.
                         Internal Control Objectives.
                         Fiscal Year 2005 Medicare Control Objectives.
                         Policies and Procedures.
                         Control Activities.
                         Testing Methods.
                         Documentation and Working Papers.
                         Requirements.
                         Certification Statement.
                         Executive Summary.
                         Certification Package for Internal Controls
                          Report of Material Weaknesses.
                         Certification Package for Internal Controls
                          Report of Reportable Conditions.
                         Definitions and Examples of Reportable
                          Conditions and Material Weaknesses.
                         Material Weaknesses Identified During the
                          Fiscal Year.
                         Corrective Action Plans.
                         Submission, Review, and Approval of Corrective
                          Action Plans.
                         Corrective Action Plan Reports.
                         CMS Finding Numbers.
                         Initial Corrective Action Plan Report.
                         Quarterly Corrective Action Plan Report.
                         Entering Data: Initial or Quarterly Corrective
                          Action Plan Report.
------------------------------------------------------------------------
            Medicare State Operations Manual (CMS Pub. 100-07)
------------------------------------------------------------------------
 00....................  None
------------------------------------------------------------------------
              Medicare Program Integrity (CMS Pub. 100-08))
------------------------------------------------------------------------
 93....................  This Transmittal has been rescinded and
                          replaced by Transmittal 102.
------------------------------------------------------------------------

[[Page 36629]]

 
94.....................  Informing Beneficiaries About Which Local
                          Medical Review Policy and/or Local Coverage
                          Determination and/or National Coverage.
                         Determination Is Associated With Their Claim
                          Denial.
                         Prepayment Edits.
95.....................  Change in Provider Enrollment Appeals Process.
                         Administrative Appeals.
96.....................  Consent Settlements.
                         Postpayment Review Case Selection.
                         Location of Postpayment Reviews.
                         Re-adjudication of Claims.
                         Calculation of the Correct Payment Amount and
                          Subsequent Over/Underpayment.
                         Notification of Provider(s) or Supplier(s) and
                          Beneficiaries of the Postpayment Review
                          Results.
                         Provider(s) or Supplier(s) Rebuttal(s) of
                          Findings.
                         Evaluation of the Effectiveness of Postpayment
                          Review and Next Steps.
                         Consent Settlement Instructions.
                         Background on Consent Settlement.
                         Opportunity to Submit Additional Information
                          Before Consent Settlement Offer.
                         Consent Settlement Offer.
                         Election to Proceed to Statistical Sampling for
                          Overpayment Estimation.
                         Acceptance of Consent Settlement Offer.
                         Consent Settlement Budget and Performance
                          Requirements for Medicare Contractors.
97.....................  Provider Enrollment and Inpatient
                          Rehabilitation Facility (IRF) Compliance
                          Reviews.
98.....................  Psychotherapy Notes.
                         Additional Documentation Requests During
                          Prepayment or Postpayment Medical Review.
99.....................  Program Integrity Manual Modification--Changes
                          Waivers Approved by the Regional Office by
                          Replacing Regional Office With Central Office.
                         Contractor Medical Director.
                         Benefit Integrity Security Requirements.
                         The Carrier Advisory Committee.
100....................  Review of Documentation During Medical Review.
                         Additional Documentation Requests During
                          Prepayment or Postpayment Medical Review.
                         Documentation in the Patient's Medical Records.
101....................  Benefit Integrity Personal Information Manager
                          Revisions.
                         Sources of Data for Program Safeguard
                          Contractors.
                         Procedural Requirements.
                         Benefit Integrity Security Requirements.
                         Requests for Information From Outside
                          Organizations.
                         Program Safeguard Contractor and Medicare
                          Contractor Coordination With Other Program.
                         Safeguard Contractors and Medicare Contractors.
                         Complaint Screening.
                         Types of Fraud Alerts.
                         Alert Specifications.
                         Editorial Requirements.
                         Coordination.
                         Distribution of Alerts.
                         Information Not Captured in the Fraud
                          Investigation Database.
                         Initial Entry Requirements for Investigations.
                         Designated Program Safe Guard and Medicare
                          Contractor Background Investigation.
                         Unit Staff and the Fraud Investigation
                          Database.
                         Affiliated Contractor and Program Safeguard
                          Contractor Coordination on Voluntary Refunds.
                         Referral of Cases to the Office of the
                          Inspector General/Office of Investigations.
                         Referral to State Agencies or Other
                          Organizations.
                         Civil Monetary Penalties Delegated to Office of
                          the Inspector General.
                         Annual Deceased-Beneficiary Postpayment Review.
                         Vulnerability Report.
102....................  Medical Review of Rural Air Ambulance Services.
                         ``Reasonable'' Requests.
                         Emergency Medic
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.