[Federal Register: June 27, 2008 (Volume 73, Number 125)] [Notices] [Page 36595-36694] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27jn08-120] [[Page 36595]] ----------------------------------------------------------------------- Part II Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--January Through March 2008; Notice [[Page 36596]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9046-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--January Through March 2008 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 2008 through March 2008, 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 and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery 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 need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing 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 CMS manual instructions in Addendum III may be addressed to Ismael Torres, 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) 786-1864. Questions concerning regulation documents published in the Federal Register in Addendum IV may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954. 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, C1-13- 04, 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 Melissa Musotto, 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) 786-6962. Questions concerning Medicare-approved carotid stent facilities in Addendum VIII may be addressed 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 Medicare's recognition of the American College of Cardiology-National Cardiovascular Data Registry sites in Addendum IX may be addressed to JoAnna Baldwin, MS, 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) 786-7205. Questions concerning Medicare's active coverage-related guidance documents in Addendum X may be addressed to Beverly Lofton, 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) 786-7136. Questions concerning one-time notices regarding national coverage provisions in Addendum XI may be addressed to Beverly Lofton, 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) 786-7136. Questions concerning National Oncologic Positron Emission Tomography Registry sites in Addendum XII may be addressed to Stuart Caplan, RN, MAS, 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) 786-8564. Questions concerning Medicare-approved ventricular assist device (destination therapy) facilities in Addendum XIII may be addressed to JoAnna Baldwin, MS, 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) 786-7205. Questions concerning Medicare-approved lung volume reduction surgery facilities listed in Addendum XIV may be addressed to JoAnna Baldwin, MS, 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) 786-7205. Questions concerning Medicare-approved bariatric surgery facilities listed in Addendum XV may be addressed to Kate Tillman, RN, MA, 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) 786-9252. Questions concerning fluorodeoxyglucose positron emission [[Page 36597]] tomography for dementia trials listed in Addendum XVI may be addressed to Stuart Caplan, RN, MAS, 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) 786-8564. 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 11 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 standards for performing carotid artery stenting for high risk patients. Addendum IX includes a list of the American College of Cardiology's National Cardiovascular Data registry sites. We cover implantable cardioverter defibrillators (ICDs) for certain indications, as long as information about the procedures is reported to a central registry. Addendum X includes a list of active CMS guidance documents. As required by section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173, enacted on December 8, 2003), we will begin listing the current versions of our guidance documents in each quarterly listings notice. Addendum XI includes a list of special one-time notices regarding national coverage provisions. We are publishing a list of issues that require public notification, such as a particular clinical trial or research study that qualifies for Medicare coverage. Addendum XII includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. Addendum XIII includes a listing of Medicare-approved facitilites that receive coverage for ventricular assist devices used as destination therapy. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy. Addendum XIV includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial are also eligible to receive coverage. Addendum XV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities [[Page 36598]] must meet our standards in order to receive coverage for bariatric surgery procedures. Addendum XVI includes a listing of Medicare-approved clinical trials for fluorodeoxyglucose positron emission tomography (FDG-PET) for dementia and neurodegenerative diseases. 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: http://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) 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 http:// 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. CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. 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 http:// 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, 2005. (Updated titles of the Social Security Laws are available on the Internet at http://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 Benefit Policy publication titled ``Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions,'' use CMS-Pub. 100-03, Transmittal No. 80. (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 4, 2008. Jacquelyn Y. 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. March 24, 2006 (71 FR 14903) June 23, 2006 (71 FR 36101) September 29, 2006 (71 FR 57604) December 22, 2006 (71 FR 77202) March 30, 2007 (72 FR 15282) June 22, 2007 (72 FR 34508) September 28, 2007 (72 FR 55282) December 28, 2007 (72 FR 73990) April 1, 2008 (73 FR 17422) 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 [[Page 36599]] 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 2008 ------------------------------------------------------------------------ Transmittal No. Manual/Subject/Publication No. ------------------------------------------------------------------------ Medicare General Information (CMS-Pub. 100-01) ------------------------------------------------------------------------ 00.......................... None. ------------------------------------------------------------------------ Medicare Benefit Policy (CMS-Pub. 100-02) ------------------------------------------------------------------------ 80.......................... Requirements for Ordering and Following Orders for Diagnostic Tests Clinical Laboratory Services; Requirements for Ordering and Following Orders for Diagnostic Tests Definitions; Interpreting Physician Determines a Different Diagnostic Test is Appropriate; Rules for Testing Facility to Furnish Additional Tests; Rules for Testing Facility Interpreting Physician to Furnish Different or Additional Tests; Surgical/Cytopathology Exception. 81.......................... Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen. 82.......................... January 2008 Update of the Hospital Outpatient Prospective Payment System; Manualization; Outpatient Hospital Services; Limitations on Coverage of Certain Services Furnished to Hospital Outpatients; General Rule; Exception to Limitation; Outpatient Defined; Encounter Defined; Diagnostic Services Defined; Coverage of Outpatient Diagnostic Services; Outpatient Diagnostic Services Under Arrangements; Diagnostic Services Defined; Coverage of Outpatient Diagnostic Services; Outpatient Diagnostic Services Under Arrangements; Outpatient Therapeutic Services; Diagnostic Service Defined; Coverage of Outpatient Diagnostic Services; Outpatient Diagnostic Services Under Arrangements; Outpatient Therapeutic Services; Coverage of Outpatient Therapeutic Services Incident to a Physicians Service; Furnished on or After August 1, 2000; Outpatient Observation Services; Laboratory Services Furnished to Nonhospital Patients by Hospital Laboratory. 83.......................... Clinical Lab: New Automated Test for the AMCC Panel Payment Algorithm Automated Multi-Channel Chemistry Tests. 84.......................... Update to Audiology Policies; Audiological Diagnostic Testing; Definition of Qualified Audiologist. 85.......................... Psychological and Neuropsychological Tests. ------------------------------------------------------------------------ Medicare National Coverage Determination (CMS-Pub. 100-03) ------------------------------------------------------------------------ 80.......................... Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions. ------------------------------------------------------------------------ Medicare Claims Processing (CMS-Pub. 100-04) ------------------------------------------------------------------------ 1405........................ SUBJECT: Reprocessing of Certain Hospital Inpatient Prospective Payment System Claims. 1406........................ January 2008 Quarterly Average Sales Price Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files. 1407........................ Outpatient Therapy Caps Without KX Modifier Exceptions Start January 1, 2008 The Financial Limitation. 1408........................ Modification to the Model Medicare Redetermination Notice (for Partly or Fully Unfavorable Redeterminations); Medicare Redetermination Notice (for Partly or Fully Unfavorable Redeterminations). 1409........................ Correction to Pub. 100-04, Chapter 17, Section 100.2.1; CAP Required Modifiers. 1410........................ Annual Type of Service Update. 1411........................ April 2008 Update to the Medicare Code Editor and Group. 1412........................ Reporting of Hematocrit or Hemoglobin Levels on All Claims for the Administration of Erythropoiesis Stimulating Agents Implementation of New Modifiers for Non-ESRD Indications, and Reporting of Hematocrit/Hemoglobin Levels on all Non-ESRD, Non-ESA Claims Requesting Payment for Anti-Anemia Drugs; Epoetin Alfa (EPO) Provided in the Hospital Outpatient Department; Payment for Aranesp in the Hospital Outpatient Department; Reporting of Hematocrit and/ or Hemoglobin Levels; Required Modifiers for ESAs As Administered to Non-ESRD Patients; Hospitals Billing for EPO and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients; The Competitive Acquisition Program for Drugs and Biologicals Not Paid on a Cost or Prospective Payments Basis; Claims Processing Instructions for CAP Claims for the Local Carriers; Items 14-33 Provider of Service or Supplier Information. 1413........................ Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions; Claims Processing Rules for ESAs Administered to Cancer Patients for Anti- Anemia Therapy. 1414........................ Outpatient Therapy Caps without KX Modifier Exceptions Start January 1, 2008 The Financial Limitation. 1415........................ Additional Payable ``C'' Drug Codes for January 1, 2008 in ASCs. 1416........................ Clarification of Bone Mass Measurement Billing Requirements; Bone Mass Measurements; Payment Methodology and Healthcare Common Procedure Coding Systems (HCPCS) Coding. 1417........................ January 2008 Update of the Hospital Outpatient Prospective Payment System. 1418........................ New Healthcare Common Procedure Coding System Modifiers when Billing for Patient Care in Clinical Research Studies; Carrier Specific Requirements for Certain Specialties/Services; Billing Requirements for Providers Billing Routine Costs of Clinical Trials; Involving a Category A Investigation Device Exemptions; Billing Requirements for Providers Billing Routine Costs of Clinical Trials; Involving a Category B Investigation Device Exemptions; Billing Requirements for Clinical Trials; Reserved for Future Use. 1419........................ January 2008 Integrated Outpatient Code Specifications Version 9.0. 1420........................ Clarification Regarding the Coordination of Benefits Agreement; Medigap Claim- Based Crossover Process; Supplemental Coverage/Medigap; COB Training Partner and Medigap Plan Crossover Claim Requirements; Patient and Insured Information; MSN Messages; Coordination of Benefits Agreement Medigap Claim-Based Crossover Process. [[Page 36600]] 1421........................ Update of Institutional Claims References; Billing Form as Request for Payment; Beneficiary Request for Payment on Provider Record--UB-92 and Electronic Billing (Part A and Part B); When an Inpatient Admission May Be Changed to Outpatient Status; Noncovered Charges on Outpatient Bills; Line-Item Modifiers Related to Reporting of Noncovered Charges When Covered and Noncovered Services Are on the Same Institutional Claim; Form Prescribed by CMS In Accordance with CMS Instructions; Handling Incomplete or Invalid Submissions; Payment Floor Standards; Data Element Requirements Matrix; Claim Change Reason Codes; Inpatient Part A Hospital Adjustment Bills; (previously 130.3.1.2)--Tolerance Guides for Submitting SNF Inpatient Adjustment Request; (previously 130.3.3)--SNF Inpatient Claim Adjustment Instructions; (previously 130.3.4)--Patient Does Not Return From SNF Leave of Absence, and Last Bill Reported Patient Status as Still Patient (30); Billing and Claims Processing Requirements Related to HINNs; Billing and Claims Processing Requirements Related to Expedited Determinations; Source of Admission-- Outpatient Hospital; Forms; DRG Grouper Program; Payment to Hospitals and Units Excluded from IPPS for Direct Graduate; Medical Education and Nursing and Allied Health (NandAH); Education for Medicare Advantage Enrollees; Adjustment Bills; Billing Requirements Under IRF PPS; Shared Systems and CWF Edits; System Edits; Benefits Exhausted; Completion of the Uniform (Institutional Provider) Bill (Form CMS-1450); Notice of Election for RNHCI; Required Data Elements on Claims for RNHCI Services; IPF PPS System Edits; Where to Report Modifiers on the UB-92 (Form CMS-1450) and ANSI X12N Formats; Optional Method for Outpatient Services: Cost-Based Facility Services Plus 115; Percent Fee Schedule Payment for Professional Services; Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers; Line Item Date of Service Reporting for Partial Hospitalization; Line Item Date of Service Reporting on Form CMS-1450; Off-Site CORF Services; Notifying Patient of Service Denial; Billing Skilled Nursing Facility PPS Service; Input/ Output Record Layout; Leave of Absence; Services in Excess of Covered Services; Billing Formats; Billing; Calculation of Case Mix Adjusted Composite Rate; In- Facility Dialysis Bill Processing Procedures; Required Information for In- Facility Claims Paid Under the Composite Rate; EPO Facility Billing Requirements; Aranesp Facility Billing Requirements; General Intermediary Bill Processing Procedures for Method I Home Dialysis Services; Required Billing Information for Method I Claims; Billable Revenue Codes Under Method II; Unbillable Revenue Codes Under Method II; General Billing Requirements; General Guidelines for Processing Home Health Agency Claims; Special Billing Situations Involving OASIS Assessment; Heathcare Common Procedure Coding System Coding Requirements; Payment Methodology and HCPCS Coding; General Billing Guidelines-- Intermediaries and Carriers; Intermediary Guidelines; Hospital Billing Under Part B; Billing and Payment Instructions for Fiscal Intermediaries (FIs); Requirements for Billing FIs for Immunosuppressive Drugs; Claims Submitted to FIs for Mass Immunizations of Influenza and Pneumococcal Pneumonia Vaccine; Healthcare Common Procedure Coding System and Diagnosis Codes for Mammography Services Diagnoses Codes; HHA Recertification for Home Oxygen Therapy; Billing/Claim Formats; ICD-9-CM Diagnosis and Procedure Codes; Billing Requirements for HBO Therapy for the Treatment of Diabetic Wounds of the Lower Extremities; Billing Requirements for Providers Billing Category B IDEs. 1423........................ Summary of Policies in the 2008 Medicare Physician Fee Schedule and the Telehealth Originating Site Facility Fee Payment Amount. 1424........................ Correction to Low Utilization Payment Adjustment Add-on Payments Under the Refined Home Health Prospective Payment System; Composition of Health Insurance Prospect Payment System Codes for Home Health Prospective Payment System; Request for Anticipated Payment; Home Health Prospective Payment System Claims; Input/Output Record Layout; Decision Logic Used by the Pricer on RAPs; Decision Logic Used by the Pricer on Claims; Special Billing Situations Involving OASIS Assessments; Temporary Suspension of Home Health Services. 1425........................ Medicare Part A Skilled Nursing Facility Prospective Payment System Pricer; Update FY 2008 for 2 Core-Based Statistical Areas with New Wage Index; Values-- Correction. 1426........................ Announcement of Medicare Rural Health Clinics and Federally Qualified Health Centers Payment Rate Increases; Payment Rate for Independent and Provider Based Rural Health Clinics and Federally Qualified Health Clinics. 1427........................ New Value Code to Report Patient Prior Payments. 1428........................ Issued to a specific audience, not posted Internet/Intranet due to Confidentiality of Instruction. 1429........................ Modification of Payment Window Edits in the Common Working File to Look at Line Item Dates of Service on Outpatient Claims; Outpatient Services Treated as Inpatient Services. 1430........................ Use of HCPCS V2787 When Billing Approved Astigmatism-Correcting; Intraocular Lens in Ambulatory Surgery Centers Physician Offices, and Hospital Outpatient Departments; Payment for Services and Supplies; Coding and General Billing Requirements. 1431........................ Update to the Implementation Date for Home Health Agencies Providing Durable Medical Equipment in Competitive Bidding Areas; General Guidelines for Processing Home Health Agency Claims; Home Health Prospective Payment System Consolidated Billing. 1432........................ Medicare Fee-for-Service Legacy Provider IDs Prohibited on Form CMS-1500 and Form CMS-1450 (UB-04) Claims; Carrier Data Element Requirements; Item 14-3 Provider of Service or Supplier Information. 1433........................ Smoking and Tobacco Use Cessation Counseling BILLING CODE Update; Health Common Procedure Coding System and Diagnosis Coding; Carrier Billing Requirements; FI Billing Requirements. 1434........................ Extension of the Dates of Service Eligible for the Physician Scarcity Area; Bonus Payment; Billing and Payment in a Physician Scarcity Area; ZIP Code Files; Billing and Payment in a Physician Scarcity Area; Identifying Physician Scarcity Area Locations. 1435........................ Emergency Update to the 2008 Medicare Physician Fee Schedule Database. 1436........................ Modifications to the National Coordination of Benefits Agreement; Crossover Process; Consolidated Claims Crossover Process; Consolidation of the Claims Crossover Process; Coordination of Benefits Agreement; Detailed Error Report Notification Process. 1437........................ Change in the Amount in Controversy Requirement for Administrative Law; Judge Hearings and Federal District Court Appeals; Right to an ALJ Hearing; Requests for U.S. District Court Review by a Party. 1438........................ Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 1439........................ Removal of Outdated References to Christian Science Sanatoria from Medicare Systems. 1440........................ Medicare, Medicaid, and State Children's Health Insurance Program Extension Act of 2007 Changes to Independent Laboratory Billing for the Technical Component of Physician Pathology Services; Technical Component of Physician Pathology; Hospital Patients. 1441........................ New ``K'' Code for Replacement Interface Material. 1442........................ Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. [[Page 36601]] 1443........................ Home Health Prospective Payment System Refinement and Rate; Update for Calendar Year 2008; Basis of Medicare Prospective Payment Systems and Case-Mix. 1444........................ Modification to Existing Medicare Summary Notice Procedures; Regarding the MSN Customer Service Information Box, Beneficiary Estate Information and the Appeals Address; Title Section of the MSN Appeals Section; Title Section. 1445........................ January 2008 Update of the Hospital Outpatient Prospective Payment System; Manualization; Payment Status Indicators; APC Payment Groups; Composite APCs; Calculation of APC Payment Rates; Packaging; Combinations of Packaged Services of Different Types That Are Furnished on the Same Date of Service; Discounting; Payment Adjustments; Outlier Adjustments; Calculation of Overall Cost to Charge Ratios for Hospitals; Paid Under the Outpatient Prospective Payment System and Community Mental Health Centers Paid Under the Hospital; Requirement to Calculate CCRs for Hospitals Paid Under OPPS and for CMHC Circumstances in Which CCRs Are Used; Selection of the CCR To Be Used; Mergers, Acquisitions, and Other Ownership Changes; New Providers and Providers with Cost Report Periods Less Than a Full Year; Substitution of Statewide CCRs for Extreme OPPS Hospital Specific CCRs; Methodology for Calculation of Hospital Overall CCR for Hospitals That Do Not Have Nursing and Paramedical Education Programs; Methodology for Calculation of Hospital Overall CCR for Hospitals That Have Nursing and Paramedical Education Programs; Methodology for Calculation of CCR for CMHCs; Location of Statewide CCRs, Tolerances for Use of Statewide CCRs in Lieu of Calculated CCRs, and Cost Centers To Be Used in the Calculation of CCRs; Reporting of CCRs for Hospitals Paid Under OPPS and for CMHCs; Packaged Revenue Codes; Revenue Codes for ``Sometimes Therapy'' Services; Use of Modifiers for Discontinued Services; OPPS Coinsurance; Outpatient Pricer; Outpatient Provider Specific File; Changes to the OPPS Pricer Logic Effective January 1, 2003; Billing for Devices Under the OPPS; Billing and Payment for Brachytherapy Sources; Billing for Brachytherapy Sources-- General; Definition of Brachytherapy Source for Separate Payment; Billing of Brachytherapy Sources Ordered for a Specific Patient; Billing for Brachytherapy Source Supervision, Handling, and Loading Costs; Transitional Outpatient Payments for CY 2006-CY 2008; Clinic and Emergency Visits; Critical Care Services; Special Services for OPPS Billing; Billing for Corneal Tissue; Hospital Services For Patients with End- Stage Renal Disease; Billing Codes for Intensity Modulated Radiation Therapy and Stereotactic; Billing for IMRT Planning and Delivery; Additional Billing Instructions for IMRT Planning; Billing for Multi-Source Photon (Cobalt 60-Based) Stereotactic Radiosurgery; Planning and Delivery; Billing for Linear Accelerator (Robotic Image-Guided and Non-Robotic Image-Guided) SRS Planning and Delivery; Billing for Amniotic Membrane; Billing and Payment for Cardiac Rehabilitation Services; Billing and Payment for Alcohol and/or Substance Abuse Assessment and Intervention Services; Billing for Cardiac Echocardiography Services; Cardiac Echocardiography Without Contrast; Cardiac Echocardiography With Contrast; Billing for Nuclear Medicine Procedures; Coding and Payment for Drugs, Biologicals, and Radiopharmaceuticals; Coding and Payment for Drug Administration; Observation Services Overview; Reporting Hours of Observation; Billing and Payment for Observation Services Furnished Between January 1, 2006 and December 31, 2007; Billing and Payment for All Hospital Observation Services Furnished Between January 1, 2006 and December 31, 2007; Separate and Packaged Payment for Direct Admission to Observation Between January 1, 2006 and December 31, 2007; Separate and Packaged Payment for Observation Services Furnished Between January 1, 2006 and December 31, 2007; Billing and Payment for Observation Services Furnished on or After January 1, 2008; Billing and Payment for Observation Services Beginning January 1, 2008; Billing and Payment for Direct Admission to Observation Care Beginning January 1, 2008; Services Not Covered as Observation Services; Hospital Billing Under Part B; Payment Rules for Drugs and Biologicals; Drugs, Biologicals, and Radiopharmaceuticals. 1446........................ Update to Common Working File (CWF Edits) 7284 and 7548; Indian Health Service/ Tribal Hospital Inpatient Social Admits; FI--Social Admissions. 1447........................ Reporting of Additional Data To Describe Services on Hospice Claims; Levels of Care; Data Required on Claim to FI. 1448........................ Adjudicating Claims for Immunosuppressive Drugs When Medicare Did Not Pay for the Original Transplant; Billing for Immunosuppressive Drugs. 1450........................ Update to the Common Working File to Allow the Posting of Skilled Nursing Facility and Swing Bed Claims to the Beneficiary's Spell of Illness When Qualifying Stay Criteria Are Not Met; Billing When Qualifying Stay or Transfer Criteria Are Not Met. 1451........................ Clinical Lab: New Automated Test for the AMCC Panel Payment Algorithm; Organ or Disease Oriented Panel. 1452........................ Instructions for Downloading the Medicare ZIP Code File for July 2008. 1453........................ Systems Changes for Prescription Order Numbers for the Competitive Acquisition Program for Part B Drugs and Biologicals; Submitting the Prescription Order Numbers and No Pay Modifiers; Further Editing on the Prescription Order Number; Carrier Specific Requirements for Certain Specialties/Services. 1454........................ Department of Veterans Affairs Claims Adjudication Services Project--New IOM Chapter--Pub. 100-04, Chapter 37 ``Department of Veterans Affairs Claims Adjudication Services Project''; Background on the Veterans Affairs Claims Adjudication Services Project; Requirements for Processing Veterans Affairs Claims; Department of Veterans Affairs Claims Adjudication: Coinsurance and Deductible; Generating Unsolicited Responses to the Veterans Affairs; Use of Legacy Provider Numbers After National Provider Identifiers Are Fully Implemented. 1455........................ Part B Drug Competitive Acquisition Program Quarterly Drug List Update. 1456........................ Manualization of Payment for Outpatient End-Stage Renal Disease-Related Services; Monthly Capitation Payment Method for Physicians' Services Furnished to Patients on Maintenance Dialysis; Payment for End-Stage Renal Disease-Related Services Under the Monthly Capitation Payment; (Center-Based Patients); Payment for Managing Patients on Home Dialysis; Patients Who Switch Modalities (Center to Home and Vice Versa); Payment for End- Stage Renal Disease-Related Services (Per Diem); Guidelines for Physician or Practitioner Billing (Per Diem); Data Required on Claim for Monthly Capitation Payment; Controlling Claims Paid Under the Monthly Capitation Payment Method. 1457........................ Redeterminations of Overpayments; The Redetermination. 1458........................ Teaching Physician Requirements for End- Stage Renal Disease Monthly; Capitation Payment; Miscellaneous. 1459........................ Comprehensive Outpatient Rehabilitation Facility Billing Requirement; Updates for Fiscal Year 2008; Allowable Revenue Codes on Comprehensive Outpatient Rehabilitation Facility; 75x Bill Types; Proper Reporting of Nursing Services by CORFS--FIs; Payment of Drugs, Biologicals, and Supplies in a Comprehensive Outpatient Rehabilitation Facility; Billing for Social Work and Psychological Services in a Comprehensive Outpatient Rehabilitation Facility; Billing for Respiratory Therapy Services in a Comprehensive Outpatient Rehabilitation Facility; FI Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis B; Virus Vaccines and Their Administration. 1460........................ Subsequent Hospital Visits and Hospital Discharge Day Management Services (Codes 99231--99239). [[Page 36602]] 1461........................ Clarification to CR 5744--Payment Allowance Update for the Influenza Virus Vaccine CPT 90660 and Further Instruction Regarding the Pneumococcal Vaccine CPT 90669; Healthcare Common Procedure Coding System and Diagnosis Codes. 1462........................ Healthcare Provider Taxonomy Codes Update April 2008. 1463........................ ZIP Code Files by Date of Service; Claims Processing Instructions for Payment Jurisdiction for Claims Received on or after April 1, 2004; Transition Overview. 1464........................ Quarterly Update to Correct Coding Initiative (CCI) Edits, Version 14.1, Effective April 1, 2008. 1465........................ Payment for Initial Hospital Care Services (Codes 99221-99233) and Observation or Inpatient Care Services (Including Admission and Discharge Services) (Codes 99234-99236). 1466........................ Payment for Hospital Observation Services (Codes 99217-99220) and Observation or Inpatient Care Services (Including Admission and Discharge Services--Codes 99234-99236). 1467........................ Modification to Existing Medicare Summary Notice Procedures Regarding the Customer Service Information Box; Title Section of the Medicare Summary Notice; Appeals Section. 1468........................ Claim Status Category Code and Claim Status Code Update. 1469........................ Document Control Number Search Feature. 1470........................ Update to Audiology Policies; Audiological Diagnostic Tests, Speech-Language Evaluations and Treatments. 1471........................ Healthcare Common Procedure Coding System Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments Edits. 1472........................ Update of Institutional Claims References; Billing Form as Request for Payment; Beneficiary Request for Payment on Provider Record--UB-04 and Electronic Billing (Part A and Part B); When an Inpatient Admission May Be Changed to Outpatient Status; Noncovered Charges on Outpatient Bills; Line-Item Modifiers Related to Reporting of Noncovered Charges; When Covered and Noncovered Services Are on the Same Institutional Claim Form Prescribed by CMS In Accordance with CMS Instructions; Handling Incomplete or Invalid Submissions; Payment Floor Standards; Data Element Requirements Matrix; Claim Change Reason Codes; Inpatient Part A Hospital Adjustment Bills; Tolerance Guides for Submitting SNF Inpatient Adjustment Requests; SNF Inpatient Claim Adjustment Instructions; Patient Does Not Return From SNF Leave of Absence, and Last Bill Reported; Patient Status as Still Patient (30); Billing and Claims Processing Requirements Related to HINNs; Billing and Claims Processing Requirements Related to Expedited Determinations; Data Element Requirements Matrix (FI); Source of Admission-- Outpatient Hospital; Forms; DRG GROUPER Program; Payment to Hospitals and Units Excluded from IPPS for Direct Graduate Medical Education and Nursing and Allied Health (NandAH) Education for Medicare AdvantageEnrollees; Adjustment Bills; Billing Requirements Under IRF PPS; Shared System and CWF Edits; System Edits; Benefits Exhausted; Completion of the Uniform (Institutional Provider) Bill (Form CMS-1450) Notice of Election for RNHCI; Required Data Elements on Claims for RNHCI Services; IPF PPS System Edits; Where to Report Modifiers on the UB-92 (Form CMS-1450) and ANSI X12N Formats; Bill Review for Partial Hospitalization; Services Provided in Community Mental Health Centers; Line Item Date of Service Reporting for Partial Hospitalization; Line Item Date of Service Reporting on Form CMS-1450; Off-Site CORF Services; Notifying Patient of Service Denial; Billing SNF PPS Services; Input/Output Record Layout; Leave of Absence; Services in Excess of Covered Services; Billing Formats; Billing; Calculation of Case Mix Adjusted Composite Rate; Facility Dialysis Bill Processing Procedures; Required Information for In-Facility Claims Paid Under the Composite Rate; Epoetin Alfa (EPO) Facility Billing Requirements; Darbepoetin Alfa (Aranesp) Facility Billing Requirements; General Intermediary Bill Processing Procedures for Method I Home Dialysis Services; Required Billing Information for Method I Claims; Billable Revenue Codes Under Method II; Unbillable Revenue Codes Under Method II; General Billing Requirements; Special Billing Situations Involving OASIS Assessments; Healthcare Common Procedure Coding System Coding Requirements; Payment Methodology and Healthcare Common Procedure Coding System Coding; General Billing Guidelines-- Intermediaries and Carriers; Intermediary Guidelines; Hospital Billing Under Part B; Billing and Payment Instructions for FIs; Requirements for Billing FI for Immunosuppressive Drugs; Claims Submitted to FIs for Mass Immunizations of Influenza and PPV; HCPCS and Diagnosis Codes for Mammography Services; Diagnoses Codes; HHA Recertification for Home Oxygen Therapy; Billing/Claim Formats; ICD-9-CM Diagnosis and Procedure Codes; Billing Requirements for HBO Therapy for th