[Federal Register Volume 67, Number 17 (Friday, January 25, 2002)]
[Proposed Rules]
[Pages 3641-3662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Chapter IV

[CMS-9877-P]
RIN 0938-AH53


Medicare and Medicaid Programs; Terms, Definitions, and 
Addresses: Technical Amendments

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

ACTION: Proposed rule.

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SUMMARY: This technical regulation would amend CMS rules--
    To simplify and rationalize the system of definitions and increase 
uniformity in the use of terms;
    To clarify which steps of the appeals process are ``final'' and 
which are ``binding'';
    To correct outdated addresses and organizational unit names;
    To remove content that is outdated or duplicative; and
    To make other editorial changes and technical corrections.
    These revisions are necessary to preclude confusion regarding our 
regulations and to better ensure uniform understanding and application. 
By updating and removing content that is outdated, unnecessary, or 
duplicative, these changes would also shorten our rules and make them 
easier to use.

DATES: Comment date: We will consider all comments received at one of 
the addresses indicated below no later than 5 p.m. on March 26, 2002.

ADDRESSES: Please mail written comments (one original and three copies) 
to the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: HCF-9877-FC, P.O. Box 8013, Baltimore, MD 
21244-8013.
    Please allow sufficient time for mailed comments to be received in 
the event of delivery delays.
    If you prefer, you may deliver your written comments by courier 
(one original and three copies) to one of the following addresses:
    Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, 
SW., Washington, DC 20201; or
    Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    Comments mailed to the above addresses indicated as appropriate for 
hand or courier delivery may be delayed and could be considered late.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code CMS-9877-FC. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room C5-12-08 
of the headquarters Centers for Medicare & Medicaid Services, 7500 
Security Blvd., Baltimore, MD, on Monday through Friday of each week 
from 8:30 a.m. to 4 p.m. To schedule an appointment to view public 
comments, phone: (410) 786-7197.

FOR FURTHER INFORMATION CONTACT: Margaret Teeters, (410) 786-4678.

SUPPLEMENTARY INFORMATION:

A Simplification and Rationalization of the System of Definitions

    In revising the definitions system, we aim to ensure that each 
definition would meet the following conditions:
    1. Is worded so as to preclude confusion or misinterpretation.
    2. Is not duplicated.
    3. Does not include requirements or prohibitions (which belong in 
the text of the rules); or personnel qualifications (which need to be 
identified as such).
    4. If it is of general applicability, is located at the beginning 
of chapter IV.
    5. If it is of limited applicability, is presented as a basic 
definition in that part of the regulations to which it is most 
pertinent or in which it is most frequently used. (When the term is 
used elsewhere, with the same meaning it has in the basic definition, 
we cite that basic definition and do not duplicate it. A separate 
definition of that term would be presented only if it is used with a 
special, different meaning (for example, in a broader or more limited 
sense).
    We do not include definitions of terms that are not used in the 
text, are used in their ordinary, usual sense, or are used only once or 
twice. (In the latter case, the word is explained where used, not 
placed in a definitions section.)
    We would keep all the acronyms for both programs in Sec. 400.200.
    Because of the great number of definitions in CMS's regulations, 
attempting to deal with all of them now would unduly delay issuance of 
this rule. That would not be desirable for a rule that includes content 
(updating and correcting) that must be made available promptly to those 
who implement our regulations and to the general public. We will be 
developing another technical rule to deal with the remaining 
definitions.
    With respect to personnel qualifications, which have sometimes been 
presented as ``definitions,'' our goal has been to include in a new 
Sec. 400.210, the qualifications for the practitioners whose services 
are most frequently used in the Medicare program. The personnel 
qualifications for practitioners who furnish less frequently used 
services would be retained in their current locations.
    Qualifications that are different from the basic qualifications set 
forth in the new section would also be retained where they have been.
    A proposed rule identified as BPD-819-P was published on March 10, 
1997 at 62 FR 11005. The final rule, identified as CMS-3819-F, will 
revise part 484 of the CMS regulations, which

[[Page 3642]]

sets forth the conditions of participation for home health agencies. 
The revision includes changes to the personnel qualifications for 
speech language pathologists, physical and occupational therapists and 
their assistants, and social workers and social work assistants. For 
that reason, this rule proposes no changes in part 484, and does not 
include in the new Sec. 400.210 the qualifications for the above-noted 
skilled professionals.

B. Effect of Appeals Decisions

    Several sections in part 417 pertaining to the appeals process 
would be revised to clarify which steps in the process are ``binding'' 
but not ``final.'' The aim is to make clear that the last step in the 
administrative appeals process must be completed before the appellant 
has any right to judicial review.

C. Correction of Addresses

    We would revise the following sections of the regulations to 
reflect CMS's new address and any applicable name changes that result 
from the reorganization of CMS: 401.128, 401.148, 412.63, 412.210, 
430.62, 483.102, 485.623.

D. Conforming Amendments

    We would correct or remove cross-references to reflect removal or 
transfer of definitions and personnel qualifications, and outdated or 
duplicative rules.

E. Clarifying Editorial Revisions

    The editorial revisions would--
    1. Shorten the regulations and, in order to improve clarity, make 
the following kinds of changes:
     Eliminate repetition and highlight the similarities and 
differences among rules that apply to different types of providers or 
practitioners. Part 456 (Utilization Control) currently includes 3 
subparts that repeat all the requirements that apply equally to 
hospitals, mental hospitals, and intermediate care facilities for the 
mentally retarded (ICFs/MR).
     Shorten the content and highlight the similarities and 
differences by presenting the common requirements once in subpart C 
(``Utilization Control: All Hospitals'') and revising subparts D and F 
to set forth only the additional requirements that apply to mental 
hospitals and to ICFs/MR, respectively.
     Remove undesignated centered headings and either 
substitute designated subparts, or incorporate the content of the 
undesignated heading into the section headings. Undesignated centered 
headings, unlike designated subparts, cannot be used to refer to the 
whole group of sections they encompass. They are usually followed by 
incomplete section headings because the writer depends too much on the 
centered heading language--even when the section may appear many pages 
after the centered heading. This kind of change would be made in part 
456 and also in part 447 (Payments for Services).
     Provide an overview of disclosure of information rules set 
forth in several sections. A single section lists and designates the 
kinds of information that must be disclosed and the entities that must 
make disclosure. (Part 420--Program Integrity: Medicare)
    2. Make numerous minor modifications to--
     Reflect the fact that the nursing home reform amendments 
identify Medicaid facilities as ``nursing facilities'' (NFs) rather 
than ``skilled nursing facilities'' (SNFs); and
     Limit ``intermediate care facilities'' (ICFs) to those 
that serve persons with mental retardation and related conditions.
    3. In part 498, which establishes rules for appeals from CMS 
determinations, we are proposing to--
     Remove references to the Office of the Inspector General 
(OIG) because the OIG now has its own appeals regulations in part 1005 
of chapter V of this title; and
     In Sec. 498.3(d), restore a sentence removed by a previous 
technical amendment. That sentence makes absolutely clear that the only 
administrative actions that qualify as ``initial determinations'' are 
those listed in paragraph (b) of the section.
    4. Remove regulations that are no longer in effect.
    Subpart E of part 417 would be removed because the requirements 
applicable to employer group health plans that include HMOs have become 
outdated.
    Subpart I of part 456 would be removed because section 4751 of the 
Balanced Budget Act (BBA) of 1997 amended sections 1902(a)(26) and 
1902(a)(31) of the Social Security Act to remove the requirement for 
States to perform Inspection of Care (IoC) reviews in institutions for 
mental diseases and ICFs/MR.
    5. Correct cross-references that have become outdated through 
changes made by other regulations, as in parts 410 and 424.

F. Deferred Changes

    The definitions in subpart J of part 411 and parts 435 and 436 
would not be revised because those rules are undergoing extensive 
changes included in other Federal Register documents.

Other Required Information

A. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this preamble, and, if we proceed with a subsequent 
document, we will respond to the major comments in the preamble to that 
document.

B. Paperwork Reduction Act

    This rule contains no information collection requirements subject 
to review by the Office of Management and Budget.

C. Regulatory Impact Statement

    We have examined the impacts of this rule as required by Executive 
Order 12866 (Regulatory Planning and Review) and the Regulatory 
Flexibility Act (RFA), Public Law 96-354. Executive Order 12866 directs 
agencies to assess the costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, distributive impacts, 
and equity). A regulatory impact analysis (RIA) must be prepared for 
rules that constitute significant regulatory action, including rules 
that have an economic effect of $100 million or more annually (major 
rules). We have reviewed this rule and have determined that it is not a 
major rule. Therefore, we are not required to perform an assessment of 
the costs and savings.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses in issuing a proposed rule and a final rule that 
has been preceded by a proposed rule. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and 
government agencies. Most hospitals and most other providers and 
suppliers are small entities, either by nonprofit status or by having 
revenues of $5 million or less annually. Individuals and States are not 
included in the definition of a small entity. We are not preparing an 
analysis for the RFA because we have determined, and we certify, that 
this rule would not have a significant economic impact on a substantial 
number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a proposed rule or a final rule preceded 
by a proposed rule

[[Page 3643]]

may have a significant impact on the operations of a substantial number 
of small rural hospitals. This analysis must conform to the provisions 
of sections 603 and 604 of the RFA. For purposes of section 1102(b) of 
the Act, we define a small rural hospital as a hospital that is located 
outside of a Metropolitan Statistical Area and has fewer than 100 beds. 
We are not preparing an analysis for section 1102(b) of the Act because 
we have determined, and we certify, that this rule would not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Section 202 of the Unfunded Mandate Reform Act of 1995, Public Law 
104-4, also requires that agencies assess anticipated costs and 
benefits before issuing any proposed rule and a final rule preceded by 
a proposed rule that may result in expenditure in any one year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $110 million or more. This rule would have no 
consequential effect on the governments mentioned or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. We have reviewed this proposed rule and have determined 
that it would not have a substantial effect on State or local 
governments.
    We have reviewed this rule and determined that, under the 
provisions of Public Law 104-121, the Contract with America Act, it is 
not a major rule.
    In accordance with the provisions of Executive Order 12866, this 
rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 400

    Grant programs--health, Health facilities, Health maintenance 
organizations (HMOs), Medicaid, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 401

    Claims, Freedom of information, Health facilities, Medicare, 
Privacy.

42 CFR Part 402

    Administrative practice and procedure, Health facilities, Health 
Professions, Medicaid, Medicare, Penalties.

42 CFR Part 403

    Health insurance, Hospitals, Intergovernmental relations, Medicare, 
Reporting and recordkeeping requirements.

42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements, Rural areas, X-rays.

42 CFR Part 406

    Health facilities, Kidney diseases, Medicare.

42 CFR Part 409

    Health facilities, Medicare.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Rural areas, X-ray.

42 CFR Part 411

    Kidney diseases, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 412

    Administrative practice and procedure, Health facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 413

    Health facilities, Kidney diseases, Medicare, Puerto Rico, 
Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney disease, Medicare, Reporting and record keeping 
requirements, Rural areas, X-rays.

42 CFR Part 416

    Health facilities, Kidney diseases, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 417

    Administrative practice and procedure, Grant programs--health, 
Health care, Health facilities, Health insurance, Health maintenance 
organizations (HMOs), Loan programs--health, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 420

    Fraud, Health facilities, Health professions, Medicare.

42 CFR Part 421

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 422

    Health maintenance organizations (HMO), Medicare+Choice, Provider 
sponsored organizations (PSO).

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare.

42 CFR Part 430

    Administrative practice and procedure, Grant programs--health, 
Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 431

    Grant programs--health, Health facilities, Medicaid, Privacy, 
Reporting and recordkeeping requirements.

42 CFR Part 433

    Administrative practice and procedure, Child support, Claims, Grant 
programs--health, Medicaid, Reporting and recordkeeping requirement.

42 CFR Part 434

    Grant programs--health, Health maintenance organizations (HMOs), 
Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 440

    Grant programs--health, Medicaid.

42 CFR Part 441

    Family planning, Grant programs--health, Infants and children, 
Medicaid, Penalties, Reporting and record keeping requirements.

42 CFR Part 442

    Grant programs--health, Health facilities, Health professions, 
Medicaid, Nursing homes, Reporting and recordkeeping requirements.

42 CFR Part 447

    Accounting, Administrative practice and procedure, Drugs, Grant 
programs--health, Health facilities, Health professions, Medicaid, 
Reporting and recordkeeping requirements, Rural areas.

42 CFR Part 455

    Fraud, Grant programs--health, Health facilities, Health 
professions, Investigations, Medicaid, Reporting and recordkeeping 
requirements.

42 CFR Part 456

    Administrative practice and procedure, Grant programs--health,

[[Page 3644]]

Health facilities, Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 475

    Grant programs--health, Health care, Health professions, Peer 
Review Organizations (PROs).

42 CFR Part 476

    Grant programs--health, Health care, Health facilities, Health 
professions, Peer Review organizations (PROs), Reporting and record 
keeping requirements.

42 CFR Part 478

    Administrative practice and procedure, Health care, Health 
professions, Peer Review Organizations (PROs), Reporting and record 
keeping requirements.

42 CFR Part 480

    Health care, Health professionals, Health records, Peer Review 
Organizations (PROs), Penalties, Privacy, Reporting and recordkeeping 
requirements.

42 CFR 482

    Grant programs--health, Hospitals, Medicare, Medicaid, Reporting 
and record keeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 485

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements.

42 CFR Part 488

    Health facilities, Medicare, Reporting and record keeping 
requirements.

42 CFR Part 489

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 491

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements, Rural areas.

42 CFR Part 493

    Grant programs--health, Health facilities, Laboratories, Medicaid, 
Medicare, Reporting and recordkeeping requirements.

42 CFR Part 498

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirement.
    For the reasons set forth in the preamble, 42 CFR Chapter IV would 
be amended as follows:

PART 400--INTRODUCTION: DEFINITIONS; PERSONNEL QUALIFICATIONS; 
COLLECTIONS OF INFORMATION

    A. Part 400 is amended as set forth below.
    1. The heading of part 400 is revised to read as set forth above.
    2. The authority citation for part 400 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C.1302 and 1395hh) and 44 U.S.C. Chapter 35.

Subpart B--Definitions and Personnel Qualifications

    3. The heading of subpart B is revised to read as set forth above.
    4. In Sec. 400.200, the following changes are made:
    a. The definitions of ``Area'', DAB'', ``ICF'', and ``United 
States'' are removed.
    b. In the definition of ``FQCH'', ``means'' is revised to read 
``stands for:''.
    c. The following definitions are added in alphabetical order to 
read as follows:


Sec. 400.200  General definitions.

* * * * *
    Anesthetist means a physician anesthetist, an anesthesiologist 
assistant, or a certified registered nurse anesthetist.
* * * * *
    CAH stands for critical access hospital.
* * * * *
    Departmental Appeals Board means either of the following:
    (1) A panel of members of a Board established in the office of the 
Secretary to provide impartial review of disputed decisions made by the 
operating components of the Department or by ALJs.
    (2) The Medicare Appeals Council designated by the Board Chair to 
review ALJ decisions under part 405, subparts G and H; part 417, 
subpart Q; part 422, subpart M; and part 478, subpart B.
    EACH stands for essential access community hospital.
* * * * *
    FMAP stands for Federal medical assistance percentage.
* * * * *
    HIO stands for health insuring organization.
* * * * *
    Hospital means an institution that meets the requirements of 
section 1861(e) of the Act.
    ICD-9-CM stands for International Classification of Diseases, Ninth 
Revision, Clinical Modification.
* * * * *
    IMD stands for institution for mental diseases.
* * * * *
    MCO stands for managed care organization.
* * * * *
    NF stands for nursing facility.
* * * * *
    PHP stands for prepaid health plan.
    PHS stands for Public Health Service, and PHS Act means the Public 
Health Service Act.
    Practitioner means a physician or any other individual who has the 
credentials to practice within a recognized health care discipline and 
who furnishes the services of that discipline to patients.
* * * * *
    Qualified practitioner means a practitioner who meets the personnel 
qualification requirements set forth in the statute, or in this part or 
elsewhere in this chapter, as a condition for coverage of his or her 
services under Medicare or Medicaid, or both.
* * * * *
    Religious nonmedical health care institution means an institution 
that meets the requirements of section 1861(ss)(1) of the Act.
* * * * *
    RNHCI stands for religious nonmedical health care institution.
* * * * *
    Significant business transaction means a business transaction or 
series of transactions carried out by an entity involved in the 
furnishing of health care services, the total of which, during any 
fiscal year, exceeds 5 per cent of the facility's total operating 
expenses or $25,000, whichever is less.
* * * * *
    State means any of the 50 States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, 
or the Northern Mariana Islands.
    State survey agency means the State health agency or other 
appropriate State or local agency that--
    (1) Has an agreement with CMS under section 1864 of the Act, under 
which it performs surveys and inspections of health care facilities and 
recommends to CMS whether they meet the applicable requirements of 
section 1819, section 1832, section 1861, or subpart C of title XVIII 
of the Act; and
    (2) Is used by the State to determine, on the basis of surveys and 
inspections,

[[Page 3645]]

whether health care facilities meet the requirements for participation 
in Medicaid.
* * * * *
    5. In Sec. 400.202, the following changes are made:
    a. In the definition of ``Carrier'', the phrase ``payable on a 
charge basis'' is removed.
    b. In the definition of ``Intermediary'', ``(or under any 
Prospective Payment System)'' is added immediately after ``payable on a 
cost basis''.
    c. The following definitions are added in alphabetical order to 
read as follows:


Sec. 400.202  Definitions specific to Medicare.

* * * * *
    Assignment means that the beneficiary transfers the right to claim 
payment for a service to the physician or other supplier of the 
service.
* * * * *
    Covered services means services for which payment may be made to or 
on behalf of a Medicare beneficiary, subject to all requirements and 
limitations imposed by title XVIII of the Act and by this chapter.
* * * * *
    Deductible means any of the following:
    (1) The fixed amount for which the beneficiary is liable when he or 
she receives inpatient services in a hospital or CAH for the first time 
in a benefit period.
    (2) The specified amount of expenses that a beneficiary must incur 
for covered Part B services in a calendar year before Medicare payment 
may be made, on his or her behalf, for additional Part B services 
(other than those specifically exempted under section 1833(b) of the 
Act and elsewhere in this chapter) furnished in that year.
    (3) The expenses incurred for the first three pints of whole blood 
or units of packed red cells furnished to a beneficiary during a 
calendar year under Medicare Part A or Part B.
* * * * *
    Medicare enrollee means a beneficiary who has elected to have his 
or her Medicare coverage provided through an HMO, CMP, HCPP, or M+C 
organization that participates in Medicare.
* * * * *
    Physician means--
    (1) A doctor of medicine or osteopathy authorized to practice 
medicine and surgery in the State in which he or she performs the 
function; and
    (2) For certain specified services, a doctor of dental surgery or 
dental medicine, a doctor of podiatric medicine, a doctor of optometry, 
and a chiropractor. (The specific services are set forth in subpart B 
of part 410 of this chapter.)
* * * * *
    Skilled nursing facility (SNF) means a facility that meets the 
requirements of sections 1819(a) through 1819(d) of the Act.
* * * * *
    6. In Sec. 400.203, the following changes are made:
    a. The definition of ``State'' is removed.
    b. A definition of ``Institution for mental diseases'' is added in 
alphabetical order.
    c. The definitions of ``FMAP'' and ``Nursing facility'' are revised 
to read as set forth below.


Sec. 400.203  Definitions specific to Medicaid.

* * * * *
    Federal medical assistance percentage (FMAP) means the percentage 
used to calculate the amount of the Federal share of State expenditures 
under the Medicaid program in accordance with section 1905(b) of the 
Act.
* * * * *
    Institution for mental diseases (IMD) means a facility that meets 
the requirements of section 1905(i) of the Act and the definition in 
Sec. 435.1009 of this chapter.
* * * * *
    Nursing facility (NF) means a facility that meets the requirements 
of sections 1919(a) through 1919(d) of the Act.
* * * * *
    7. A new Sec. 400.210 is added to read as follows:


Sec. 400.210  Personnel qualifications for Medicare.

    (a) Basis and scope. (1) Basis. In order to participate in the 
Medicare program, providers and certain suppliers must use qualified 
staff. In order to be paid for the services they furnish to Medicare 
beneficiaries, physicians and other practitioners must meet specified 
qualifications.
    (2) Scope. (i) This section sets forth the specific qualifications 
that must be met by those practitioners whose services are most 
frequently and widely used in the Medicare program.
    (ii) Qualifications required of practitioners whose services are 
less frequently used or that are different for a particular program 
aspect are set forth in the subparts or sections that deal with those 
program aspects.
    (b) Specific requirements. As a condition for Medicare payment to 
the providers and suppliers that employ them, or for the services that 
they furnish in independent practice, practitioners must meet the 
requirements for State licensing, certification, or approval, and the 
additional qualifications set forth in this section.
    (c) An anesthesiologist assistant must meet the following 
requirements:
    (1) Work under the direction of an anesthesiologist.
    (2) Be in compliance with all applicable requirements of State law, 
including any licensure requirements the State imposes on anesthetists 
who are not physicians.
    (3) Be a graduate of a medical school-based anesthesiologist's 
assistant educational program that--
    (i) Is accredited by the Committee on Allied Health Education and 
Accreditation; and
    (ii) Includes approximately 2 years of specialized basic science 
and clinical education in anesthesia at a level that builds on a 
premedical undergraduate science background.
    (d) A certified registered nurse anesthetist must meet the 
following requirements:
    (1) Be licensed as a registered professional nurse by the State in 
which he or she practices.
    (2) Meet any licensure requirements the State imposes on 
anesthetists who are not physicians.
    (3) Be a graduate of a nurse anesthesia educational program that 
meets the standards of the Council on Accreditation of Nurse Anesthesia 
Programs or any other accreditation organization that CMS designates.
    (4) Meet one of the following conditions:
    (i) Have passed a certification examination of the Council on 
Certification of Nurse Anesthetists, the Council on Recertification of 
Nurse Anesthetists, or any other certification organization that CMS 
designates.
    (ii) Be a graduate of a program described in the qualification in 
paragraph (d)(3) of this section and, within 24 months after that 
graduation, meet the condition in paragraph (d)(4)(i) of this section.
    (e) A nurse-midwife must meet the requirements in paragraphs (e)(1) 
and (2) of this section, and the requirement in paragraph (e)(3) or the 
requirement in paragraph (e)(4):
    (1) Be currently licensed to practice in the State as a registered 
professional nurse.
    (2) Be legally authorized under State law or regulations to 
practice as a nurse-midwife.
    (3) Have completed a State-specified program of study and clinical 
experience for nurse-midwives.

[[Page 3646]]

    (4) If there is no State-specified program of study and clinical 
experience for nurse-midwives, meet one of the following conditions:
    (i) Be currently certified as a nurse-midwife by the American 
College of Nurse-Midwives.
    (ii) Have successfully completed a formal educational program (of a 
least 1 academic year) that, upon completion, qualifies the nurse to 
take the certification examination offered by the American College of 
Nurse-Midwives.
    (iii) Have successfully completed a formal educational program for 
preparing registered nurses to furnish gynecological and obstetrical 
care to women during pregnancy, delivery, and the post-partum period 
and care to normal newborns; and have practiced as a nurse-midwife for 
a total of 12 months during any 18-month period between August 8, 1976 
and July 16, 1982.
    (f) A nurse practitioner must meet one of the following 
requirements:
    (1) Be a registered professional nurse who--
    (i) Is authorized by the State in which he or she furnishes the 
services to practice as a nurse practitioner in accordance with State 
law; and
    (ii) Is certified as a nurse practitioner by a recognized national 
certifying body that has established standards for nurse practitioners.
    (2) Be a registered professional nurse who--
    (i) Is authorized by the State in which he or she furnishes the 
services to practice as a nurse practitioner under State law; and
    (ii) Has been granted a Medicare billing number as a nurse 
practitioner by December 31, 2000.
    (3) Be a nurse practitioner who--
    (i) On or after January 1, 2001, applies for a Medicare billing 
number for the first time; and
    (ii) Meets the requirements specified in paragraph (f)(1) of this 
section
    (4) Be a nurse practitioner who--
    (i) On or after January 1, 2003, applies for a Medicare billing 
number for the first time;
    (ii) Has a master's degree in nursing; and
    (iii) Meets the requirements specified in paragraph (f)(1) of this 
section.
    (g) A physician assistant must meet all of the following 
requirements:
    (1) Have graduated from a physician assistant educational program 
that is accredited by the National Commission on Accreditation of 
Allied Health Education Programs;
    (2) Have passed the national certification examination of the 
National Commission on Certification of Physician Assistants; and
    (3) Be licensed by the State to practice as a physician assistant.

PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS

    B. Part 401 is amended as set forth below.
    1. The authority citation for part 401 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1895hh). Subpart F is also issued under the 
authority of the Federal Claims Collection Act (31 U.S.C. 3711).


Sec. 401.128  [Amended]

    2. In paragraph (a)(3), under ``Region IX'', ``Trust Territory of 
Pacific Islands'' is removed, and ``Northern Mariana Islands'' is added 
after ``American Samoa''.
    3. In paragraph (b), the address ``Director, Office of Research, 
Demonstrations, and Statistics, CMS, Baltimore, Maryland 21235'' is 
revised to read ``Privacy Officer, CMS, 7500 Security Boulevard, 
Baltimore, MD 21244-1850'', and ``, Office of Research, Demonstrations 
and Statistics'', the second time it appears, is removed.


Sec. 401.148  [Amended]

    4. In Sec. 401.148, the address ``CMS, 700 East High Rise Building, 
6401 Security Boulevard, Baltimore, Maryland 21235,'' is revised to 
read ``Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850''.

PART 402--CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS

    C. Part 402 is amended as set forth below.
    1. The authority citation for part 402 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 402.113  [Amended]

    2. In Sec. 402.113, in paragraph (c), ``DAB'' is revised to read 
``Departmental Appeals Board (the Board).''.

PART 403--SPECIAL PROGRAMS AND PROJECTS

    D. Part 403 is amended as set forth below.
    1. The authority citation for part 403 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 403.300  [Amended]

    2. In Sec. 403.300, the section heading is revised to read ``Basis 
and scope'' and the heading of paragraph (b) is revised to read 
``Scope''.


Sec. 403.302  [Amended]

    3. In Sec. 403.302, the following changes are made:
    a. The definition of ``Chief executive officer of a State'' is 
removed.
    b. The definition of ``State system or system'' is amended by 
placing a period after ``control system'' and removing all that 
follows.
    4. In Sec. 403.304, the following changes are made:
    a. The section heading is revised.
    b. Paragraph (a) is revised.
    c. Paragraph (b)(1) is revised.
    The changes read as follows:


Sec. 403.304  Minimum requirements for approval of a State system.

    (a) Application and submission of documentation. The State Governor 
or his or her designee is responsible for submitting the application 
for system approval and any assurances and other documentation required 
under this subpart.
    (b) Basis for approval: Specific requirements. (1) CMS may approve 
the making of Medicare payments under a State reimbursement control 
system if CMS determines that the system meets the requirements of 
paragraphs (b) and (c) and, if applicable, paragraph (d), of this 
section.
    (i) CMS evaluates any application for approval of a State system 
and gives the State notice of its determination within 60 days.
    (ii) CMS may reconsider a denied application in accordance with 
Sec. 403.316.
* * * * *


Secs. 403.312 and 403.314  [Removed]

    5. Secs. 403.312 and 403.314 are removed.

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

    E. Part 405 is amended as set forth below.
    1. In subpart C, the authority citation is revised to read as 
follows:

    Authority: Secs. 1102, 1870, and 1871 of the Social Security Act 
(42 U.S.C. 1302, 1395gg, and 1395hh), and 31 U.S.C. 3711.

    2. In Sec. 405.400, the definition of ``Emergency care services'' 
is removed, and the definition of ``Emergency services'' is added to 
read as follows:


Sec. 405.400  Definitions.

* * * * *

[[Page 3647]]

    Emergency services has the meaning given the term in Sec. 422.113 
of this chapter.
* * * * *
    3. In subparts G and H, the authority citations are revised to read 
as follows:

    Authority: Secs. 1102, 1869 and 1871 of the Social Security Act 
(42 U.S.C. 1302, 1395ff and 1395hh).

    4. In Sec. 405.802, the definition of ``Assignment'' is removed.


Sec. 405.855  [Amended]

    5. In Sec. 405.855, in paragraph (c)(1)(i), ``DAB'' is revised to 
read ``Departmental Appeals Board''.


Sec. 405.857  [Amended]

    6. In Sec. 405.857, in paragraph (a), ``DAB'', the first time it 
appears, is revised to read ``Departmental Appeals Board''.


Sec. 405.1875  [Corrected]

    7. In Sec. 405.1875, in paragraph (a)(2), ``Attorney Advisory'' is 
corrected to read ``Attorney Advisor''.


Sec. 405.1877  [Amended]

    8. In Sec. 405.1877, the following changes are made:
    a. In paragraph (b) ``must file its appeal'' is revised to read 
``must file the civil action''.
    b. The heading of paragraph (e) is revised to read ``Group 
actions.''.
    c. The heading of paragraph (f) is revised to read ``Venue for 
group actions.''.

Subpart U [Amended]

    9. In subpart U, the authority citation is revised to read as 
follows:

    Authority: Secs. 1102, 1871, and 1881 of the Social Security Act 
(42 U.S.C. 1302, 1395hh, and 1395qq).

    10. In Sec. 405.2401, the definitions of ``Act'', ``Beneficiary'', 
``Carrier'', ``CMS'', ``Covered services'', ``Deductible'', ``Nurse-
midwife'', ``Nurse practitioner and physician assistant'', ``Reporting 
period'', and ``Secretary'' are removed, and the definition of 
``Physician'' is revised to read as follows:


Sec. 405.2401  Scope and definitions.

* * * * *
    Physician includes residents who meet the definition of 
Sec. 415.152 of this chapter and meet the requirements of 
Sec. 415.206(b) of this chapter for payment under the physician fee 
schedule.
* * * * *

PART 406--HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT

    F. Part 406 is amended as set forth below.
    1. The authority citation for part 406 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

    2. In Sec. 406.21, paragraph (f)(1) is revised to read as follows:


Sec. 406.21  Individual enrollment.

* * * * *
    (f) Transfer enrollment period for HMO and CMP enrollees. (1) 
Applicability. This paragraph applies to an enrollee of an HMO or CMP 
that has a contract with CMS under subpart L of part 417 of this 
chapter.
* * * * *

PART 409--HOSPITAL INSURANCE BENEFITS

    G. Part 409 is amended as set forth below.
    1. The authority citation for part 409 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 409.3  [Amended]

    2. In Sec. 409.3, the definition of ``Covered'' is removed.


Sec. 409.60  [Amended]

    3. In Sec. 409.60, in paragraph (c), ``405.330'', wherever it 
appears, is revised to read ``Sec. 411.400''.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

    H. Part 410 is amended as set forth below.
    1. The authority citation for part 410 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh unless otherwise indicated).


Sec. 410.1  [Amended]

    2. In Sec. 410.1, paragraph (b), ``copayment'' is revised to read 
``coinsurance'', and ``subpart C of part 405'' is revised to read 
``part 411''.
    3. In Sec. 410.2, the definition of ``nominal charge provider'' is 
revised to read as follows:


Sec. 410.2  Definitions.

* * * * *
    Nominal charge provider has the meaning given the term in 
Sec. 409.3 of this chapter.
* * * * *


Sec. 410.32  [Amended]

    4. In Sec. 410.32, in paragraph (d)(1), ``RPCH'' is revised to read 
``CAH''.


Sec. 410.50  [Amended]

    5. In Sec. 410.50, in paragraph (b), the word ``independent'' is 
removed and ``subpart M of part 405 of this chapter.'' is revised to 
read ``part 493 of this chapter.''.


Sec. 410.58  [Amended]

    6. In Sec. 410.58, the following changes are made:
    a. In paragraph (a)(1), ``as defined in Sec. 491.2 of this 
chapter,'' is removed.
    b. In paragraph (a)(2), ``as defined in Sec. 417.416'' is revised 
to read ``who has the qualifications specified in Sec. 417.416(d)(2)''.
    7. In Sec. 410.62, the following changes are made:
    a. Paragraph (a)(2)(i) is revised to read as set forth below.
    b. In paragraph (a)(2)(iii), ``Sec. 410.63'' is revised to read 
``Sec. 424.24''.


Sec. 410.62  Outpatient speech pathology services: Conditions and 
exclusions.

    (a) * * *
    (2) * * *
    (i) Is established either by a physician or by the speech 
pathologist who will provide the services to the particular individual;
* * * * *
    8. Section 410.69 is revised to read as follows:


Sec. 410.69  Services of a certified registered nurse anesthetist or an 
anesthesiologist assistant.

    Medicare Part B pays for anesthesia services and related care 
furnished by a certified registered nurse anesthetist or an 
anesthesiologist assistant who--
    (a) Is legally authorized to perform the services by the State in 
which he or she performs them; and
    (b) Meets the qualifications specified in Sec. 400.210 of this 
chapter.


Sec. 410.74  [Amended]

    9. In Sec. 410.74, the following changes are made:
    a. In paragraph (a)(2)(i), ``paragraph (c) of this section'' is 
revised to read ``Sec. 400.210 of this chapter''.
    b. Paragraph (c) is removed and reserved.
    10. In Sec. 410.75, paragraph (b) is revised to read as follows:


Sec. 410.75  Nurse practitioner's services.

* * * * *
    (b) Qualifications. For Medicare Part B coverage of his or her 
services, a nurse practitioner must meet one of the requirements 
specified in Sec. 400.210(f) of this chapter.
* * * * *

[[Page 3648]]

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

    I. Part 411 is amended as set forth below.
    1. The authority citation for part 411 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 411.6  [Amended]

    2. In Sec. 411.6, in paragraph (b)(4), ``(as defined in Sec. 409.3 
of this chapter)'' is removed.


Sec. 411.15  [Amended]

    3. In Sec. 411.15, the following changes are made:
    a. In paragraph (m)(1), ``(as defined in Sec. 409.3 of this 
chapter)'' is removed.
    b. Paragraph (m)(3)(vi) is revised to read ``Services of a 
certified registered nurse anesthetist or of an anesthesiologist's 
assistant.''.

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

    J. Part 412 is amended as set forth below.
    1. The authority citation for part 412 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 412.50  [Amended]

    2. In Sec. 412.50, in paragraph (c), ``(as defined in Sec. 409.3 of 
this chapter)'' is removed.


Secs. 412.63 and 412.210  [Amended]

    3. In Sec. 412.63(b)(3) and Sec. 412.210(b)(2), the address ``CMS, 
East High Rise Building, Room 132, 6325 Security Boulevard, Baltimore, 
Maryland, 21207'' is revised to read ``Centers for Medicare & Medicaid 
Services, 7500 Security Boulevard, Baltimore, MD 21244-1850''.


Sec. 412.108  [Amended]

    4. In Sec. 412.108, paragraph (a)(1)(i), ``as defined in'' is 
revised to read ``as determined under''.
    5. In Sec. 412.113, in paragraph (c)(2)(i)(B), the first sentence 
is revised to read as follows:


Sec. 412.113  Other payments.

* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (B) The hospital must, as of January 1, 1988, have employed or 
contracted with a certified registered nurse anesthetist or an 
anesthesiologist's assistant to perform anesthesia services in that 
hospital.
* * * * *

PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR 
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT 
RATES FOR SKILLED NURSING FACILITIES

    K. Part 413 is amended as set forth below.
    1. The authority citation for part 413 continues to read as 
follows:

    Authority: Secs. 1102, 1861(v)(1)(A), and 1871 of the Social 
Security Act (42 U.S.C. 1302, 1395x(v)(1)(A), and 1395hh).


Sec. 413.20   [Amended]

    2. In Sec. 413.20, in paragraph (c) introductory text, ``provider 
of services (as defined in Sec. 400.202 of this chapter)'' is revised 
to read ``provider''.


Sec. 413.53  [Amended]

    3. In Sec. 413.53, in the table for Hospital K, ``ICF-type'', 
wherever it appears, is revised to read ``NF-type''.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

    L. Part 414 is amended as set forth below.
    1. The authority citation for part 414 continues to read as 
follows:

    Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).


Sec. 414.2  [Amended]

    2. In Sec. 414.2, the following changes are made:
    a. The definitions for CY and FY are removed.
    b. In paragraph (3) of the definition of ``Physician services'', 
remove ``of services as defined in Sec. 400.202 of this chapter''.

PART 416--AMBULATORY SURGICAL SERVICES

    M. Part 416 is amended as set forth below.
    1. The authority citation for part 416 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 416.42  [Amended]

    2. In Sec. 416.42, in paragraph(b)(2), ``as defined in 
Sec. 410.68(b) of this chapter'' is removed.


Sec. 416.61  [Amended]

    3. In Sec. 416.61, in paragraph (b), ``include items and services'' 
is revised to read ``include services'', and ``of part 405'' is 
removed.

PART 417--HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL 
PLANS, AND HEALTH CARE PREPAYMENT PLANS

    N. Part 417 is amended as set forth below.
    1. The authority citation for part 417 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh), secs. 1301, 1306, and 1310 of the Public 
Health Service Act (42 U.S.C. 300e, 300e-5, and 300e-9); and 31 
U.S.C. 9701.


Sec. 417.1  [Amended]

    2. In Sec. 417.1, the following changes are made:
    a. The definitions of ``Secretary'' and ``Significant business 
transaction'' are removed.
    b. In the definition of ``Furnished'', ``maid'' is corrected to 
read ``made'', and ``dierctly'' is corrected to read ``directly''.


Sec. 417.101  [Amended]

    3. In Sec. 417.101, in paragraph (c), ``Secs. 417.168 and 
417.169,'' is revised to read
    ``Sec. 417.142(g) and (h),''.
    4. In Sec. 417.126, the following changes are made:
    a. In paragraph (b)(1), ``(as defined in paragraph (c) of this 
section)'' is revised to read ``(as defined in Sec. 400.200 of this 
chapter)''.
    b. Paragraph (c) is revised to read as set forth below.
    c. Paragraphs (d) and (e), the first time they appear, are removed.


Sec. 417.126  Recordkeeping and reporting requirements.

* * * * *
    (c) Business transaction defined. As used in paragraph (b) of this 
section, a business transaction is any of the following kinds of 
transactions:
    (1) Sale, exchange, or lease of property.
    (2) Goods, services, or facilities furnished for a monetary 
consideration, including management services but not including--
    (i) Salaries paid to employees for services performed in the normal 
course of their employment; or
    (ii) Health services furnished to the HMO's enrollees by hospitals 
and other providers and by HMO staff, medical groups, IPAs, or any 
combination of these entities.
* * * * *

[[Page 3649]]

Sec. 417.143  [Amended]

    5. In Sec. 417.143, in paragraph (b)(2), ``417.168 and 427.169 of 
subpart F.'' is revised to read ``Sec. 417.142(g) and (h).''.

Subpart E [Removed]

    6. Subpart E, consisting of Secs. 417.150 through 417.159, is 
removed and reserved.


Sec. 417.404  [Amended]

    7. In Sec. 417.404, in paragraph (a)(1), ``Sec. 117.142'' is 
revised to read ``Sec. 417.142''.


Sec. 417.416  [Amended]

    8. In Sec. 417.416, in paragraph (d)(1),''(as defined in Sec. 491.2 
of this chapter)'' is removed.


Sec. 417.602  [Removed]

    9. Sec. 417.602 is removed.


Sec. 417.604  [Amended]

    10. In Sec. 417.604, in paragraph (b)(3), the parenthesis preceding 
``Sec. 427.440(b)(2)'' is moved to precede ``under''.


Secs. 417.646, 417.658, and 417.690  [Amended]

    11. in Sec. 417.646 introductory text, Sec. 417.658, and 
Sec. 417.690(c), ``final and binding'' is revised to read ``binding''.


Sec. 417.800  [Amended]

    12. In Sec. 417.800, the definition of ``Medicare enrollee'' is 
removed.

PART 418--HOSPICE CARE

    O. Part 418 is amended as set forth below.
    1. The authority citation for part 418 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 418.3  [Amended]

    2. In Sec. 418.3, the definition of ``Physician'' is removed.


Sec. 418.98  [Amended]

    3. In 418.98(b)(2), ``An ICF'' is revised to read ``An NF''.


Sec. 418.202  [Amended]

    4. In Sec. 418.202, in paragraph (c), ``as defined in Sec. 410.20 
of this chapter'' is removed.

PART 420--PROGRAM INTEGRITY: MEDICARE

    P. Part 420 is amended as set forth below.
    1. The authority citation for part 420 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).
    2. Sec. 420.200 is revised to read as follows:


Sec. 420.200  Basis, scope, and applicability.

    (a) Basis and scope. This subpart is based on sections 1124, 1124A, 
1126, and 1861(v)(1)(I) of the Act. It sets forth requirements for 
providers, Part B suppliers, health maintenance organizations, and 
intermediaries and carriers to disclose information about the following 
matters and persons.
    (1) The hiring of an intermediary's former employees by a provider.
    (2) Any person who--
    (i) Has an ownership or control interest in the provider or 
supplier or serves as the agent or managing employee of the provider or 
supplier;
    (ii) Has been convicted of a criminal offense, subjected to a civil 
money penalty, or excluded from the program, as a result of any 
activities related to involvement in Medicare, Medicaid, the Maternal 
and Child Health program under title V of the Act, or the Social 
Services program under title XX of the Act, at any time since the 
inception of these programs; or
    (iii) Has an ownership or control interest in, or is the agent or 
managing employee of, an entity that has been sanctioned as described 
in paragraph (a)(2)(ii) of this section.
    (3) Significant business transactions between the provider or 
supplier and any subcontractor or wholly owned supplier.
    (b) Applicability. The following are subject to the requirements of 
this subpart as disclosing entities:
    (1) A provider of services as defined in section 1861(u) of the Act 
or a Part B supplier.
    (2) A clinical laboratory.
    (3) A renal disease facility.
    (4) A rural health clinic.
    (5) A Federally qualified health center.
    (6) A health maintenance organization as defined in section 1301(a) 
of the PHS Act.
    (7) A Medicare intermediary or carrier.
    (8) A Medicare+Choice organization, as defined in section 1859 of 
the Act.
    (9) A managed care entity as defined in section 1932 of the Act.
    3. In Sec. 420.201, the following changes are made:
    a. The definition of ``Significant business transaction'' is 
removed.
    b. The definitions of ``Disclosing entity'', ``Other disclosing 
entity'', ``Indirect ownership interest'' and ``Ownership interest'' 
are revised and the newly revised definition of Other disclosing entity 
is transferred to proper alphabetical order, to read as follows:


Sec. 420.201  Definitions.

* * * * *
    Disclosing entity means any of the entities specified in 
Sec. 420.200(b).
    Indirect ownership interest means an ownership interest in an 
entity that has a direct or indirect ownership interest in a disclosing 
entity.
* * * * *
    Other disclosing entity means any entity (other than an individual 
practitioner or group of practitioners) that--
    (1) Is not listed in Sec. 420.200 (b) and does not participate in 
Medicare; but
    (2) Is required to disclose ownership and control information 
because it furnishes health-related services under any of the programs 
established under title V, XIX, or XX of the Act, or serves as a 
Medicaid fiscal agent.
* * * * *
    Ownership interest means the possession of equity in the capital, 
the stock, or the profits of a disclosing entity.
* * * * *


Sec. 420.301  [Amended]

    4. In Sec. 420.301, the definition of ``Provider'' is removed.

PART 421--INTERMEDIARIES AND CARRIERS

    Q. Part 421 is amended as set forth below.
    1. The authority citation for part 421 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Secs. 421.1 and 421.3  [Revised]

    2. Secs. 421.1 and 421.3 are revised to read as follows:


Sec. 421.1  Basis and scope.

    (a) Basis. (1) This part is based on the indicated provisions of 
the following sections of the Act:
    1124--Requirements for disclosure of certain information.
    1816 and 1842--Use of organizations and agencies to make Medicare 
payments to providers and suppliers of covered services.
    (2) Section 421.118 is also based on 42 U.S.C. 1395b-1(a)(1)(F), 
which authorizes demonstration projects involving intermediary 
agreements and carrier contracts.
    (b) Scope. This part sets forth--
    (1) The procedures for selecting intermediaries and carriers;
    (2) The requirements for approval of intermediary agreements and 
carrier contracts;
    (3) The functions that intermediaries and carriers are required to 
perform;

[[Page 3650]]

    (4) The criteria for--
    (i) Evaluating intermediary and carrier performance;
    (ii) Designating intermediaries and carriers to serve a class of 
providers on a regional or national basis; and
    (iii) Assigning and reassigning providers or suppliers to 
particular intermediaries.
    (5) CMS's authority to perform certain functions directly or by 
contract; and
    (6) The appeal rights of intermediaries and carriers dissatisfied 
with specified adverse actions.


Sec. 421.3  Definition.

    For purposes of designation of intermediaries (Sec. 421.117) and 
application of performance criteria and standards (Secs. 421.120 and 
421.122) ``intermediary'' includes a Blue Cross plan that has entered 
into a CMS-approved subcontract with the Blue Cross and Blue Shield 
Association to perform intermediary functions.

PART 422--MEDICARE+CHOICE PROGRAM

    R. Part 422 is amended as set forth below.
    1. The authority citation for part 422 continues to read as 
follows:

    Authority: Secs.1102, 1851 through 1857, 1859, and 1871 of the 
Social Security Act (42 U.S.C. 1302, 1395w-21 through 1395w-27, and 
1395hh).


Sec. 422.500  [Amended]

    2. In Sec. 422.500, the definition of ``Significant business 
transaction'' is removed.


Sec. 422.562  [Amended]

    3. In paragraph (b)(3)(v), ``DAB'' is revised to read 
``Departmental Appeals Board''.

PART 424--CONDITIONS FOR MEDICARE PAYMENT

    S. Part 424 is amended as set forth below.
    1. The authority citation for part 424 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 424.3  [Amended]

    2. In Sec. 424.3, the definition of ``ICD-9-CM'' is removed.


Sec. 424.20  [Amended]

    3. In Sec. 424.20(e)(2), ``neither of whom has'' is revised to read 
``who does not have''.

PART 430--GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS

    Part 430 is amended as set forth below.
    1. The authority citation for part 430 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


Sec. 430.25  [Amended]

    2. In Sec. 430.25(c)(2), ``SNF, ICF, or ICF/MR'' is revised to read 
``NF or ICF/MR''.


Sec. 430.30  [Amended]

    3. In Sec. 430.30(e), the language following ``under this 
subpart:'' is revised to read as follows:


Sec. 430.30  Grants procedures.

* * * * *
    (e) * * *
    Sec. 74.12--Forms for applying for HHS financial assistance.
    Sec. 74.23--Cost sharing or matching.
    Sec. 74.25--Revision of budget and program plans.
    Sec. 74.52--Financial reporting.


Sec. 430.62  [Amended]

    4. In Sec. 430.62, the name and address ``Docket Clerk, Hearing 
Staff, Bureau of Eligibility, Reimbursement, and Coverage, 300 East 
High Rise, 6325 Security Boulevard, Baltimore, Maryland 21207. 
Telephone: (301) 594-8261'' is revised to read ``Centers for Medicare & 
Medicaid Services, Office of Hearings, 7500 Security Boulevard, 
Baltimore, MD 21244-1850''.

PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION

    U. Part 431 is amended as set forth below.
    1. The authority citation for part 431 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).
    2. Throughout this subpart E, all references to ``skilled nursing 
facility'' are removed.


Sec. 431.57  [Amended]

    3. In Sec. 431.57, the following changes are made:
    a. In paragraphs (b) and (c),''subchapter'' is revised to read 
``chapter''.
    b. In paragraph (e), ``of this part'' is removed.


Sec. 431.200  [Amended]

    4. In Sec. 431.200, remove ``skilled nursing facilities and''.


Sec. 431.201  [Amended]

    5. In Sec. 431.201:
    a. In the definition of ``Action'', remove ``skilled nursing 
facilities and''.
    b. The definition of ``Date of action'' is removed.


Sec. 431.206  [Amended]

    6. In Sec. 431.206, in paragraph (c)(3), remove ``a skilled nusring 
facility or''.


Sec. 431.210  [Amended]

    7. In Sec. 431.210, in paragraph (a), remove ``State, skilled 
nursing facility, or nursing facility'' and add in its place ``State or 
nursing facility''.
    8. Section 431.211 is revised to read as follows:


Sec. 431.211  Advance notice.

    Except as permitted under Secs. 431.213 and 431.214, the State or 
local agency must mail the notice required under Sec. 431.206(c)(2) 
through (c)(4) at least 10 days before the intended effective date of 
the action.
    9. In Sec. 431.213, the following changes are made:
    a. The introductory text and paragraph (h) are revised to read as 
set forth below.
    b. Remove the semicolons at the end of paragraphs (a) through (g) 
and add periods in their place, and remove the ``or'' after paragraph 
(g).


Sec. 431.213  Exceptions to advance notice requirements.

    The agency may mail the notice no later than the effective date of 
the action or the date of the determination, as applicable, under any 
of the following circumstances:
* * * * *
    (h) The discharge or transfer of the recipient will be effective in 
less that 10 days and the timing exception of Sec. 483.12(a)(5)(ii) of 
this chapter applies.
    10. In Sec. 431.214, the introductory text is revised to read as 
follows:


Sec. 431.214  Notice in cases of probable fraud.

    The agency may shorten the period of advance notice to 5 days 
before the effective date of the action or the date of the 
determination, as applicable, if--
* * * * *


Sec. 431.220  [Amended]

    11. In Sec. 431.220, in paragraph (a)(3), remove ``skilled nursing 
facility or''.


Sec. 431.241  [Amended]

    12. In Sec. 431.241, in paragraph (c), remove ``skilled nursing 
facility or''.


Sec. 431.242  [Amended]

    13. In Sec. 431.242, in paragraph (a)(2), remove ``skilled nursing 
facility''.
    14. In Sec. 431.610, the following changes are made:
    a. In paragraph (g)(1), ``subchapter'' is revised to read 
``chapter''.

[[Page 3651]]

    b. Paragraph (g)(3) is revised to read as follows:


Sec. 431.610  Relations with standard-setting and survey agencies.

* * * * *
    (g) * * *
    (3) Have qualified personnel perform on-site inspections at least 
once during each certification period, or more often if there is a 
compliance question.
* * * * *
    15. In Sec. 431.620, paragraph (b) is revised to read as follows:


Sec. 431.620  Agreement with State mental health authority or mental 
institutions.

* * * * *
    (b) Definition. Institution for mental diseases (IMD) has the 
meaning given the term in Sec. 400.203 of this chapter.
* * * * *


Sec. 431.701  [Amended]

    16. In Sec. 431.701, the following changes are made:
    a. Under the definition of ``Nursing home'', paragraphs (a) and (b) 
are redesignated as paragraphs (1) and (2).
    b. In newly designated paragraph (2), ``subchapter'' is revised to 
read ``chapter''.
    17. In Sec. 431.804, the definitions of ``active case'' and 
``administrative period'' are revised to read as follows:


Sec. 431.804  Definitions.

* * * * *
    Active case means an individual or family that the State agency has 
determined to be currently eligible for Medicaid.
    Administrative period means the 2-month period (review month and 
preceding month) during which a case error is not cited for the State 
agency's failure to take any action required by a change in case 
circumstances.
* * * * *

PART 433--STATE FISCAL ADMINISTRATION

    V. Part 433 is amended as set forth below.
    1. The authority citation for part 433 is revised to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


Sec. 433.1  [Removed]

    2. Sec. 433.1 is removed.
    3. In subpart A, a new Sec. 433.5 is added, to read as follows:


Sec. 433.5  Basis and scope.

    (a) Basis. Most of the sections in this subpart identify the 
statutory provisions on which the rules are based. Certain portions of 
section 1902(a) of the Act are the basis for general administrative 
requirements such as those for accounting systems, cost allocation, 
reporting, and the handling of checks that are uncashed or canceled.
    (b) Scope. This subpart sets forth the conditions for, and the 
rates of, FFP and the general administrative requirements related to 
the State's fiscal activities.
    4. Section 433.111 is amended to revise the section heading and 
paragraph (b) to read as follows:


Sec. 433.111  Terminology.

* * * * *
    (b) Mechanized claims processing and information retrieval system 
or system means the system of hardware and software used to process 
Medicaid claims and to produce and retrieve services utilization and 
management information required by the Medicaid single State agency and 
the Federal Government for program administration and auditing.
    (1) The claims are from providers of medical care and services 
furnished to recipients under the Medicaid program.
    (2) The system consists of the following:
    (i) Required subsystems specified in the State Medicaid Manual.
    (ii) Required changes to the required system or subsystem, 
published in accordance with Sec. 433.123, and specified in the State 
Medicaid Manual.
    (iii) System enhancements approved by CMS.
    (3) Eligibility determination systems are not part of the claims 
processing and information retrieval system or enhancements to that 
system.
    5. In Sec. 433.304, the following changes are made:
    a. The definitions of ``Provider'' and ``Recoupment'' are removed.
    b. The definitions of ``Abuse'', ``Fraud'', ``Overpayment'', and 
``Third party'' are revised; and a definition of ``Sixty-day period'' 
is added to read as set forth below.


Sec. 433.304  Definitions.

    Abuse has the meaning given the term in Sec. 455.2 of this chapter.
* * * * *
    Fraud has the meaning given the term in Sec. 455.2 of this chapter.
    Overpayment means the portion of a Medicaid payment to a provider--
    (1) That is in excess of the amount allowable for the services 
under section 1902 of the Act and implementing regulations; and
    (2) That must be refunded to CMS by the State under section 1903 of 
the Act and this subpart.
* * * * *
    Sixty-day period means the 60 calendar days immediately following 
discovery of an overpayment, allowed for the State agency to recover or 
seek to recover the overpayment.
    Third party has the meaning given the term in Sec. 433.136.

PART 434--CONTRACTS

    W. Part 434 is amended as set forth below.
    1. The authority citation for part 434 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


Sec. 434.2  [Corrected]

    2. In Sec. 434.2, the definition of ``Prepaid health plan'', 
``Medical agency'' is corrected to read ``Medicaid agency''.


Sec. 434.6  [Amended]

    3. In Sec. 434.6(a)(1), ``appendix G;'' is revised to read 
``appendix A;''.


Sec. 434.21  [Amended]

    4. In Sec. 434.21(b)(3), ``Skilled nursing facility (SNF) 
services'' is revised to read ``Nursing facility services''.

PART 440--SERVICES: GENERAL PROVISIONS

    X. Part 440 is amended as set forth below.
    1. The authority citation for part 440 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


Sec. 440.10  [Amended]

    2. In Sec. 440.10(b), ``SNF and ICF services'' is revised to read 
``NF services''.
    3. In Sec. 440.20, the following changes are made:
    a. The introductory text of paragraph (b) and paragraph (b)(1) are 
revised to read as set forth below.
    b. In paragraph (b)(2), ``(as defined in Secs. 405.2401 and 491.2 
of this chapter)'' is removed.
    c. In paragraph (c), second sentence, ``furnishd'' is corrected to 
read ``furnished''.


Sec. 440.20  Outpatient hospital services and rural health clinic 
services.

* * * * *
    (b) Rural health clinic services means the following services when 
they are furnished by a rural health clinic that has been certified in 
accordance with part 491 of this chapter, and by practitioners who are 
acting within the scope of their practice under State law and who meet 
the conditions specified in this paragraph:

[[Page 3652]]

    (1) Services furnished by a physician in the clinic and services 
furnished away from the clinic if the physician's contract with the 
clinic so provides.
    4. In Sec. 440.40, paragraph (a) is revised to read as follows:


Sec. 440.40  Nursing facility services for individuals age 21 or older 
(other than services in institutions for mental diseases), EPSDT, and 
family planning services and supplies.

    (a) Nursing facility services. (1) ``Nursing facility services for 
individuals age 21 or older other than services in an institution for 
mental disease'' means inpatient care that meets the requirements of 
paragraphs (a)(2) and (a)(3) of this section and includes the 
following:
    (i) Skilled nursing care and related services for residents who 
require medical or nursing care.
    (ii) Rehabilitation services for the rehabilitation of injured, 
disabled, or sick persons.
    (iii) Health related care and services for individuals who, because 
of their mental or physical condition, require, on a regular basis, 
services that--
    (A) Are above the level of room and board; and
    (B) Must be made available on an inpatient basis.
    (2) The services must be ordered by, and furnished under the 
direction of, a physician.
    (3) The services must be provided by one of the following:
    (i) A facility or distinct part of a facility that is certified as 
meeting the requirements for participation that are set forth in 
subpart B of part 483 of this chapter.
    (ii) If specified in the State plan, a swing-bed hospital that has 
CMS approval to furnish SNF services under Medicare.
    (iii) Any facility located on an Indian reservation if the facility 
is certified by the Secretary as meeting the requirements of subpart B 
of part 483 of this chapter.
* * * * *


Sec. 440.50  [Amended]

    5. In paragraph (a) introductory text, ``skilled'' and ``by a 
physician'' are removed.
    6. In Sec. 440.70. paragraph (c) is revised to read as follows:


Sec. 440.70  Home health services.

* * * * *
    (c) Services furnished to a recipient whose place of residence is a 
hospital or a nursing facility are not ``home health services''. 
However, home health services may be furnished to residents of an ICF/
MR if they are services other than those required under subpart I of 
part 483 of this chapter. For example, a registered nurse may provide 
short-term care for a recipient in an ICF/MR to avoid having to 
transfer the recipient to a nursing facility.
* * * * *


Sec. 440.80  [Amended]

    7. In Sec. 440.80(c)(3), ``A skilled nursing facility'' is revised 
to read ``A nursing facility''.
    8. In Sec. 440.140, the following changes are made:
    a. The section heading is revised to read as follows: 
``Sec. 440.140 Inpatient hospital services and nursing facility 
services for individuals age 65 or older in institutions for mental 
diseases.''
    b. In paragraph (a), introductory text, ``(b), (c), and (e)'' is 
removed.
    c. In paragraph (a)(2), ``subpart H of'' is removed.


Sec. 440.165  [Amended]

    9. Section 440.165 is amended by revising paragraph (b) to read as 
follows:


Sec. 440.165  Nurse-midwife service.

* * * * *
    (b) ``Nurse-midwife'' means a registered professional nurse who 
meets the applicable qualifications set forth in Sec. 400.210(b) of 
this chapter.


Sec. 440.166  [Amended]

    10. In Sec. 440.166, in paragraph (d), ``this subchapter.'' is 
revised to read ``this chapter.''.


Sec. 440.220  [Amended]

    11. In Sec. 440.220, in paragraph (a)(3), ``skilled'' is removed.


Sec. 440.250  [Amended]

    12. In Sec. 440.250, the following changes are made:
    a. In paragraph (a), ``skilled nursing facility services'' is 
revised to read ``nursing facility services''.
    b. In paragraph (m), ``(as defined in Sec. 440.255)'' is removed.
    13. Paragraph (b)(1) is revised to read as follows:


Sec. 440.255  Limited services available to certain aliens.

* * * * *
    (b) * * *
    (1) Emergency services as defined in Sec. 447.53(b) of this 
chapter.
* * * * *

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

    Y. Part 441 is amended as set forth below.
    1. The authority citation for part 441 continues to read as 
follows:

    Authority: Section 1102 of the Social Security Act (42 U.S.C. 
1302).


Sec. 441.1  [Amended]

    2. In Sec. 441.1, the following changes are made:
    a. The word ``subchapter'', wherever it appears, is revised to read 
``chapter''.
    b. Revise ``intermediate care facility services for the mentally 
retarded'' to read ``nursing facilities and intermediate care 
facilities for persons with mental retardation''.


Sec. 441.15  [Amended]

    3. In Sec. 441.15, the following changes are made:
    a. In the introductory text, the word ``subchapter'' is revised to 
read ``chapter''.
    b. In paragraph (b)(2), ``skilled'' and ``individuals;'' are 
removed.
    c. In paragraph (b)(3), ``skilled nursing facility'' is revised to 
read ``nursing facility''.
    4. Section 441.17 is revised to read as follows:


Sec. 441.17  Laboratory services.

    (a) The plan must provide for payment for laboratory services as 
defined in Sec. 440.30 of this chapter, if they are furnished by 
entities that meet the following additional requirements, as 
appropriate:
    (1) For hospital-based laboratories, the requirements of 
Sec. 482.27 of this chapter.
    (2) For services furnished by rural health clinics, the 
requirements of Sec. 491.9(c)(2) of this chapter.
    (3) For NF-based laboratories, the requirements of Sec. 483.75(j) 
of this chapter
    (b) Laboratory records must contain the name (or other identifier 
approved by the Medicaid agency) of the person from whom the specimen 
was taken.


Sec. 441.100  [Amended]

    5. In Sec. 441.100, ``, skilled nursing services, and intermediate 
care facility services'' is revised to read ``and nursing facility 
services''.


Sec. 441.150  [Amended]

    6. In Sec. 441.150, ``subchapter'' is revised to read ``chapter''.


Sec. 441.152  [Amended]

    7. In Sec. 441.152, the following changes are made:
    a. The designation ``(a)'' is removed and ``Sec. 441.154'' is 
revised to read``Sec. 441.153''.
    b. The designations ``(1)'', ``(2)'', and ``(3)'' are revised to 
read ``(a)'', ``(b)'', and ``(c)'', respectively.
    c. Paragraph (b) is removed.

[[Page 3653]]

Sec. 441.155  [Amended]

    8. In Sec. 441.155, the following changes are made:
    a. In paragraph (a), ``to the extent that'' is revised to read ``to 
the point at which''.
    b. Paragraph (d) is removed.


Sec. 441.181  [Amended]

    9. In paragraph (a)(2), the parenthetical statement at the end is 
removed.


Sec. 441.302  [Amended]

    10. In Sec. 441.302, the following changes are made:
    a. Throughout Sec. 441.302, ``a NF'' is revised to read ``an NF''.
    b. In Sec. 441.302(d), ``an SNF, ICF, or ICF/MR'' is revised to 
read ``an NF or ICF/MR''.


Sec. 441.354  [Amended]

    11. In Sec. 441.354, the following changes are made:
    a. In paragraph (b)(1), ``an SNF or ICF'' is revised to read ``an 
NF'', and ``(NF effective October 1, 1990)'' is removed.
    b. In paragraph (c), in the ``P'' and ``Q'' factors of the formula, 
``for SNF and ICF'' is revised to read ``for NF'', and ``(NF effective 
October 1, 1990)'' is removed.

PART 442--STANDARDS FOR PAYMENT TO NURSING FACILITIES AND 
INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED

    Z. Part 442 is amended as set forth below.
    1. The authority citation for part 442 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302), unless otherwise noted.


Sec. 442.2  [Amended]

    2. In Sec. 442.2, the definition of ``Immediate jeopardy'' is 
revised to read as follows:


Sec. 442.2  Terms.

* * * * *
    Immediate jeopardy has the meaning given that term in Sec. 488.1 of 
this chapter.
* * * * *

PART 447--PAYMENT FOR SERVICES

    AA. Part 447 is amended as set forth below.
    1. The authority citation for part 447 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).

    2. Subparts B and C are redesignated as subparts C and D, 
respectively.
    3. The undesignated centered heading ``Cost Sharing'' is removed 
and the following is added in its place:
* * * * *

Subpart B--Cost Sharing

* * * * *


Sec. 447.50  [Amended]

    4. In Sec. 447.50, the following changes are made:
    a. The heading of Sec. 447.50 is revised to read ``Basis and 
purpose.''.
    b. The designation ``(a)'' is removed.
    c. ``Secs. 447.51 through 447.59 prescribe `` is revised to read 
``this subpart prescribes''.
    5. The undesignated centered heading immediately preceding 
Sec. 447.51 is removed.


Sec. 447.51  [Amended]

    6. In Sec. 447.51, the following changes are made:
    a. The heading of Sec. 447.51 is revised to read ``Enrollment fees 
and premiums or similar charges: Requirements and options.''.
    b. In paragraph (a), ``subchapter'' is revised to read ``chapter''.


Sec. 447.52  [Amended]

    7. In Sec. 447.52, the heading is revised to read ``Enrollment fees 
and premiums or similar charges: Minimum and maximum income-related 
charges.''.
    8. The undesignated centered heading immediately preceding 
Sec. 447.53 is removed.
    9. In Sec. 447.53, the following changes are made:
    a. The heading of Sec. 447.53 is revised to read as set forth 
below.
    b. The heading for paragraph (a) is revised to read ``Basic 
rule.''.
    c. Paragraphs (b) and (c) are revised to read as follows:


Sec. 447.53  Deductibles, coinsurance, and copayment, or similar 
charges: General rules.

* * * * *
    (b) Exceptions. The plan may not provide for imposition of a 
deductible, coinsurance, copayment, or similar charge for the following 
services furnished to categorically needy or medically needy 
individuals:
    (1) Services to children. This means services to individuals under 
18 years of age or (at State option) to individuals under 21, 20, or 19 
years of age, or any reasonable category of individuals 18 years of age 
or over but under 21.
    (2) Services related to pregnancy. This means services furnished to 
pregnant women if the services are related to the pregnancy or to any 
other condition that may complicate the pregnancy. These services 
include the following:
    (i) Routine prenatal care.
    (ii) Labor and delivery.
    (iii) Routine postpartum care.
    (iv) Family planning services.
    (v) Services for complications likely to affect pregnancy or 
delivery, such as hypertension, diabetes, or urinary tract infection.
    (vi) Services furnished during the postpartum period for conditions 
or complications related to the pregnancy.(The postpartum period begins 
on the last day of the pregnancy and ends on the last day of the month 
in which the subsequent 60-day period ends.)
    (3) Services to individuals in institutions. This means services 
furnished to any individual who--
    (i) Is an inpatient of a hospital, NF, other medical institution, 
or ICF/MR; and
    (ii) Is required, as a condition for receiving services in the 
institution, to contribute to the medical care costs all but the 
minimum amount of income he or she needs for personal expenses. 
(Sections 435.725, 435.733, 435.832, and 436.832 of this chapter 
specify the groups to which this requirement applies.)
    (4) Emergency services. This means services furnished in a 
hospital, clinic, office, or other facility that is equipped to furnish 
emergency services, that is, services that are required after the 
sudden onset of a medical condition manifesting itself by acute 
symptoms so severe (including severe pain) that failure to provide 
immediate medical attention could reasonably be expected to result in--
    (i) Serious jeopardy to the patient's health;
    (ii) Serious impairment of bodily functions; or
    (iii) Serious dysfunction of any bodily organ or part.
    (5) Family planning services. This means family planning services 
furnished to individuals of child-bearing age.
    (6) Hospice care. This means hospice care as defined in section 
1905(o) of the Act.
    (c) Optional exclusions. States may, at their option--
    (1) Exempt from cost sharing all services furnished to pregnant 
women; and
    (2) Exempt from copayment charges any HMO services furnished to 
medically needy Medicaid enrollees.
* * * * *


Sec. 447.54  [Amended]

    10. In Sec. 447.54, the section heading is revised to read: 
``Maximum allowable cost sharing amounts.''.

[[Page 3654]]

    11. The undesignated center heading immediately preceding 
Sec. 447.59 is removed.
    12. Sec. 447.59 is revised to read as follows:


Sec. 447.59  Federal financial participation (FFP): Limits related to 
cost sharing.

    (a) Basic rule. Except as provided in paragraph (b) of this 
section, FFP is not available for expenditures for cost sharing amounts 
(enrollment fees or premiums, deductibles, coinsurance, copayment, or 
similar charges) that a recipient should have paid.
    (b) Exception. FFP is available for the amounts that the agency 
pays as bad debts of providers under Sec. 447.57. (We note that FFP is 
not available for payments the agency makes on behalf of an ineligible 
individual even if he or she has paid any required premium or 
enrollment fee.)
    13. The undesignated center headings immediately preceding 
Secs. 447.251, 447.257, 447.271, and 447.280 are removed.
    14. Section 447.253 is amended to revise paragraph (b)(1)(ii)(B) to 
read as follows:


Sec. 447.253  Other requirements.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * *
    (B) If a State elects to cover services furnished at an 
inappropriate level of care (hospital inpatient services furnished to 
patients who require nursing facility level of care), the State's 
methods and standards specify that payment for this type of care is at 
the lower rates appropriate for nursing facility care, consistent with 
section 1861(v)(1)(G) of the Act; and
* * * * *


Sec. 447.257  [Amended]

    15. The heading of Sec. 447.257 is revised to read ``Limits on 
FFP.''.


Sec. 447.272  [Amended]

    16. In Sec. 447.272, paragraph (c), ``Secs. 447.296 through 
447.299.'' is revised to read ``subpart E.''.


Sec. 447.280  [Amended]

    17. The heading of Sec. 447.280 is revised to read ``Special rules 
for swing-bed hospitals.''.

Subpart F [Amended]

    18. All undesignated center headings in subpart F are removed.


Sec. 447.331  [Amended]

    19. In Sec. 447.331, in paragraph (a), ``set forth in paragraph 
(b)'' is revised to read ``set forth in paragraph (b) of this 
section''.
    20. In Sec. 447.332, the following changes are made:
    a. In paragraph (a)(1) introductory text, ``will establish'' is 
revised to read ``establishes''.
    b. In paragraph (a)(3), ``will identify'' is revised to read 
``identifies''.
    c. Paragraph (b) is revised to read as follows:


Sec. 447.332  Upper limits for multiple source drugs.

* * * * *
    (b) Specific upper limits. (1) The agency's payments for multiple 
source drugs identified and listed in accordance with paragraph (a) of 
this section may not exceed, in the aggregate, payment levels 
determined by applying, for each drug entity--
    (i) A reasonable dispensing fee established by the agency; plus
    (ii) An amount established by CMS that is equal to 150 percent of 
the published price at which the least costly therapeutic equivalent 
can be purchased by pharmacists.
    (2) In selecting the size of the drug entity, the agency must--
    (i) For non-liquids commonly available in quantities of 100 tablets 
or capsules, use that size;
    (ii) For non-liquids not commonly available in quantities of 100 
tablets or capsules, use the commonly listed package size; and
    (iii) For liquids, use the commonly listed package size.
    (3) In determining the least costly equivalent, the agency must use 
all available national compendia.


Sec. 447.333  [Amended]

    21. In Sec. 447.333, in paragraphs (b)(1)(i) and (b)(1)(ii), ``this 
subpart'' is revised to read ``this part''.


Sec. 447.334  [Amended]

    22. In Sec. 447.334, the following changes are made:
    a. ``skilled nursing facility services'' is revised to read 
``nursing facility services''.
    b. ``and intermediate care facility services'' is removed.

PART 455--PROGRAM INTEGRITY: MEDICAID

    BB. Part 455 is amended as set forth below.
    1. The authority citation for part 455 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


Sec. 455.2  [Amended]

    2. In Sec. 455.2, the following changes are made:
    a. The definitions of ``Practitioner'' and ``Suspension'' are 
removed.
    b. The definition of ``Exclusion'' is revised to read as follows:


Sec. 455.2  Definitions.

* * * * *
    Exclusion means denial of participation in the Medicaid program for 
a provider that has defrauded or abused the program, or been convicted 
of a program-related offense under a Federal, State, or local law.
* * * * *
    3. In Sec. 455.3, the following changes are made:
    a. The introductory text is republished and paragraph (a) is 
revised to read as set forth below.
    b. In paragraph (b), ``or suspended practitioners'' is removed.
    c. In paragraph (c), ``or suspension'' is removed.


Sec. 455.3  Other applicable regulations.

    Part 1002 of this title sets forth the following:
    (a) State plan requirements for excluding providers for fraud or 
abuse or for conviction of program-related crimes.
* * * * *
    4. Section 455.100 is revised to read as follows:


Sec. 455.100  Basis and scope.

    (a) This subpart implements sections 1124, 1126, 1902(a)(38), and 
1903(i)(2) of the Act.
    (b) It sets forth State plan requirements for disclosure of 
information regarding--
    (1) Ownership and control of providers and fiscal agents, and their 
subcontractors;
    (2) Persons convicted of criminal offenses related to their 
involvement in any program under Medicare, Medicaid, or the social 
services program under title XX of the Act; and
    (3) Business transactions between providers and their 
subcontractors or wholly owned suppliers.
    (c) It also provides instructions for determining ownership or 
control percentages, and specifies the penalties for failure to furnish 
the required information timely.


Sec. 455.101  [Amended]

    5. In Sec. 455.101, the definition of ``Significant business 
transaction'' is removed, and the definitions of ``Indirect ownership 
interest'' and ``Ownership interest'' are revised to read as follows:


Sec. 455.101  Definitions.

* * * * *

[[Page 3655]]

    Indirect ownership interest has the meaning given the term in 
Sec. 420.201 of this chapter.
* * * * *
    Ownership interest has the meaning given the term in Sec. 420.201 
of this chapter.
* * * * *

PART 456--UTILIZATION CONTROL

    CC. Part 456 is amended as set forth below.
    1. The authority citation for part 456 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302), unless otherwise noted.

Subpart A [Amended]

    2. In subpart A, the following changes are made:


Sec. 456.1  [Amended]

    a. In Sec. 456.1, the following changes are made:
    1. In paragraph (b)(2), in the last full sentence of the 
introductory text, ``and intermediate care facilities (ICF's).'' is 
revised to read ``and ICFs/MR.''.
    2. In paragraph (b)(5), ``(IMD's)'' is revised to read ``(IMDs)'', 
and ``ICF's'' is revised to read ``ICFs/MR''.
    b. Sec. 456.5 is revised to read as follows:


Sec. 456.5  Evaluation criteria.

    (a) The agency must establish and use written criteria for 
evaluating the quality and appropriateness of Medicaid services.
    (b) The utilization review (UR) plan must provide that the UR 
committee--
    (1) Develops written criteria for assessment of the need for 
admission and the need for continued stay; and
    (2) Develops more extensive written criteria for cases that its 
experience shows are--
    (i) Associated with high costs;
    (ii) Associated, frequently, with the furnishing of excessive 
services; or
    (iii) Attended by physicians whose patterns of care are frequently 
found to be questionable.
    c. A new Sec. 456.10 is added, to read as follows:


Sec. 456.10  Definitions.

    As used in this part--
    Medical care appraisal norms or norms means numerical or 
statistical measures of usually observed performance; and
    Medical care criteria or criteria means predetermined elements 
against which aspects of the quality of a medical service may be 
compared.

Subpart C--Utilization Control: All Hospitals

    3. In subpart C, the following changes are made:
    a. The heading of subpart C is revised to read as set forth above.
    b. All undesignated centered headings in subpart C are removed.
    c. Sec. 456.50 is revised to read as follows:


Sec. 456.50  Scope.

    This subpart sets forth the requirements that all hospitals must 
meet for certification of need for care, plan of care, and utilization 
review (UR) plans.


Sec. 456.51  [Removed]

    d. Section 456.51 is removed.


456.60  [Amended]

    e. In Sec. 456.60, in paragraph (b)(1), ``(as defined in Sec. 491.2 
of this chapter)'' is removed.
    f. Sec. 456.100 is revised to read as follows:


Sec. 456.100  UR plan: Basic requirement.

    The State plan must provide that each hospital furnishing inpatient 
services under the plan has in effect a written UR plan that meets the 
requirements of this subpart.


Sec. 456.101  [Removed]

    g. Sec. 456.101 is removed.


Sec. 456.111  [Amended]

    h. In Sec. 456.111, the following changes are made:
    1. In paragraph (d), ``Sec. 456.70.'' is revised to read 
``Sec. 456.80.''.
    2. In paragraph (h), ``(or, in an ICF/MR, the mental retardation 
professional)'' is inserted immediately before ``believes continued 
stay is necessary.''.
    i. Section 456.133 is revised to read as follows:


Sec. 456.133  Subsequent continued stay review dates.

    The UR plan must provide as follows:
    (a) The committee assigns subsequent continued stay review dates in 
accordance with Secs. 456.128 and 456.134(a).
    (b) The committee assigns a subsequent review date each time it 
decides that the continued stay is needed and, for a mental hospital 
patient, it schedules subsequent reviews for at least every 90 days.
    (c) The committee ensures that each continued stay review date it 
assigns is entered in the recipient's record.
    j. Section 456.135 is amended to revise paragraphs (f), (g), and 
(h) to read as follows:


Sec. 456.135  Continued stay review process.

* * * * *
    (f) If the committee, subgroup, or designee finds that a continued 
stay is not needed, it notifies the recipient's attending physician (in 
the case of a mental hospital patient, it may be the attending or staff 
physician) and provides an opportunity for the physician to present his 
or her views before it makes a final decision.
    (g) If the attending or staff physician does not present additional 
information or clarification of the need for continued stay, the 
decision of the committee, subgroup, or designees is final.
    (h) If the attending or staff physician presents additional 
information or clarification, at least two physician members of the 
committee (at least one of which is knowledgeable about mental 
diseases) review the need for continued stay. If they find that the 
patient no longer needs inpatient care, their decision is final.
    k. Section 456.136 is amended to revise paragraph (b), to read as 
follows:


Sec. 456.136  Notification of adverse decision.

* * * * *
    (b) The attending physician (or the attending or staff physician in 
a mental hospital);
* * * * *


Sec. 456.141  Medical care evaluation studies: Purpose and general 
description.

    l. The section heading is revised to read as set forth above.

Subpart D--Utilization Control: Additional Requirements for Mental 
Hospitals

    4. In subpart D, the following changes are made:
    a. The subpart heading is revised to read as set forth above.
    b. All undesignated center headings are removed.
    c. Section 456.150 is revised to read as follows:


Sec. 456.150  Scope.

    This subpart sets forth the utilization control requirements that 
mental hospitals must meet in addition to those required of all 
hospitals as set forth in subpart C of this part.


Secs. 456.151 and 456.160  [Removed]

    d. Secs. 456.151 and 456.160 are removed.
    e. Sec. 456.180 is revised to read as follows:


Sec. 456.180  Individual written plan of care.

    For mental hospital patients, the following rules apply:
    (a) The plan of care required under Sec. 456.80 must be expanded to 
include--

[[Page 3656]]

    (1) Objectives;
    (2) Any orders for therapies or for special procedures recommended 
for the patient's health and safety; and
    (3) Provision for modifying the plan of care as needed.
    (b) The attending or staff physician must participate in reviewing 
the plan at least every 90 days (rather than every 60 days as is 
required for all other hospitals).


Secs. 456.200, 456.201, and 456.205  [Removed]

    f. Sections 456.200, 456.201, and 456.205 are removed.
    g. Section 456.206 is revised to read as follows:


Sec. 456.206  Organization of UR committee; disqualification from UR 
committee membership.

    The rules for mental hospitals differ from those set forth in 
Sec. 456.106 only in that--
    (a) One of the physician members of the UR committee must be 
knowledgeable in the diagnosis and treatment of mental diseases; and
    (b) A member is disqualified on the basis of financial interest 
only if it is an interest in a mental hospital.


Secs. 456.211 through 456.213  [Removed]

    h. Sections 456.211 through 456.213 are removed.
    i. Sec. 456.231 is revised to read as follows:


Sec. 456.231  Continued stay review: Basic requirement.

    The UR plan must provide for a review of each recipient's continued 
stay in a mental hospital to decide whether it is needed, in accordance 
with the applicable requirements of subpart C of this part and this 
subpart.


Sec. 456.232  [Removed]

    j. Section 456.232 is removed.
    k. Section 456.233 is revised to read as follows:


Sec. 456.233  Date of initial continued stay review.

    (a) For mental hospital patients, the following rules apply, in 
addition to those set forth in Sec. 456.128.
    (b) If an individual applies for Medicaid while a patient in a 
mental hospital--
    (1) The committee sets the date for initial continued stay review 
within 1 working day after the hospital receives notice of the 
application; and
    (2) That date may not be later than 30 days after admission of the 
patient or 30 days after receipt of notice of his or her application 
for Medicaid, whichever is earlier.


Secs. 456.234 through 456.245  [Removed]

    l. Sections 456.234 through 456.245 are removed.

Subpart F--Utilization Control: Intermediate Care Facilities for 
Persons with Mental Retardation (ICFs/MR)

    5. In subpart F, the following changes are made:
    a. The heading of subpart F is revised as set forth above.
    b. All undesignated center headings in subpart F are removed.
    c. Section 456.350 is revised to read as follows:


Sec. 456.350  Scope.

    This subpart sets forth the requirements that ICFs/MR must meet in 
addition to those specified, for hospitals, in subparts C and D of this 
part. In applying the rules of those subparts, references to 
``hospitals'' must be read as references to ``ICF/MR''.
    d. Sec. 456.351 is revised to read as follows:


Sec. 456.351  Definition.

    ICF/MR services means services that meet the conditions specified 
in Sec. 440.150 of this chapter, but exclude services furnished in a 
religious nonmedical health care institution as defined in 
Sec. 440.170(b) of this chapter.
    e. Section 456.360 is revised to read as follows:


Sec. 456.360  Certification and recertification of need for inpatient 
care.

    The rules of Sec. 456.60 apply, except that recertification is 
required every 12 months rather than every 60 days.
    f. In Sec. 456.370, the following changes are made:
    1. Paragraphs (a) and (b) are revised to read as set forth below.
    2. In paragraph (c)(8), ``ICF'', wherever it appears, is revised to 
read ``ICF/MR''.


Sec. 456.370  Medical, social, and psychological evaluations.

    (a) Before admission to an ICF/MR, or before authorization of 
payment, an interdisciplinary team of health professionals must make a 
comprehensive medical and social evaluation, and if appropriate, a 
psychological evaluation, of each applicant's or recipient's need for 
care in an ICF/MR.
    (b) The psychological evaluation must be made not more than 3 
months before admission.
* * * * *


Sec. 456.371  [Amended]

    g. In Sec. 456.371, ``ICF services'' is revised to read ``ICF/MR 
services''.
    h. Sec. 456.380 is revised to read as follows:


Sec. 456.380  Individual written plan of care.

    The plan of care must meet the requirements set forth in 
Sec. 456.180 for a plan of care for a mental hospital patient.
    i. Section 456.381 is revised to read as follows:


Sec. 456.381  Reports and evaluations of plans of care.

    The rules for mental hospitals, as set forth in Sec. 456.181, also 
apply to ICFs/MR.
    j. Sec. 456.400 is revised to read as follows:


Sec. 456.400  Utilization review plan: General requirements.

    The State plan must--
    (a) Provide that each ICF/MR has on file and implements a written 
UR plan that provides for review of each recipient's need for the 
services the ICF/MR furnishes, and meets the requirements of this 
subpart; and
    (b) Specify the method used to perform UR, which may be any of the 
following:
    (1) Review conducted by the facility.
    (2) Direct review in the facility by individuals who are--
    (i) Employed by the medical assistance unit of the Medicaid agency; 
or
    (ii) Under contract to the Medicaid agency.
    (3) Any other method.


Sec. 456.401  [Removed]

    k. Sec. 456.401 is removed.
    l. Section 456.405 is revised to read as follows:


Sec. 456.405  UR plan: Administrative requirements.

    The UR plan must meet the following requirements:
    (a) Specify how and when UR review is performed.
    (b) Provide that review is performed by a group of professional 
personnel that--
    (1) Includes at least one physician and one mental retardation 
professional; and
    (2) Does not include any individual who--
    (i) Is responsible for the care of the individual being reviewed;
    (ii) Is employed by the ICF/MR; or
    (iii) Has a financial interest in any ICF/MR.
    (c) Describe the UR support responsibilities of the ICF/MR's 
administrative staff and the procedures used by that staff to take 
corrective action.

[[Page 3657]]

Secs. 456.406 and 456.407  [Removed]

    m. Secs. 456.406 and 456.407 are removed.
    n. Sec. 456.411 is revised to read as follows:


Sec. 456.411  UR plan: Information requirements.

    (a) Recipient records. The UR plan must provide that each 
recipient's record contains the information specified in Sec. 456.111 
and also the name of the qualified mental retardation professional. 
(The qualifications for this professional are set forth in Sec. 483.430 
of this chapter.)
    (b) Other records and reports, and confidentiality. The 
requirements set forth in Secs. 456.112 and 456.113 apply also to ICFs/
MR.


Secs. 456.412 and 456.413  [Removed]

    o. Secs. 456.412 and 456.413 are removed.
    p. In Sec. 456.431, the following changes are made:
    1. In paragraph (a), ``recipients'' is revised to read 
``recipient's''.
    2. The section heading and paragraphs (b) introductory text, 
(b)(1), and (b)(2) are revised to read as follows:


Sec. 456.431  Continued stay review.

* * * * *
    (b) The UR plan requirement for continued stay review may be met by 
either of the following:
    (1) Reviews that apply the criteria specified in Sec. 456.5(b) and 
are performed in accordance with this subpart.
    (2) Reviews that meet the onsite inspection requirements of subpart 
I of this part provided--
    (i) The composition of the independent professional review team 
meets the requirements of Sec. 456.405; and
    (ii) The reviews are conducted at least every 6 months.


Sec. 456.432  [Removed]

    q. Sec. 456.432 is removed.
    r. Sec. 456.433 is revised to read as follows:


Sec. 456.433  Initial continued stay review date.

    The UR plan must--
    (a) Provide that, when a recipient is admitted to an ICF/MR, the UR 
committee assigns, for the initial continued stay review, a specific 
date that is--
    (1) Not later than 6 months after admission; and
    (2) May be earlier than 6 months after admission if indicated at 
the time of admission.
    (b) Describe the methods and criteria that are the basis for 
assigning the date; and
    (c) Ensure that the date is entered in the recipient's record.


Sec. 456.434  [Amended]

    s. In Sec. 456.434, in paragraph (a), ``Sec. 456.435.'' is revised 
to read ``the methods and criteria required to be described under 
Sec. 456.433(b).''.


Sec. 456.435  [Removed]

    t. Sec. 456.435 is removed.
    u. In Sec. 456.436, the following changes are made:
    1. In paragraph (c), ``ICF'' is revised to read ``ICF/MR'', 
``Sec. 456.411'' is revised to read ``Sec. 456.411(a)'', 
``Sec. 456.432'' is revised to read ``Sec. 456.5(b)(1)'', and 
``Sec. 456.432(b)'' is revised to read ``Sec. 456.5(b)(2)''.
    2. Paragraph (f) is revised to read as set forth below.
    3. In paragraphs (g) and (h), ``attending physician or'' is 
removed.
    4. In paragraph (i), ``ICF services'' is revised to read ``ICF/MR 
services''.


Sec. 456.436  Continued stay review process.

* * * * *
    (f) If the group or subgroup making the review under paragraph (e) 
of this section finds that a continued stay is not needed, it notifies 
the recipient's qualified mental retardation professional within one 
working day of its decision and allows 2 working days from the date of 
notice for the professional to present his or her views before it makes 
a final decision.
* * * * *
    v. Sec. 456.437 is revised to read as follows:


Sec. 456.437  Notification of adverse decision.

    The UR plan must provide that the UR committee gives written notice 
of any adverse decision on the need for continued stay--
    (a) Not later than 2 days after the final decision; and
    (b) To the following:
    (1) The administrator of the ICF/MR.
    (2) The qualified mental retardation professional.
    (3) The Medicaid agency.
    (4) The recipient.
    (5) If possible, the next of kin or sponsor.


Sec. 456.438  [Removed]

    w. Sec. 456.438 is removed.

Subpart H [Amended]

    6. In subpart H, the following changes are made:
    a. The undesignated center heading immediately preceding 
Sec. 456.505 is removed.
    b. The heading of Sec. 456.505 is revised to read as follows:


Sec. 456.505  Basis for waiver of UR requirements.

* * * * *

Subpart I [Removed]

    7. Subpart I, consisting of Secs. 456.600 through 456.614, is 
removed and reserved.


Sec. 456.722  [Amended]

    8. In Sec. 456.722(c)(1), in the second sentence, ``subpart P and 
appendix G-O of OMB circular A-102'' is removed.

PART 475--PEER REVIEW ORGANIZATIONS

    DD. Part 475 is amended as set forth below.
    1. The authority citation for part 475 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 475.1  [Amended]

    2. In Sec. 475.1, the following changes are made:
    a. The introductory text is revised to read ``As used in this 
subchapter--''.
    b. Definitions of ``Affiliate of a payor organization'', ``Non-
facility organization'', and ``PRO area'' are added, in alphabetical 
order.
    c. The heading Health care facility is revised to read Health care 
facility or facility.
    d. The definitions of ``Payor organization'' and ``Physician'' are 
revised to read as set forth below.


Sec. 475.1  Definitions.

* * * * *
    Affiliate of a payor organization means an organization with a 
governing body, two or more members of which are--
    (1) Governing body members, officers, partners, or 5 percent or 
more owners of the payor organization; or
    (2) Managing employees of an HMO or CMP.
* * * * *
    Non-facility organization means a corporate entity that--
    (1) Is not a health care facility;
    (2) Is not a 5 percent or more owner of a health care facility; and
    (3) Is not owned by one or more health care facilities or any 
association of facilities in the PRO area.
    Payor organization means any organization (other than a self-
insured employer) that pays providers or practitioners (directly or 
indirectly) for services that the organization reviews,

[[Page 3658]]

or would review if it entered into a PRO contract.
    Physician includes--
    (1) An intern, resident, or Federal Government employee authorized 
under State or Federal law to practice medicine, surgery, or osteopathy 
in the PRO area; and
    (2) An individual licensed to practice medicine in American Samoa 
or the Northern Mariana Islands.
    PRO area means the geographic area designated as the area within 
which a designated PRO performs utilization and quality control review 
under its PRO contract with CMS.


Sec. 475.100  [Amended]

    3. In Sec. 475.100, ``Social Security'' and ``as amended by the 
Peer Review Improvement Act of 1982 (Pub. L. 97-248)'' are removed.


Sec. 475.105  [Amended]

    4. In paragraph (b) of Sec. 475.105, ``Effective November 15, 1984, 
the'' is removed, and ``The'' is added in its place, and ``will not 
apply'' is revised to read ``does not apply''.
    5. Section 475.106 is revised to read as follows:


Sec. 475.106  Prohibition against contracting with payor organizations 
and affiliates of payor organizations.

    Payor organizations and their affiliates are not eligible to become 
PROs for the area in which they make payments unless CMS determines, on 
the basis of lack of response to an appropriate Request for Proposal, 
that there is not available any eligible organization that is not a 
payor organization or affiliate of a payor organization.


Sec. 475.107  [Amended]

    6. In Sec. 475.107, the following changes are made:
    a. In the introductory text, ``will take'' is revised to read 
``takes''.
    b. In paragraphs (a) and (b), ``Identify'' is revised to read 
``Identifies''.
    c. In paragraph (c), ``Assign'' is revised to read ``Assigns''.
    d. In paragraph (d), ``award'' is revised to read ``awards''.

PART 476--UTILIZATION AND QUALITY CONTROL REVIEW

    EE. Part 476 is amended as set forth below.
    1. The authority citation for part 476 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 476.1  [Amended]

    2. In Sec. 476.1, the following changes are made:
    a. The definitions of ``Five percent or more owner'', ``Health care 
facility or facility'', ``Health care practitioners other than 
physicians'', ``Hospital'', ``Non-facility organization'', 
``Physician'', ``Practitioner'', ``Preadmission certification'', 
``Review responsibility'' and ``Skilled nursing facility'' are removed.
    b. The following definitions are revised to read as follows:


Sec. 476.1  Definitions.

* * * * *
    Active staff privileges means authorization, on a regular, rather 
than an infrequent or courtesy basis--
    (1) For a physician or other health care practitioner to order the 
admission of patients to a facility; and
    (2) For a physician to perform diagnostic and treatment services in 
the facility.
* * * * *
    Diagnosis related group (DRG) means a system for classifying 
inpatient hospital discharges as a basis for Medicare payment under the 
prospective payment system.
    DRG validation means PRO validation to the effect that the DRG 
classification assigned to a discharge is based on the correct 
diagnostic and procedural information.
* * * * *
    Hospital means a health care institution or distinct part of an 
institution as defined in section 1861(e) through (g) of the Act, 
including a religious nonmedical health care institution as defined in 
section 1861(ss)(1) of the Act.
* * * * *
    Peer review means review of services by health care practitioners 
in the same professional field as the practitioner who ordered or 
furnished the services.
* * * * *
    3. Sec. 476.74 is revised to read as follows:


Sec. 476.74  General requirements for the assumption of review.

    In assuming review responsibility, a PRO must comply with the 
following conditions:
    (a) Assume review responsibility in accordance with the schedule, 
functions, and negotiated objectives specified in its contract with 
CMS.
    (b) Notify the appropriate Medicare fiscal intermediary or carrier 
of its assumption of review in particular health care facilities no 
later than 5 working days after the day it assumes review in the 
facility.
    (c) Maintain and make available for public inspection at its 
principal business office--
    (1) A copy of each agreement with a Medicare intermediary or 
carrier;
    (2) A copy of its current approved review plan, including its 
method for implementing review; and
    (3) Copies of all subcontracts for the conduct of review.
    (d) Limit subcontracts for review by health care facilities to 
review of quality of care. (There is no limit to the types of review 
that the PRO may subcontract to organizations that are not health care 
facilities.)
    (e) If required by CMS--
    (1) Compile statistics based on the criteria specified in 
Sec. 411.402 of this chapter;
    (2) Make limitation of liability determinations in accordance with 
subpart K of part 411 of this chapter; and
    (3) Notify providers regarding these determinations. (Appeals from 
these determinations are subject to the rules set forth in part 405 of 
this chapter--subpart G for Part A services, and subpart H for Part B 
services.)
    (f) Make its responsibilities under its contract with CMS primary 
to all its other interests and activities.


Sec. 476.86  [Amended]

    4. In Sec. 476.86(b), ``or SNF care'' is removed 
and``Secs. 405.1035, 405.1042, and 405.1137 of this chapter.'' is 
revised to read ``Sec. 482.30 of this chapter.''.

PART 478--RECONSIDERATIONS AND APPEALS

    FF. Part 478 is amended as set forth below.
    1. The authority citation for part 478 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 478.46  [Revised]

    2. Section 478.46 is revised to read as follows:


Sec. 478.46  Departmental Appeals Board review and judicial review.

    (a) Board review. The circumstances under which the Departmental 
Appeals Board (the ``Board'') will review an ALJ hearing decision or 
dismissal are the same as those set forth at 20 CFR 404.970 for Appeals 
Council review.
    (b) Basis for seeking judicial review. (1) The affected party may 
seek judicial review of the Board's decision, or of the ALJ's hearing 
decision if the Board denies review, if the amount in controversy is 
$2,000 or more.
    (2) The party must file the civil action within 60 days from the 
date of receipt

[[Page 3659]]

of the notice of the Board's determination or denial of review.

PART 480--ACQUISITION, PROTECTION, AND DISCLOSURE OF PEER REVIEW 
INFORMATION

    GG. Part 480 is amended as set forth below.
    1. The authority citation for part 480 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart B--PRO Information: General Provisions

    2. The heading of subpart B is revised to read as set forth above.
    3. The undesignated centered heading immediately preceding 
Sec. 480.101 is removed.


Sec. 480.101  [Amended]

    4. In Sec. 480.101, the following changes are made:
    a. The definitions of ``Health care facility or facility'', ``Non-
facility organization'', and ``practitioner'' are removed.
    b. The definition of Implicitly identify (ies) is removed and a new 
definition of Implicitly identifies is added in its place to read as 
follows:


Sec. 480.101  Scope and definitions.

* * * * *
    (b) * * *
    Implicitly identifies refers to data so unique, or to numbers so 
small, that the identity of a particular patient, practitioner, or 
reviewer would be obvious.
    5. Sec. 480.103 is amended to revise paragraph (b) to read as 
follows:


Sec. 480.103  Statutory bases for disclosure of information.

* * * * *
    (b) Section 1160 of the Act provides that PRO information must be 
held in confidence and not disclosed to any person except--
    (1) To the extent necessary to carry out the purposes of title XI, 
part B, of the Act;
    (2) In cases and circumstances specified by regulation to ensure 
adequate protection of the rights and interests of patients, 
practitioners, and providers of health care; and
    (3) As necessary to assist the following agencies in the 
performance of their duties:
    (i) Federal and State agencies recognized by the Secretary as 
having responsibility for identifying and investigating cases or 
patterns of fraud or abuse.
    (ii) Federal and State agencies recognized by the Secretary as 
having responsibility for identifying cases or patterns involving risks 
to the public health.
    (iii) Appropriate State agencies responsible for licensing or 
certifying providers or practitioners.
    (iv) Federal or State health planning agencies that need PROs to 
furnish them aggregate statistical data on a geographical, 
institutional, or other basis.

Subpart C--PRO Access to Information and PRO Responsibilities

    6. The heading of subpart C is revised to read as set forth above.
    7. The undesignated center heading immediately preceding 
Sec. 480.115 is removed.

Subpart D--Disclosure of Nonconfidential Information

    8. The heading of subpart D is revised to read as set forth above.

Subpart E--Disclosure of Confidential Information

    9. The heading of subpart E is revised to read as set forth above.

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

    HH. Part 482 is amended as set forth below.
    1. The authority citation for part 482 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 482.30  [Amended]

    2. In Sec. 482.30(a)(2), ``Sec. 456.50 through 456.245 of this 
chapter.'' is revised to read ``part 456 of this chapter.''.


Sec. 482.52  [Amended]

    3. In Sec. 482.52, in paragraphs (a)(4) and (a)(5), ``, as defined 
in Sec. 410.69(b) of this chapter,'' is removed.

PART 483--REQUIREMENTS FOR STATES AND FOR LONG TERM CARE FACILITIES

    II. Part 483 is amended as set forth below.
    1. The authority citation for part 483 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 483.40  [Amended]

    2. In Sec. 483.40, in paragraph (e)(1)(i), ``the applicable 
definition in Sec. 491.2 of this chapter'' is revised to read ``the 
qualifications set forth in Sec. 400.210 of this chapter''.


Sec. 483.102  Applicability and evaluation criteria.

    3. In Sec. 483.102, the following changes are made:
    a. The section heading is revised to read as set forth above.
    b. The paragraph heading Applicability is inserted immediately 
after the designation (a).
    c. The heading of paragraph (b) is revised to read Evaluation 
criteria.
    d. Footnotes 1 and 2 are revised to read as set forth below.
* * * * *
    1 The Diagnostic and Statistical Manual of Mental 
Disorders is available for inspection at the Centers for Medicare & 
Medicaid Services, CMS Library, Room C2-07-13, 7500 Security Boulevard, 
Baltimore, MD 21244-1850, or at the Office of the Federal Register, 
suite 700, 800 North Capitol St., NW., Washington, DC. Copies may be 
obtained from the American Psychiatric Association, Division of 
Publications and Marketing, 4100 K Street, NW., Washington, DC 20005.
* * * * *
    2 The American Association on Mental Retardation's 
Manual on Classification in Mental Retardation is available for 
inspection at the Centers for Medicare & Medicaid Services, CMS 
Library, Room C2-07-13, 7500 Security Boulevard, Baltimore, MD 21244-
1850, or at the Office of the Federal Register, suite 700, 800 North 
Capitol St., NW., Washington, DC. Copies may be obtained from the 
American Association on Mental Retardation, 1719 Kalorama Rd., NW., 
Washington, DC 20009.


Sec. 483.460  [Amended]

    4. In Sec. 483.460--
    a. In paragraph (b)(1), ``that specified plan of care requirements 
for ICFs'' is removed.
    b. In paragraph (b)(2), the phrase ``physicians must participate 
in'' is removed.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

    JJ. Part 485 is amended as set forth below.
    1. The authority citation for part 485 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

    2. Section 485.51 is revised to read as follows:

[[Page 3660]]

Sec. 485.51  Definition.

    As used in this subpart, unless the context indicates otherwise, 
Comprehensive outpatient rehabilitation facility, CORF, or facility 
means a nonresidential facility that is established and operated, at a 
single fixed location, exclusively for the purpose of providing 
outpatient diagnostic, therapeutic, and restorative services that are 
for the rehabilitation of injured, disabled, or sick persons, and that 
are furnished by, or under the supervision of, a physician.


Sec. 485.70  [Amended]

    3. In Sec. 485.70, the following changes are made:
    a. In paragraph (c), ``Sec. 405.1202(f) and (g) of this chapter.'' 
is revised to read``Sec. 484.4 of this chapter.''
    b. In paragraph (m),''Sec. 485.705(f) of this chapter.'' is revised 
to read ``Sec. 484.4 of this chapter.''.
    4. In Sec. 485.604, paragraphs (b) and (c) are removed, and a new 
paragraph (b) is added, to read as follows:


Sec. 485.604  Personnel qualifications.

* * * * *
    (b) A nurse practitioner and a physician assistant must meet the 
qualifications specified in Sec. 400.210(f) and (g) of this chapter.
* * * * *


Sec. 485.639  [Amended]

    5. In Sec. 485.639, in paragraphs (c)(1)(v) and (c)(1)(vi), ``, as 
defined in Sec. 410.69(b) of this chapter'' is removed.


Sec. 485.705  [Amended]

    6. In Sec. 485.705, paragraphs (b)(2) and (c)(8) are revised to 
read as set forth below.


Sec. 485.705  Personnel qualifications.

* * * * *
    (b) * * *
    (2) For a speech/language pathologist, the qualifications set forth 
in Sec. 484.4 of this chapter.
* * * * *
    (c) * * *
    (8) A nurse practitioner is a person who must meet one of the 
requirements specified in Sec. 400.210(f) of this chapter.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

    KK. Part 488 is amended as set forth below.
    1. The authority citation for part 488 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 488.1  [Amended]

    2. In Sec. 488.1, the following changes are made:
    a. The definitions of ``Act'', ``Provider of services or 
provider'', and ``State'' are removed.
    b. The following definition is added in alphabetical order:


Sec. 488.1  Definitions.

* * * * *
    Immediate jeopardy means a situation in which the provider's 
noncompliance with one or more of the requirements for participation 
has caused, or is likely to cause, serious injury, harm, impairment, or 
death to a patient or resident.
* * * * *
    c. In the definition of ``Substantial allegation of 
noncompliance'', ``raises doubts as to a provider's or supplier's 
noncompliance'' is revised to read ``raises doubts as to a provider's 
or supplier's compliance''.


Sec. 488.56  [Amended]

    3. In Sec. 488.56, in paragraph (b) introductory text and paragraph 
(b)(2), ``Sec. 488.75(i)'' is corrected to read ``Sec. 483.75''.
    4. In Sec. 488.64, the following changes are made:
    a. Paragraph (b) is revised to read as set forth below.
    b. In paragraphs (c), and (d), ``Sec. 405.1137 of this chapter, or 
Sec. 482.30 of this chapter, as applicable.'' is revised to read 
``Sec. 482.30 of this chapter.''.
    c. In paragraph (g), ``pursuant to Sec. 405.1137 of this chapter or 
Sec. 482.30'' is revised to read ``in accordance with Sec. 482.30 of 
this chapter''.


Sec. 488.64  Remote facility variances for utilization review 
requirements.

* * * * *
    (b) The Secretary may grant a facility a variance from the 
utilization review time-frames set forth in Sec. 482.30 of this chapter 
if the requesting facility can show, to CMS's satisfaction, that it has 
been unable to comply with those time-frames by reason of lack of 
sufficient professional personnel available to conduct the reviews.
* * * * *


Sec. 488.301  [Amended]

    5. In Sec. 488.301, the following changes are made:
    a. In the definition of ``Validation survey'', ``Secretary'' is 
revised to read ``CMS''.
    b. The definition of ``Immediate jeopardy'' is removed.

PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVALS

    LL. Part 489 is amended as set forth below.
    1. The authority citation for part 489 is revised to read as 
follows:

    Authority: Secs. 1102, 1819, and 1871 of the Social Security Act 
(42 U.S.C. 1302, 1395i-3, and 1395hh).


Sec. 489.3  [Amended]

    2. In Sec. 489.3, the definition of ``Immediate jeopardy'' is 
revised and a definition of ``Supplier approval'' is added, in 
alphabetical order, to read as follows:


Sec. 489.3  Definitions.

    Immediate jeopardy has the meaning given the term in Sec. 488.1 of 
this chapter.
* * * * *
    Supplier approval means approval by CMS for a supplier to receive 
payment for Medicare covered services it furnishes to Medicare 
beneficiaries.

PART 491--CERTIFICATION OF CERTAIN FACILITIES

    MM. Part 491 is amended as set forth below.
    1. The authority citation for part 491 is revised to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh), and sec. 332 of the Public Health Service 
Act (42 U.S.C. 254e).


Sec. 491.2  [Amended]

    2. In Sec. 491.2, the following changes are made:
    a. The definitions of ``Nurse practitioner'', ``Physician'', 
``Physician assistant'', and ``Secretary'' are removed.
    b. The definition of ``FQHC'' is removed and a new definition of 
Federally qualified health center (FQHC) is added in its place to read 
as follows:


Sec. 491.2  Definitions.

* * * * *
    Federally qualified health center (FQHC) has the meaning given the 
term in Sec. 405.2401(b) of this chapter.
* * * * *


Sec. 491.3  [Amended]

    3. In Sec. 491.3, ``subpart S of 42 CFR part 405'' is revised to 
read ``subparts A through C of part 488 of this chapter.''.

PART 493--LABORATORY REQUIREMENTS

    NN. Part 493 is amended as set forth below.
    1. The authority citation for part 493 is revised to read as 
follows:

    Authority: Sec. 353 of the Public Health Service Act and secs. 
1102 and 1871 of the

[[Page 3661]]

Social Security Act (42 U.S.C. 263a, 1302, and 1395hh).


Sec. 493.1  [Corrected]

    2. In Sec. 493.1, ``the sentence following section 1861(s)(13),'' 
is removed.


Sec. 493.2  [Amended]

    3. In Sec. 493.2, the following changes are made:
    a. The statements and definitions for ``HHS'', ``Physician'', and 
``State survey agency'' are removed.
    b. The definition of ``immediate jeopardy'' is revised to read as 
set forth below.
    c. In the definition of ``party'', the word ``imposed'' is inserted 
immediately before ``by CMS''.
    d. The definitions of ``sample'', ``State'' and ``Substantial 
allegation of noncompliance'' are revised to read as follows:


Sec. 493.2  Definitions.

* * * * *
    Immediate jeopardy has the meaning given that term in Sec. 488.1 of 
this chapter.
* * * * *
    Sample, in relation to proficiency testing, means the material that 
is to be tested by the participants in the proficiency testing program.
    State includes any political subdivision to which the State has 
expressly delegated powers sufficient to enable it to enforce 
requirements equal to, or more stringent than, CLIA requirements.
* * * * *
    Substantial allegation of noncompliance has the meaning given that 
term in Sec. 488.1 of this chapter.
* * * * *


Sec. 493.57  [Amended]

    4. In Sec. 493.57, in paragraph (e)(2), ``as defined in subpart C 
of this part;'' is revised to read ``as set forth in subpart C of this 
part;''.


Sec. 493.61  [Amended]

    5. In Sec. 493.61, the following changes are made:
    a. In paragraph (e)(2), ``for a certificate as defined in subpart C 
of this part; and'' is revised to read ``for one of the certificates 
specified in subpart C of this part; and''.
    b. In paragraph (i)(2), ``for a certificate as defined in subpart C 
of this part; '' is revised to read ``for any of the certificates 
specified in subpart C of this part;''

PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT 
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT 
AFFECT THE PARTICIPATION OF ICFs/MR AND CERTAIN NFs IN THE MEDICAID 
PROGRAM

    OO. Part 498 is amended as set forth below.
    1. The authority citation for part 498 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec. 498.2  [Amended]

    2. In Sec. 498.2, the definitions of ``Departmental Appeals 
Board'', ``OHA'', and ``OIG'' are removed.


Sec. 498.3  [Amended]

    3. In Sec. 498.3:
    a. Paragraph (a)(1) is revised to read as set forth below.
    b. In paragraph (c), the introductory text is designated as 
``(1)'', paragraph designations ``(1)'', ``(2)'', and ``(3)'' are 
revised to read ``(i)'', ``(ii)'', and ``(iii)'', respectively.
    c. A new paragraph (c)(2) is added to read as set forth below.
    d. Paragraph (d) introductory text is revised as set forth below.


Sec. 498.3  Scope and applicability.

    (a) Scope. (1) This part sets forth procedures for reviewing 
initial determinations that CMS makes with respect to the matters 
specified in paragraph (b) of this section, and identifies, in 
paragraph (c) of this section, matters for which the OIG makes initial 
determinations and provides appeals procedures. It also specifies, in 
paragraph (d) of this section, administrative actions that are not 
subject to appeal under this part.
* * * * *
    (c) * * *
    (2) Appeals procedures for OIG determinations are set forth in part 
1005 of this chapter.
* * * * *
    (d) CMS Administrative actions that are not initial determinations. 
CMS administrative actions other than those specified in paragraph (b) 
of this section are not initial determinations and thus are not subject 
to appeal under this part. Administrative actions that are not initial 
determinations (and therefore not subject to appeal under this part) 
include but are not limited to the following:
* * * * *


Sec. 498.5  [Amended]

    4. In Sec. 498.5(j)(2)(i), ``the SNF or ICF'' is revised to read 
``the ICF/MR'', and ``patients'' is revised to read ``residents''.


Sec. 498.22  [Amended]

    5. In Sec. 498.22, in paragraph (a), the parenthetical statement at 
the end of the paragraph is removed.


Sec. 498.40  [Amended]

    6. In Sec. 498.40, in paragraph (a)(1), ``or the OIG, as 
appropriate, or with OHA.'' is removed and ``or the Departmental 
Appeals Board.'' is added in its place.


Sec. 498.42  [Amended]

    7. In Sec. 498.42, insert a period after ``CMS'', and remove the 
remainder of the sentence.
    8. Section 498.44 is revised to read as follows:


Sec. 498.44  Designation of hearing official.

    (a) The Chair of the Departmental Appeals Board (the Board) or his 
or her delegate designates an ALJ or a member or members of the Board 
to conduct the hearing.
    (b) If appropriate, the Chair or the delegate may substitute a 
different ALJ or member or members of the Board to conduct the hearing.
    (c) As used in this part, ``ALJ'' includes a member or members of 
the Board who are designated to conduct a hearing.


Sec. 498.56  [Amended]

    9. In Sec. 498.56, in paragraph (b)(5), ``SNFs or ICFs'' is revised 
to read ``ICFs/MR''.


Sec. 498.82  [Amended]

    10. In Sec. 498.82, paragraph (a)(2), the following changes are 
made:
    a. The term ``the OHA'' is revised to read ``the Board''.
    b. ``Departmental Appeals Board'' is revised to read ``Board''.
    c. ``Sec. 98.22(c)(3)'' is corrected to read ``Sec. 498.22(b)(3)''.
    11. In Sec. 498.83, paragraph (d) is revised to read as follows:


Sec. 498.83  Departmental Appeals Board action on request for review.

* * * * *
    (d) Review panel. If the Board grants a request for review of the 
ALJ decision, the review is conducted by a panel of three members of 
the Board designated by the Chair or Deputy Chair.
    PP. Nomenclature changes.
    1. Throughout this chapter IV:
    a. ``DAB'', wherever it appears, is revised to read ``Board''.
    b. ``DAB's'', wherever it appears, is revised to read ``Board's''.

[[Page 3662]]

    c. ``(DAB)'', wherever it appears, is removed.
    2. Throughout this chapter IV, ``a SNF'', and ``a NF'', wherever 
they appear, are revised to read ``an SNF'' and ``an NF'', 
respectively.
    3. Throughout chapter IV, ``intermediate care facility for the 
mentally retarded'' wherever it appears, is revised to read 
``intermediate care facility for persons with mental retardation and 
related conditions''.
    4. In the following locations, ``co-payment'' wherever it appears, 
is revised to read ``copayment'': Secs. 447.54(a)(3) (table heading), 
447.55(a) and (b), 447.56, and 447.58.
    5. In Sec. 447.54(a)(3) text, ``co-payments'' is revised to read 
``copayments''.
    6. In the following locations, ``the OIG, as appropriate,'' is 
removed: Sec. 498.20(a)(1), Sec. 498.25(b)(1), and Sec. 498.32(a)(1).
    7. In the following locations, ``or the OIG'' is 
removed:Sec. 498.32(b)(2), Sec. 498.56(a)(2), Sec. 498.56(d), heading 
and text, Sec. 498.66(b)(2),Sec. 498.78(a), and Sec. 498.83(a), heading 
and text.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance; Program No. 93.778, Medical 
Assistance)

    Dated: August 8, 2001.
Ruben J. King-Shaw, Jr.,
Deputy Administrator and Chief Operating Officer, Centers for Medicare 
& Medicaid Services.
    Dated: September 9, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 02-1065 Filed 1-24-02; 8:45 am]
BILLING CODE 4120-01-P