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  Professionals   Governments   Consumers   Public Affairs

The CMS Quarterly Provider Update
July 2004


Published Regulations




CMS-1492-IFC      PUB DATE: 07/01/2004

Medicare Program; Medicare Ambulance MMA Temporary Rate Increases Beginning July 1, 2004


This interim final rule codifies the four payment provisions for Medicare covered ambulance services contained in section 414 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA).

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CMS-2033-F      PUB DATE: 07/23/2004

Requirements for the Group Health Insurance Market; Non-Federal Governmental Plans Exempt From HIPAA Title I Requirements


This rule finalizes existing exemption election requirements that apply to self-funded non-Federal governmental plans. In it, we clarify the conditions under which plan sponsors may exempt these plans from most of the requirements of title XXVII of the PHS Act, and provide guidance on the procedures, limitations, and documentation associated with exemption elections. Finally, we revise the requirements to reinforce beneficiary protections for exemption elections.

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CMS-2152-F2      PUB DATE: 07/23/2004

Amendment to the Interim Final Regulation for Mental Health Parity


This document contains an amendment to the interim final regulation that implements the Mental Health Parity Act (MHPA) to conform the sunset date of the regulation to the sunset date of the statute under legislation passed by the 108th Congress.

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CMS-6146-P      PUB DATE: 07/23/2004

Medicare Program; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures


This proposed rule would establish the procedures for imposing exclusions for certain violations of the Medicare program. These procedures are based on the procedures that the Office of Inspector General has published for civil money penalties, assessments, and exclusions under their delegated authority. These regulations would protect beneficiaries from health care providers and entities found in noncompliance with Medicare rules and regulations and would otherwise improve the safeguard provisions under the Medicare statute.

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CMS-2187-N      PUB DATE: 07/23/2004

State Children's Health Insurance Program (SCHIP); Extended Availability of Unexpended SCHIP Funds From the Appropriation for Fiscal Years 1998 Through 2001; and Provision of Authority for Qualifying States To Use a Portion of SCHIP Funds for Medicaid Expenditures


This notice describes the extension of availability to the end of Federal fiscal year (FY) 2004 of the amounts of States' unexpended FY 1998 and FY 1999 allotment funds. Additionally, this notice sets forth the amounts of States' unexpended FY 2000 allotments that remained at the end of FY 2002 that will be available under a statutory formula for each of the 50 States, the District of Columbia, and the Commonwealths and Territories through the end of a subsequent period of availability ending September 30, 2004. This notice also sets forth the amounts of States' unexpended FY 2001 allotments that remained at the end of FY 2003 that will be available under a statutory formula for each of the 50 States, the District of Columbia, and the Commonwealths and Territories through the end of a subsequent period of availability ending September 30, 2005. Finally, this notice permits "Qualifying States" to elect to receive a portion of their available SCHIP allotments as increased Federal matching funding for certain expenditures in their Medicaid programs.

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CMS-2202-PN      PUB DATE: 07/23/2004

Medicare and Medicaid Programs; Application by the American Association for Accreditation of Ambulatory Surgery Facilities, Inc., for Continued Deeming Authority for Ambulatory Surgical Centers


This proposed notice acknowledges the receipt of a renewal application by the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for approval as a national accreditation program for ambulatory surgical centers that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's written request, CMS publish a proposed notice that identifies the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period.

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CMS-3112-NC2      PUB DATE: 07/23/2004

Medicare Program; Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers


This notice with public comment period acknowledges receipt of materials submitted by entities requesting review of the appropriateness of the Medicare payment amount for new technology lenses furnished by Ambulatory Surgical Centers (ASCs). In response to the February 27, 2004 Federal Register notice entitled "Medicare Program; Calendar Year 2004 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers" we received a total of three timely applications for review by the March 29, 2004 public comment due date. Of the three received, one application was withdrawn by the requester. In this notice we summarize timely applications received and solicit public comments on the two intraocular lenses (IOL) under review.

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CMS-3142-NC      PUB DATE: 07/23/2004

Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Contracts


This notice describes the evaluation criteria we intend to use to evaluate the Quality Improvement Organizations (QIOs) under their contracts with CMS, for efficiency and effectiveness in accordance with the Social Security Act. These evaluation criteria are based on the tasks and related subtasks set forth in the QIO's Scope of Work (SOW). The current 7th SOW includes Tasks 1 through 4, with subtasks included under all tasks, excluding Task 4. QIOs were awarded contracts for the 7th SOW, or 7th Round, for three years, with staggered starting dates beginning August 2002, November 2002, and February 2003.

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CMS-4074-N      PUB DATE: 07/23/2004

Medicare Program; Meeting of the Advisory Panel on Medicare Education--September 9, 2004


In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education on September 9, 2004. The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

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CMS-1334-N      PUB DATE: 07/23/2004

Medicare Program; Public Meeting in Calendar Year 2004 for Coding and Payment Determinations for Power Wheelchairs


This notice announces a public meeting to be held on September 1, 2004 to discuss coding and payment for power wheelchairs. This meeting provides a forum for interested parties to hear various proposals presented to us regarding changes to wheelchair coding. This meeting will provide an opportunity for the public to make oral presentations or to submit written comments in response to preliminary coding and pricing recommendations presented by CMS at this meeting. Discussion will be directed toward response to alternative coding recommendations, and will be limited to discussions of the proposed recommendations presented at the meeting on coding and payment of power wheelchairs.

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CMS-1364-N      PUB DATE: 07/23/2004

Medicare Program; August 30, 2004, Meeting of the Practicing Physicians Advisory Council and Request for Nominations


In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Practicing Physicians Advisory Council (the Council) and invites all organizations representing physicians to submit nominees for membership on the Council. There will be several vacancies on the Council as of February 28, 2005. The Council will be meeting to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of the Department of Health and Human Services (the Secretary). This meeting is open to the public.

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CMS-6014-F      PUB DATE: 07/30/2004

Medicare Program; Interest Calculation


This final rule changes the way we calculate interest on Medicare overpayments and underpayments to providers, suppliers, health maintenance organizations, competitive medical plans, and health care prepayment plans to be more reflective of current business practices. This change reduces the amount of interest assessed on overpayments and underpayments and simplifies the way the interest is calculated. This change in the way we calculate interest also applies to Medicare Secondary Payer debt.

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CMS-4068-N      PUB DATE: 07/30/2004

Medicare Program; Open Public Meeting Regarding the Development of the Model Guidelines for Categories and Classes of Drugs


This notice announces a public meeting to provide pharmaceutical benefit managers and other interested parties, an opportunity to provide individual comments on the Model Guidelines for Classes and Categories of Drugs (Model Guidelines) developed by the United States Pharmacopeia (USP). Interested parties include beneficiaries, advocacy groups, managed care organizations, trade and professional associations, prescription drug plans, healthcare practitioners, providers, pharmaceutical manufacturers, and others. USP is a nongovernmental organization, as set forth under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA provides for the development of Model Guidelines by USP in consultation with pharmaceutical benefit managers and other interested parties.

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CMS-1249-N      PUB DATE: 07/30/2004

Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--Update--Notice


This notice updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2005, as required by statute. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (the BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (the BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the MMA), relating to Medicare payments and consolidated billing for SNFs.

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CMS-1360-N      PUB DATE: 07/30/2004

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Fiscal Year 2005


This notice updates prospective payment rates for inpatient rehabilitation facilities for Federal fiscal year (FY) 2005 as authorized under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before August 1 before each fiscal year, the classifications and weighting factors for the inpatient rehabilitation facility (IRF) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year.

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CMS-1265-CN      PUB DATE: 07/30/2004

Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005; Correction Notice


This document corrects technical errors that appeared in the proposed rule published in the Federal Register on June 2, 2004 entitled "Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2005."

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CMS-4068-P      PUB DATE: 08/03/2004

Medicare Program; Medicare Prescription Drug Benefit


This proposed rule would implement the new Medicare Prescription Drug Benefit. This new voluntary prescription drug benefit program was enacted into law on December 8, 2003, in section 101 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). The addition of a prescription drug benefit to Medicare represents a landmark change to the Medicare program that will significantly improve the health care coverage available to millions of Medicare beneficiaries. The MMA specifies that the prescription drug benefit program will become available to beneficiaries beginning on January 1, 2006. Please see the executive summary in the SUPPLEMENTARY INFORMATION section for further synopsis of this rule.

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CMS-4069-P      PUB DATE: 08/03/2004

Medicare Program; Establishment of the Medicare Advantage Program


This proposed rule would implement provisions of the Social Security Act (the Act) establishing and regulating the Medicare Advantage (MA) program. The MA program was enacted in Title II of The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) on December 8, 2003. The MA program replaces the Medicare+Choice (M+C) program established under Part C of title XVIII of the Act, while retaining most key features of the M+C program. The MA program attempts to broadly reform and expand the availability of private health plan options to Medicare beneficiaries. See the executive summary in the SUPPLEMENTARY INFORMATION section for an outline of the key features of the MA program.

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CMS-1275-N      PUB DATE: 08/05/2004

Medicare Program; Meeting of the Advisory Panel on Ambulatory Payment Classification Groups--September 1, 2, and 3, 2004


In accordance with section 10(a) of the Federal Advisory Committee Act (FACA)(5 U.S.C. Appendix 2), this notice announces the second biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2004. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The Secretary and the Administrator consider the Panel's advice as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking.

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CMS-1429-P      PUB DATE: 08/05/2004

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005


This proposed rule would refine the resource-based practice expense relative value units (RVUs) and make other changes to Medicare Part B payment policy. The proposed policy changes concern: supplemental survey data for practice expense, updated geographic practice cost indices for physician work and practice expense, updated malpractice RVUs, revised requirements for supervision of therapy assistants, revised payment rules for low osmolar contrast media, changes to payment policies for physicians and practitioners managing dialysis patients, clarification of care plan oversight requirements, revised requirements for supervision of diagnostic psychological testing services, clarifications to the policies affecting therapy services, revised requirements for assignment of Medicare claims, addition to the list of telehealth services, and several coding issues. We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. We solicit comments on these proposed policy changes. This proposed rule also addresses the following provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA): coverage of an initial preventive physical examination; coverage of cardiovascular screening blood tests; coverage of diabetes screening tests; incentive payment improvements for physicians in shortage areas; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; coverage of routine costs associated with certain clinical trials of category A devices as defined by the Food and Drug Administration; hospice consultation service; indexing the Part B deductible to inflation; extension of coverage of intravenous immune globulin (IVIG) for the treatment in the home of primary immune deficiency diseases; revisions to reassignment provisions; clinical conditions for payment of covered items of durable medical equipment; and payment for diagnostic mammograms. In addition, we discuss physicians' services associated with drug administration services and payment for set-up of portable x-ray equipment.

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CMS-1428-F      PUB DATE: 08/11/2004

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates


We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems; and to implement a number of changes made by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that was enacted on December 8, 2003. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 2004. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. Among the policy changes that we are making are: Changes to the classification of cases to the diagnosis-related groups (DRGs); changes to the long-term care (LTC)-DRGs and relative weights; changes in the wage data, labor-related share of the wage index, and the geographic area designations used to compute the wage index; changes in the qualifying threshold criteria for and the approval of new technologies and medical services for add-on payments; changes to the policies governing postacute care transfers; changes to payments to hospitals for the direct and indirect costs of graduate medical education; changes to the payment adjustment for disproportionate share rural hospitals; changes in requirements and payments to critical access hospitals (CAHs); changes to the disclosure of information requirements for Quality Improvement Organization (QIOs); and changes in the hospital conditions of participation for discharge planning and fire safety requirements for certain health care facilities.

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CMS-1427-P      PUB DATE: 08/16/2004

Medicare Program; Proposed Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2005 Payment Rates


This proposed rule would revise the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. In addition, the proposed rule describes proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes would be applicable to services furnished on or after January 1, 2005.

View Part 1 of CMS-1427-P from the "Federal Register" (PDF - 2.32 MB)
View Part 2 of CMS-1427-P from the "Federal Register" (PDF - 5.39 MB)
View Part 3 of CMS-1427-P from the "Federal Register" (PDF - 5.48 MB)
View Part 4 of CMS-1427-P from the "Federal Register" (PDF - 4.22 MB)
View Part 5 of CMS-1427-P from the "Federal Register" (PDF - 4.34 MB)

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CMS-6146-CN      PUB DATE: 08/27/2004

Medicare Program; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures


This document corrects a technical error that appeared in the proposed rule published in the Federal Register on July 23, 2004 entitled "Medicare Program; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures."

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CMS-6026-P      PUB DATE: 08/27/2004

Medicaid Program and State Children's Health Insurance Program (SCHIP): Payment Error Rate Measurement


This proposed rule would require State agencies to estimate improper payments in the Medicaid program and SCHIP program. The Improper Payments Information Act of 2002 requires Federal agencies to annually review and identify those programs and activities that may be susceptible to significant erroneous payments, estimate the amount of improper payments and report those estimates to the Congress and, if necessary, submit a report on actions the agency is taking to reduce erroneous payments. The intended effect and expected results of this proposed rule would be for States to produce improper payment estimates for their Medicaid and SCHIP programs and to identify existing and emerging vulnerabilities that can be addressed by the States through actions taken to reduce the rate of improper payments and produce a corresponding increase in program savings at both the State and Federal levels.

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CMS-1269-N2      PUB DATE: 08/27/2004

Medicare Program; Second Request for Nominations for Two Specific Categories of Members of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG)


This notice solicits nominations for members in two categories, patient representatives and State survey agency representatives, for which no nominations were received in response to our May 28, 2004 Federal Register notice. It also describes the establishment of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG).

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CMS-2201-N      PUB DATE: 08/27/2004

State Children's Health Insurance Program; Final Allotments to States, the District of Columbia, and U.S. Territories and Commonwealths for Fiscal Year 2005


Title XXI of the Social Security Act (the Act) authorizes payment of Federal matching funds to States, the District of Columbia, and U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the State Children's Health Insurance Program (SCHIP). This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2005. States may implement SCHIP through a separate State program under title XXI of the Act, an expansion of a State Medicaid program under title XIX of the Act, or a combination of both.

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CMS-4067-PN      PUB DATE: 08/27/2004

Medicare and Medicaid Programs; Application by the Utilization Review Accreditation Commission (URAC) for Deeming Authority for Medicare Advantage


This proposed notice announces the receipt of an application from the Utilization Review Accreditation Commission for recognition as a national accreditation program for managed care organizations that wish to participate in the Medicare Advantage program. The statute requires that within 60 days of receipt of an organization's complete application, we will announce our receipt of the accreditation organization's application for approval, describe the criteria we will use in evaluating the application, and provide at least a 30-day public comment period.

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CMS-1264-N      PUB DATE: 08/27/2004

Medicare Program; Hospice Wage Index for Fiscal Year 2005


This notice announces the annual update to the hospice wage index as required by statute. This fiscal year 2005 update is effective from October 1, 2004 through September 30, 2005. The wage index is used to reflect local differences in wage levels. The hospice wage index methodology and values are based on recommendations of a negotiated rulemaking advisory committee and were originally published in the August 8, 1997 Federal Register.

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CMS-5025-CN      PUB DATE: 08/27/2004

Medicare Program; Medicare Replacement Drug Demonstration; Correction


This document corrects technical and typographical errors that appeared in the notice published in the Federal Register on June 29, 2004 entitled "Medicare Replacement Drug Demonstration (69 FR 38898)." That notice announced the implementation of a demonstration that would pay through December 31, 2005 under Medicare Part B for drugs and biologicals that are prescribed as replacements for existing covered Medicare drugs and biologicals described in section 1861(s)(2)(A) or 1861(s)(2)(Q), or both, of title XVIII of the Social Security Act.

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CMS-3136-N      PUB DATE: 08/27/2004

Medicare Program; Meeting of the Medicare Coverage Advisory Committee--September 28, 2004


This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns the use of portable multichannel home sleep testing devices as an alternative to facility-based polysomnography in the evaluation of obstructive sleep apnea. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

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CMS-1279-N2      PUB DATE: 08/27/2004

Medicare Program; Public Meeting of the Program Advisory and Oversight Committee (PAOC) for Quality Standards and Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)


This notice announces the date, location, and registration requirements for the first public meeting of the Program Advisory and Oversight Committee (PAOC) for the competitive acquisition of certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The October 6, 2004 meeting will provide a forum for the PAOC to consider issues related to competitive bidding for DMEPOS items and to furnish advice to the Secretary regarding these issues. Requirements for the PAOC are specified by section 302 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). The public is invited to attend this meeting to observe the committee's discussion. While non-committee members attending the meeting as interested observers will not have the opportunity to make oral comments or presentations, written comments will be accepted.

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CMS-8020-N      PUB DATE: 09/09/2004

Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2005


In accordance with section 1839 of the Social Security Act (the Act), this notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) enrollees for the Part B account in the Medicare Supplementary Medical Insurance (SMI) trust fund for 2005. It also announces the monthly Part B premium to be paid by enrollees during 2005. The monthly actuarial rates for 2005 are $156.40 for aged enrollees and $191.80 for disabled enrollees. The monthly Part B premium rate for 2005 is $78.20. (The 2004 premium rate was $66.60.) The 2005 Part B premium is equal to 50 percent of the monthly actuarial rate for aged enrollees, or about 25 percent of Part B costs for aged enrollees.

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CMS-8021-N      PUB DATE: 09/09/2004

Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for 2005


This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year 2005 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. The inpatient hospital deductible will be $912. The daily coinsurance amounts will be: (a) $228 for the 61st through 90th day of hospitalization in a benefit period; (b) $456 for lifetime reserve days; and (c) $114 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

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CMS-8022-N      PUB DATE: 09/09/2004

Medicare Program; Part A Premium for 2005 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement


This notice announces the Hospital Insurance premium for calendar year 2005 under Medicare's Hospital Insurance program (Part A) for the uninsured, not otherwise eligible aged (hereafter known as the ``uninsured aged'') and for certain disabled individuals who have exhausted other entitlement. The monthly Medicare Part A premium for the 12 months beginning January 1, 2005 for these individuals is $375. The reduced premium for certain other individuals as described in this notice is $206. Section 1818(d) of the Social Security Act specifies the method to be used to determine these amounts.

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CMS-6027-N      PUB DATE: 09/09/2004

Medicare Program; September 30, 2004 Open Door Forum: Requirements for Coordination Between Plans Primary or Secondary to Medicare Part D Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)


This notice announces a September 30, 2004 Open Door Forum for the purpose of discussing the establishment of requirements of benefit coordination among Medicare Part D plans, State Pharmaceutical Assistance Programs (SPAPs), States, pharmaceutical benefit managers, employers, data processing experts, pharmacists, pharmaceutical manufacturers, and other interested and affected parties (or customers and partners). This Forum will enable interested parties to comment and raise issues regarding requirements for enrollment file-sharing, claims processing, claims reconciliation reports, application of the catastrophic out-of-pocket protection under Section 1860D-2(b)(4) and other administrative procedures under the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Interested parties will also have the opportunity to ask questions and raise issues regarding the potential paperwork burden that these MMA provisions may impose. The MMA requires that these requirements be established before July 1, 2005.

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CMS-1380-F      PUB DATE: 09/16/2004

Medicare Program; Manufacturer Submission of Manufacturer's Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals


On April 6, 2004, we published an interim final rule in the Federal Register implementing the provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) related to the calculation and submission of manufacturer's average sales price (ASP) data on certain Medicare Part B drugs and biologicals by manufacturers. This final rule responds to the public comments received on the interim final rule concerning the methodology for estimating price concessions associated with manufacturers' ASP reporting requirements. Other issues and comments relating to the interim final rule will be addressed at a future time.

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CMS-2256-PN      PUB DATE: 09/24/2004

Medicare and Medicaid Programs; Application by the Community Health Accreditation Program (CHAP) for Home Health Agencies


This proposed notice with comment period acknowledges the receipt of an application from the Community Health Accreditation Program for continued recognition as a national accreditation program for Home Health Agencies that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we will publish a notice that will announce our receipt of the accreditation organization's application for approval, describe the criteria we will use in evaluating the application, and provide at least a 30-day public comment period.

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CMS-3137-N      PUB DATE: 09/24/2004

Medicare Program; Meeting of the Medicare Coverage Advisory Committee--November 4, 2004


This notice announces a public meeting of the Medicare Coverage Advisory Committee. This Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns bariatric surgery for the treatment of morbid obesity. Notice is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

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CMS-3141-N      PUB DATE: 09/24/2004

Procedure for Producing Guidance Documents Describing Medicare's Coverage Process


This notice implements part of section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 by describing a method of developing, and making available to the public, guidance documents under the Medicare program. The guidance documents would explain the factors considered in making national coverage determinations of whether an item or service is reasonable and necessary.

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CMS-3154-N      PUB DATE: 09/24/2004

Medicare Program; Request for Nominations for Members for the Medicare Coverage Advisory Committee


This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC).

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CMS-1810-IFC2      PUB DATE: 09/24/2004

Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase II); Correcting Amendment


In the March 26, 2004 issue of the Federal Register (69 FR 16054), we published an interim final rule with comment period that incorporated into regulations certain provisions of the physician self- referral prohibition in section 1877 of the Social Security Act. The effective date of that rule was July 26, 2004. This correcting amendment corrects a technical error identified in the March 26, 2004 interim final rule. Specifically, this rule reinstates the physician self-referral advisory opinion regulations, which were inadvertently deleted from Part 411 in the March 26, 2004 interim final rule.

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CMS-2200-N4      PUB DATE: 09/24/2004

Medicare Program; Meeting of the State Pharmaceutical Assistance Transition Commission--October 14, 2004


This notice announces a public meeting of the State Pharmaceutical Assistance Transition Commission (SPATC). Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The SPATC will develop a proposal for addressing the unique transitional issues facing State Pharmaceutical Assistance Programs (SPAPs) and SPAP participants due to the implementation of the voluntary prescription drug benefit program under Part D of title XVIII of the Social Security Act. This notice also announces the appointment of an additional member to serve on the SPATC. This individual is Dennis R. O'Dell, Corporate Vice President, Health Services, Walgreen CO, Deerfield, IL.

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CMS-2204-PN      PUB DATE: 09/24/2004

Medicare and Medicaid Programs; Application by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Home Health Agencies


This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission on Accreditation of Healthcare Organizations for continued recognition as a national accreditation program for Home Health Agencies that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we will publish a notice that will announce our receipt of the accreditation organization's application for approval, describe the criteria we will use in evaluating the application, and provide at least a 30-day public comment period.

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CMS-2208-PN      PUB DATE: 09/24/2004

Medicare and Medicaid Programs; Application by the American Osteopathic Association for Continued Approval of Deeming Authority for Hospitals


This proposed notice with comment period acknowledges the receipt of an application from the American Osteopathic Association (AOA) for continued recognition as a national accreditation program for hospitals that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

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CMS-4018-F      PUB DATE: 09/24/2004

Medicare Program; Continuation of Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity


This final rule will conform the existing Medicare eligibility regulations to reflect a change made by the Ticket to Work and Work Incentives Improvement Act (TWWIIA) of 1999. That statutory change that was implemented effective October 1, 2000, provides working disabled individuals with continued Medicare entitlement for an additional 54 months beyond the previous limit of 24 months, for a total of 78 months of Medicare coverage following the 15th month of the reentitlement period.

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CMS-4077-PN      PUB DATE: 09/24/2004

Medicare and Medicaid Programs; Application by the National Committee for Quality Assurance Preferred Provider Organization for Deeming Authority for Medicare Advantage


This proposed notice announces the receipt of an application from the National Committee for Quality Assurance for recognition as a national accreditation program for preferred provider organizations that wish to participate in the Medicare Advantage program. The statute requires that within 60 days of receipt of an organization's complete application, we will announce our receipt of the accreditation organization's application for approval, describe the criteria we will use in evaluating the application, and provide at least a 30-day public comment period.

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CMS-6026-CN      PUB DATE: 09/24/2004

Medicaid Program and State Children's Health Insurance Program (SCHIP); Payment Error Rate Measurement; Correction


This document corrects an incorrect date for the close of the public comment period that appeared in the proposed rule that was published in the Federal Register on August 27, 2004 entitled ``Medicaid Program and State Children's Health Insurance Program (SCHIP) Payment Error Rate Measurement.''

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CMS-9023-N      PUB DATE: 09/24/2004

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--April 2004 Through June 2004


This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2004 through June 2004, 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. 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, 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.

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CMS-6026-CN      PUB DATE: 09/30/2004

Medicaid Program and State Children's Health Insurance Program (SCHIP); Payment Error Rate Measurement; Correction


In proposed rule document 04-21198 appearing on page 57244, in the issue of Friday, September 24, 2004, make the following correction: On page 57244, in the second column, under the DATES heading, in the fourth line, "October 21, 2004" should read "October 27, 2004".

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