[Federal Register Volume 60, Number 170 (Friday, September 1, 1995)]
[Rules and Regulations]
[Pages 45673-45682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21626]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 417

[OMC-011-FC]


Medicare Program; Contracts With Health Maintenance Organizations 
(HMOs) and Competitive Medical Plans (CMPs)

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This rule clarifies and updates portions of the HCFA 
regulations that pertain to the following:
     The conditions that an HMO or CMP must meet to qualify for 
a Medicare contract (Subpart J).
     The contract requirements (Subpart L).
     The rules for enrollment, entitlement, and disenrollment 
of Medicare beneficiaries in a contracting HMO or CMP (Subpart K).
     How a Medicare contract is affected when there is change 
of ownership or leasing of facilities of a contracting HMO or CMP 
(Subpart M).
    These are technical and editorial changes that do not affect the 
substance of the regulations. They are intended to make it easier to 
find particular provisions, to provide overviews of the different 
program aspects, and to better ensure uniform understanding of the 
rules.

DATES: Effective Date: These rules are effective as of October 1, 1995.
    Comment Date: We will consider comments received by October 31, 
1995.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: OMC-011-FC, P.O. Box 26688, 
Baltimore, MD 21207.
    If you prefer, you may deliver your written comments to one of the 
following addresses:

Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201-0001, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850

    Because of staffing and resource limitations, we cannot accept 
comments 

[[Page 45674]]
by facsimile (FAX) transmission. In commenting, please refer to file 
code OMC-011-FC. Comments received timely will be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of the document, in Room 309-G of the 
Department's offices at 200 Independence Avenue, SW., Washington, DC, 
Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: 
(202) 690-7890)).

FOR FURTHER INFORMATION CONTACT: Tracy Jensen, (410) 786-1033.

SUPPLEMENTARY INFORMATION:

I. Background

    This rule is the fourth in a series of technical amendments that 
aim to--
    1. Make it easier to find particular provisions, for example, by 
providing paragraph headings to serve as sign posts, using more 
sections (their headings will appear in the table of contents), and by 
listing and designating separate provisions that have been ``lost'' in 
90-word sentences.
    2. Clarify, simplify, and update, for example--
    a. By using--
     Shorter words, sentences, and paragraphs;
     The active voice--showing who does what; and
     The most precise terms available, such as ``enrollee'' 
(rather than ``member'') for a beneficiary enrolled in an HMO or CMP; 
``HCFA'' (rather than ``the Secretary'') since the responsibility for 
the prepaid health care programs has been delegated to HCFA; ``that'' 
(rather than ``which'') when the term limits or defines.
    b. By eliminating unnecessary verbiage and outdated provisions.
II. Changes Made by This Rule

    1. This rule amends Sec. 417.1 to revise the definition of 
``service area'' and to remove from the definition of ``health 
maintenance organizations'' the reference to Secs. 417.168 and 417.169. 
Those sections were removed by a rule published on September 30, 1994 
at 59 FR 49834.
    2. The changes in subpart J are purely editorial, such as providing 
paragraph headings in Sec. 417.410, and using present indicative to 
describe what HCFA does on a continuing basis.
    3. In subpart K--
    a. Special rules are highlighted by upgrading paragraphs to section 
status (new Sec. 417.423).
    b. Excessively long sentences are broken down to list and designate 
the separate provisions (paragraph (c) of Sec. 417.440).
    c. In Sec. 417.460 (Disenrollment and termination of payments), we 
have reorganized the content to specify separately the circumstances 
under which disenrollment is required and those under which it is 
optional. We have also used more sections and eliminated unnecessary 
verbiage.
    4. In subpart L, we have made technical and editorial changes, 
changes that, for example--
     Provide additional headings and more precise cross 
references; and
     Avoid unnecessary repetition.
    5. In subpart M, we eliminated a ``definitions'' paragraph because, 
of the three terms defined, one was never used in the subpart, one was 
unnecessary, and the third was better explained in the only place it is 
used.

III. Waiver of Proposed Rulemaking and Delayed Effective Date

    The changes made by this rule are technical and editorial in 
nature. Their aim is to simplify, clarify, and update subparts J, K, L, 
and M without substantive change. They have no impact on program costs. 
Accordingly, we find that notice and opportunity for public comment are 
unnecessary and contrary to the public interest and that, therefore, 
there is good cause to waive proposed rulemaking procedures.
    In addition, it is important, for the convenience of the public, 
that these changes be effective as of October 1, l995, so that they 
will be included in the 1995 edition of Title 42 of the Code of Federal 
Regulations on which the public relies. Accordingly, we find good cause 
to waive the usual 30-day delay in the effective date.
    As previously indicated, however, we will consider timely comments 
from anyone who believes that, in making the technical and editorial 
changes, we have unintentionally altered the substance. Although we 
cannot respond to comments individually, if we change these rules as a 
result of comments, we will discuss all timely comments in the preamble 
to the revised rules.

IV. Paperwork Reduction Act

    These regulations contain no new information collection 
requirements subject to review by the Office of Management and Budget 
under the Paperwork Reduction Act of 1980.

V. Regulatory Impact Statement

    Consistent with the Regulatory Flexibility Act (RFA), and section 
1102(b) of the Social Security Act (the Act), we prepare a regulatory 
flexibility analysis for each rule, unless we can certify that the rule 
will not have a significant economic impact on a substantial number of 
small entities, or a significant impact on the operation of a 
substantial number of small rural hospitals.
    The RFA defines ``small entity'' as a small business, a nonprofit 
enterprise, or a governmental jurisdiction (such as a county, city, or 
township) with a population of less than 50,000. We also consider all 
providers and suppliers of services to be small entities. For purposes 
of section 1102(b) of the Act, we define a small rural hospital as a 
hospital that has fewer than 50 beds, and is not located in a 
metropolitan statistical area. We have not prepared a regulatory 
flexibility analysis because we have determined and we certify that 
this rule will not have a significant economic impact on a substantial 
number of small entities or a significant impact on the operation of a 
substantial number of small rural hospitals.
    We have not prepared a regulatory flexibility analysis because we 
have determined and certify that this rule will not have a significant 
economic impact on a substantial number of small entities or a 
significant impact on the operation of a substantial number of small 
rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
rule was not reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 417

    Administrative practice and procedure, Health maintenance 
organizations (HMOs), Medicare.

    42 CFR Part 417 is amended as set forth below:

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

    A. The authority citation for Part 417 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act 
(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.

    B. Subpart A is amended as follows:

Subpart A--General Provisions

    1. In Sec. 417.1, the following changes are made:
    a. In the definition of ``health maintenance organization,'' the 
last comma and the words ``and Secs. 417.168 and 417.169'' are removed.
    b. The definition of ``service area'' is revised to read as set 
forth below.


Sec. 417.1  Definitions.

* * * * * 

[[Page 45675]]

    Service area means a geographic area, defined through zip codes, 
census tracts, or other geographic measurements, that is the area, as 
determined by HCFA, within which the HMO furnishes basic and 
supplemental health services and makes them available and accessible to 
all its enrollees in accordance with Sec. 417.106(b).
* * * * *


Sec. 417.2  [Amended]

    2. In paragraph (a) of Sec. 417.2, ``Subparts A through F'' is 
revised to read ``Subparts B through F''.
    C. Subpart J is amended as set forth below:

Subpart J--Qualifying Conditions for Medicare Contracts

    1. Section 417.400 is revised to read as follows:


Sec. 417.400  Basis and scope.

    (a) Statutory basis. The regulations in this subpart implement 
section 1876 of the Act, which authorizes Medicare payment to HMOs and 
CMPs that contract with HCFA to furnish covered services to Medicare 
beneficiaries.
    (b) Scope. (1) This subpart sets forth the requirements an HMO or 
CMP must meet in order to enter into a contract with HCFA under section 
1876 of the Act. It also specifies the procedures that HCFA follows to 
evaluate applications and make determinations.
    (2) The rules for payment to HMOs and CMPs are set forth in 
subparts N, O, and P of this part.
    (3) The rules for HCPP participation in Medicare under section 
1833(a)(1)(A) of the Act are set forth in subpart U of this part.
    2. Sec. 417.401 is amended to add definitions of ``cost contract'', 
``cost HMO or CMP'', and ``risk HMO or CMP'', in alphabetical order, 
and revise all other definitions except the definitions of ``adjusted 
average per capita cost'', ``demonstration project'', and ``geographic 
area'', to read as follows:


Sec. 417.401  Definitions.

* * * * *
    Adjusted average per capita cost * * *
    Adjusted community rate (ACR) is the equivalent of the premium that 
a risk HMO or CMP would charge Medicare enrollees independently of 
Medicare payments if the HMO or CMP used the same rates it charges non-
Medicare enrollees for a benefit package limited to covered Medicare 
services.
    Arrangement means a written agreement between an HMO or CMP and 
another entity, under which--
    (1) The other entity agrees to furnish specified services to the 
HMO's or CMP's Medicare enrollees;
    (2) The HMO or CMP retains responsibility for the services; and
    (3) Medicare payment to the HMO or CMP discharges the beneficiary's 
obligation to pay for the services.
    Benefit stabilization fund means a fund established by HCFA, at the 
request of a risk HMO or CMP, to withhold a portion of the per capita 
payments available to the HMO or CMP and pay that portion in a 
subsequent contract period for the purpose of stabilizing fluctuations 
in the availability of the additional benefits the HMO or CMP provides 
to its Medicare enrollees.
    Cost contract means a Medicare contract under which HCFA pays the 
HMO or CMP on a reasonable cost basis.
    Cost HMO or CMP means an HMO or CMP that has in effect a cost 
contract with HCFA under section 1876 of the Act and subpart L of this 
part.
    Demonstration project * * *
    Emergency services means covered inpatient or outpatient services 
that are furnished by an appropriate source other than the HMO or CMP 
and that meet the following conditions:
    (1) Are needed immediately because of an injury or sudden illness.
    (2) Are such that the time required to reach the HMO's or CMP's 
providers or suppliers (or alternatives authorized by the HMO or CMP) 
would mean risk of permanent damage to the enrollee's health.
    Once initiated, the services continue to be considered emergency 
services as long as transfer of the enrollee to the HMO's or CMP's 
source of health care or authorized alternative is precluded because of 
risk to the enrollee's health or because transfer would be 
unreasonable, given the distance and the nature of the medical 
condition.
    Geographic area * * *
    Medicare enrollee means a Medicare beneficiary who has been 
identified on HCFA records as an enrollee of an HMO or CMP that has a 
contract with HCFA under section 1876 of the Act and subpart L of this 
part.
    New Medicare enrollee means a Medicare beneficiary who--
    (1) Enrolls with an HMO or CMP after the date on which the HMO or 
CMP first enters into a risk contract under subpart L of this part; and
    (2) Was not enrolled with the HMO or CMP at the time he or she 
became entitled to benefits under Part A or eligible to enroll in Part 
B of Medicare.
    Risk contract means a Medicare contract under which HCFA pays the 
HMO or CMP on a risk basis for Medicare covered services.
    Risk HMO or CMP means an HMO or CMP that has in effect a risk 
contract with HCFA under section 1876 of the Act and subpart L of this 
part.
    Urgently needed services means covered services that are needed by 
an enrollee who is temporarily absent from the HMO's or CMP's 
geographic area and that--
    (1) Are required in order to prevent serious deterioration of the 
enrollee's health as a result of unforeseen injury or illness; and
    (2) Cannot be delayed until the enrollee returns to the HMO's or 
CMP's geographic area.
    3. Secs. 417.404, 417.406, and 417.407 are revised to read as 
follows:


Sec. 417.404  General requirements.

    (a) In order to contract with HCFA under the Medicare program, an 
entity must--
    (1) Be determined by HCFA to be an HMO or CMP (in accordance with 
Secs. 117.142 and 417.407, respectively); and
    (2) Comply with the contract requirements set forth in subpart L of 
this part.
    (b) HCFA enters into or renews a contract only if it determines 
that action would be consistent with the effective and efficient 
implementation of section 1876 of the Act.


Sec. 417.406  Application and determination.

    (a) Responsibility for making determinations. HCFA is responsible 
for determining whether an entity meets the requirements to be an HMO 
or CMP.
    (b) Application requirements. (1) The application requirements for 
HMOs are set forth in Sec. 417.143.
    (2) The requirements of Sec. 417.143 also apply to CMPs except that 
there are no application fees.
    (c) Determination. HCFA uses the procedures set forth in 
Sec. 417.144(a) through (d) to determine whether an entity is an HMO or 
CMP.
    (d) Oversight of continuing compliance. (1) HCFA oversees an 
entity's continued compliance with the requirements for an HMO as 
defined in Sec. 417.1 or for a CMP as set forth in Sec. 417.407.
    (2) If an entity no longer meets those requirements, HCFA 
terminates the contract of that entity in accordance with Sec. 417.494.


Sec. 417.407  Requirements for a Competitive Medical Plan (CMP).

    (a) General rule. To qualify as a CMP, an entity must be organized 
under the 

[[Page 45676]]
laws of a State and must meet the requirements of paragraphs (b) 
through (f) of this section.
    (b) Required services--(1) Basic rule. Except as provided in 
paragraph (b)(2) of this section, the entity furnishes to its enrollees 
at least the following services:
    (i) Physicians' services performed by physicians.
    (ii) Laboratory, x-ray, emergency, and preventive services.
    (iii) Out-of-area coverage.
    (iv) Inpatient hospital services.
    (2) Exception for Medicaid prepayment risk contracts. An entity 
that had, before 1970, a Medicaid prepayment risk contract that did not 
include provision of inpatient hospital services is not required to 
provide those services.
    (c) Compensation for services. The entity receives compensation 
(except for deductibles, coinsurance, and copayments) for the health 
care services it provides to enrollees on a periodic, prepaid 
capitation basis regardless of the frequency, extent, or kind of 
services provided to any enrollee.
    (d) Source of physicians' services. The entity provides physicians' 
services primarily through--
    (1) Physicians who are employees or partners of the entity; or
    (2) Physicians or groups of physicians (organized on a group or 
individual practice basis) under contract with the entity to provide 
physicians' services.
    (e) Assumption of financial risk. The rules set forth in 
Sec. 417.120(b) for HMOs apply also to CMPs except that reference to 
``basic services'' must be read as reference to the required services 
listed in paragraph (b) of this section.
    (f) Protection of enrollees. The entity provides adequately against 
the risk of insolvency by meeting the requirements of Secs. 417.120(a) 
and 417.122 for protection of enrollees against loss of benefits and 
liability for payment of any fees that are the legal responsibility of 
the entity.


Sec. 417.408  [Amended]

    4. In Sec. 417.408, the following changes are made:
    a. In paragraph (a), the designation ``(1)'' is inserted before the 
first sentence, the designation ``(2)'' is inserted before the second 
sentence, and ``will exempt'' is revised to read ``exempts''.
    b. In paragraphs (b)(1) and (c) introductory text, ``will give'' is 
revised to read ``gives''.
    5. Section 417.410 is amended to revise the section heading and 
provide headings for paragraphs (a) through (f), to read as follows:


Sec. 417.410  Qualifying conditions: General rules.

    (a) Basic requirement. * * *
    (b) Other qualifying conditions. * * *
    (c) Standards. * * *
    (d) Application of standards. * * *
    (e) Requirements for a risk contract. * * *
    (f) Requirements for a reasonable cost contract. * * *
* * * * *


Sec. 417.412  [Amended]

    6. In Sec. 417.412, the following changes are made:
    a. Paragraph (a) and the designation ``(b)'' are removed.
    b. Paragraphs (b)(1) and (b)(2) are redesignated as paragraphs (a) 
and (b), respectively.
    7. In Sec. 417.413, paragraphs (b) introductory text, (b)(1), 
(b)(2), (c), (d)(2)(i), (d)(3), (d)(5), and (d)(6) are revised to read 
as follows:


Sec. 417.413  Qualifying condition: Operating experience and 
enrollment.

* * * * *
    (b) Standard: Enrollment and operating experience for HMOs or CMPs 
to contract on a risk basis. To be eligible to contract on a risk 
basis--
    (1) A nonrural HMO or CMP must currently have the following:
    (i) At least 5,000 enrollees; and
    (ii) At least 75 Medicare enrollees or a plan acceptable to HCFA 
for achieving a Medicare enrollment of 75 within 2 years from the 
beginning of its initial contract period.
    (2) A rural HMO or CMP must currently have--
    (i) At least 1,500 enrollees; and
    (ii) At least 75 Medicare enrollees or a plan acceptable to HCFA 
for achieving a Medicare enrollment of 75 within 2 years from the 
beginning of its initial contract period.
* * * * *
    (c) Standard: Enrollment and operating experience for HMOs or CMPs 
to contract on a cost basis. To be eligible to contract on a reasonable 
cost basis, an HMO or CMP must currently have enrollees sufficient in 
number to provide a reasonable basis for entering into a contract, as 
follows:
    (1) At least 1,500 enrollees.
    (2) At least 75 Medicare enrollees, or a plan acceptable to HCFA 
for achieving--
    (i) A Medicare enrollment of 75 within 2 years from the beginning 
of its initial contract period; and
    (ii) At least 250 Medicare enrollees by the beginning of its fourth 
contract period.
    (d) Standard: Composition of enrollment.
    (1) * * *
    (2) Waiver of composition of enrollment standard. * * *
    (i) The HMO or CMP serves a geographic area in which Medicare 
beneficiaries and Medicaid recipients constitute more than 50 percent 
of the population. (HCFA does not grant a waiver that would permit the 
percentage of Medicare and Medicaid enrollees to exceed the percentage 
of Medicare beneficiaries and Medicaid recipients in the population of 
the geographic area.)
* * * * *
    (3) Waiver granted on or before October 21, 1986. An HMO or CMP (or 
a successor HMO or CMP) that as of October 21, 1986, had been granted 
an exception, waiver, or modification of the requirements of paragraph 
(d)(1) of this section, but that does not meet the requirements of 
paragraph (d)(2) of this section, must make (and throughout the period 
of the exception, waiver, or modification continue to make) reasonable 
efforts to meet scheduled enrollment goals, consistent with a schedule 
of compliance approved by HCFA.
    (i) If HCFA determines that the HMO or CMP has complied, or made 
significant progress toward compliance, with the approved schedule, and 
that an extension is in the best interest of the Medicare program, HCFA 
may extend the waiver of modification.
    (ii) If HCFA determines that the HMO or CMP has not complied with 
the approved schedule, HCFA may apply the sanctions described in 
paragraphs (d)(6) and (d)(7) of this section.
* * * * *
    (5) Notice of sanction. Before applying the sanctions specified in 
paragraph (d)(6) of this section, HCFA sends a written notice to the 
HMO or CMP stating the proposed action and its basis. HCFA gives the 
HMO or CMP 15 days after the date of the notice to provide evidence 
establishing the HMO's or CMP's compliance with the requirements in 
paragraph (d)(1), (d)(2), or (d)(3) of this section, as applicable.
    (6) Sanctions. If, following review of the HMO's or CMP's timely 
response to HCFA's notice, HCFA determines that an HMO or CMP does not 
comply with the requirements of paragraphs (d)(1), (d)(2), or (d)(3) of 
this section, HCFA may apply either of the following sanctions:
    (i) Require the HMO or CMP to stop accepting new enrollment 
applications after a date specified by HCFA.
    (ii) Deny payment for individuals who are formally added or 
``accreted'' to 

[[Page 45677]]
HCFA's records as Medicare enrollees after a date specified by HCFA.
* * * * *


Sec. 417.414  [Amended]

    8. In Sec. 417.414, the following changes are made:
    a. In paragraph (b)(1), the word ``that'' is revised to read ``to 
the extent that they''.
    b. Paragraph (b)(4) is removed.
    9. Section 417.416 is amended by revising paragraphs (b) and (d), 
to read as follows:


Sec. 417.416  Qualifying condition: Furnishing of services.

* * * * *
    (b) Standard: Conformance with conditions of participation, 
conditions for coverage, and conditions for certification. (1) 
Hospitals, SNFs, HHAs, CORFs, and providers of outpatient physical 
therapy or speech-language pathology services must meet the applicable 
conditions of participation in Medicare, as set forth elsewhere in this 
chapter.
    (2) Suppliers must meet the conditions for coverage or conditions 
for certification of their services, as set forth elsewhere in this 
chapter.
    (3) If more than one type of practitioner is qualified to furnish a 
particular service, the HMO or CMP may select the type of practitioner 
to be used.
* * * * *
    (d) Exceptions to physician supervision requirement. The following 
services may be furnished without the direct personal supervision of a 
physician:
    (1) Services of physician assistants and nurse practitioners (as 
defined in Sec. 491.2 of this chapter), and the services and supplies 
incident to their services. The conditions for payment, as set forth in 
Secs. 405.2414 and 405.2415 of this chapter for services furnished by 
rural health clinics and Federally qualified health centers, 
respectively, also apply when those services are furnished by an HMO or 
CMP.
    (2) When furnished by a risk HMO or CMP, services of clinical 
psychologists, and services and supplies incident to their professional 
services. For purposes of this section, a clinical psychologist is an 
individual who--
    (i) Holds a doctoral degree in psychology from an educational 
institution that is accredited by an organization recognized by the 
Council on Post-Secondary Accreditation;
    (ii) Is licensed or certified at the independent practice level of 
psychology in the State in which he or she practices; and
    (iii) Has 2 years of supervised clinical experience at least l of 
which is postgraduate.
* * * * *
    D. Subpart K is amended as set forth below:


Sec. 417.420  [Amended]

    1. In Sec. 417.420, the following changes are made:
    a. In paragraph (b), ``Medicare will make payments to the HMO or 
CMP'' is revised to read ``HCFA pays the HMO or CMP''.
    b. In paragraph (b), the phrase ``, as described in Sec. 417.440,'' 
is removed.
    c. In paragraph (c)(1), the phrase ``as authorized in 
Sec. 417.440'' is removed.


Sec. 417.422  [Amended]

    2. In Sec. 417.422, the following changes are made:
    a. In paragraph (a), the designation ``(a)'' and the heading are 
removed and ``Sec. 417.424 and paragraphs (b) and (c) of this section'' 
is revised to read ``Secs. 417.423 and 417.424''.
    b. The designation of paragraphs (a)(1) through (a)(7), is changed 
to ``(a)'' through ``(g)'', respectively.
    c. Paragraphs (b) and (c) are removed.
    3. A new Sec. 417.423 is added, to read as follows:


Sec. 417.423  Special rules: ESRD and hospice patients.

    (a) ESRD patients. (1) A Medicare beneficiary who has been 
medically determined to have end-stage renal disease is not eligible to 
enroll in an HMO or CMP.
    (2) However, if a beneficiary is already enrolled in an HMO or CMP 
when he or she is determined to have end-stage renal disease, the HMO 
or CMP--
    (i) Must reenroll the beneficiary as required by Sec. 417.434; and
    (ii) May not disenroll the beneficiary except as provided in 
Sec. 417.460.
    (b) Hospice patients. A Medicare beneficiary who elects hospice 
care under Sec. 418.24 of this chapter is not eligible to enroll in an 
HMO or CMP as long as the hospice election remains in effect.


Sec. 417.424  [Amended]

    4. In Sec. 417.424, the following changes are made:
    a. In paragraph (b), the designation ``(1)'' is inserted before the 
first sentence and the designation ``(2)'' is inserted before the 
second sentence.
    b. In newly designated paragraph (b)(2), the phrase ``(as defined 
in Sec. 417.413(f)(2))'' is removed, and the phrase ``its proportion to 
the general population'' is revised to read ``the subgroup's proportion 
of the general population''.
    c. The following parenthetical statement is added at the end of 
newly designated paragraph (b)(2): ``(A subgroup is a class of Medicare 
enrollees of an HMO or CMP that HCFA constructs on the basis of 
actuarial factors.)''.
    5. In Sec. 417.426, paragraphs (b)(2) and (c) are revised to read 
as follows:


Sec. 417.426  Open enrollment requirements.

* * * * *
    (b) Capacity to accept new enrollees. * * *
    (2) HCFA evaluates the HMO's or CMP's submittal under paragraph 
(b)(1) of this section.
* * * * *
    (c) Reserved vacancies. (1) Subject to HCFA's approval, an HMO or 
CMP may set aside a reasonable number of vacancies for an anticipated 
new group contract or for anticipated new enrollees under an existing 
group contract that will have its enrollment period after the Medicare 
open enrollment period during the contract year.
    (2) Any set aside vacancies that are not filled within a reasonable 
time after the beginning of the group contract enrollment period must 
be made available to Medicare beneficiaries and other nongroup 
applicants under the requirements of this subpart.


Sec. 417.428  [Amended]

    6. In Sec. 417.428, paragraph (c), ``risk reimbursement'' is 
revised to read ``payment on a risk basis''.
    7. In Sec. 417.430, the following changes are made:
    a. Paragraph (b)(3) is revised to read as set forth below.
    b. In paragraph (b)(6)(i), ``accepted while the organization was 
enrolled to capacity'' is revised to read ``accepted (for future 
enrollment) while there were no vacancies.''


Sec. 417.430  Application procedures.

* * * * *
    (b) Handling of applications. * * *
    (3) The HMO or CMP gives the beneficiary prompt written notice of 
acceptance or rejection of the application.
* * * * *


Sec. 417.432  [Corrected]

    8. In Sec. 417.432, the heading of paragraph (e) is corrected to 
read: ``(e) Expedited submittal of information to HCFA.'' 
    9. Section 417.440 is amended to revise paragraphs (b)(1), (c), and 
(d) introductory text, to read as follows: 

[[Page 45678]]



Sec. 417.440  Entitlement to health care services from an HMO or CMP.

* * * * *
    (b) Scope of services--(1) Part A and Part B services. Except as 
specified in paragraphs (c), (d), and (e) of this section, a Medicare 
enrollee is entitled to receive from an HMO or CMP all the Medicare-
covered services that are available to individuals residing in the 
HMO's or CMP's geographic area, as follows:
    (i) Medicare Part A and Part B services if the enrollee is entitled 
to benefits under both programs.
    (ii) Medicare Part B services if the enrollee is entitled only 
under that program.
* * * * *
    (c) Limitation on hospice care--(1) Extent of limitation--(i) Basic 
rule. Except as provided in paragraph (c)(1)(ii) of this section, a 
Medicare enrollee who elects to receive hospice care under Sec. 418.24 
of this chapter waives the right to receive from the HMO or CMP any 
Medicare services (including services equivalent to hospice care) that 
are related to the terminal condition for which the enrollee elected 
hospice care, or to a related condition.
    (ii) Exception. An enrollee who elects hospice care retains the 
right to services furnished by his or her attending physician if that 
physician--
    (A) Is an employee or contractor of the HMO or CMP; and
    (B) Is not an employee of the designated hospice and does not 
receive compensation from the hospice for those services.
    (2) Effective date of limitation. The limitation in paragraph 
(c)(1) of this section begins on the effective date of the 
beneficiary's election of hospice care and remains in effect until the 
earlier of the following:
    (i) The effective date of the enrollee's revocation of the election 
of hospice care as described in Sec. 418.28 of this chapter.
    (ii) The date the enrollee exhausts his or her hospice benefits.
    (3) Payment to HMO or CMP. For the period that the Medicare 
enrollee's election of hospice care is in effect, HCFA pays a cost HMO 
or CMP only as described in Sec. 417.585.
    (d) Limitation on provision of inpatient hospital services. If a 
beneficiary's effective date of coverage, as specified in Sec. 417.450, 
in a risk HMO or CMP occurs during an inpatient stay in a hospital paid 
for under part 412 of this chapter, the HMO or CMP--
* * * * *
    10. In Sec. 417.442, the heading and paragraph (a) are revised to 
read as follows:


Sec. 417.442  Risk HMOs and CMPs: Conditions for provision of 
additional benefits.

    (a) General rule. Except as provided in paragraph (b) of this 
section, a risk HMO or CMP must, during any contract period, provide to 
its Medicare enrollees the additional benefits described in 
Sec. 417.440(b)(4) if its ACRs (calculated in accordance with 
Sec. 417.594) are less than the average per capita rates that HCFA pays 
for the Medicare enrollees during the contract period.
    11. In Sec. 417.450, paragraph (c) is revised to read as follows:


Sec. 417.450  Effective date of coverage.

* * * * *
    (c) Notice of effective date of coverage. For each beneficiary 
added to HCFA's records as an enrollee of an HMO or CMP, HCFA gives the 
HMO or CMP prompt written notice of the month with which HCFA's 
liability begins.


Sec. 417.452  [Amended]
    12. In Sec. 417.452, the following changes are made:
    a. In paragraph (a)(1), ``under Sec. 417.442'' is revised to read 
``under the additional benefits provision of Sec. 417.442''.
    b. In paragraph (a)(2) ``may be paid by the enrollee or on his or 
her behalf by another individual, organization or entity.'' is revised 
to read ``may be paid by or on behalf of the enrollee in the form of a 
premium, membership fee, charge per unit, or other similar charge.'', 
and the second sentence is removed.
    c. In paragraph (b) introductory text, ``provided under 
Sec. 417.442'' is revised to read ``provided as additional benefits 
under Sec. 417.442''.


Sec. 417.454  [Amended]

    13. In Sec. 417.454, the heading of paragraph (a) is revised to 
read ``Limits on charges.''


Sec. 417.456  [Amended]

    14. In Sec. 417.456, in paragraph (f), ``will reduce'' is revised 
to read ``reduces'', and ``arrange'' is revised to read ``arranges''.


Sec. 417.458  [Amended]

    15. In Sec. 417.458, introductory text, ``agrees to recoup'' is 
revised to read ``agrees not to recoup'', and ``only in the following 
circumstances'' is revised to read ``except in the following 
circumstances''.
    16. Section 417.460 is revised and new sections 417.461 and 417.464 
are added, to read as follows:


Sec. 417.460  Disenrollment of beneficiaries by an HMO or CMP.

    (a) General rule. Except as provided in paragraphs (b) through (i) 
of this section, an HMO or CMP may not--
    (1) Disenroll a Medicare beneficiary; or
    (2) Orally or in writing, or by any action or inaction, request or 
encourage a Medicare enrollee to disenroll.
    (b) Bases for disenrollment: Overview--(1) Optional disenrollment. 
Generally, an HMO or CMP may disenroll a Medicare enrollee if he or 
she--
    (i) Fails to pay the required premiums or other charges;
    (ii) Commits fraud or permits abuse of his or her enrollment card; 
or
    (iii) Behaves in a manner that seriously impairs the HMO's or CMP's 
ability to furnish health care services to the particular enrollee or 
to other enrollees.
    (2) Required disenrollment. Generally, an HMO or CMP must disenroll 
a Medicare enrollee if he or she--
    (i) Moves out of the HMO's or CMP's geographic area;
    (ii) Fails to convert to the risk provisions of the HMO's or CMP's 
Medicare contract;
    (iii) Loses entitlement to Medicare Part B benefits; or
    (iv) Dies.
    (3) Related provisions. Specific requirements, limitations, and 
exceptions are set forth in paragraphs (c) through (i) of this section.
    (c) Failure to pay premiums or other charges--(1) Basic rule. 
Except as specified in paragraph (c)(2) of this section, an HMO or CMP 
may disenroll a Medicare enrollee who fails to pay premiums or other 
charges imposed by the HMO or CMP for deductible and coinsurance 
amounts for which the enrollee is liable, if the HMO or CMP--
    (i) Can demonstrate to HCFA that it made reasonable efforts to 
collect the unpaid amount;
    (ii) Gives the enrollee written notice of disenrollment, including 
an explanation of the enrollee's right to a hearing under the HMO's or 
CMP's grievance procedures; and
    (iii) Sends the notice of disenrollment to the enrollee before it 
notifies HCFA.
    (2) Exception. If the enrollee fails to pay the premium for 
optional supplemental benefits (that is, a package of benefits that an 
enrollee is not required to accept), but pays the basic premium and 
other charges, the HMO or CMP may discontinue the optional 

[[Page 45679]]
benefits but may not disenroll the beneficiary.
    (d) Enrollee commits fraud or permits abuse of the enrollment 
card--(1) Basis for disenrollment. An HMO or CMP may disenroll a 
Medicare beneficiary if the beneficiary--
    (i) Knowingly provides, on the application form, fraudulent 
information that materially affects the beneficiary's eligibility to 
enroll in the HMO or CMP; or
    (ii) Intentionally permits others to use his or her enrollment card 
to obtain services from the HMO or CMP.
    (2) Notice requirement. If disenrollment is for either of the 
reasons specified in paragraph (d)(1) of this section, the HMO or CMP 
must give the beneficiary a written notice of termination of 
enrollment.
    (i) The notice must be mailed to the enrollee before submission of 
the disenrollment notice to HCFA.
    (ii) The notice must include an explanation of the enrollee's right 
to have the disenrollment heard under the grievance procedures 
established in accordance with Sec. 417.436.
    (3) Report to the Inspector General. The HMO or CMP must report to 
the Office of the Inspector General of the Department any disenrollment 
based on fraud or abuse by the enrollee.
    (e) Disenrollment for cause--(1) Basis for disenrollment. An HMO or 
CMP may disenroll a Medicare enrollee for cause if the enrollee's 
behavior is disruptive, unruly, abusive, or uncooperative to the extent 
that his or her continuing enrollment in the HMO or CMP seriously 
impairs the HMO's or CMP's ability to furnish services to either the 
particular enrollee or other enrollees.
    (2) Effort to resolve the problem. The HMO or CMP must make a 
serious effort to resolve the problem presented by the enrollee, 
including the use (or attempted use) of internal grievance procedures.
    (3) Consideration of extenuating circumstances. The HMO or CMP must 
ascertain that the enrollee's behavior is not related to the use of 
medical services or to mental illness.
    (4) Documentation. The HMO or CMP must document the problems, 
efforts, and medical conditions as described in paragraphs (e)(1) 
through (e)(3) of this section.
    (5) HCFA review of an HMO's or CMP's proposed disenrollment for 
cause. (i) HCFA decides on the basis of review of the documentation 
submitted by the HMO or CMP, whether disenrollment requirements have 
been met.
    (ii) HCFA makes this decision within 20 working days after receipt 
of the documentation material, and notifies the HMO or CMP within 5 
working days after making its decision.
    (6) Effective date of disenrollment. If HCFA permits an HMO or CMP 
to disenroll an enrollee for cause, the disenrollment takes effect on 
the first day of the calendar month after the month in which the HMO or 
CMP gives the enrollee a written notice of disenrollment that meets the 
requirements set forth in paragraphs (d)(2)(i) and (d)(2)(ii) of this 
section.
    (f) Enrollee moves out of the HMO's or CMP's geographic area--(1) 
Basic rules--(i) Disenrollment. Except as provided in paragraph (f)(2) 
of this section, an HMO or CMP must disenroll a Medicare enrollee who 
moves out of its geographic area if the HMO or CMP establishes, on the 
basis of a written statement from the enrollee, or other evidence 
acceptable to HCFA, that the enrollee has permanently moved out of its 
geographic area.
    (ii) Notice requirement. The HMO or CMP must comply with the notice 
requirements set forth in paragraph (d)(2) of this section.
    (iii) Effect on geographic area. Failure to disenroll an enrollee 
who has moved out of the HMO's or CMP's geographic area does not expand 
that area to encompass the location of the enrollee's new residence.
    (2) Exception. An HMO or CMP may retain a Medicare enrollee who is 
absent from its geographic area for an extended period, but who remains 
within the United States as defined in Sec. 400.200 of this chapter if 
the enrollee agrees. For purposes of this exception, the following 
provisions apply:
    (i) An absence for an extended period means an uninterrupted 
absence from the HMO's or CMP's geographic area for more than 90 days 
but less than 1 year.
    (ii) The HMO or CMP and the enrollee may mutually agree upon 
restrictions for obtaining services while the enrollee is absent for an 
extended period from the HMO's or CMP's geographic area. However, 
restrictions may not be imposed on the scope of services described in 
Sec. 417.440.
    (iii) HMOs and CMPs that choose to exercise this exception must 
make the option available to all Medicare enrollees who are absent for 
an extended period from their geographic areas. However, HMOs and CMPs 
may limit this option to enrollees who go to a geographic area served 
by an affiliated HMO or CMP.
    (iv) As used in this paragraph, ``affiliated HMO or CMP'' means an 
HMO or CMP that--
    (A) Is under common ownership or control of the HMO or CMP that 
seeks to retain the absent enrollees; or
    (B) Has in effect an agreement to furnish services to enrollees who 
are on an extended absence from the geographic area of the HMO or CMP 
that seeks to retain them.
    (v) When the enrollee returns to the HMO's or CMP's geographic area 
(even temporarily), the restrictions of Sec. 417.448(a) (which limit 
payment for services not provided or arranged for by the HMO or CMP) 
apply again immediately.
    (vi) If the enrollee fails to return to the HMO's or CMP's 
geographic area within 1 year from the date he or she left that area, 
the HMO or CMP must disenroll the beneficiary on the first day of the 
month following the anniversary of the date the enrollee left that area 
in accordance with paragraph (f)(1) of this section.
    (g) Failure to convert to risk provisions of Medicare contract--(1) 
Basis for disenrollment. A risk HMO or CMP must disenroll a nonrisk 
Medicare enrollee who refuses to convert to the risk provisions of the 
Medicare contract after HCFA determines that all of the HMO's or CMP's 
nonrisk Medicare enrollees must convert.
    (2) Advance notice requirement. At least 30 days before it gives 
HCFA notice of disenrollment, the HMO or CMP must give the enrollee 
written notice of the fact that failure to convert will result in 
disenrollment.
    (h) Loss of entitlement to Medicare benefits--(1) Loss of 
entitlement to Part A benefits. If an enrollee loses entitlement to 
benefits under Part A of Medicare but remains entitled to benefits 
under Part B, the enrollee automatically continues as a Medicare 
enrollee of the HMO or CMP and is entitled to receive and have payment 
made for Part B services, beginning with the month immediately 
following the last month of his or her entitlement to Part A benefits.
    (2) Loss of entitlement to Part B benefits. If a Medicare enrollee 
loses entitlement to Part B benefits, the HMO or CMP must disenroll him 
or her as a Medicare enrollee effective with the month following the 
last month of entitlement to Part B benefits. However, the HMO or CMP 
may continue to enroll the individual under its regular plan if the 
individual so chooses.
    (i) Death of the enrollee. Disenrollment is effective with the 
month following the month of death.


Sec. 417.461  Disenrollment by the enrollee.

    (a) Request for disenrollment. (1) A Medicare enrollee who wishes 
to 

[[Page 45680]]
disenroll may at any time give the HMO or CMP a signed, dated request 
in the form and manner prescribed by HCFA.
    (2) The enrollee may request a certain disenrollment date but it 
may be no earlier than the first day of the month following the month 
in which the HMO or CMP receives the request.
    (b) Responsibilities of the HMO or CMP. The HMO or CMP must--
    (1) Submit a disenrollment notice to HCFA promptly;
    (2) Provide the enrollee with a copy of the request for 
disenrollment; and
    (3) In the case of a risk HMO or CMP, also provide the enrollee 
with a statement explaining that he or she--
    (i) Remains enrolled until the effective date of disenrollment; and
    (ii) Until that date, is subject to the restrictions of 
Sec. 417.448(a) under which neither the HMO or CMP nor HCFA pays for 
services not provided or arranged for by the HMO or CMP.
    (c) Effect of failure to submit disenrollment notice to HCFA 
promptly. If the HMO or CMP fails to submit timely the correct and 
complete notice required in paragraph (b)(1) of this section, the HMO 
or CMP must reimburse HCFA for any capitation payments received after 
the month in which payments would have ceased if the requirement had 
been met timely.


Sec. 417.464  End of HCFA's liability for payment: Disenrollment of 
beneficiaries and termination or default of contract.

    (a) Effect of disenrollment: General rule. (1) HCFA's liability for 
monthly capitation payments to the HMO or CMP generally ends as of the 
first day of the month following the month in which disenrollment is 
effective, as shown on HCFA's records.
    (2) Disenrollment is effective no earlier than the month 
immediately after, and no later than the third month after, the month 
in which HCFA receives the disenrollment notice in acceptable form.
    (b) Effect of disenrollment: Special rules--(1) Fraud or abuse by 
the enrollee. If disenrollment is on the basis of fraud committed or 
abuse permitted by the enrollee, HCFA's liability ends as of the first 
day of the month in which disenrollment is effective.
    (2) Loss of entitlement to Part B benefits. If disenrollment is on 
the basis of loss of entitlement to Part B benefits, HCFA's liability 
ends as of the first day of the month following the last month of Part 
B entitlement.
    (3) Death of enrollee. If the enrollee dies, HCFA's liability ends 
as of the first day of the month following the month of death.
    (4) Disenrollment at enrollee's request. If disenrollment is in 
response to the enrollee's request, HCFA's liability ends as of the 
first day of the month following the month of termination requested by 
the enrollee.
    (c) Effect of termination or default of contract--(1) Termination 
of contract. If the contract between HCFA and the HMO or CMP is 
terminated by mutual consent or by unilateral action of either party, 
HCFA's liability for payments ends as of the first day of the month 
after the last month for which the contract is in effect.
    (2) Default of contract. If the HMO or CMP defaults on the contract 
before the end of the contract year because of bankruptcy or other 
reasons, HCFA--
    (i) Determines the month in which its liability for payments ends; 
and
    (ii) Notifies the HMO or CMP and all affected Medicare enrollees as 
soon as practicable.
    E. Subpart L is amended as set forth below:

Subpart L--Requirements for Medicare Contracts

    1. Section 417.472 is amended to revise paragraphs (a) and (b) to 
read as follows:


Sec. 417.472  Basic contract requirements.

    (a) Submittal of contract. An HMO or CMP that wishes to contract 
with HCFA to furnish services to Medicare beneficiaries must submit a 
signed contract that meets the requirements of this subpart and any 
other requirements established by HCFA.
    (b) Agreement to comply with regulations and instructions. The 
contract must provide that the HMO or CMP agrees to comply with all the 
applicable requirements and conditions set forth in this subpart and in 
general instructions issued by HCFA.
* * * * *
    2. Sections 417.474 and 417.476 are revised to read as follows:


Sec. 417.474  Effective date and term of contract.

    (a) Effective date. The contract must specify its effective date, 
which may not be earlier than the date it is signed by both HCFA and 
the HMO or CMP.
    (b) Term. The contract must specify the duration of its term as 
follows:
    (1) For the initial term, at least 12 months, but no more than 23 
months.
    (2) For any subsequent term, 12 months.


Sec. 417.476  Waived conditions.

    If HCFA waives any of the qualifying conditions required under 
subpart J of this part, the contract must specify the following 
information for each waived condition:
    (a) The specific terms of the waiver.
    (b) The expiration date of the waiver.
    (c) Any other information required by HCFA.
    3. Section 417.480 is amended to revise the heading and the 
introductory text to read as follows:


Sec. 417.480  Maintenance of records: Cost HMOs and CMPs.

    A reasonable cost contract must provide that the HMO or CMP agrees 
to maintain books, records, documents, and other evidence of accounting 
procedures and practices that--
* * * * *
    4. In Sec. 417.481, the heading and the introductory text are 
revised to read as follows:


Sec. 417.481  Maintenance of records: Risk HMOs and CMPs.

    A risk contract must provide that the HMO or CMP agrees to maintain 
and make available to HCFA upon request, books, records, documents, and 
other evidence of accounting procedures and practices that--
* * * * *
    5. In Sec. 417.486, the following changes are made:
    a. In the introductory text, the word ``agrees'' is revised to read 
``agrees to the following:''.
    b. In paragraph (a)(1), ``Secs. 417.530 through 417.576'' is 
revised to read ``subpart O of this part''.
    c. At the end of paragraphs (b) and (c), periods are substituted 
for the ``;'' and ``; and ``, respectively.
    d. Paragraph (d) is revised to read as follows:


Sec. 417.486  Disclosure of information and confidentiality.

* * * * *
    (d) To meet the confidentiality requirements of Sec. 482.24(b)(3) 
of this chapter for medical records and for all other enrollee 
information that is--
    (1) Contained in its records or obtained from HCFA or other 
sources; and
    (2) Not covered under paragraph (c) of this section.
    6. Section 417.488 is revised to read as follows.


Sec. 417.488  Notice of termination and of available alternatives: Risk 
contract.

    A risk contract must provide that the HMO or CMP agrees to give 
notice as follows if the contract is terminated:
    (a) At least 60 days before the effective date of termination, to 
give its Medicare enrollees a written notice that--
    (1) Specifies the termination date; and
    (2) Describes the alternatives available for obtaining Medicare 
services after termination. 

[[Page 45681]]

    (b) To pay the cost of the written notices.
    7. In Sec. 417.492, the introductory text of paragraph (a)(1) is 
republished and paragraphs (a)(l)(iii) and (b) are revised to read as 
follows:


Sec. 417.492  Nonrenewal of contract.

    (a) Nonrenewal by the HMO or CMP. (1) If an HMO or CMP does not 
intend to renew its contract, it must--
* * * * *
    (iii) Notify the general public at least 30 days before the end of 
the contract period, by publishing a notice in one or more newspapers 
of general circulation in each community or county located in the HMO's 
or CMP's geographic area.
* * * * *
    (b) Nonrenewal by HCFA--(1) Notice of nonrenewal. If HCFA decides 
not to renew a contract, it gives written notice of nonrenewal as 
follows:
    (i) To the HMO or CMP at least 90 days before the end of the 
contract period.
    (ii) To the HMO's or CMP's Medicare enrollees at least 60 days 
before the end of the contract period.
    (iii) To the general public at least 30 days before the end of the 
contract period.
    (2) Notice of appeal rights. HCFA gives the HMO or CMP written 
notice of its right to appeal the nonrenewal decision, in accordance 
with subpart R of this part, if HCFA's decision was based on any of the 
reasons specified in Sec. 417.494(b).
    8. Section 417.494 is amended to revise paragraphs (a)(3), 
(b)(1)(iv), (b)(2), (b)(4), (c)(4), and (c)(5), to read as follows:


Sec. 417.494  Modification or termination of contract.

    (a) Modification or termination by mutual consent. * * *
    (3) If the contract is terminated, the HMO or CMP must notify its 
Medicare enrollees, and HCFA notifies the general public, at least 30 
days before the termination date.
    (b) Termination by HCFA. (1) * * *
    (iv) HCFA determines that the HMO or CMP no longer meets the 
requirements of section 1876 of the Act and this subpart for being an 
HMO or CMP.
    (2) If HCFA decides to terminate a contract, it sends a written 
notice informing the HMO or CMP of its right to appeal the termination 
in accordance with subpart R of this part.
    (3) * * *
    (4) HCFA notifies the HMO's or CMP's Medicare enrollees and the 
general public of the termination at least 30 days before the effective 
date of termination.
    (c) Termination by the HMO or CMP. * * *
    (4) The contract is terminated effective 60 days after the HMO or 
CMP mails the notice to Medicare enrollees as required in paragraph 
(c)(2) of this section.
    (5) HCFA's liability for payment ends as of the first day of the 
month after the last month for which the contract is in effect.


Sec. 417.500  [Amended]

    9. In Sec. 417.500, the following changes are made:
    a. In paragraph (a) introductory text, ``termination'' is revised 
to read ``termination of contract'', and ``with a contract under this 
subpart'' is removed.
    b. In paragraphs (a)(3) and (a)(4), ``this part'' is revised to 
read ``subpart K of this part''.
    c. The heading of paragraph (b) is revised to read ``Notice of 
sanction and opportunity to respond.''
    d. The heading ``Notice of sanction.'' is added to paragraph 
(b)(1).
    e. The heading ``Opportunity to respond.'' is added to paragraph 
(b)(2).
    F. Subpart M is amended as set forth below:

Subpart M--Change of Ownership and Leasing of Facilities: Effect on 
Medicare Contracts

    1. Section 417.520 is revised to read as follows:


Sec. 417.520  General provisions.

    (a) What constitutes change of ownership--(1) Partnership. The 
removal, addition, or substitution of a partner, unless the partners 
expressly agree otherwise as permitted by applicable State law, 
constitutes a change of ownership.
    (2) Unincorporated sole proprietor. Transfer of title and property 
to another party constitutes change of ownership.
    (3) Corporation. (i) The merger of the HMO's or CMP's corporation 
into another corporation or the consolidation of the HMO or CMP with 
one or more other corporations, resulting in a new corporate body, 
constitutes a change of ownership.
    (ii) Transfer of corporate stock or the merger of another 
corporation into the HMO's or CMP's corporation, with the HMO or CMP 
surviving, does not ordinarily constitute change of ownership.
    (b) Advance notice requirement. (1) An HMO or CMP that has a 
Medicare contract in effect and is considering or negotiating a change 
in ownership must notify HCFA at least 60 days before the anticipated 
effective date of the change.
    (2) If the HMO or CMP fails to give HCFA the required notice 
timely, it continues to be liable for capitation payments that HCFA 
makes to it on behalf of Medicare enrollees after the date of change of 
ownership.
    (c) Novation agreement defined. A novation agreement is an 
agreement among the current owner of the HMO or CMP, the prospective 
new owner, and HCFA--
    (1) That is embodied in a document executed and signed by all three 
parties;
    (2) That meets the requirements of Sec. 417.522; and
    (3) Under which HCFA recognizes the new owner as the successor in 
interest to the current owner's Medicare contract.
    (d) Effect of change of ownership without novation agreement. 
Except to the extent provided in paragraph (b)(2) of this section, the 
effect of a change of ownership without a novation agreement is that--
    (1) The existing contract becomes invalid; and
    (2) If the new owner wishes to participate in the Medicare program, 
it must apply for, and enter into, a contract in accordance with 
subpart L of this part.
    (e) Effect of change of ownership with novation agreement. If the 
HMO or CMP submits a novation agreement that meets the requirements of 
Sec. 417.522, and HCFA signs it, the new owner becomes the successor in 
interest to the current owner's Medicare contract.


Sec. 417.521  [Removed]

    2. Section 417.521 is removed.


Sec. 417.522  [Amended]

    3. In Sec. 417.522, the following changes are made:
    a. In paragraph (a) introductory text, ``will approve'' is revised 
to read ``approves''.
    b. In paragraph (a)(3)(iii), ``under this part'' is revised to read 
``under subpart J of this part''.


Sec. 417.523  [Amended]

    4. In Sec. 417.523, the following changes are made:
    a. In paragraph (a), the heading is revised to read ``General 
effect of leasing.''.
    b. In the text of paragraph (a) and in paragraph (b)(2), ``the 
lessee'' is revised to read ``the other entity''.

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


[[Page 45682]]

    Dated: May 22, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-21626 Filed 8-31-95; 8:45 am]
BILLING CODE 4120-01-P