[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Rules and Regulations]
[Pages 71673-71678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 422

[HCFA-1011-F]
RIN 0938-AI83


Medicare Program; Solvency Standards for Provider-Sponsored 
Organizations

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

ACTION: Final rule.

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SUMMARY: The Balanced Budget Act of 1997 established a new 
Medicare+Choice (M+C) program that offers eligible individuals Medicare 
benefits through enrollment in one of an array of private health plans 
that contract with us. Among the new options available to Medicare 
beneficiaries is enrollment in a provider-sponsored organization (PSO). 
This final rule revises and responds to comments on solvency standards 
that certain entities must meet to contract as PSOs under the new M+C 
program. These standards, originally established in an interim final 
rule published on May 7, 1998, apply to PSOs that have received a 
waiver of the requirement that M+C organizations must be licensed by a 
State as risk-bearing entities.

DATES: Effective date: These regulations are effective on January 21, 
2000.

FOR FURTHER INFORMATION CONTACT: Marty Abeln, (410) 786-1032.

SUPPLEMENTARY INFORMATION:

I. Background--Balanced Budget Act of 1997 and the Medicare+Choice 
Program

    Section 4001 of the Balanced Budget Act (BBA) (Public Law 105-33), 
enacted August 5, 1997, added a new Part C (sections 1851 through 1859) 
to title XVIII of the Social Security Act (the Act), establishing the 
``Medicare+Choice'' (M+C) program. Under Part C, M+C eligible 
individuals (generally individuals with both Part A and Part B coverage 
who do not have End Stage Renal Disease (ESRD) may elect to receive 
their Medicare benefits through private health plans (M+C 
organizations) that choose to contract with HCFA. M+C organizations may 
offer one or more M+C plans of one of three types. Under ``coordinated 
care plans,'' beneficiaries receive benefits through a network of 
providers, as in the case of an health maintenance organization (HMO) 
or preferred provider organization (P.O.). A ``provider sponsored 
organization'' (PSO), which is owned by providers through which it 
provides benefits, and which is the subject of this final rule, 
necessarily offers a coordinated care plan. (See section 1851(a)(2)(A) 
of the Act). Other M+C plan options provided for in Part C, but not yet 
offered by any M+C organization, are private-fee-for service plans and 
medical savings account (MSA) plans (that is, a combination of a high 
deductible, catastrophic insurance plan with a contribution to an M+C 
MSA account). Interim final regulations for the overall implementation 
of the M+C program were published in the Federal Register on June 26, 
1998 (63 FR 34968) and are set forth in part 422 of title 42 of the 
Code of Federal Regulations (CFR). Provisions enacted by the BBA and 
implemented in the interim final M+C regulations establish broad and 
comprehensive requirements for contracting as an M+C organization, 
including basic benefits, payment, access to service, quality 
assurance, beneficiary hold harmless, continuation of benefits, appeals 
mechanisms, marketing, and enrollment processes. These overall M+C 
regulations apply to M+C organizations that are PSOs.
    A PSO is described in section 1855(d) of the Act as a public or 
private entity--
     That is established or organized, and operated, by a 
health care provider or group of affiliated health care providers;
     That provides a substantial proportion of the health care 
items and services directly through the provider or affiliated group of 
providers; and
     With respect to which the affiliated providers share, 
directly or indirectly, substantial financial risk for the provision of 
these items and services and have at least a majority financial 
interest in the entity.
    On April 14, 1998, we published an interim final rule in the 
Federal Register at 63 FR 18124, titled ``Definition of Provider-
Sponsored Organization and Related Requirements'' with an opportunity 
for public comment setting out the PSO definition, clarifying certain 
terms, and establishing related requirements. This PSO definitions rule 
established 42 CFR part 422 and subpart H of that part, dealing with 
PSOs. The terms and requirements related to the definition of a PSO are 
now found at Secs. 422.350 through 422.356. On May 7, 1998, we 
published an interim final rule in the Federal Register at 63 FR 25360 
titled ``Waiver Requirements and Solvency Standards for Provider 
Sponsored Organizations,'' establishing solvency requirements that 
apply to PSOs that obtain a waiver of the M+C State licensure 
requirement and setting forth procedures and standards that apply to 
requests for the waivers. The solvency portion of the interim final PSO 
regulation was based on the work of the PSO negotiated rulemaking 
committee, as required at section 1856(a) of the Act, which provides 
that the Secretary establish through a negotiated rulemaking process 
the solvency standards that entities will be required to meet if they 
obtain a waiver of the otherwise applicable requirement that

[[Page 71674]]

they be licensed by a State. The results of the PSO solvency negotiated 
rulemaking committee are described in the preamble to the interim final 
regulation published on May 7, 1998 (63 FR 25360).
    In this final rule, we focus solely on the solvency standards that 
will apply to PSOs that have obtained a waiver. Other PSO provisions 
will be addressed in the upcoming overall final M+C regulation. We note 
that based on Secs. 422.352(a) and 422.380, State-licensed 
organizations that meet the PSO definition (see Secs. 422.350 through 
422.356) may qualify for the minimum enrollment standards established 
under section 1857(b) of the Act but are not subject to these solvency 
standards.

II. Response to Comments

    The PSO solvency standards are the result of a negotiated 
rulemaking process. The participants in the negotiated rulemaking 
described their agreement on the PSO solvency standards in a Committee 
Statement titled ``Negotiated Rulemaking Committee on PSO Solvency 
Standards'' dated March 5, 1998. Based on these agreed upon PSO 
solvency standards, we published an interim final PSO solvency 
regulation on May 7, 1998 (63 FR 25360). The participants in the 
negotiated rulemaking process agreed not to submit negative comments on 
the interim final rule unless they determined that any provision of the 
interim rule incorrectly reflects the Committee solvency agreement. 
Section 1856(a)(9) of the Act, as amended by the BBA, requires that we 
publish final solvency standards within 1 year of the interim final 
regulations. Accordingly, this final regulation will address only the 
solvency standards for PSOs. Other comments on PSOs (for example, on 
the waiver process and definitions) will be addressed in the final M+C 
regulation due to be published in the fall of 1999.
    We received eight public comments. Seven of the letters were from 
major organizations, and one letter was from a State. The comments we 
received are summarized below along with our responses.
    Comment: We received several comments regarding whether unique 
solvency standards should be established for PSOs operating in rural 
areas. Several commenters discouraged establishing separate solvency 
standards for rural PSOs. One commenter noted that no State has 
separate solvency standards for entities that operate in distinct 
geographic areas. Another commenter stated that developing a successful 
Medicare managed care program is more difficult in a rural area than in 
an urban area in part because enrollment growth is smaller in rural 
areas, making it more difficult to cover fixed administrative costs. 
The commenter was also concerned that it would be difficult to track 
``rural'' and ``nonrural'' PSOs within a State. According to the 
commenter, regulators would have the additional burden of monitoring 
the rural PSOs to determine whether, through growth or other reasons, 
it no longer met the definition of a rural PSO. If the PSO was no 
longer considered rural, there could be a possible disruption of 
services since the PSO would have to recapitalize in order to meet the 
higher solvency requirements for non-rural PSOs. The commenters also 
pointed out that rural PSOs, given less stringent solvency standards, 
would have a more difficult time making the transition from meeting the 
standards required for a Federal waiver to meeting the solvency 
requirements of a State once the 36-month waiver period expires.
    Two commenters suggested that we consider allowing rural PSOs to 
``aggregate'' specifically for purposes of meeting solvency standards 
(Regional PSOs). For example, we could permit rural providers or local 
rural PSOs that band into a regional PSO or rural PSOs that link to 
nonrural PSOs to be considered as one entity for the purpose of 
satisfying the PSO solvency standards. The commenter contended that 
such a regional approach to PSOs is likely to produce greater financial 
stability and greater access to care and would reduce unnecessary 
redundancy of solvency requirements as applied to individual entities 
that comprise the regional plan.
    Another commenter recommended that solvency adjustments for rural 
PSOs be allowed in circumstances under which the commenter believes the 
solvency rules require more financial resources than might be necessary 
for smaller rural PSOs. The commenter suggested that certain solvency 
requirements could be reduced for rural PSOs without placing the PSO in 
financial jeopardy. Specifically, this commenter recommended that we 
have discretion to--(1) selectively allow for reductions in the minimum 
cash and liquidity requirements for rural PSOs; (2) allow for a 
reduction in the insolvency deposit for small and rural PSOs; (3) allow 
the use of irrevocable letters of credit for the insolvency deposit; 
and (4) allow for a reduction in the minimum cash portion of a rural 
PSO's net worth requirement.
    Response: At this time, we will not establish separate solvency 
standards for rural PSOs. We believe that the lack of current rural PSO 
activity makes it difficult to realistically evaluate under what 
circumstances it would be feasible for us to reduce certain solvency 
standards for rural PSOs. We note that the States do not have different 
solvency requirements depending on whether an entity is operating in a 
rural area compared to an urban area. As a commenter noted, PSOs will 
be subject to State standards at the end of the 36-month waiver period. 
In addition, we are concerned about lessening solvency requirements and 
thereby putting beneficiaries at increased risk if the rural PSO 
becomes insolvent.
    With respect to the proposal to allow rural PSOs to band together 
for the purpose of collectively meeting the solvency requirements, we 
are concerned that if more than one of these PSOs becomes insolvent, 
there will not be adequate funds available to protect beneficiaries. We 
believe the possibility of two PSOs becoming insolvent at the same time 
is significant because the PSOs will be operating in the same region. 
Accountability questions would also be raised if we allow organizations 
to combine for the purpose of meeting certain requirements in 
regulations. If several PSOs combine to meet the solvency standards, it 
is not clear whether these combined PSOs would be in noncompliance if 
one of the PSOs experienced financial difficulty. In regard to 
recommendations that we reduce or modify various solvency reserves, we 
believe these changes would be a significant departure from the 
solvency standards carefully worked out during the negotiated 
rulemaking process. For that reason and those cited above, we will not 
selectively reduce the solvency requirements for rural PSOs.
    Comment: A commenter noted that with respect to affiliate 
guarantees, the Solvency Committee agreed that it was up to us to 
determine which entities could provide guarantees. Because of this 
agreement, the commenter believed that it is appropriate to comment on 
this part of the interim final regulation. The commenter recommended 
that the independently audited financial statement provided by a 
guarantor can only be acceptable to us if it consists of unqualified 
opinions from the auditor.
    Response: We will not require that guarantee opinions in audited 
independent financial statements always be unqualified. There may be 
circumstances where a qualification of a financial opinion does not 
significantly affect the conclusions regarding the entity's ability to 
meet the financial solvency standards. Accordingly, we reserve the 
right to accept or reject a

[[Page 71675]]

financial statement depending on the nature and significance of the 
qualification of the opinion.
    Comment: Several commenters requested that we clarify in this 
regulation whether Federal bankruptcy or State receivership law should 
take precedence if a PSO goes bankrupt.
    Response: We recognize the importance of this question. 
Accordingly, we are researching the alternatives regarding the 
appropriate jurisdiction and venue in which to administer a financially 
insolvent PSO. However, resolving the precedence of Federal bankruptcy 
law versus State receivership law is beyond the scope of this 
regulation.
    Comment: Several commenters stated that a current ratio of 1:1 
should be a factor we will use in evaluating the ongoing solvency of a 
PSO but not an absolute requirement as indicated at Sec. 422.386 of the 
interim final rule. Section 422.386(d) of the interim final regulations 
states that if a PSO fails to maintain a current ratio requirement of 
1:1, we will require the PSO to initiate corrective action. The 
commenters pointed out that the Liquidity section of the PSO Solvency 
Committee Statement states that we may require a PSO to initiate 
corrective action if either of the following is evident--(1) the 
current ratio declines significantly, or (2) there is a continued 
downward trend in the current ratio.
    The corrective action may include change in the distribution of 
assets, a reduction of liabilities, or alternative arrangements to 
secure additional funding requirements to restore the current ratio to 
1:1.
    Response: We agree that the Committee Statement indicates that a 
PSO current ratio of 1:1 should be a factor we will use in evaluating 
the solvency of a PSO but not an absolute requirement that will always 
result in corrective action when violated. Accordingly, we will change 
Sec. 422.386(d) in the final regulation to read as follows:

    (d) If HCFA determines that a PSO fails to meet the requirement 
of paragraph (b)(2) of this section, HCFA may require the PSO to 
initiate corrective action to* * *

    Comment: A commenter noted that Sec. 422.382(a) requires that the 
initial net worth requirement be met at ``* * * the time an 
organization applies to contract with us as a PSO.'' The commenter 
recommended that this requirement be changed to require that the 
initial net worth requirement be met at the time the application is 
approved or the contract entered into, rather than on the date the 
application is first submitted. The commenter expressed concern that 
since the application process can take a number of months, the PSO 
might have drawn down its net worth in the intervening months after the 
initial application and may have an inadequate net worth by the time 
the PSO actually enters into the contract with us.
    Response: The Committee Statement on the PSO solvency standards 
specifies that the PSO minimum net worth amount must be met when the 
PSO submits the initial application. The interim final PSO regulations 
at Sec. 422.382 reflect this Committee Statement. We believe it is 
necessary that the net worth requirement be met at the start of the 
application process to ensure that the applicant is financially able to 
enter into a contract with us. We also believe that the ongoing net 
worth requirement will ensure that PSOs have adequate net worth on the 
effective date of the contract.
    Comment: Section 422.382(b) describes the ongoing net worth 
requirement as the greater of four amounts. The fourth amount, set 
forth in Sec. 422.382(b)(4), begins with the statement ``Using the most 
recent annual financial statement filed with HCFA, an amount equal to 
the sum of * * *'' A commenter contended that this language was 
intended to be an adaptation of a similar provision set forth in 
Section 13.A.(2)(d) of the National Association of Insurance 
Commissioners (NAIC) HMO Model Act, requiring that the calculation be 
based ``* * * on the most recent financial statement filed with the 
commissioner * * *'' rather than the most recent annual financial 
statement.
    The commenter noted that while the calculation results in an 
annualized number, the calculation should be based on the most recent 
HCFA filing, which could be a quarterly statement, not an annual 
statement. Accordingly, the commenter requested that the word 
``annual'' be deleted from Sec. 422.382(b)(4) in order to conform to 
the NAIC structure.
    Response: We agree with the commenter that the word ``annual'' 
should be removed from Sec. 422.382(b)(4). This is also consistent with 
the PSO Committee Agreement in which the ongoing minimum net worth 
requirements are specified and verification is through ``* * * the most 
recent financial statement filed with us.'' Accordingly, we will revise 
Sec. 422.382(b)(4) to read as follows:

    Using the most recent financial statement filed with us, an 
amount equal to the sum of * * *

    Comment: A commenter noted that Sec. 422.384(b)(5) requires 
certification of reserves and actuarial liabilities by a ``qualified 
HMO actuary,'' which is not defined (the regulation does define 
``qualified actuary''). The commenter requested clarification of what 
is meant by ``qualified HMO actuary.''
    Response: We agree that the use of the phrase ``qualified HMO 
actuary'' at Sec. 422.384(b)(5) is confusing. Accordingly, we will 
change the reference at Sec. 422.384(b)(5) to read ``qualified 
actuary.'' We are not imposing any requirements on the qualifications 
of an actuary employed by a PSO beyond what is stated in the definition 
of qualified actuary under Sec. 422.350(b).
    Comment: Section 422.382(b)(4) describes the four-tiered minimum 
net worth test that will be applied to a PSO after the effective date 
of its M+C contract. Section 422.382(b)(4)(iii) states that the annual 
health care expenditures that are paid on a capitated basis to 
affiliated providers must not be included in the calculation of net 
worth under paragraphs (a) and (b)(4) of Sec. 422.382. A commenter 
noted that the negotiated rulemaking committee specifically addressed 
this issue and was careful to note that the exclusion set forth in 
paragraph (b)(4)(iii) of Sec. 422.382 would apply regardless of the 
downstream risk arrangements among providers. The commenter recommended 
that this nuance be noted in the text of the regulations.
    Response: We agree as referenced in the Committee Statement that 
the exclusion from the net worth requirement calculation at 
Sec. 422.382(b)(4)(iii) applies regardless of the downstream risk 
arrangements among providers. Accordingly, we will change the 
regulation at Sec. 422.382(b)(4)(iii) by adding the following 
parenthetical clarification:

    Annual health care expenditures that are paid on a capitated 
basis to affiliated providers are not included in the calculation of 
the net worth requirement (regardless of downstream arrangements 
from the affiliated provider) under paragraphs (a) and (b)(4) of 
this section.

    Comment: A commenter recommended that a statement be added to the 
preamble of the final solvency regulation clarifying (1) that funds 
accumulated by a PSO as subordinated liabilities may be disbursed to 
the affiliated providers if they are not needed to satisfy net worth 
requirements during the period for which the funds were held and (2) 
that the PSO has the flexibility to convert those funds to equity or 
debt to benefit the providers.

[[Page 71676]]

    Response: As long as the minimum net worth requirement is 
maintained, any assets including those associated with subordinated 
liabilities may be disbursed as the PSO deems appropriate on the basis 
of sound business judgment. We do not believe any additional 
clarification in the preamble is necessary.
    Comment: Under Sec. 422.386(b)(3), in determining liquidity, we 
evaluate the level of outside financial resources to the PSO. A 
commenter recommended that we change Sec. 422.386(e) to clarify that we 
will require a PSO to obtain funding from alternative financial 
resources under this provision only if there has been a change in the 
availability of outside financial resources available to the PSO. In 
support of its recommendation, the commenter pointed out that the 
language of the Solvency Standards Agreement (under the Part C 
Liquidity requirements) reads, ``If there is a change in the 
availability of the outside resources, we will require the PSO to 
obtain funding from alternative financial resources.''
    Response: We agree with this comment. Section 422.386(b)(3) 
provides that, in monitoring liquidity, we will examine the 
``availability of outside financial resources to the PSO.'' We will 
change Sec. 422.386(e) to read as follows:

    If HCFA determines that there has been a change in the 
availability of outside financial resources as required by paragraph 
(b)(3) of this section, HCFA requires the PSO to obtain funding from 
alternative financial resources.

    Comment: Under Sec. 422.390(d)(2)(ii), a guarantor must agree to 
not subordinate the PSO guarantee to any other claim on its resources. 
A commenter contended that in a typical PSO scenario, a tax-exempt 
hospital or health system may provide the guarantee to the PSO. In this 
case, the commenter believes it is likely that the hospital or health 
system has tax-exempt bonds in place that contain certain covenants 
with respect to the use and disposition of assets, including a pledge 
of revenues. Under most circumstances and bond documents, it would not 
be problematic in the commenter's view to satisfy the requirements at 
Sec. 422.390(d)(2)(ii). However, the commenter believes that if a PSO 
were able to demonstrate that this requirement was unduly and 
substantially burdensome to the guarantor, we should have the authority 
to consider the specific facts and circumstances and sufficient 
discretion to modify this requirement.
    Response: Section 422.390(a) of the Medicare+Choice regulations 
explicitly states that we have the discretion to approve or deny 
approval of the use of a guarantor. We believe this authority generally 
allows us to exercise discretion in the approval or modification of a 
guarantor agreement. We do not believe further clarification of this 
authority in the regulations is necessary.
    Comment: One commenter expressed concerns that the requirement that 
the guarantor have a net worth of three times the amount of the 
guarantee may not always be adequate. The commenter noted that this 
amount may be adequate for some companies, but it may be a very slender 
margin. As an alternative approach, the commenter suggested that 
perhaps the net worth of a guarantor be determined as a percentage of 
assets or related to total liabilities in some fashion.
    Response: While we agree with the commenter's concern that the 
guarantor having a net worth of three times the amount of the guarantee 
may not always be adequate, we do not believe it is necessary to change 
the regulation to address this concern. Section 422.390(a) explicitly 
states that we have the discretion to approve or deny approval of the 
use of a guarantor. We believe this authority generally allows us to 
exercise discretion in determining the net worth to be required of a 
particular guarantor that could be based on alternative approaches like 
those suggested by the commenter.
    Comment: Section 422.384(e)(i) provides that guarantees will be an 
acceptable resource to fund projected losses of a PSO provided that, 
before the effective date of the PSO's M+C contract, the PSO obtains 
from the guarantor cash or cash equivalents to fund the amount of 
projected losses for the first two quarters. A commenter noted that the 
preamble to the interim final rule stated that funding for the first 
two quarters will need to be in the PSO ``at least (45) days before the 
effective date of the contract''. The commenter recommended that, 
rather than enforcing a uniform 45-day requirement, we exercise 
discretion consistent with the current language of Sec. 422.384(e)(i). 
The commenter maintained that under certain circumstances the 45-day 
requirement could prove to be unduly burdensome and we have sufficient 
discretion to ensure that the guarantee amounts are sufficiently 
prefunded for the first quarter of operation under the contract.
    Response: The preamble of the May 7, 1998 interim final rule (63 FR 
25370) calls for organizations to have assets to fund the first two 
quarters of projected losses on their balance sheets 45 days before the 
effective date of the contract. However, this 45-day time period is a 
guideline to ensure that there is adequate time before the contract 
date for us to update necessary data systems. If a PSO is unable to 
have this funding in place 45 days before the contract effective date, 
this may result in a delay in the implementation of the contract.

III. Provisions of the Final Rule

    We have agreed to the following changes in regulations text in 
response to comments on the interim final rule: Each change is based on 
a commenter establishing that the interim final regulation was not 
consistent with the agreement developed through the solvency negotiated 
rulemaking process.
     We have revised Sec. 422.382(b)(4), which states that the 
ongoing net worth requirement be evaluated based on the most recent 
financial statement filed with us and not restricted to the most recent 
``annual'' financial statement.
     We have accepted a comment to clarify in the final 
regulation that the exclusion from the net worth requirement 
calculation at Sec. 422.382(b)(4)(iii) applies regardless of the 
downstream risk arrangements among providers.
     We have clarified that we are not imposing any requirement 
on the qualification of an actuary employed by a PSO beyond what is 
stated in the definition of a qualified actuary at Sec. 422.384.
     We have changed Sec. 422.386(d) to state that the PSO 
current ratio will be a factor we will use in evaluating the solvency 
of a PSO but not an absolute requirement that will always result in 
corrective action being imposed by us when violated.
     We have accepted a comment to change Sec. 422.386(e) to 
make it clear that we will require a PSO to obtain funding from 
alternative financial resources if there is a change in the 
availability of outside financial resources available to the PSO.

IV. Regulatory Impact Analysis

A. Introduction

    We have examined the impact of this final rule as required by 
Executive Order 12866, the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4), and the Regulatory Flexibility Act (RFA) (Public Law 96-
354). Executive Order 12866 directs agencies to assess all 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

[[Page 71677]]

effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more annually). The Regulatory 
Flexibility Act (RFA) requires agencies to analyze options for 
regulatory relief for small businesses, unless we certify that the 
regulation will not have a significant economic impact on a substantial 
number of small entities. Most hospitals, and most other providers, 
physicians, and health care suppliers, are small entities either by 
nonprofit status or by having revenues of less than $5 million 
annually. The impact of this regulation will be to create a new 
business opportunity for these small entities to form provider-
sponsored organizations to contract with the Medicare program.
    Section 1102(b) of the Act requires us to prepare a regulatory 
impact analysis if a final rule may have a significant impact on the 
operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 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 a Metropolitan 
Statistical Area and has fewer than 50 beds. We are not preparing an 
analysis for section 1102(b) of the Act because we have determined, and 
we certify, that this final rule will not have a significant impact on 
the operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in an expenditure in any one year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $100 million. This final rule does not mandate any 
requirements for State, local, or tribal governments. Therefore, we 
have not prepared an assessment of anticipated costs and benefits of 
this final rule.
    Because of the probability that these solvency standards may have 
an impact on certain hospitals, physicians, health plans, and other 
providers we prepared the following analysis which constitutes both a 
regulatory impact analysis and a regulatory flexibility analysis.

B. Background

    While the term ``provider-sponsored organization'' has been used 
generally in reference to health care delivery systems that providers 
own or control and operate, the term has a more specific meaning for 
purposes of the M+C program. Accordingly, we defined, by regulation, 
the fundamental organizational requirements for entities seeking to be 
PSOs. These definitions are set forth at Sec. 422.350. Organizations 
that meet these definitional requirements can apply for a Federal 
waiver and an M+C contract. Having defined the term PSO and the waiver 
process in earlier regulations, the purpose of this final rule is to 
finalize the interim standards for financial solvency to which these 
Federally waived organizations must adhere.
    The solvency standards only affect organizations that have received 
a Federal waiver and are either applying for or actually have received 
an M+C contract. It is likely that waiver activity will be greater in 
States that have solvency standards that differ significantly from the 
standards developed in this regulation. Below we consider the 
anticipated impact of this rule.

C. Anticipated Effects

1. Effects on Providers
    This final regulation establishes solvency standards for PSOs that 
have an approved waiver and are applying for a Medicare PSO contract. 
These solvency requirements are designed to ensure that provider groups 
have the necessary financial resources to participate in the M+C 
program. In addition, the regulations are intended to ensure the 
ongoing solvency of PSOs and to protect enrolled beneficiaries if an 
insolvency occurs. Through the negotiated rulemaking process and our 
own deliberations, we have carefully balanced the PSO solvency 
requirements to ensure that we are not imposing unreasonable financial 
barriers to the participation of provider groups in the M+C program. We 
believe that these solvency requirements will make it easier for 
provider groups to participate in the M+C program.
2. Effects on the Market Place
    Since solvency standards vary by State, and State standards are 
evolving, it is difficult to assess the relative effect of these 
solvency standards. However, with several key exceptions (for example, 
a different initial minimum net worth requirement and a lower 
insolvency deposit), these solvency standards track the HMO Model Act. 
Therefore, we do not believe there will be a significant impact due to 
the existence of an unlevel playing field between PSOs and other 
entities. We believe that establishing standards of financial solvency 
is necessary to ensure that PSOs have the financial resources to 
provide adequate quality care and to reduce the possibility of 
disrupting beneficiary care.
3. Effects on States
    For PSOs that obtain a Federal waiver, responsibility for 
monitoring their financial solvency will be transferred from the States 
to us. This a temporary reduction, since waivers last only 36 months 
and the Secretary's authority to grant waivers ends on November 1, 
2002. By the end of a PSO's waiver, it will need a State license in 
order to continue its M+C contract. Therefore, to ease the transition 
from a Federal waiver to a State license, we encourage PSOs to 
establish a relationship with regulators in their respective States 
soon after receiving a waiver.
4. Effects on Beneficiaries
    We expect that the advent of PSOs and M+C in general will have the 
effect of further mainstreaming managed care plans among Medicare 
enrollees. We do not anticipate an increase in the potential for 
service interruptions because these new PSOs will be subject to the 
same beneficiary hold-harmless provisions and continuation of benefits 
requirements as all M+C organizations. Lastly, section 1855(a)(2)(G) of 
the Act requires PSOs to comply with all existing State consumer 
protection and quality standards as if the PSO were licensed under 
State law.

D. Effects on the Medicare Program

    We assume that PSOs will be more prone to favorable selection than 
other coordinated care plans since the providers in the PSO will, in 
many cases, know their patients. This may increase the level of 
favorable selection for the M+C program and could result in increased 
costs for the Medicare program. However, since PSOs are expected to 
make up a very small part of the M+C program, for the foreseeable 
future any PSO favorable selection will have a minimal dollar impact on 
the Medicare program.
    We expect a greater insolvency rate from the PSOs than from the 
current coordinated care plans because PSOs generally have less 
business experience and they are smaller. Despite the insolvency rules 
including hold harmless, Medicare can lose money when there is an 
insolvency. This is particularly true when insolvency is imminent and 
providers therefore defer nonemergency procedures to the next month. 
Medicare may have to pick up the costs, especially if the beneficiary 
elects fee-or-service. However, as noted above, given the small number 
of PSOs participating in the M+C program, the

[[Page 71678]]

expected cost of insolvencies for the Medicare program is low.

E. Alternatives Considered

    As previously discussed, the PSO solvency standards were developed 
through a formal negotiated rulemaking process. During the negotiated 
rulemaking, a number of alternatives were considered in the process of 
developing a consensus regarding the PSO solvency regulations. Please 
refer to the interim final PSO solvency regulation published in the 
Federal Register on May 7, 1998 for details on the negotiated 
rulemaking process including the solvency alternatives considered.

F. Conclusion

    We conclude that this regulation will have an indeterminable impact 
on small health service providers. The provisions of this final rule 
are expected to be favorable for the managed care community as a whole, 
as well as for the beneficiaries that they serve. We have also 
determined, and the Secretary certifies, that this final rule will not 
result in a significant economic impact on a substantial number of 
small entities and will not have a significant impact on the operations 
of a substantial number of rural hospitals.
    In accordance with the provisions of Executive order 12866, this 
regulation was reviewed by the Office of Management and Budget.

G. Federalism

    Executive Order 13132, Federalism, establishes certain requirements 
that an agency must meet when it promulgates regulations that impose 
substantial direct compliance costs on State and local governments, 
preempt State law, or otherwise have Federalism implications.
    In this final rule, we focus solely on the solvency standards that 
apply to PSOs that have obtained a waiver from State licensure 
requirements. The PSO waiver provisions that describe the process by 
which a PSO obtains a waiver from HCFA of State licensure requirements 
will be addressed in the final M+C regulation expected to be published 
in the first quarter of 2000.
    The solvency portion of the PSO regulation in this final regulation 
is based on the work of the PSO negotiated rulemaking committee, as 
required at section 1856(a) of the Act, which provides that we 
establish through a negotiated rulemaking the solvency standards that 
entities will be required to meet if they obtain a waiver of the 
otherwise applicable requirement that they be licensed by a State. The 
negotiated rulemaking process and participants are discussed in the 
preamble to the interim final waiver and solvency regulations published 
in the Federal Register on May 7, 1998 (63 FR 25364). Among the 
participants in the negotiated rulemaking were the National Association 
of Insurance Commissioners, which is the organization of the chief 
insurance regulators from the 50 States, the District of Columbia, and 
four U.S. territories. This final solvency regulation is consistent 
with the solvency standards agreed upon by all participants in the 
negotiated rulemaking process, which, as noted, included the NAIC. We 
received no comments on the interim final waiver and solvency 
regulation and made no determinations that materially altered the PSO 
solvency standards agreed upon in the negotiated rulemaking. It is also 
notable that with limited exceptions these solvency standards track 
those in the HMO model act which are the model solvency standards 
developed by all of the States through the NAIC. Accordingly, we 
believe this final regulation meets Federalism requirements because we 
have consulted with the appropriate State officials who are in 
agreement with these solvency standards.

List of Subjects in 42 CFR Part 422

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

    For the reasons set forth in the preamble, 42 CFR Chapter IV, part 
422, is amended as follows:

PART 422--MEDICARE--CHOICE PROGRAM

    1. The authority citation for part 422 continues to read as 
follows:

    Authority: Secs. 1851 and 1855 of the Social Security Act.

Subpart H--Provider-Sponsored Organization

    2. In Sec. 422.382, the introductory text to paragraph (b) is 
republished, and the introductory text to paragraph (b)(4) and 
paragraph (b)(4)(iii) are revised to read as follows:


Sec. 422.382  Minimum net worth amount.

* * * * *
    (b) After the effective date of a PSO's M+C contract, a PSO must 
maintain a minimum net worth amount equal to the greater of--
* * * * *
    (4) Using the most recent financial statement filed with HCFA, an 
amount equal to the sum of--
* * * * *
    (iii) Annual health care expenditures that are paid on a capitated 
basis to affiliated providers are not included in the calculation of 
the net worth requirement (regardless of downstream arrangements from 
the affiliated provider) under paragraphs (a) and (b)(4) of this 
section.
* * * * *


Sec. 422.384  [Amended]

    3. In Sec. 422.384, in paragraph (b)(5), the phrase ``qualified 
health maintenance organization actuary'' is removed and the phrase 
``qualified actuary'' is added in its place.
    4. In Sec. 422.386, the introductory text to paragraph (d) and 
paragraph (e) are revised to read as follows:


Sec. 422.386  Liquidity.

* * * * *
    (d) If HCFA determines that a PSO fails to meet the requirement of 
paragraph (b)(2) of this section, HCFA may require the PSO to initiate 
corrective action to--
* * * * *
    (e) If HCFA determines that there has been a change in the 
availability of outside financial resources as required by paragraph 
(b)(3) of this section, HCFA requires the PSO to obtain funding from 
alternative financial resources.

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

    Dated: August 3, 1999.
Michael M. Hash,
Deputy Administrator, Health Care Financing Administration.
    Approved: August 16, 1999.
Donna E. Shalala,
Secretary.
[FR Doc. 99-32939 Filed 12-21-99; 8:45 am]
BILLING CODE 4120-01-P