Notices. Notice
3,864 words·~18 min read·
/register/2005/05/27/05-10263A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1293-N] Medicare Program; Public Meeting in Calendar Year 2005 for New Clinical Laboratory Tests Payment Determinations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology
(CPT)codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2006, which will be effective on January 1, 2006. Discussion is directed toward technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the CMS meeting. DATES: The public meeting is scheduled for Monday, July 18, 2005, from 10 a.m. to 4 p.m., e.d.t. ADDRESSES: The meeting will be held in the auditorium at the Centers for Medicare & Medicaid Services, located at 7500 Security Boulevard, Baltimore, Maryland 21244. FOR FURTHER INFORMATION CONTACT: Anita Greenberg,
(410)786-4601. SUPPLEMENTARY INFORMATION: I. Background Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), Pub. L. 106-554, mandated procedures that permit public consultation for payment determinations for new clinical laboratory tests under Part B of title XVIII of the Social Security Act (the Act) in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases (ICD-9-CM). The procedures and public meeting announced in this notice for new clinical laboratory tests are in accordance with the procedures published on November 23, 2001, in the **Federal Register** (66 FR 58743) to implement section 531(b) of BIPA. Also, section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108-173, amends section 1833(h)(8)(B)(iii) of the Act to require that we convene a public meeting to receive comments and recommendations (and data on which recommendations are based) for establishing payment amounts for new clinical laboratory tests. The public meeting is intended to provide expert input on the nature of new clinical laboratory tests and receive recommendations to either cross-walk or gap-fill for payment. Decisions regarding payment for the newly created Physicians' Current Procedural Terminology
(CPT)codes will not be made at this meeting. A summary of the new codes and the payment recommendations that are presented during the public meeting will be posted on our website by September 8, 2005 and can be accessed at *http://www.cms.hhs.gov/suppliers/clinlab.* The summary will also display our tentative payment determinations, and interested parties may submit written comments on the tentative payment determinations by September 23, 2005, to the address specified in the summary. II. Registration *Registration Procedures:* Beginning June 20, 2005, registration may be completed on-line at *http://www.cms.hhs.gov/suppliers/clinlab.* To register by telephone contact Anita Greenberg at
(410)786-4601. The following information must be submitted when registering: • Name; • Company name; • Address; • Telephone number(s); and • E-mail address(es). When registering, individuals who want to make a presentation must also specify which new clinical laboratory test code(s) they will be presenting. A confirmation will be sent upon receipt of the registration. Individuals may also register by calling Anita Greenberg at
(410)786-4601. *Registration Deadline:* Individuals must register by July 14, 2005. III. Presentations This meeting is open to the public. The on-site check-in for visitors will be held from 9:30 a.m. to 10 a.m., followed by opening remarks. Registered persons from the public may discuss and recommend payment determinations for specific new CPT codes for the 2005 Clinical Laboratory Fee Schedule. A newly created CPT code can either represent a refinement or modification of existing test methods, or a substantially new test method. The newly created CPT codes for the calendar year 2005 will be listed at the Web site *http://www.cms.hhs.gov/suppliers/clinlab* on or after June 20, 2005. Oral presentations must be brief, and must be accompanied by three written copies. Presenters may also make copies available for approximately 50 meeting participants. Presenters should address the new test code(s) and descriptor, the test purpose and method, costs, charges, and a recommendation with rationale for one of two methods (cross-walking or gap-fill) for determining payment for new clinical laboratory codes. The first method, called cross-walking, a new test is determined to be similar to an existing test, multiple existing test codes, or a portion of an existing test code. The new test code is then assigned the related existing local fee schedule amounts and resulting national limitation amount. The second method, called gap-filling, is used when no comparable, existing test is available. When using this method, instructions are provided to each Medicare carrier to determine a payment amount for its geographic area(s) for use in the first year, and the carrier-specific amounts are used to establish a national limitation amount for following years. For each new clinical laboratory test code, a determination must be made to either cross-walk or to gap-fill, and, if cross-walking is appropriate, to know what tests to which to cross-walk. IV. Security, Building, and Parking Guidelines The meetings are held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, participants must bring government-issued photo identification and a copy of your written meeting registration confirmation. Persons without proper identification may be denied access. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting each day. Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a presentation. Parking permits and instructions are issued upon arrival by the guards at the main entrance. All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. V. Special Accommodations Individuals attending a meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance or accommodations, must provide this information when registering for the meeting. Authority: Section 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 42 U.S.C. 1395hh). Dated: May 12, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 05-10263- 5-26-05; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Statement of Organization, Functions, and Delegations of Authority Part F of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), ( **Federal Register** , Vol. 68, No. 34, pp. 8297-8299, dated February 20, 2003) is amended to reflect changes to the organizational structure of CMS. The changes include:
(1)Renaming the Public Affairs Office to the Office of External Affairs,
(2)restructuring the Center for Beneficiary Choices to implement Titles I and II of the Medicare Prescription Drug, Improvement and Modernization Act of 2003,
(3)realigning functions of the Center for Medicaid and State Operations,
(4)renaming the Office of Health Insurance Portability and Accountability Acts Standards to the Office of E-Health Standards and Services, and
(5)establishing the Office of Acquisition and Grants Management. The specific amendments to Part F. are described below: • Section F.10. (Organization) is amended to read as follows: 1. Office of External Affairs (FAC). 2. Center for Beneficiary Choices (FAE). 3. Office of Legislation (FAF). 4. Center for Medicare Management (FAH). 5. Office of Equal Opportunity and Civil Rights (FAJ). 6. Office of Research, Development, and Information (FAK). 7. Office of Clinical Standards and Quality (FAM). 8. Office of the Actuary (FAN). 9. Center for Medicaid and State Operations (FAS). 10. Office of Operations Management (FAY). 11. Office of Information Services (FBB). 12. Office of Financial Management (FBC). 13. Office of Strategic Operations and Regulatory Affairs (FGA). 14. Office of E-Health Standards and Services (FHA). 15. Office of Acquisition and Grants Management (FKA). • Section F. 20. (Functions) is amended by deleting the functional statements in their entirety for the Public Affairs Office, the Center for Beneficiary Choices, the Office of Health Insurance Portability and Accountability Act Standards, and the Center for Medicaid and State Operations. The new functional statements for the Office of External Affairs, Center for Beneficiary Choices, Center for Medicaid and State Operations, Office of E-Health Standards and Services, and the Office of Acquisition and Grants Management read as follows: 1. Office of External Affairs
(FAC)• Serves as the focal point for the Agency to the news media and provides leadership for the Agency in the area of intergovernmental affairs. Advises the Administrator and other Agency components in all activities related to the media and on matters that affect other units and levels of government. • Coordinates CMS activities with the Office of the Assistant Secretary for Public Affairs and the Secretary's intergovernmental affairs officials. • Serves as senior counsel to the Administrator in all activities related to the media. Provides consultation, advice, and training to the Agency's senior staff with respect to relations with the news media. • Develops and executes strategies to further the Agency's relationship and dealings with the media. Maintains a broad based knowledge of the Agency's structure, responsibilities, mission, goals, programs, and initiatives in order to provide or arrange for rapid and accurate response to news media needs. • Prepares and edits appropriate materials about the Agency, its policies, actions and findings, and provides them to the public through the print and broadcast media. Develops and directs media relations strategies for the Agency. • Responds to inquiries from a broad variety of news media, including major newspapers, national television and radio networks, national news magazines, local newspapers and radio and television stations, publications directed toward the Agency's beneficiary populations, and newsletters serving the health care industry. • Manages press inquiries, coordinates sensitive press issues, and develops policies and procedures for how press and media inquiries are handled. • Arranges formal interviews for journalists with the Agency's Administrator or other appropriate senior Agency staff; identifies for interviewees the issues to be addressed, and prepares or obtains background materials as needed. • For significant Agency initiatives, issues media advisories and arranges press conferences as appropriate; coordinates material and personnel as necessary. • Serves as liaison with the Department of Health and Human Services and White House press offices. • Serves as focal point for all Agency interactions with Native American and Alaskan Native tribes. • Coordinates State program issues/concerns ( *i.e.* , waiver reviews, Medigap, Medicare-Select, survey and certification, Clinical Laboratory Improvement Act (CLIA), tribal affairs) with program staff and regional offices. • Serves as coordinator of State health care policy and as liaison between CMS and State and local officials, and individual lobbyists representing State and local officials and advocate groups. • Serves as coordinator of tribal affairs issues and liaison between CMS and State and local officials representing tribal affairs groups. • Responsible for handling highly sensitive and complex correspondence from and to State and local elected officials. Reviews proposed regulations affecting States. • Coordinates roll-out of waivers or other significant announcements relating to States. • Manages CMS activities to better hear and interact with those beneficiaries, providers, and other stakeholders interested in the delivery of quality healthcare for our nation's seniors and beneficiaries with disabilities. Leads and coordinates an ongoing series of ‘Open Door Forums' that provide a dialogue about both the many individual service areas and beneficiary needs within CMS. • Manages and coordinates the Physicians Regulatory Issues Team
(PRIT)consisting of CMS subject matter experts who work to reduce the regulatory burden on physicians who participate with the Medicare program. • Manages and operates CMS' video production studio and satellite network to include product activities, design, development, installation, and monitoring of technological aspects of video broadcast and projection systems, and the development of policies and procedures for production operations. • Administers CMS' identity and branding programs, develops related communication policies, standards and procedures, and oversees, executes and evaluates communication strategies. • Represents the Administrator and senior executive staff in speaking engagements with Physician and Provider groups on the Agency's expectations regarding ongoing patient care. Serves as an Agency liaison with physician and provider groups on the development and implementation of evaluation management guidelines. • In cooperation with senior executive staff, oversees and implements an outreach strategy to physicians and other provider organizations in order to educate them regarding the various options available under the Medicare program and how to discuss those options with patients. 2. Center for Beneficiary Choices
(FAE)• Serves as Medicare Beneficiary Ombudsman, as well as the focal point for all Agency interactions with beneficiaries, their families, care givers, health care providers, and others operating on their behalf concerning improving beneficiaries ability to make informed decisions about their health and about program benefits administered by the Agency. These activities include strategic and implementation planning, execution, assessment and communications. • Assesses beneficiary and other consumer needs, develops and oversees activities targeted to meet these needs, and documents and disseminates results of these activities. These activities focus on Agency beneficiary service goals and objectives and include: development of baseline and ongoing monitoring information concerning populations affected by Agency programs; development of performance measures and assessment programs; design and implementation of beneficiary services initiatives; development of communications channels and feedback mechanisms within the Agency and between the Agency and its beneficiaries and their representatives; and close collaboration with other Federal and State agencies and other stakeholders with a shared interest in better serving our beneficiaries. • Develops national policy for all Medicare Parts A, B, C and D beneficiary eligibility, enrollment, entitlement, premium billing and collection, coordination of benefits, rights and protections, dispute resolution process, as well as policy for managed care enrollment and disenrollment to assure the effective administration of the Medicare program, including the development of related legislative proposals. • Oversees the development of privacy and confidentiality policies pertaining to the collection, use, and release of individually identifiable data. • Coordinates beneficiary-centered information, education, and service initiatives. • Develops and tests new and innovative methods to improve beneficiary aspects of health care delivery systems through Title XVIII, XIX, and XXI demonstrations and other creative approaches to meeting the needs of Agency beneficiaries. • Assures, in coordination with other Centers and Offices, the activities of Medicare contractors, including managed care plans, agents, and State Agencies, meet the Agency's requirements on matters concerning beneficiaries and other consumers. • Plans and administers the contracts and grants related to beneficiary and customer service, including the State Health Insurance Assistance Program grants. • Formulates strategies to advance overall beneficiary communications goals and coordinates the design and publication process for all beneficiary-centered information, education, and service initiatives. • Builds a range of partnerships with other national organizations for effective consumer outreach, awareness, and education efforts in support of Agency programs. • Serves as the focal point for all Agency interactions with managed health care organizations for issues relating to Agency programs, policy and operations. • Develops national policies and procedures related to the development, qualification and compliance of health maintenance organizations, competitive medical plans and other health care delivery systems and purchasing arrangements (such as prospective pay, case management, differential payment, selective contracting, etc.) necessary to assure the effective administration of the Agency's programs, including the development of statutory proposals. • Handles all phases of contracts with managed health care organizations eligible to provide care to Medicare beneficiaries. • Coordinates the administration of individual benefits to assure appropriate focus on long term care, where applicable, and assumes responsibility for the operational efforts related to the payment aspects of long term care and post-acute care services. • Serves as the focal point for all Agency interactions with employers, employees, retirees and others operating on their behalf pertaining to issues related to Agency policies and operations concerning employer sponsored prescription drug coverage for their retirees. • Develops national policies and procedures to support and assure appropriate State implementation of the rules and processes governing group and individual health insurance markets and the sale of health insurance policies that supplement Medicare coverage. • Primarily responsible for all operations related to Medicare Prescription Drug Plans and Medicare Advantage Prescription Drug (Part D) plans. • Performs activities related to the Medicare Parts A & B processes (42 CFR Part 405, Subparts G and H), Part C (42 CFR Part 422, Subpart M), Part D (42 CFR Part 423, Subpart M) and the PACE program for claims-related hearings, appeals, grievances and other dispute resolution processes that are beneficiary-centered. • Develops, evaluates, and reviews regulations, guidelines, and instructions required for the dissemination of appeals policies to Medicare beneficiaries, Medicare contractors, Medicare Advantage
(MA)plans, Prescription Drug Plans (PDPs), CMS regional offices, beneficiary advocacy groups and other interested parties. 9. Center for Medicaid and State Operations
(FAS)• Serves as the focal point for all Centers for Medicare & Medicaid Services activities relating to Medicaid, the State Children's Health Insurance Program, the Clinical Laboratory Improvement Act (CLIA), the survey and certification of health facilities and all interactions with States and local governments (including the Territories). • Develops national Medicaid policies and procedures which support and assure effective State program administration and beneficiary protection. In partnership with States, evaluates the success of State Agencies in carrying out their responsibilities and, as necessary, assists States in correcting problems and improving the quality of their operations. • Develops, interprets, and applies specific laws, regulations, and policies that directly govern the financial operation and management of the Medicaid program and the related interactions with States and regional offices. • In coordination with other components, develops, implements, evaluates and refines standardized provider performance measures used within provider certification programs. Supports States in their use of standardized measures for provider feedback and quality improvement activities. Develops, implements and supports the data collection and analysis systems needed by States to administer the certification program. • Reviews, approves and conducts oversight of Medicaid managed care waiver programs. Provides assistance to States and external customers on all Medicaid managed care issues. • Develops national policies and procedures on Medicaid automated claims/encounter processing and information retrieval systems such as the Medicaid Management Information System
(MMIS)and integrated eligibility determination systems. • In coordination with the Office of Financial Management (OFM), directs, coordinates, and monitors program integrity efforts and activities by States and regions. Works with OFM to provide input in the development of program integrity policy. • Through administration of the home and community-based services program and policy collaboration with other Agency components and the States, promotes the appropriate choice and continuity of quality services available to frail elderly, disabled and chronically ill beneficiaries. • Directs the planning, coordination, and implementation of the survey, certification, and enforcement programs for all Medicare and Medicaid providers and suppliers, and for laboratories under the auspices of the CLIA. Reviews and approves applications by States for “exemption” from CLIA and applications from private accreditation organizations for deeming authority. Develops assessment techniques and protocols for periodically evaluating the performance of these entities. Monitors the performance of proficiency testing programs under the auspices of CLIA. 14. Office of E-Health Standards and Services
(FHA)• Develops and coordinates implementation of a comprehensive e-health strategy for CMS. Coordinates and supports internal and external technical activities related to e-health services and ensures that individual initiatives tie to the overall agency and Federal e-health goals strategies. • Promotes and leverages innovative component initiatives. Facilitates cross-component awareness of various e-health projects. • Develops regulations and guidance materials, and provides technical assistance on the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), including transactions, code sets, identifiers, and security. • Develops and implements the enforcement program for HIPAA Administrative Simplification provisions. • Develops and implements an outreach program for HIPAA Administrative Simplification provisions. Formulates and coordinates a public relations campaign, prepares and delivers presentations and speeches, responds to inquiries on HIPAA issues, and maintains liaison with industry representatives. • Adopts and maintains messaging and vocabulary standards supporting electronic prescribing under Medicare Part D. • Serves as agency point of reference on Federal and private sector e-health initiatives. Works with Federal departments and agencies to identify and adopt universal messaging and clinical health data standards, and represents CMS and HHS in national projects supporting the national health enterprise architecture and the national health information infrastructure. • Coordinates and provides guidance on legislative and regulatory issues related to e-health standards and services. • Collaborates with HHS on policy issues related to e-health standards, and serves as the central point of contact for the Office of the National Coordinator for Health Information Technology. 15. Office of Acquisition and Grants Management
(FKA)• Serves as the Agency's Head of the Contracting Activity. Plans, organizes, coordinates and manages the activities required to maintain an agency-wide acquisition program. • Serves as the Agency's Grants Management Office, with responsibility for all CMS discretionary grants. • Ensures the effective management of the Agency's acquisition and grant resources. • Serves as the lead for developing and overseeing the Agency's acquisition planning efforts. • Develops policy and procedures for use by acquisition staff and internal CMS staff necessary to maintain efficient and effective acquisition and grant programs. • Advises and assists the Administrator, senior staff, and Agency components on acquisition and grant related issues. • Plans, develops, and interprets comprehensive policies, procedures, regulations, and directives for CMS acquisition functions. • Represents CMS at departmental acquisition and grant forums and functions, such as the Executive Council on Acquisition and the Executive Council for Grants Administration Policy. • Serves as the CMS contact point with HHS and other Federal agencies relative to grant and cooperative agreement policy matters. • Coordinates and/or conducts training for contracts and grant personnel, as well as project officers in CMS components. • Develops agency-specific procurement guidelines for the utilization of small and disadvantaged business concerns in achieving an equitable percentage of CMS’ contracting requirements. • Provides cost/price analyses and evaluations required for the review, negotiation, award, administration, and closeout of grants and contracts. Provides support for field audit capability during the pre-award and closeout phases of contract and grant activities. • Develops and maintains an automated procurement management system. Manages procurement information activities ( *i.e.* , collecting, reporting, and analyzing procurement data). Dated: April 28, 2005. Karen Pellham O'Steen, Director, Office of Operations Management, Centers for Medicare & Medicaid Services. [FR Doc. 05-10262 Filed 5-26-05; 8:45 am]
Connectionstraces to 2
5 references not yet in our index
- Pub. L. 106-554
- Pub. L. 108-173
- 42 CFR 405
- 42 CFR 422
- 42 CFR 423
Citation graph
cites case law
Notices
Notice
Pub. L.Pub. L. 106-554
Pub. L.Pub. L. 108-173
Cite42 CFR 405
Cite42 CFR 422
Cite42 CFR 423
Cites 7Cited by 0 across 0 sources