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 2003 through March 2003, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare. Finally, this notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations.
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, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.
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 Karen Bowman, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-5252.
Questions concerning national coverage determinations in Addendum V should be directed 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 Investigational Device Exemptions items in Addendum VI may be addressed to Sharon Hippler, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C5-13-27, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4633.
Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Dawn Willingham, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6141.
Questions concerning all other information may be addressed to Margie Teeters, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-13-18, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4678.
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 these 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, fiscal intermediaries and carriers 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, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the 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, national coverage determinations, and Food and Drug Administration-approved investigational device exemptions published during the timeframe 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 Coverage Issues Manual (CIM) may wish to review the August 21, 1989 publication (54 FR 34555). Those interested in the procedures used in making national coverage determinations under the Medicare program may review the April 27, 1999 publication (64 FR 22619).
To aid the reader, we have organized and divided this current listing into six 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 instruction or many. 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 quarters covered by this notice. For each item we list the—
- Date published;
- Federal Register citation;
- Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
- Agency file code number; and
- Title of the regulation.
- Addendum V includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the CIM 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 Food and Drug Administration-approved investigational device exemption categorizations, using the investigational device exemption numbers the Food and Drug Administration 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 investigational device exemption 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 of the Code of Federal Regulations (CFR) and in title 45 CFR, subchapter C. These collections of information, which OMB has approved, are being included for the first time in this quarterly listing of program issuances.
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.access.gpo.gov/nara/index.html,, by using local WAIS client software, or by telnet to swais.access.gpo.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 http://cms.hhs.gov/rulings.
D. CMS's 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 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.
Superintendent of Documents numbers for each CMS publication are shown in Addendum III, along with the CMS publication and transmittal numbers. To help FDLs locate the materials, use the Superintendent of Documents number, plus the transmittal number. For example, to find the Part 3—Claims Process, (CMS Pub. 13-3) transmittal entitled “Ambulance Services,” use the Superintendent of Documents No. HE 22.8/6 and the transmittal number 1877.
(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 19, 2003.
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.
August 11, 1998 (63 FR 42857)
September 16, 1998 (63 FR 49598)
December 9, 1998 (63 FR 67899)
May 11, 1999 (64 FR 25351)
November 2, 1999 (64 FR 59185)
December 7, 1999 (64 FR 68357)
January 10, 2000 (65 FR 1400)
May 30, 2000 (65 FR 34481)
June 28, 2002 (67 FR 43762)
September 27, 2002 (67 FR 61130)
December 27, 2002 (67 FR 79109)
March 28, 2003 (68 FR 15196)
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 Medicare Coverage Issues Manual (CIM) 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 (57 FR 47468).
Addendum III.—Medicare and Medicaid Manual Instructions
[January 2003 through March 2003]
| Transmittal No. | Manual/subject/publication No. | |
|---|---|---|
| Intermediary Manual | ||
| Part 2—Audits, Reimbursement, Program | ||
| Administration | ||
| (CMS-Pub. 13-2) | ||
| (Superintendent of Documents No. HE 22.8/6-3) | ||
| 421 | • | Provider Communications—Provider Education and Training |
| 422 | • | Beneficiary Services |
| 423 | • | Provider Services, Inquiries |
| Intermediary Manual | ||
| Part 3—Claims Process | ||
| (CMS-Pub. 13-3) | ||
| (Superintendent of Documents No. HE 22.8/6) | ||
| 1872 | • | Prospective Payment for Outpatient Rehabilitation Services and the Financial Limitation |
| 1873 | • | Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines |
| 1874 | • | Pneumococcal Pneumonia, Influenza Virus and Hepatitis B Vaccines |
| 1875 | • | Review of Form HCFA-1450 for Inpatient and Outpatient Bills |
| 1876 | • | Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers |
| Hospital Outpatient Partial Hospitalization Services | ||
| 1877 | • | Ambulance Services |
| 1878 | • | Intestinal and Multi-Visceral Transplants |
| Provider Education | ||
| Carriers Manual | ||
| Part 2—Program Administration | ||
| (Superintendent of Documents No. HE 22.8/7-3) | ||
| (CMS-Pub. 14-2) | ||
| 146 | • | Provider/Supplier Communications—Provider/Supplier Education and Training |
| 147 | • | Beneficiary Services |
| 148 | • | Provider Services, Inquiries |
| Carriers Manual | ||
| Part 3—Claims Process | ||
| (CMS-Pub. 14-3) | ||
| (Superintendent of Documents No. HE 22.8/7) | ||
| 1785 | • | Coding for Non-Covered Services and Services Not Reasonable and Necessary |
| 1786 | • | Carrier Use of Undeliverable Notices for Utilization, Fraud, and Quality Control |
| 1787 | • | Ordering Diagnostic Tests |
| Payment Conditions for Radiology Services | ||
| 1788 | • | HCPCS Coding |
| 1789 | • | Railroad Retirement Beneficiary Carrier |
| United Mine Workers of America | ||
| Title XIX Beneficiaries Residing in California | ||
| Disposition of Misdirected Claims | ||
| 1790 | • | Zip Code File on the Direct Connect |
| 1791 | • | Disposition of Misdirected Claims |
| Parenteral and Enteral Nutrition (PEN) Claims Jurisdiction | ||
| 1792 | • | Claims Processing Procedures for Physician/Supplier Services to HMO Members |
| Program Memorandum | ||
| Intermediaries (CMS-Pub. 60A) | ||
| (Superintendent of Documents No. HE 22.8/6-5) | ||
| A-02-128 | • | Revision to 42 CFR 405.371 Suspension, Offset and Recoupment of Medicare Payments to Providers and Suppliers of Services |
| A-02-129 | • | 2003 Update of the Hospital Outpatient Prospective Payment System |
| A-03-001 | • | January Medicare Outpatient Code Editor Specifications Version 18.1 For Bills From Hospitals That Are Not Paid Under the Outpatient Prospective Payment System |
| A-03-002 | • | Installation of Version 28.0 Add-On of the Provider Statistical and Reimbursement Report |
| A-03-003 | • | January Outpatient Code Editor Specifications Version (V4.0) |
| A-03-004 | • | Calculating Provider-Specific Medicare Outpatient Cost-to-Charge Ratios and Instructions on Cost Report Treatment of Hospital Outpatient Services Paid on a Reasonable Cost Basis |
| A-03-005 | • | Health Insurance Portability and Accountability Act Transaction 835v4010 Companion Document Update for Intermediaries |
| A-03-006 | • | Update the Medicare Secondary Payment Module to Apportion Prospective Payment System (PPS) Outlier Amounts to all Service Lines With Medicare Reimbursement That Are PRICER Related and Potential Outlier Service Lines |
| A-03-007 | • | Payment to Hospitals and Units Excluded from the Acute Inpatient Prospective Payment System for Direct Graduate Medical Education and Nursing and Allied Health Education for Medicare+Choice Enrollees |
| A-03-008 | • | Clarification of 3-Day Payment Window vs. 1-Day Payment Window for Hospitals Excluded from Inpatient Prospective Payment System |
| A-03-009 | • | Medical Nutrition Therapy Services for Beneficiaries with Diabetes or Renal Disease |
| A-03-010 | • | Manual Medical Review Indicator for the Comprehensive Error Rate Testing Program |
| A-03-011 | • | Changes in Payment for Certain Services Provided by Outpatient Physical Therapy Providers Under the Medicare Physician Fee Schedule |
| A-03-012 | • | The Report of Benefit Savings |
| A-03-013 | • | 3-Day Payment Window Refinements Under the Short-Term Hospital Inpatient Prospective Payment System |
| A-03-014 | • | Further Guidance Regarding Billing Under the Outpatient Prospective Payment System |
| A-03-015 | • | Electromagnetic Stimulation |
| A-03-016 | • | Continuous Home Care Under Medicare Hospice |
| A-03-017 | • | Payment for Services To Be Paid on a Fee Schedule But for Which There Is No Price |
| A-03-018 | • | Installation of Version 28.0 Second Add-On of the Provider Statistical and Reimbursement Report |
| A-03-019 | • | Reactivation of Outpatient Prospective Payment System Outpatient Code Editor Edit 15, “Service Unit Out Of Range” and Guidance on Editing for Low Osmolar Contrast Media Procedures |
| A-03-020 | • | April 2003 Update of the Hospital Outpatient Prospective Payment System |
| A-03-021 | • | Announcement of Medicare Rural Health Clinics and Federally Qualified Health Centers Payment Rate Increases, Clarification on Coverage and Payment of Diabetes Self-Management Training Services and Medical Nutrition Therapy Services |
| A-03-022 | • | Installation of Version 29.0 of the Provider Statistical and Reimbursement Reporting System—Modification |
| A-03-023 | • | Implementation of the Temporary Equalization of Urban and Rural Standardized Payment Amounts Under the Medicare Inpatient Hospital Prospective Payment System as Required by Section 402(b) of Public Law 108-7 |
| Program Memorandum | ||
| B-03-001 | • | Emergency Update to the 2003 Medicare Physician Fee Schedule Database |
| B-03-002 | • | DMERCs-VIPS Medicare System Implementation To Process ICD-9 CM Codes Using Date of Service and Not Date of Receipt |
| B-03-003 | • | Processing Initial Denials, of the DMEPOS Refund Requirements Implementation of Limits on Beneficiary Liability for Medical Equipment and Supplies—Change |
| B-03-004 | • | CWF Change for Billing for Glucose Test Strips and Supplies—Follow-up to Change Request 2156 |
| B-03-005 | • | Reporting of Accident Date and Ambulance Certification Information on the X12N 837 (version 4010) Coordination of Benefits Transaction |
| B-03-006 | • | Program Integrity Management Reporting System for Part B—Correction of Multiple Reports of Savings by VIPS Standard Systems (i.e., VIPS Medicare System and Durable Medical Equipment Regional Contractor System) |
| B-03-007 | • | Minimum Number of Pricing Files That Must Be Maintained Online for Medicare Physician Fee Schedule Services |
| B-03-008 | • | Medical Review Progressive Corrective Action Continuation of Work Begun in Compliance with Change Request 2433 |
| B-03-009 | • | Durable Medical Equipment Regional Carriers—New Modifier Needed To Invoke Advanced Beneficiary Notice Logic for Hard Copy and Electronic Claims |
| B-03-010 | • | Program Integrity Management Reporting System for Part B—Implementation of an Automated Edit Description Module |
| B-03-011 | • | Correct Payment of January and February 2003 Physician Services |
| B-03-012 | • | Use of the National Drug Code for Drug Claims at the Durable Medical Equipment Regional Carriers |
| B-03-013 | • | Continuation of April 2003 Change Request 2424: Create Import/Export Functionality Between the Unique Provider Identification Number System and the Provider Enrollment Chain Ownership System |
| B-03-014 | • | Continuation of April 2003 Change Request 2425: Create Import/Export Functionality Between the Medicare Claims System (MCS) and the Provider Enrollment Chain Ownership System |
| B-03-015 | • | Continuation of April 2003 Change Request 2426: Process all Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System; Modify the Medicare Claims System To Incorporate All Claim Payment and Provider Correspondence Functionality That Is Included in the Provider Enrollment System But Will Not Be a Part of Provider Enrollment Chain Ownership System |
| B-03-016 | • | Continuation of April 2003 Change Request 2427: Process all Medicare Part B Provider Enrollments in the Provider Enrollment Chain Ownership System; Create Import/Export Functionality Between the Viable Medicare System and the Provider Enrollment Chain Ownership System |
| B-03-017 | • | Add-On-Codes for Anesthesia |
| B-03-018 | • | Changes to Correct Coding Edits, Version 9.2, Effective July 1, 2003 |
| B-03-019 | • | Durable Medical Equipment Regional Carriers and Part B Carriers on the VMS Standard System—Short Descriptions of National Modifiers on the Healthcare Common Procedure Coding System Tape |
| B-03-020 | • | 2003 DMEPOS Jurisdiction List |
| B-03-021 | • | Provider Education Regarding Home Health Consolidated Billing and Provider Liability |
| B-03-022 | • | Use of Statistical Sampling for Overpayment Estimation When Performing Administrative Reviews of Part B Claims |
| Program Memorandum | ||
| AB-03-001 | • | Medicare Coverage of Non-Invasive Vascular Studies for End-Stage Renal Disease Patients |
| AB-03-002 | • | Quarterly Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement |
| B-03-003 | • | Noncoverage of Multiple Electroconvulsive Therapy |
| B-03-004 | • | Installation of a Security Firewall for Deceased Beneficiary Files (Options B & C) |
| AB-03-005 | • | FY 2003 Systems Security Activities and Due Dates |
| AB-03-006 | • | April Quarterly Update for 2003 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule |
| AB-03-007 | • | Second Clarification of Medicare Policy Regarding the Implementation of the Ambulance Fee Schedule |
| AB-03-008 | • | Clarification of Physician Certification Requirements for Medicare Hospice |
| AB-03-009 | • | The Medicare Exclusion Database Replaces Publication 69 |
| AB-03-010 | • | Shared System Maintainer Hours for Resolution of Problems Detected During Health Insurance Portability and Accountability Act Transaction Release Testing |
| AB-03-011 | • | Identifying the Primary Payer Amounts To Send to the Medicare Secondary Payer Pay Module and the Shared Systems When There Are Multiple Primary Payers on Electronic and Hardcopy Claims |
| AB-03-012 | • | Remittance Advice Remark and Reason Code Update |
| AB-03-013 | • | New Waived Tests—December 17, 2002 |
| AB-03-014 | ÷ | Single Drug Pricer |
| AB-03-015 | • | Shared Systems Changes for Name Change from HCFA to CMS (MCS and CWF External Changes Only) |
| AB-03-016 | • | CR 2240 Question and Answer Document |
| AB-03-017 | • | Scheduled Release for April Updates to Software Programs and Pricing/Coding Files |
| AB-03-018 | • | Implementation of the Financial Limitation for Outpatient Rehabilitation Services |
| AB-03-019 | • | Notice of Interest Rate for Medicare Overpayments and Underpayments |
| AB-03-020 | • | Clarification of Transmittal AB-00-107, Change Request 1163, and Transmittal AB-00-129, Change Request 1460, Regarding the Coordination of Benefits |
| Contractor and MSP Prepay Work Activities for Customer Service, MSP and Standard Systems Contractor Staff | ||
| AB-03-021 | • | Additional Documentation Requests Requirements for Ordering Providers of Laboratory Services |
| AB-03-022 | • | Use of the American Medical Association's Physicians' Current Procedural Terminology, Fourth Edition Codes on Contractors' Web Sites |
| AB-03-023 | • | Deep Brain Stimulation for Essential Tremor and Parkinson's Disease |
| AB-03-024 | • | Clarification of the Allocation of Initial Claim Entry Activities Where the Claim Is Paid Secondary by Medicare |
| AB-03-025 | • | System Networking Electronic Correspondence Referral System 1.3 User and Installation Guides for Testing and Production |
| AB-03-026 | • | Implementation of the Modifications (4010A1) to Transactions and Code Set Standards for Electronic Transactions Adopted Under the Health Insurance Portability and Accountability Act |
| AB-03-027 | • | Payment Change for the 2003 Medicare Physician Fee Schedule and Further Extension of the 2003 Participation Enrollment Process |
| AB-03-028 | • | Coverage and Billing of Sacral Nerve Stimulation |
| AB-03-029 | • | Health Care Claims Status Category Codes and Health Care Claim Status Codes for Use With the Health Care Claim Status Request and Response ASC X12N 276/277 |
| AB-03-030 | • | Changes to the Laboratory National Coverage Determination Edit Software for April 1, 2003 |
| AB-03-031 | • | Addition or Modification of Temporary “K” Codes and Change in Status for Code A4232 |
| AB-03-032 | • | File Names, Descriptions and Instructions for Retrieving the 2003 Ambulatory Surgical Center HCPCS Additions, Deletions, and Master Listing |
| AB-03-033 | • | Promoting Colorectal Cancer Screening As a Part of National Colorectal Cancer Awareness Month |
| AB-03-034 | • | Medicare Fee for Service Contractor Guidance on the HIPAA Privacy Rule |
| AB-03-035 | • | Emergency Changes to the 2003 Medicare Physician Fee Schedule Database |
| AB-03-036 | • | 270/271 Implementation and Direct Date Entry Eligibility |
| AB-03-037 | • | Provider Education Article: Medicare Payments for Part B Mental Health Services |
| AB-03-038 | • | Reporting Benefit Integrity Workload in CROWD |
| AB-03-039 | • | Procedure for Granting Extension to File Requests for Appeal Under the New 120-day Timeframe Created by section 521 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 |
| AB-03-040 | • | Provider Education Article: “Hospice Care Enhances Dignity and Peace As Life Nears Its End” |
| Hospital Manual | ||
| (Superintendent of Documents No. HE 22.8/2) | ||
| 796 | • | Pneumococcal Pneumonia, Influenza Virus, and Hepatitis B Vaccines |
| 797 | • | Pneumococcal Pneumonia, Influenza Virus, and Hepatitis B Vaccines |
| 798 | • | Billing for Hospital Outpatient Partial Hospitalization Services |
| 799 | • | Identifying Other Primary Players During the Admission Process |
| Hospice Manual | ||
| (CMS-Pub. 21) | ||
| (Superintendent of Documents No.) | ||
| 66 | • | Special Coverage Requirements |
| Coverage Issues Manual | ||
| (CMS-Pub. 6) | ||
| (Superintendent of Documents No. HE 22.8/14) | ||
| 166 | • | Multiple-Seizure Electroconvulsive Therapy |
| 167 | • | Treatment of Motor Function Disorders with Electric Nerve Stimulation—Not Covered |
| 167 | • | Deep Brain Stimulation for Essential Tremor and Parkinson's Disease |
| 168 | • | Ambulatory Blood Pressure Monitoring |
| Outpatient Physical Therapy | ||
| (CMS Pub. 9) | ||
| (Superintendent of Documents No. HE 2.8/9) | ||
| 17 | • | Billing Instructions for Partial Hospitalization Services Provided in Community Mental Health Centers |
| Provider Reimbursement Manual—Part 2 | ||
| Provider Cost Reporting Forms and Instructions | ||
| Chapter 35/Form CMS-2540-96 | ||
| (CMS-Pub. 15-2-35) | ||
| 12 | • | Skilled Nursing Facility Cost Report Form CMS-2540-96, and Is Effective for Cost Reporting Periods Ending on and After December 31, 2002 |
| Financial Management | ||
| (CMS-Pub. 100-06) | ||
| 13 | • | Intermediary Claims Accounts Receivable |
| Physician/Supplier Overpayment Reporting System Summary Entry Debts Financial Reporting for Intermediary Claims Accounts Receivable | ||
| 14 | • | General |
| 15 | • | FMFIA and the CMS Medicare Contractor |
| Risk Assessment | ||
| Fiscal Year 2003 Medicare Control Objectives | ||
| Documentation and Work Papers | ||
| Requirements | ||
| Certification Statement | ||
| Executive Summary | ||
| CPIC—Report of Material Weaknesses | ||
| CPIC—Report of Reportable | ||
| Conditions | ||
| Definitions and Examples of Reportable Conditions and Material Weaknesses | ||
| Corrective Action Plans | ||
| Submission, Review, and Approval of Corrective Action Plans | ||
| Universal Corrective Action Plan Report | ||
| CMS Finding Numbers | ||
| Program Integrity Manual | ||
| (CMS-Pub. 100-08) | ||
| 37 | • | Written Orders |
| Written Orders Prior to Delivery | ||
| 38 | • | Articles |
| 39 | • | Overview of Prepayment and Postpayment Review for MR Purposes |
| Determinations Made During Prepayment and Postpayment MR | ||
| Documentation Specifications for Areas Selected for Prepayment or Postpayment MR | ||
| Additional Documentation Requests During Prepayment of Postpayment MR | ||
| Handling Late Documentation | ||
| Denials | ||
| Documenting That a Claim Should Be Denied | ||
| Spreading Workload Evenly | ||
| Review That Involves Utilization Parameters | ||
| Prepayment Review of Claims for MR Purposes | ||
| Documentation Specifications for Areas Selected for MR | ||
| Laboratory Claims | ||
| Documentation for Non-Physician Claims | ||
| Development of Claims for Additional Documentation | ||
| Postpayment Review Case Selection | ||
| Location of Postpayment Reviews | ||
| Re-adjudication of Claims | ||
| Calculation of the Correct Payment Amount and Subsequent | ||
| Over/Underpayment | ||
| Provider(s) Rebuttal(s) of Findings |
Addendum IV.—Regulation Documents Published in the Federal Register
[January 2003 through March 2003]
| Publication date | FR Vol. 68 page | CFR Part(s) | File code* | Regulation title |
|---|---|---|---|---|
| 01/10/2003 | 1374 | 42 CFR 403, 416, 418, 460, 482, 483, 485 | CMS-3047-F | Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities. |
| 01/24/2003 | 3586 | 42 CFR 433 and 438 | CMS-2015-F | Medicaid Program; External Quality Review of Medicaid Managed Care Organizations. |
| 01/24/2003 | 3534 | CMS-3113-N | Medicare Program; Meeting of the Medicare Coverage Advisory Committee—March 12, 2003. | |
| 01/24/2003 | 3532 | CMS-2177-PN | Medicare and Medicaid Programs; Application by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Hospices. | |
| 01/24/2003 | 3482 | 42 CFR Chapter IV | CMS-6012-N4 | Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics. |
| 01/24/2003 | 3435 | 42 CFR 482 | CMS-3050-F | Medicare and Medicaid Programs; Hospital Conditions of Participation: Quality Assessment and Performance Improvement. |
| 02/10/2003 | 6750 | CMS-4051-N | Medicare Program; Renewal of the Advisory Panel on Medicare Education (APME) and Notice of Meeting of the Advisory Panel—February 27, 2003. | |
| 02/10/2003 | 6682 | 42 CFR 413 | CMS-1126-P | Medicare Program; Provider Bad Debt Payment. |
| 02/10/2003 | 6636 | 42 CFR 405 and 419 | CMS-1206-CN2 | Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates; and Changes to Payment Suspension for Unfiled Cost Reports; Correction. |
| 02/20/2003 | 8334 | 45 DCFR 160, 162, 164 | CMS-0049-F | Health Insurance Reform: Security Standards. |
| 02/28/2003 | 9681 | CMS-1225-GNC | Medicare Program; Criteria and Standards for Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2003. | |
| 02/28/2003 | 9680 | CMS-3099-N | Medicaid Program; Annual Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs). | |
| 02/28/2003 | 9673 | CMS-5002-N | Medicare Program; Demonstration: Capitated Disease Management for Beneficiaries With Chronic Illnesses. | |
| 02/28/2003 | 9672 | CMS-2165-N | Medicaid Program; Infrastructure Grant Program To Support the Competitive Employment of People With Disabilities. | |
| 02/28/2003 | 9671 | CMS-1245-N | Medicare Program; Request for Nominations To the Advisory Panel on Ambulatory Payment Classifications Groups. | |
| 02/28/2003 | 9567 | 42 CFR 410, 414, 485 | CMS-1204-F2 | Medicare Program; Physician Fee Schedule Update for Calendar Year 2003. |
| 03/05/2003 | 10420 | 42 CFR 412 | CMS-1243-P | Medicare Program; Proposed Change in Methodology for Determining Payment for Extraordinarily High-Cost Cases (Cost Outliers) Under the Acute Care Hospital Inpatient Prospective Payment System. |
| 03/07/2003 | 11234 | 42 CFR 412 | CMS-1472-P | Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Proposed Annual Payment Rate Updates and Policy Changes. |
| 03/07/2003 | 10987 | 42 CFR 412 | CMS-1177-F2 | Medicare Program; Prospective Payment System for Long-Term Care Hospitals: Implementation and FY 2003 Rates; Correcting Amendment. |
| 03/28/2003 | 15268 | 42 CFR 416 | CMS-1885-FC | Medicare Program; Update of Ambulatory Surgical Center List of Covered Procedures Effective July 1, 2003. |
| 03/28/2003 | 15207 | CMS-1230—N | Medicare Program; Public Meetings in Calendar Year 2003 for New Durable Medical Equipment Coding and Payment Determinations. | |
| 03/28/2003 | 15206 | CMS-1474-N | Medicare Program; Town Hall Meeting on the Inpatient Rehabilitation Facility Prospective Payment System. | |
| 03/28/2003 | 15196 | CMS-9016-N | Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October 2002 Through December 2002. | |
| 03/28/2003 | 15139 | 42 CFR Chapter IV | CMS-6012-N5 | Medicare Program; Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for Prosthetics and Certain Custom-Fabricated Orthotics; Meeting Announcement |
Addendum V—National Coverage Determinations [January 2003 Through March 2003]
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, 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 became effective 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 impending decisions or, in some cases, explain why it was not appropriate to issue an NCD. We identify completed decisions by section of the CIM 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 website at http://cms.hhs.gov/coverage.
National Coverage Decisions for Quarterly Notices
Coverage Issues Manual (CIM) HCFA Pub. 06
| CIM section | Title | Issue date | Effective date |
|---|---|---|---|
| 50-42 | Ambulatory Blood Pressure Monitoring | 03/28/03 | 07/01/03 |
| 35-103 | Multiple Monitored Electroconvulsive Therapy | 01/10/03 | 04/01/03 |
| 65-19 | Deep Brain Stimulation for Parkinson's | 02/14/03 | 04/01/03 |
| 35-102 | Electrical Stimulation for Wounds | 01/15/03 | 04/01/03+ |
Program Memorandum (PM)
| PM No. | Title | Issue date | Effective date |
|---|---|---|---|
| AB-03-030 | Clinical Laboratory Edit Update | 02/28/03 | 04/01/03 |
Addendum VI—Categorization of Food and Drug Administration-Allowed Investigational Device Exemptions
Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices fall into one of three classes. Also, under the new categorization process to assist CMS, the Food and Drug Administration assigns each device with a Food and Drug Administration-approved investigational device exemption to one of two categories.) Category A refers to experimental/investigational device exemptions, and Category B refers to nonexperimental/investigational device exemptions. 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 information presents the device number and category (A or B) for the first quarter, January through March 2003.
Investigational Device Exemption Numbers, 1st Quarter 2003
IDE/Category
G000247 B
G003004 B
G010216 B
G020225 B
G020231 B
G020240 A
G020244 B
G020247 B
G020248 B
G020262 B
G020279 B
G020299 B
G020301 B
G020308 B
G020310 B
G020311 B
G020314 B
G020315 B
G020317 B
G020318 B
G020319 B
G020320 B
G020324 B
G030003 A
G030004 B
G030006 B
G030012 B
G030013 B
G030014 B
G030016 B
G030018 B
G030019 B
G030020 B
G030021 B
G030023 B
G030024 B
G030025 B
G030028 B
G030030 B
G030033 B
G030035 B
G030036 B
G030037 B
G030041 B
G030043 A
G030048 B
G030049 B
G030052 B
G030053 B
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 and title 45, subchapter C, of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:
| OMB control nos. | Approved CFR sections in title 42 and title 45 |
|---|---|
| 0938-0008 | 414.40, 424.32, 424.44 |
| 0938-0022 | 413.20, 413.24, 413.106 |
| 0938-0023 | 424.103 |
| 0938-0025 | 406.28, 407.27 |
| 0938-0027 | 486.100-486.110 |
| 0938-0034 | 405.821 |
| 0938-0035 | 407.40 |
| 0938-0037 | 413.20, 413.24 |
| 0938-0041 | 408.6 |
| 0938-0042 | 410.40, 424.124 |
| 0938-0045 | 405.711 |
| 0938-0046 | 405.2133 |
| 0938-0050 | 413.20, 413.24 |
| 0938-0062 | 431.151, 435.1009, 440.250, 440.220, 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 |
| 0938-0065 | 485.701-485.729 |
| 0938-0074 | 491.1—491.11 |
| 0938-0080 | 406.13 |
| 0938-0086 | 420.200-420.206, 455.100-455.106 |
| 0938-0101 | 430.30 |
| 0938-0102 | 413.20, 413.24 |
| 0938-0107 | 413.20, 413.24 |
| 0938-0146 | 431.800-431.865 |
| 0938-0147 | 431.800-431.865 |
| 0938-0151 | 493.1-493.2001 |
| 0938-0155 | 405.2470 |
| 0938-0170 | 493.1269-493.1285 |
| 0938-0193 | 430.10-430.20, 440.167 |
| 0938-0202 | 413.17, 413.20 |
| 0938-0214 | 411.25, 489.2, 489.20 |
| 0938-0236 | 413.20, 413.24 |
| 0938-0242 | 416.44, 418.100, 482.41, 483.270, 483.470 |
| 0938-0245 | 407.10, 407.11 |
| 0938-0251 | 406.7 |
| 0938-0266 | 416.41, 416.83, 416.47, 416.48 |
| 0938-0267 | 485.56, 485.58, 485.60, 485.64, 485.66, 410.65 |
| 0938-0269 | 412.116, 412.632, 413.64, 413.350, 484.245 |
| 0938-0270 | 405.376 |
| 0938-0272 | 440.180, 441.300-441.305 |
| 0938-0273 | 485.701—85.729 |
| 0938-0279 | 424.5 |
| 0938-0287 | 447.31 |
| 0938-0296 | 413.170 |
| 0938-0300 | 431.800 |
| 0938-0301 | 413.20, 413.24 |
| 0938-0302 | 418.22, 418.24, 418.28, 418.56, 418.58, 418.70, 418.74, 418.83, 418.96, 418.100 |
| 0938-0313 | 418.1—418.405 |
| 0938-0328 | 482.12, 482.22, 482.27, 482.30, 482.41, 482.43, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, 482.66 |
| 0938-0334 | 491.9 |
| 0938-0338 | 486.104, 486.106, 486.110 |
| 0938-0354 | 441.60 |
| 0938-0355 | 484.10-484.52 |
| 0938-0357 | 409.40-409.50, 410.36, 410.170, 411.4-411.15, 421.100, 424.22, 484.18, 489.21 |
| 0938-0358 | 412.20-412.30 |
| 0938-0359 | 412.40-412.52 |
| 0938-0360 | 405.2100-405.2184 |
| 0938-0365 | 484.10, 484.11, 484.12, 484.14, 484.16, 484.18, 484.20, 484.36, 484.48, 484.52 |
| 0938-0372 | 414.330 |
| 0938-0378 | 482.60-482.62 |
| 0938-0379 | 418.1-418.405 |
| 0938-0380 | 482.1-482.66 |
| 0938-0386 | 405.2100-405.2171 |
| 0938-0391 | 488.18, 488.26, 488.28 |
| 0938-0426 | 476.104, 476.105, 476.116, 476.134 |
| 0938-0429 | 447.53 |
| 0938-0443 | 473.18, 473.34, 473.36, 473.42 |
| 0938-0444 | 1004.40, 1004.50, 1004.60, 1004.70 |
| 0938-0445 | 412.44, 412.46, 431.630, 456.654, 466.71, 466.73, 466.74, 466.78 |
| 0938-0447 | 405.2133 |
| 0938-0449 | 440.180, 441.300-441.310 |
| 0938-0454 | 424.20 |
| 0938-0456 | 412.105 |
| 0938-0463 | 413.20, 413.24 |
| 0938-0465 | 411.404, 411.406, 411.408 |
| 0938-0467 | 431.17, 431.306, 435.910, 435.920, 435.940-435.960 |
| 0938-0469 | 417.107, 417.478 |
| 0938-0470 | 417.143, 417.408 |
| 0938-0477 | 412.92 |
| 0938-0484 | 424.123 |
| 0938-0486 | 498.40-498.95 |
| 0938-0501 | 406.15 |
| 0938-0502 | 433.138 |
| 0938-0512 | 486.301-486.325 |
| 0938-0526 | 475.100 Subpart C, 475.106, 475.107, 462.102, 462.103 |
| 0938-0534 | 410.38, 424.5 |
| 0938-0544 | 493.1-493.2001 |
| 0938-0565 | 411.20-411.206 |
| 0938-0566 | 411.404, 411.406, 411.408 |
| 0938-0567 | 498 Subpart D, E, and H and 20 CFR 404.933 |
| 0938-0573 | 412.256, 412.230 |
| 0938-0581 | 493.1-493.2001 |
| 0938-0599 | 493.1-493.2001 |
| 0938-0600 | 405.371, 405.378, 413.20 |
| 0938-0610 | 417.436, 417.801, 417.436, 422.128, 430.12, 431.20, 431.107, 434.28, 483.10, 484.10, 489.102 |
| 0938-0612 | 493.1-493.2001 |
| 0938-0618 | 433.68, 433.74, 447.272 |
| 0938-0653 | 493 |
| 0938-0655 | 493.180 |
| 0938-0657 | 405.2110, 405.2112 |
| 0938-0658 | 405.2110, 405.2112 |
| 0938-0667 | 482.12, 488.18, 489.20, 489.24 |
| 0938-0673 | 430.10 |
| 0938-0679 | 410.38 |
| 0938-0685 | 410.32, 410.71, 413.17, 424.57, 424.73, 424.80, 440.30, 484.12 |
| 0938-0686 | 493.551-93.557 |
| 0938-0688 | 486.301-486.325 |
| 0938-0690 | 488.4-488.9, 488.201 |
| 0938-0691 | 412.106 |
| 0938-0692 | 466.78, 489.20, 489.27 |
| 0938-0700 | 417.479, 417.500; 422.208, 422.210; 434.44, 434.67, 434.70; 1003.100, 1003.101, 1003.103 & 1003.106 |
| 0938-0701 | 422.152 |
| 0938-0702 | 45 CFR 146 |
| 0938-0703 | 45 CFR 148 |
| 0938-0714 | 411.370-411.389 |
| 0938-0717 | 424.57 |
| 0938-0721 | 410.33 |
| 0938-0722 | 422.370-422.378 |
| 0938-0723 | 421.300-421.318 |
| 0938-0730 | 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, 424.24 |
| 0938-0732 | 417.126, 417.470 |
| 0938-0734 | 45 CFR 5b |
| 0938-0739 | 413.337, 413.343, 424.32, 483.20 |
| 0938-0742 | 422.300-422.312 |
| 0938-0749 | 424.57 |
| 0938-0753 | 422.000-422.700 |
| 0938-0754 | 441.152 |
| 0938-0758 | 413.20, 413.24 |
| 0938-0760 | 484 Subpart E, 484.55 |
| 0938-0761 | 484.11, 484.20 |
| 0938-0763 | 422.1-422.10, 422.50-422.80, 422.100-422.132, 422.300 -422.312, 422.400-422.404, 422.560-422.622 |
| 0938-0768 | 417.800-417.840 |
| 0938-0770 | 410.2 |
| 0938-0778 | 422.64, 422.111, 422.560-422.622 |
| 0938-0779 | 417.470, 417.126, 422.210, 422.64 |
| 0938-0781 | 411.404-411.406, 484.10 |
| 0938-0786 | 438.360, 438.362, 438.364 |
| 0938-0787 | 406.28, 407.27 |
| 0938-0790 | 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, 460.100, 460.102, 460.104, 460.106, 460.110, 460.112, 460.116, 460.118, 460.120, 460.122, 460.124, 460.132, 460.152, 460.154, 460.156, 460.160, 460.164, 460.168, 460.172, 460.190, 460.196, 460.200, 460.202, 460.204, 460.208, 460.210 |
| 0938-0792 | 491.3, 491.8, 491.11 |
| 0938-0797 | 45 CFR 148 |
| 0938-0798 | 413.24, 413.65, 419.42 |
| 0938-0802 | 419.43 |
| 0938-0810 | 482.45 |
| 0938-0818 | 410.141-410.145, 414.63 |
| 0938-0819 | |
| 0938-0823 | 420.410 |
| 0938-0824 | 482.13, 440.10 |
| 0938-0827 | 45 CFR 146.141 |
| 0938-0829 | 422.568 |
| 0938-0832 | 489 |
| 0938-0833 | 483.350-483.376 |
| 0938-0840 | 422.152 |
| 0938-0841 | 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, 457.810, 457.940, 457.945, 457.965, 457.985, 457.1005, 457.1015, 457.1180 |
| 0938-0842 | 412, 413 |
| 0938-0846 | 411.1, 411.350-411.357, 424.22 |
| 0938-0857 | 419 |
| 0938-0860 | 419 |
| 0938-0866 | 45 CFR Part 162 |
| 0938-0872 | 483.20, 413.337 |
| 0938-0873 | 422.152 |
| 0938-0874 | 45 CFR Parts 160 and 162 |
| 0938-0878 | 422 Subpart F & G |
| 0938-0883 | 45 CFR parts 160 and 164 |
| 0938-0884 | 405.940 |
| 0938-0885 | 403.804, 403.806, 403.808, 403.810, 403.811, 403.820 |
| Note: Sections in title 45 are preceded by “45 CFR.” |
[FR Doc. 03-16058 Filed 6-26-03; 8:45 am]
BILLING CODE 4120-01-P