Establishment of Revisit User Fee Program for Medicare Survey and Certification Activities, 53628-53649 [E7-18458]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 181 (Wednesday, September 19, 2007)]
[Rules and Regulations]
[Pages 53628-53649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18458]



[[Page 53627]]

-----------------------------------------------------------------------

Part II





Department of Health and Human Services





-----------------------------------------------------------------------



Centers for Medicare & Medicaid Services



-----------------------------------------------------------------------



42 CFR Parts 424, 488, and 489



Establishment of Revisit User Fee Program for Medicare Survey and 
Certification Activities; Final Rule

Federal Register / Vol. 72, No. 181 / Wednesday, September 19, 2007 / 
Rules and Regulations

[[Page 53628]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 424, 488, and 489

[CMS-2268-F]
RIN 0938-AO96


Establishment of Revisit User Fee Program for Medicare Survey and 
Certification Activities

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

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule will establish a system of revisit user fees 
applicable to health care facilities that have been cited for 
deficiencies during initial certification, recertification, or 
substantiated complaint surveys and require a revisit to confirm that 
corrections to previously-identified deficiencies have been remedied. 
Consistent with the President's long-term goal to promote quality of 
health care and to cut the deficit in half by fiscal year (FY) 2009, 
the FY 2007 Department of Health and Human Services' (HHS) budget 
request included both new mandatory savings proposals and a requirement 
that user fees be applied to health care providers that have failed to 
comply with Federal quality of care requirements. The ``Revisit User 
Fees'' will affect only those providers or suppliers for which a 
revisit is required to confirm that previously-identified failures to 
meet federal quality of care requirements have been remedied. The fees 
are estimated at $37.3 million annually and will recover the costs 
associated with the Medicare Survey and Certification program's revisit 
surveys. The fees will take effect on the date of publication of the 
final rule and will be in effect until the date that the continued 
authority provided by Congress expires. At the time of publication of 
this regulation the applicable date is September 30, 2007. If no 
legislation is enacted, the fees are not retroactive to the beginning 
of the fiscal year. Any provider or supplier that has a revisit survey 
conducted on or after the date of publication will be assessed a 
revisit user fee and will be notified of the assessment upon data 
system reconciliation which can occur following the closing of the 
fiscal year. The fees will be available to CMS until expended. The 
revisit user fee is included in the President's proposed FY 2008 
budget. We note through the publication of this final rule that if 
authority for the revisit user fee is continued, we will use the 
current fee schedule in this rule for the assessment of such fees until 
such time as a new fee schedule notice is proposed and published in 
final form.

DATES: Effective Date: These regulations are effective on September 19, 
2007.

FOR FURTHER INFORMATION CONTACT: Carla McGregor, (410) 786-0663

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

A. Overview

    In the June 29, 2007 Federal Register (72 FR 35673), we published 
the proposed rule entitled, ``Establishment of Revisit User Fee Program 
for Medicare Survey and Certification Activities'' and provided for a 
60 day comment period. This rule sets forth final requirements and the 
final Fee Schedule for providers and suppliers who require a revisit 
survey as a result of deficiencies cited during an initial 
certification, recertification, or substantiated complaint survey.
    The Centers for Medicare & Medicaid Services (CMS) has in place an 
outcome-oriented survey process that is designed to determine whether 
existing Medicare-certified providers and suppliers or providers and 
suppliers seeking initial Medicare certification are actually meeting 
statutory and regulatory requirements, conditions of participation, or 
conditions for coverage. These health and safety requirements apply to 
the environments of care and the delivery of services to residents or 
patients served by these facilities and agencies. The Secretary of the 
Department of Health and Human Services (``HHS'') has designated CMS to 
enforce the conditions of participation/coverage and other requirements 
with these programs. The revisit user fee will be assessed for revisits 
conducted in order to determine whether deficiencies cited as a result 
of carrying out CMS's survey process obligations have been corrected.

B. Requirements for Issuance of Regulations

    Section 20615(b) of The Continuing Appropriations Resolution 
(``Continuing Resolution'') budget bill passed by the Congress and 
signed by the President directed HHS to implement the revisit user fees 
in FY 2007. Section 20615(b) states as follows:

    The Secretary of Health and Human Services shall charge fees 
necessary to cover the costs incurred under `Department of Health 
and Human Services, Centers for Medicare and Medicaid Services, 
Program Management' for conducting revisit surveys on health care 
facilities cited for deficiencies during initial certification, 
recertification, or substantiated complaints surveys. Not 
withstanding section 3302 of title 31, United States Code, receipts 
from such fees shall be credited to such account as offsetting 
collections, to remain available until expended for conducting such 
surveys (Pub. L. 110-5, H.J.Res.20, Sec.  20615(b)(2007)).

    As directed by the Secretary, in the June 29, 2007 Federal Register 
(72 FR 35673), CMS established revisit user fees for revisit surveys 
and put forth in regulation the definitions, criteria for determining 
the fee, the fee schedule, collection of fees, reconsideration process 
for revisit user fees, enforcement and regulatory language addressing 
enrollment and billing privileges, and provider agreements. In the 
proposed rule, cost projections were based on FY 2006 actual data and 
were expected to amount to $37.3 million on an annual basis. These 
calculations were included in section IV Regulatory Impact Analysis in 
the proposed rule (72 FR 35678).
    The fees will take effect on the date of publication of the final 
rule and will be in effect until the date that the authority provided 
by the Congress expires. At the time of publication of this regulation 
the applicable date is September 30, 2007. As discussed thoroughly in 
the proposed rule, based on the Congress' knowledge of section 1864(e) 
of the Social Security Act and already established survey and 
certification activities, the unambiguous nature of section 20615(b) of 
the Continuing Resolution, and the principles of lex posterior derogate 
legi priori or ``last-in-time'' rule, the Secretary has the authority 
to implement this revisit user fee and establish a final fee schedule. 
See 72 FR 35674-35675 (discussing section 1864(e) of the Social 
Security Act).

II. Summary of the Proposed Provisions and Response to Comments

    In the June 29, 2007 Federal Register (72 FR 35673), we published 
the proposed rule entitled, ``Establishment of Revisit User Fee Program 
for Medicare Survey and Certification Activities'' and provided for a 
60 day comment period.
    We received a total of 74 comments from various providers, 
suppliers, health care associations, and individual health care 
professionals and other individuals. The comments ranged from general 
support of the survey process or general opposition to the proposed 
provisions to very specific questions or comments regarding the 
proposed new revisit user fee.

[[Page 53629]]

    Brief summaries of each proposed provision, a summary of the public 
comments we received and our responses to the comments are set forth 
below. Comments related to the paperwork burden and the impact analyses 
are addressed in the Collection of Information and the Regulatory 
Impact Analysis sections in this preamble.

General Comments

1. Time Period for Levying Fees
    Comment: Several commenters suggested that CMS should not allow 
user fees for nursing home revisits beyond the end of the fiscal year. 
The commenters believe that nursing homes bear the brunt of the overall 
survey process because surveys are conducted annually for nursing homes 
and as such CMS should ensure that the fee is not renewed.
    Response: The President's HHS budget for FY 2007, as enacted by the 
Congress, directs the HHS Secretary to implement the revisit user fees 
during FY 2007. Since the provisions for the revisit user fee were put 
forth through the annual appropriations process, continuation of the 
fees under this regulation beyond September 30, 2007 will depend on 
Congressional renewal or extension of the time period under which fees 
may be assessed. While nursing homes have the most frequent surveys, 
they also have the largest number of revisits. Revisits in nursing 
homes represent the largest single source revisit costs. While there 
would be cost to some--but not all--nursing homes as a result of the 
revisit fees, nursing homes also benefit from being able to reassure 
prospective nursing home residents and their families that the nursing 
home is federally certified and that there is an objective and 
independent system of oversight to assure quality. The revisit survey 
is an essential element of that quality assurance system. We also note 
that the revisit fees are not restricted to nursing homes, but apply to 
almost all providers and suppliers that require a revisit to confirm 
that identified deficiencies are remedied.
2. Authority to Assess a Revisit User Fee
    Comment: A few commenters expressed concern that revisit fees would 
be imposed when the authority granted to levy fees expires on September 
30, 2007 and that there does not appear to be legislation pending that 
would extend CMS' authority to impose these fees beyond FY 2007. One 
commenter stated that if the Congress does not extend this authority, 
then it appears that this rule will be void. Another commenter 
disagrees with CMS interpretation of section 1864(e) of the Social 
Security Act (the Act) as giving HHS the ``authority to assess revisit 
user fees.'' The commenter felt that clearly the inclusion and specific 
wording in this section within the Act indicates Congress intended that 
the Secretary ``may not impose'' any fee on any facility for any survey 
(revisit or otherwise) for determining compliance ``with any 
requirement of this title.''
    Response: We are frequently expected to implement legislation that 
is promulgated by the Congress and therefore has the force of law, as 
in the passed FY 2007 appropriations bill. We strive to implement the 
provisions in an efficient and effective manner once it becomes law. 
The commenter is correct that the current authority to impose the 
revisit user fee expires for revisits occurring after September 30, 
2007, unless otherwise authorized via legislation or through the FY 
2008 appropriations bill, as examples. The revisit user fee is included 
in the President's proposed FY 2008 budget. We acknowledge the 
commenter's disagreement with the Congress' intent as it relates to 
authority to impose any fee based on the Social Security Act. However, 
as we discussed in the Proposed Rule, we believe that Congress intended 
to give the Secretary authority to implement this revisit user fee 
program when Congress enacted section 20615(b) of the Continuing 
Resolution.
3. ``Good Performers Versus Poor Performers''
    Comment: Several commenters believed that those nursing homes 
considered to be providing excellent care would be required to pay a 
revisit user fee along with nursing homes that are considered poor 
performers. The commenters believe that even minor infractions 
uncovered during an annual survey for these higher quality nursing 
homes would still lead to the imposition of a revisit user fee. A 
commenter questioned whether or not those facilities going above and 
beyond to provide higher level care through higher costs of operations 
should be subjected to this user fee in the same manner as those 
facilities that are performing at the bare minimum requirements with 
lower costs of operations if the goal is to promote a better health 
care environment.
    Response: We believe that many nursing homes will pay no revisit 
user fees because they consistently provide high quality care, have no 
deficiencies identified through the survey process, and therefore will 
require no revisits. Other nursing homes may require some revisits but 
with minimal costs because the deficiencies are not serious, and the 
revisit may be accomplished through an offsite survey. We have 
established a much lower fee for offsite surveys since actual costs to 
the survey program for these revisit surveys are much less than the 
costs for onsite surveys, and the user fee is intended only to recoup 
average actual costs. We believe we have designed the user fee program 
to result in a positive correlation between quality of care and amount 
of the fees--the better the quality of care, the lower the fees. We 
also expect that the prospect of fees for revisits will promote greater 
compliance with federal quality of care requirements, thereby making 
for fewer revisits and fewer fees over time.
4. Revisit User Fee Compared to Penalty
    Comment: Several commenters believe the revisit user fee 
constitutes a penalty regardless of whether cited deficiencies are 
appealed and overturned. They also stated that the revisit user fee 
imposed additional penalties that may be assessed.
    Response: The revisit user fee does have some similarities to a 
quality of care penalty in so far as the revisit user fee only applies 
to providers or suppliers for which deficiencies have been identified. 
There are differences, however, between the revisit user fee and 
traditional penalties. For example, a traditional penalty, such as a 
civil monetary penalty, is assessed according to the scope and severity 
of individual deficiencies that have been identified. A penalty amount 
would be independent of the cost for the time required by surveyors to 
revisit the provider in order to confirm that corrections have been 
made. In contrast, the revisit user fee is designed only to replace the 
average actual cost associated with the revisits themselves. Second, 
currently only nursing homes are subject to civil monetary penalties; 
no other Medicare-certified providers or suppliers affected by this 
regulation are subject to CMS CMPs for quality of care deficiencies at 
this time. Among nursing homes, only approximately 12 percent of 
nursing homes are levied a CMP in any particular year, on average. If a 
revisit survey is required, a user fee will be assessed; however this 
does not necessarily mean a CMP will be levied as well.
5. Revisit User Fee Compared to Taxes
    Comment: One commenter stated that the revisit user fee amounted to 
a new tax. Another commenter felt that the revisit user fee was an 
example of extortion and that the funding to

[[Page 53630]]

administer the survey process including revisits is already in place. 
They equated this fee to have the same effect as if the IRS was to 
impose a fee when the individual's tax return is flagged for an audit. 
A commenter felt the fee would amount to financial impropriety on the 
part of the government.
    Response: We believe that the commenter's characterization of the 
revisit user fee as a ``tax'' is not accurate. Taxes are typically 
imposed regardless of whether the taxed parties actually use the 
services that the tax makes possible. Taxes must be paid regardless of 
the extent of government services that are accessed. In contrast, the 
revisit user fee will be levied only for those who fail to comply fully 
with their responsibilities to provide quality care and to abide by 
federal quality of care and related requirements under the Medicare 
Provider Agreement and applicable regulations and laws for providers 
and suppliers. Such failure obliges CMS to incur revisit survey costs 
that would not otherwise have been incurred. The revisit user fee 
amount is calibrated to match the additional resources required, on 
average, for the surveyors to verify compliance with known federal 
requirements subsequent to the provider's or supplier's initial failure 
to meet those requirements fully.
6. Effects on Resident or Patient Care
    Comment: Several commenters raised concern that the assessment and 
payment of the user fee would remove several thousand dollars per 
facility that otherwise would be available for resident care. Another 
commenter felt the ethics of this proposal would adversely affect the 
citizens of a State. The commenter felt that the revisit user fee was 
unfair. Other commenters stated, in various ways, that the revisit user 
fee would remove valuable resources that would otherwise be expended 
for patient and employee resources. They felt that a direct drawdown 
from funds used for patient care would occur, resulting in no 
improvement to the quality of resident care. Finally, they felt that 
there would be a direct adverse fiscal impact on smaller more 
financially challenged facilities.
    Response: CMS believes the providers and suppliers are the 
controlling agents in managing the quality of care of services provided 
in their healthcare facilities. Providers and suppliers may avoid 
revisit fees by ensuring sustained compliance with federal quality of 
care requirements. The revisit user fees simply compensate for the 
costs of confirming that previously-identified problems have been 
remedied. The certainty that a revisit will occur is a substantial 
incentive for a provider to make the necessary corrections; therefore, 
we believe that this quality assurance function will improve care and 
safety for Medicare beneficiaries. In addition, we believe the 
imposition of revisit user fees will likely encourage a sustained 
commitment to management systems that improve quality of care provided 
to all clients served by the provider. CMS does not believe that the 
revisit user fee should harm quality of care provided, but can instead 
become a valuable, additional incentive to encourage providers and 
suppliers to commit to sustained compliance with federal quality of 
care requirements. The quality of care message is that providers and 
suppliers will have no user fees when quality of care meets the 
appropriate federal standards. To the extent that there are 
deficiencies, providers and suppliers will have only small fees to the 
extent that the deficiencies are not serious or widespread. If quality 
problems do occur, providers and suppliers will have greater incentives 
to ensure that quality lapses are corrected more quickly than in the 
past, since the revisit fees will be less if only one revisit is 
required.
7. State Practices and Incentives for Revisits
    Comment: Several commenters expressed a concern that State survey 
teams would be instructed to find more violations if a revisit user fee 
were in place, thus increasing the number of revisit surveys. One 
commenter also raised the concern that the facility will have to pay a 
revisit user fee for a revisit survey although the State may not 
consider the deficiency severe. Another commenter raised concern that 
there would be tremendous potential for abuse, that surveyors lacked 
experience and that there existed too much financial control of the 
facilities in the hand of the state surveyors. This commenter also 
expressed concern as to whether there would be adequate monitoring of 
State agencies for potential abuse of this program. Two commenters 
believed the fee would increase the number of revisits currently being 
done, putting an extra burden on staff as well as required additional 
time for State surveyors. One commenter felt that the nursing home 
revisits would increase to 100 percent because of what they consider a 
financial incentive.
    Response: We agree that any potential conflict of interest, and any 
appearance of conflict of interest, must be addressed in the design and 
operation of any user fee program. A number of safeguards will prevent 
any such potential conflict from becoming a serious reality. First, the 
revisit user fees will be collected nationally by CMS through a 
contractor rather than by individual States. CMS makes allocations to 
States based on the effects of inflation and on overall survey and 
certification workload and performance for all survey and certification 
functions, with revisits comprising just one of many functions. The 
national survey and certification budget may not exceed the level 
established by Congress, regardless of the level of revisit fee 
collections. Second, all States must conduct revisits according to 
policies and procedures established by CMS. Those policies and 
procedures are publicly available in CMS' State Operations Manual (SOM) 
and in numbered Survey & Certifications policy memoranda published on 
the CMS Web site. Such policies and procedures define the circumstances 
under which revisit surveys, both onsite and offsite, occur and when 
they do not occur. CMS Regional Offices monitor State implementation of 
the policies and procedures. We intend to increase CMS monitoring for 
revisits. Third, States incur substantial costs in order to conduct 
revisits. Such costs are not lightly undertaken, since there are 
formidable natural and governmental constraints on a State survey 
agency's ability to make use of any added funds that might conceivably 
become available even if there were a direct fiscal connection between 
revisits and the amount of money the State survey agency were to 
receive. The single largest cost to a State survey agency, for example, 
is personnel. The ability of a State survey agency to hire new staff 
(even when new revenue becomes available) is either very limited or 
there is a long delay between the availability of such funds and the 
hiring of a surveyor. Once hired, the surveyor must typically undergo 
about six months of training and observing before being entrusted to 
conduct surveys. These constraints make it unlikely that a State survey 
agency would incur the upfront staffing costs of conducting revisits 
that were not required, or would seek to identify more deficiencies 
simply to justify a revisit and hope that at some vague future date the 
added costs might be recognized by CMS. To the extent that the revisit 
user fee does create any type of new incentive, we expect that the main 
incentive will be for providers and suppliers to maintain compliance 
with federal quality of care and safety requirements, since such 
compliance offers a clear pathway to the avoidance of revisit fees.

[[Page 53631]]

    Comment: One commenter stated that the proposed rule would increase 
fees for facilities that had follow-up for routine licensure/
certification surveys as well as complaint visits.
    Response: Revisit user fees will apply only to surveys that occur 
after an initial certification, recertification, or substantiated 
complaint survey has identified deficiencies. State licensures issues 
that a State survey agency might address during a survey or a revisit 
survey are separate activities not connected with the assessment of a 
revisit user fee. Surveyor time spent on State-only issues must also be 
cost-accounted for by State survey agencies to ensure that such costs 
are not billed to the federal government. Thus, a survey or revisit 
survey based solely on State licensure requirements would not create 
the assessment of a revisit user fee. Only the need to conduct revisit 
surveys regarding Federal conditions of participation, requirements, or 
conditions for coverage would trigger a revisit user fee.
    Comment: One commenter observed that State and federal regulations 
require nursing facilities to report allegations of abuse and other 
issues to the State survey agency. The commenter expressed concern that 
such mandatory reports will result in a visit from the Survey Agency 
inspectors, usually without any finding of regulatory deficiencies. The 
financial impact of the proposal could be very burdensome for many 
nursing facilities.
    Response: An initial visit to investigate a complaint, such as the 
allegation of abuse and or neglect mentioned by the commenter would not 
trigger a revisit user fee. A revisit would be required only if a 
deficiency is identified as a result of that complaint investigation. 
The user fee would not apply to the initial complaint investigation; it 
would apply only to the revisit once the provider has alleged to the 
State survey agency that it has addressed the deficiency identified in 
the original complaint investigation. Complaint investigations that 
find no deficiencies will not require any revisits and will therefore 
not occasion any revisit fees.
8. Revenue Seeking--Government Responsible for Funding Survey Process
    Comments: Several commenters felt that this proposed rule and the 
assessment of revisit user fees was a revenue seeking mechanism, that 
it was a way to fund and pay for the survey process. Many of these same 
commenters felt that the obligation of the survey process and the 
conducting of revisit surveys was that of the Federal government, and 
or the State Health Departments. The government has mandated these 
surveys and as such the quality assurance checks are its obligation. 
One commenter felt that the Federal government's role is to raise these 
funds, as been often done through Federal taxes, although not 
advocating a Federal tax increase, it is through these like efforts the 
commenter suggested that funds should be derived to pay for the survey 
process.
    Response: The revisit user fee is designed simply to pay for actual 
costs of conducting revisits, on average, rather than as a revenue 
generating instrument that might be unconnected with the government 
activity for which the revisit user fee is assessed. In addition, the 
revisit user fees offer the ancillary benefit of encouraging providers 
and suppliers to commit to sustained compliance with Federal quality of 
care requirements and ensure that quality lapses are remedied quickly.
9. Creating Positive Incentives
    Comment: Although some commenters felt the revisit user fee was 
punitive in nature and not proactive, several commenters did support 
added incentives to increase patient and resident safety, quality of 
care, and compliance to standards. A couple of commenters went on to 
state that a positive incentive would serve to strengthen the 
relationship between regulators and providers and would establish CMS 
as a partner rather than an adversary of the long-term care community. 
A few commenters indicated strong support of the Medicare survey 
process as one method to assure only providers and suppliers that offer 
high quality services participate in the Medicare program. One 
commenter went as far as offering three goals for which the collected 
user fees should be directed, which included improving consistency of 
the survey process, ensuring complete, provider-specific training for 
surveyors, and improving communication between State survey agencies 
and the provider community on survey rules and expectations. This 
commenter went on to state that fees derived for these survey program 
improvements should not be used to merely supplant the normal funding 
stream but dedicated to specific programs.
    Response: The intent of the revisit user fee program is to recover 
the costs associated with conducting follow-up visits for deficiencies 
cited during initial certification, recertification, and substantiated 
complaint surveys. Although the commenter offers three additional goals 
for the collected revisit user fee, we believe that those admirable 
goals go beyond Congress' intended purpose of the revisit user fee 
program.

Part 424--Conditions for Medicare Payment

Subpart P--Requirements for Establishing and Maintaining Medicare 
Billing Privileges

Section 424.535 Revocation of Enrollment and Billing Privileges in the 
Medicare Program

    We proposed to amend Sec.  424.535(a)(1) by adding a new sentence 
to the criteria for which a provider or supplier may be determined not 
in compliance and for which we may revoke enrollment and billing 
privileges in the Medicare program. We proposed to add that the 
provider or supplier may also be determined not to be in compliance if 
it has failed to pay any user fees as assessed under part 488 of this 
chapter. The paragraph will continue to read that all providers and 
suppliers are granted an opportunity to correct the deficient 
compliance requirement before a final determination to revoke billing 
privileges occurs.
    Comment: Some commenters tied in the discussion of revocation of 
billing and the termination for nonpayment as proposed in Sec.  
488.30(f) and Sec.  489.53(a)(16). One commenter felt that termination 
for nonpayment within 30 days is power disproportionate to the offense 
and is unrelated to quality of care and safety issues. Another 
commenter felt that this provision is reason not to participate in 
Medicare, or to care for Medicare patients.
    Response: While we proposed that a provider or supplier may also be 
determined not to be in compliance if a revisit user fee payment has 
not been received within 30 calendar days after receipt of the notice 
that payment is due, we also state at Sec.  424.535(a)(1) that all 
providers and suppliers are granted an opportunity to correct the 
deficient payment compliance before a final determination is made to 
revoke billing privileges. We further note that a payment-due notice 
from CMS is preceded by a survey or complaint investigation that has 
found deficiencies, a correction period afforded to the provider or 
supplier, a revisit to confirm compliance, then a later issuance of the 
payment-due notice, followed by the formal 30-day advance notice to the 
provider. As soon as a revisit occurs, each provider or supplier will 
know that a revisit user fee will follow at a later date, will know the 
amount of the fee due from the fee schedule published in this rule, and 
will know that the payment will be due

[[Page 53632]]

within 30 calendar days. While the rule specifies that enforcement 
action may occur if the bill has not been paid within 30 calendar days, 
the total amount of planning time available to the provider or supplier 
will have totaled much more than the 30 calendar day period before any 
enforcement action may occur. Finally, the revocation of billing and 
enrollment privileges is not an immediate action upon the failure of a 
provider or supplier to remit the assessed revisit user fee. In this 
final rule we therefore retain the time frames for which action will 
occur regarding this process and retain the amended language to Sec.  
424.535(a)(1) as final.

Part 488--Survey, Certification, and Enforcement

Subpart A--General Provisions

Section 488.30 Revisit User Fee for Revisit Surveys

    We proposed a new Sec.  488.30 which set forth proposed regulations 
that identifies the circumstances under which providers or suppliers be 
assessed a user fee for revisit surveys connected with deficiencies 
identified during surveys for initial certification, recertification, 
or substantiated complaints. This proposed paragraph identifies the 
assessment of fees, criteria for which the proposed fee schedule will 
be based, and collection of fees.

Section 488.30(a)--Definitions

    We proposed in Sec.  488.30(a) to define terms associated with this 
paragraph. Those terms included: ``certification,'' ``complaint 
surveys,'' ``substantiated complaint survey,'' ``provider of 
services,'' ``provider,'' ``supplier,'' and ``revisit survey.'' Many of 
the comments received for Sec.  488.30(a) dealt less with the wording 
in the definitions and more with the survey and certification 
activities and its process.

Certification (Initial or Recertification)

    We proposed that ``certification'' (both initial and 
recertification) would include those activities as defined in Sec.  
488.1. ``Certification'' as currently defined in Sec.  488.1 is a 
``recommendation made by the State survey agency on the compliance of 
providers and suppliers with the conditions of participation, 
requirements (SNFs and NFs), and conditions for coverage.''
    Comment: One commenter proposed that home health agencies and 
hospice facilities be removed from initial certifications since it can 
take 2 or more years to get initial certifications. Another commenter 
proposed that the revisit user fee should be expanded to include 
initial surveys of ESRD facilities to allow more timely surveys that 
now are delayed due to CMS budget, staff shortages, and other 
priorities.
    Response: Both commenters are referring to the issue of initial 
certification surveys conducted for new providers or suppliers, rather 
than the revisit surveys themselves.
    While we appreciate the suggestion from one commenter that CMS 
charge a fee for initial surveys so as to eliminate the current backlog 
of unsurveyed and uncertified potential Medicare providers, we are 
neither authorized by Congress nor prepared to charge such fees at this 
time.
    We also do not accept the suggestion from the other commenter that 
home health agencies and hospices simply be exempt from initial 
certification due to the survey backlog. We are not authorized to make 
such exemption. We also believe an exemption would be inadvisable, as 
it would permit those providers to begin to serve Medicare 
beneficiaries without any assurance that they meet quality of care and 
safety requirements. The proliferation of new home health and hospices 
in a few States have also given rise to considerable concerns of fraud, 
a concern that CMS is responding to through various anti-fraud 
initiatives recently announced by the Secretary.
    We do expect that the revisit user fee will indirectly help to 
resolve the problem of surveying and certifying new providers. Revisit 
costs represent a minority but still substantial portion of overall 
survey and certification expenses. By defraying such costs through the 
user fees, the States will then be in a better position to conduct tier 
III and tier IV priority work, and will be able to conduct more initial 
surveys than they have been able to conduct recently.
    While we appreciate the comments, to adhere to the Congress intent 
within the Continuing Resolution, we will not assess a fee for initial 
certification, nor at this time can we remove providers or suppliers 
based on when initial certifications are conducted. We will retain the 
proposed definition of ``certification'' as final.

``Complaint Surveys''

    We proposed that complaint surveys are those surveys conducted on 
the basis of a ``substantial allegation of noncompliance,'' as defined 
in Sec.  488.1. The term ``substantial allegation of noncompliance'' 
means:

    A complaint from any of a variety of sources (including 
complaints submitted in person, by telephone, through written 
correspondence, or in newspaper or magazine articles) that if 
substantiated, would affect the health and safety of patients and 
raises doubts as to a provider's or supplier's noncompliance with 
any Medicare condition. (42 CFR Sec.  488.1)

    We further noted that the Continuing Resolution included the term 
``substantiated complaints surveys.'' We proposed that ``substantiated 
complaint survey'' means a complaint survey that results in the proof 
or finding of noncompliance at the time of the survey, a finding that 
noncompliance was proven to exist, but was corrected prior to the 
survey, and includes any deficiency that is cited during a complaint 
survey, whether or not the deficiency was the original subject of the 
substantial allegation of noncompliance.
    We proposed that a user fee would be assessed for revisit surveys 
conducted to evaluate the extent to which deficiencies identified 
during a substantiated complaint survey have been corrected.
    Comment: Commenters requested clarification on the term 
``substantial allegation of noncompliance,'' and felt that the 
definition as a basis for the revisit fee is vague and open-ended.
    Response: CMS proposed the definition for ``complaint surveys'' to 
mean those surveys conducted on the basis of a substantial allegation 
of noncompliance, as defined in Sec.  488.1. ``Substantial allegation 
of noncompliance'' has been the term used in current survey, 
certification, and enforcement procedures and as such we intended to 
maintain a level of consistency by utilizing this definition as a means 
to define ``complaint surveys.'' It is this process that generates the 
action for which an investigation into the complaint should occur. It 
is the substantiation of this complaint survey that will determine if a 
revisit survey should be conducted and as a result a revisit user fee 
should be assessed. As we provided in the discussion of the proposed 
rule ``substantiated complaint survey'' means a complaint survey that 
results in (1) the proof or finding of noncompliance at the time of the 
survey, (2) a finding that noncompliance was proven to exist, but was 
corrected prior to the survey, and (3) includes any deficiency that is 
cited during a complaint survey, whether or not the deficiency was the 
original subject of the substantial allegation of noncompliance. If any 
of these 3 situations are determined and a revisit is required as a 
result of the situation, then a revisit user fee will be assessed. It 
will not simply be based on whether the complaint was substantiated. A 
complaint may be substantiated without

[[Page 53633]]

being determined to be non-compliant with the regulations. The 
substantiation of a complaint is a separate issue from the 
determination of compliance with the regulations and thus the 
triggering of a revisit user fee.
    Comment: One commenter contends that accepting complaints from a 
variety of sources is overly broad and permits the process to go 
forward at great length. Another commenter felt that there is nothing 
to prevent disgruntled employees from submitting complaints 
anonymously, especially once they learn that the user fee will punish 
the facility. Commenters felt that this provides incentive for 
surveyors to substantiate the compliant that triggered the revisit or 
substantiate another deficiency.
    Response: We do not expect that either the quantity of complaints 
received or the source of the complaints will affect revisit user fees 
to any measurable extent. The revisit user fee does not apply to any 
complaint investigation. Only complaints which have been substantiated 
as showing non-compliance with Federal requirements will result in 
citation of a deficiency. Only those deficiencies that require a 
revisit survey will then trigger a revisit user fee. When multiple 
complaints are received near the same point in time, State survey 
agencies typically bundle those together in one complaint 
investigation, this investigation is followed by a revisit survey only 
if one or more of the complaints is substantiated and the agency finds 
noncompliance to such an extent that a revisit is called for according 
to CMS policy. Finally, the volume of complaints reaching CMS are to 
some extent affected by the extent that the provider or supplier has an 
effective system of inviting complaints internally, and responding to 
complaints effectively such that beneficiaries or their families feel 
that there is less need to file complaints with CMS or any external 
party. We believe that beneficiary complaints represent a very 
important source of feedback for providers, suppliers, CMS and States. 
We hope such feedback can be effectively used by us and others to 
identify areas of health care that merit serious attention.
    Comment: One commenter disagreed that a ``substantiated complaint 
survey'' can cite any deficiency regardless of whether that deficiency 
was the original subject of the complaint. Two commenters raised 
concerns that a revisit user fee will be imposed even in cases where a 
``substantiated complaint'' is corrected prior to the survey or that 
CMS would require a revisit user fee in this instance and this would 
discourage a facility's internal quality assurance. A commenter raised 
the questions as to whether a substantiated complaint included 
condition and standard levels or just condition level. This commenter 
proposes that it just include condition level since those levels result 
in non-certification or decertification.
    Response: CMS published condition of participation, condition for 
coverage and other regulatory requirements typically take the form of 
specific standards, with multiple standards related to a common topic 
comprising a broader ``condition.'' Revisit surveys are almost always 
required for condition-level deficiencies and are also often required 
for standard-level deficiencies, depending on the extent and 
seriousness of the noncompliance identified. As we provided in the 
discussion of the proposed rule, ``substantiated complaint survey'' 
means a complaint survey that results in (1) the proof or finding of 
noncompliance at the time of the survey, (2) a finding that 
noncompliance was proven to exist, but was corrected prior to the 
survey, and (3) includes any deficiency that is cited during a 
complaint survey, whether or not the deficiency was the original 
subject of the substantial allegation of noncompliance. If any of these 
3 situations are determined and a revisit is required as a result of 
the situation then a revisit user fee is assessed.
    Although we disagree in part with the commenter who indicated that 
any deficiency can not be cited during a complaint survey, we reiterate 
and clarify that under our current policy for conducting complaint 
surveys, we do require that if a State surveyor in the course of 
conducting the complaint survey observes a situation that warrants 
further investigation, that the State must seek input from the CMS 
regional office to request permission to further pursue this additional 
situation. See U.S. Centers for Medicare & Medicaid Services. State 
Operations Manual, ``Complaint Procedures.'' ONLINE. 2006. CMS. 
Available: https://www.cms.hhs.gov/manuals/downloads/som107c05.pdf 
(``SOM-Complaint'').
    With regard to the two commenters'' concern that a finding that 
noncompliance was proven to exist, but was corrected prior to the 
survey, this situation alone would not trigger a revisit user fee. In 
addition, because a substantiated complaint survey can include the 
above criteria we do not believe at this time that we should make a 
distinction between a condition level deficiency and a standard level 
deficiency. As a continued part of the survey and certification process 
a complaint may be substantiated without being determined to be non-
compliant with the regulations. The substantiation of a complaint is a 
separate issue from the determination of compliance with the 
regulations and thus the triggering of a revisit user fee.
    We appreciate the comments, however to adhere to consistency across 
current survey and certification policy, we will retain the definition 
of ``complaint surveys'' to mean those surveys conducted as the basis 
of a substantial allegation of noncompliance, as defined in Sec.  488.1 
as final.

``Provider of Services, Provider, or Supplier''

    We proposed to retain the terms ``provider of services,'' 
``provider,'' or ``supplier'' as defined in Sec.  488.1. We proposed 
that all ``provider of services,'' ``providers,'' or ``suppliers,'' as 
defined in Sec.  488.1, will be subject to user fees, unless otherwise 
exempted through the final rule. We proposed that a ``provider of 
services'' or ``provider'' that may be assessed a user fee, as it 
applies in this proposed rule, includes a hospital, critical access 
hospital, skilled nursing facility, dually-participating nursing 
facility (``SNF/NF''), home health agency (``HHA''), and hospice. 
Transplant centers would also be subject to user fees and have been 
defined in Sec.  482.70 of this chapter. We proposed that ``providers 
of services'' or ``providers'' that will not be assessed a revisit user 
fee as defined in the proposed rule to be comprehensive outpatient 
rehabilitation facilities, transplant centers, and providers of 
outpatient physical therapy or speech pathology services. These 
providers are excluded from this rule because they are not subject to a 
routine survey process as are other service providers. We stated that 
Medicaid-only ``providers of services'' or ``providers'' will not be 
assessed a user fee.
    We proposed a ``supplier'' that may be assessed a user fee, as it 
applies in the proposed rule includes an end-stage renal disease 
center, a rural health clinic (``RHC''), and an ambulatory surgical 
center (``ASC''). ASCs must have an agreement with CMS to participate 
in Medicare and must meet conditions for coverage as defined in Part 
416 of this chapter.
    ``Suppliers'' that would not be assessed a user fee under the 
proposed rule are independent laboratories, portable x-ray centers, 
physical therapists in independent practice, Federally Qualified Health 
Centers (FQHCs), and chiropractors. These

[[Page 53634]]

suppliers are excluded because they are not subject to a routine survey 
process as are other suppliers. We stated that Medicaid-only 
``suppliers'' will not be assessed a user fee.
    The proposed rule would not interfere with user fees associated 
with clinical laboratories as established by the Congress, which passed 
the Clinical Laboratory Improvement Amendments (CLIA) in 1988 and 
established that outpatient clinical laboratory services are paid based 
on a fee schedule in accordance with section 1833(h) of the Act.
    We received several comments regarding our definition of ``provider 
of services,'' ``provider,'' or ``supplier'' and we have included them 
below.
    Comment: One commenter indicated that Chiropractors status among 
the Allied Health Care professions remains in dispute, this commenter 
contends that Chiropractors should be excluded from any Medicare 
provider list.
    Response: Our current regulations found in Sec.  488.1 include 
Chiropractors as identified as a supplier. This particular definition 
section also has extensive implications in various parts of the 
Medicare and Medicaid program and although we appreciate the 
commenter's concern, we do not propose to remove chiropractors from the 
definition of supplier. We do reiterate that Chiropractors are not 
subject to the revisit user fees.
    Comment: One commenter believed that the implementation of this 
rule should not coincide with the publication of the final rule for 
ESRD conditions of coverage. This commenter felt that revisits and 
assignment of fees could very well be excessive during the ``learning 
curve'' of the new regulation; if CMS has such discretion the commenter 
suggests that this final rule should state that revisit user fees for 
ESRD facilities will not apply for the first 12 months of 
implementation of new conditions for coverage.
    Response: The commenter is referring to the future publication of 
the final CMS rule revising the Conditions for Coverage for end stage 
renal disease facilities (ESRD). New rules or substantial revisions of 
new rules are typically promulgated with future effective dates. 
Considerable educational communications usually precede the effective 
date, during which providers or suppliers have an opportunity to become 
familiar with the rule and make necessary changes before the survey 
process holds them accountable. Currently, ESRD surveys are conducted 
about once every three to five years. We therefore believe that there 
will be reasonable opportunities for providers to adjust to the new 
rules before they are affected by surveys and the later revisits that 
might follow some surveys. Finally, although we appreciate the 
commenter's suggestion, we do not have the discretion at this time to 
exclude ESRD facilities from this final rule. ESRD facilities and 
revisits costs were included within the President's budget projections 
and mandated by the Congress.
    Comment: One commenter expressed concern that religious nonmedical 
health care institutions (RHNCIs) would be subject to the revisit user 
fees.
    Response: We appreciate the comment received. We inadvertently did 
not include religious nonmedical health care institutions (RHNCIs) in 
the definitions. RHNCIs should have been included, as they are subject 
to the survey and certification process. To adhere to the intent of the 
Congress and maintain consistency of definitions across Medicare and 
Medicaid programs, we will retain the definitions as proposed with the 
exception that we will include RHNCIs in the definition. However, in 
the fee schedule in this final rule we exempt them from the user fee 
program due to the very small number of such facilities and their 
relatively unusual nature. Any change to the exemption status would be 
preceded by publication of a Federal Register notice. The final 
definition of ``provider of services,'' ``provider,'' or ``supplier'' 
will read ``Provider of services, provider, or supplier'' as defined in 
Sec.  488.1, and ambulatory surgical centers, transplant centers, and 
religious nonmedical health care institutions subject to Sec.  416.2, 
Sec.  482.70, and Sec.  403.702 of this chapter, respectively, will be 
subject to user fees unless otherwise exempted.

``Revisit Survey''

    In the Proposed Rule CMS defined the term ``revisit survey'' to 
mean a survey performed with respect to a provider or supplier cited 
for deficiencies during an initial certification, recertification, or 
substantiated complaint survey and which is designed to evaluate the 
extent to which previously cited deficiencies have been corrected. We 
further proposed that for purpose of this rule revisit surveys include 
both offsite and onsite. We also reiterated that regulations 
established in Sec.  488.26 of this same part provided regulatory 
requirements for conditions of participation, conditions for coverage, 
or other regulatory requirements. Specifically Sec.  488.26 of this 
part states that the compliance determination is made by the State 
survey agency and includes a survey process that assesses compliance 
with Federal health, safety, and quality standards.
    We received only a few comments regarding the term ``revisit 
surveys'' and received the majority of comments under this section 
reflecting commenters concern regarding the survey process and the 
manner in which revisit user fees will be assessed.
1. ``Revisit Survey'' Term
    Comment: Several commenters requested that we redefine the term 
``revisit survey'' so that the definition does not include desk reviews 
or offsite surveys, that the offsite (desk) reviews be defined, that 
fees only be imposed if the survey is done in accordance with already 
established policies per provider type, that the definition include 
criteria about when onsite revisits are required, and that we limit the 
fees to ``onsite revisit surveys.''
    Response: We included offsite revisit surveys (desk reviews) 
because we wished to retain the option of the offsite revisit surveys 
where warranted, since the cost to providers and suppliers under the 
revisit fee program will be substantially less than for onsite revisit 
surveys. The function of onsite and offsite (desk review) revisit 
surveys is the same. We interpret both types to constitute revisits 
within the meaning intended by Congress. The Continuing Resolution 
requires fees to be assessed that are necessary to cover the costs 
incurred for conducting revisit surveys on health care facilities cited 
for deficiencies found during initial certification, recertification, 
or substantiated complaint surveys. As we observed, we do not interpret 
this to mean onsite revisit surveys only. Within the current survey 
process itself there are distinctions made for when an onsite or 
offsite revisit survey should occur and distinctions are made by 
provider and supplier type. See U.S. Centers for Medicare & Medicaid 
Services. State Operations Manual, ``Survey and Enforcement Process for 
Skilled Nursing Facilities and Nursing Facilities,'' Online. 2004. CMS. 
Available: https://www.cms.hhs.gov/manuals/downloads/som107c07.pdf, and 
also ``Additional Program Activities,'' Online. 2007. CMS. Available: 
https://www.cms.hhs.gov/manuals/downloads/som107c03.pdf.
    We disagree that revisit surveys should only be those that were 
conducted onsite, as there are situations in which offsite reviews are 
required to verify that the contents of the plan of correction or the 
corrective action took place. We do, however, agree that a review of a 
plan of correction that does not require verification beyond the plan

[[Page 53635]]

of correction document itself would not constitute an offsite revisit 
survey (as defined here), and thus the provider or supplier would not 
be assessed a revisit user fee in such a circumstance. A provider or 
supplier will be assessed a revisit user fee for an offsite revisit 
survey if the deficiency or deficiencies cited are of a nature that the 
content of the plan of correction and the statements made by the 
provider or supplier require verification and offsite follow-up to 
ensure that the corrective action has brought the provider back into 
compliance with federal requirements.
    We appreciate the comments received; however on the term ``revisit 
survey,'' based on our discussion we will retain the proposed 
definition of ``revisit survey'' as final.
2. Survey Process
    CMS discussed the current revisit policy and survey and 
certification process already established for all providers and 
suppliers. We identified current policy for skilled nursing facilities 
and dually-participating nursing facilities, performed at the 
discretion of CMS or the State. This revisit policy indicates 
circumstances for which onsite revisits must occur for certifying 
compliance and circumstances when onsite revisits are discretionary. 
Likewise, CMS generally permits only two revisits for hospitals, home 
health agencies, hospices, ambulatory surgical centers, rural health 
clinics, and end-stage renal disease centers. Of these two revisits 
permitted by CMS, one revisit should occur within 45 calendar days of 
the initial certification, recertification, or substantiated complaint 
survey, and one revisit subject to CMS approval, between the 46th and 
90th calendar days. See 72 FR 35676 (discussing revisit policy, 
including discussion on revisits related to Immediate Jeopardy).
2A. Survey Process: Skilled Nursing Facilities and Dually-Participating 
Nursing Facilities
    Comment: Several commenters contended that the survey process is 
inconsistent and subjective, and proposed that the revisit user fees be 
postponed until these process issues are resolved. Another commenter 
felt that revisit user fees represent punishment, especially when 
deficiencies are erroneously cited. Two commenters requested assurances 
that only legitimate deficiencies will be cited, that unnecessary 
revisits will not be conducted, and that revisits will not be conducted 
solely for the purpose of collecting user fees. One commenter felt that 
the proposed rule will complicate the subjectivity and variability that 
will always be part of the survey process. Another commenter indicated 
that the survey process is broken and subjective, and as such, fees for 
revisits would be unfair until those problems are resolved.
    Response: CMS continuously works with States to ensure that surveys 
are applied as consistently as possible. CMS also operates a national 
internal consistency program in which validation surveys are conducted 
by Federal surveyors to promote optimum consistency. For example, 
Federal surveyors conduct validation surveys on a 5% sample of nursing 
home surveys to check the accuracy and adequacy of State surveys. CMS 
then works with the States to adjust for any significant disparities. 
The issue of consistency is also monitored as part of CMS's review of 
State performance. Because no system is perfect, nursing homes have an 
opportunity to request review of any cited deficiency through a 
structured informal dispute resolution process. CMS takes the issue of 
consistency seriously, and we continue to develop additional methods to 
analyze and address consistency issues, one example is the new Quality 
Indicator Survey (QIS) process that has been pilot-tested in five 
States. The QIS process utilizes customized software and is designed as 
a staged process for use by surveyors to systematically review 
requirements and objectively investigate all triggered regulatory areas 
in an effort to meet several objectives, one of which is to improve 
consistency and accuracy of quality of care and quality of life problem 
identification. We believe that the revisit user fee will help address 
those limitations and make more feasible a number of additional 
consistency improvements that are underway.
    Comment: One commenter feared that there are no constraints to 
prevent a surveyor from citing an already corrected problem in order to 
trigger a revisit. One commenter believed that the survey process is 
already stressful for facility staff and this will only be made worse 
for employees who fear any mistake could trigger a revisit and its 
associated fee.
    Response: If a problem has already been corrected at the time of a 
standard survey or complaint investigation, the survey itself can 
confirm that the correction has brought the provider or supplier back 
into compliance with federal requirements and the surveyor would 
document such a determination. In such a case no revisit would be 
required unless the correction failed to assure compliance. We 
appreciate that the survey process can be inherently stressful for 
employees. We do not believe, however, that the amount of the revisit 
fee is so much as to add measurably to the pre-existing stress level 
for employees. The cost of a revisit fee can be compared favorably to 
the larger cost to beneficiaries from poor quality of care, or to the 
larger financial cost to providers from serious non-compliance with 
federal requirements, such as civil monetary penalties or termination 
of the provider agreement. Only in the case of multiple revisits would 
we expect the cumulative cost of revisits fees to become a significant 
expense for a particular provider. A large number of revisits would 
occur when there is a persistent pattern of poor quality and documented 
inability of a provider or supplier to sustain compliance with federal 
requirements. Such providers face more serious consequences than 
revisit user fees. We believe that the plain language of the Continuing 
Resolution mandates that a fee be collected whenever a revisit occurs 
as a result of a deficiency found during initial certification, 
recertification, or substantiated complaint surveys. Documentation 
requirements supporting deficiency citations are not being diminished, 
eliminated or otherwise changed by this proposed rule to create the 
scenario raised by the commenter.
    Comment: One commenter proposed that onsite revisits be 
discretionary for single ``G'' level deficiencies. Another commenter 
indicated that it is unclear what level deficiency would necessitate a 
revisit. A few commenters believed that oversight of correction of some 
deficiencies could be done offsite and requested clarification about 
when onsite revisits are required.
    Response: Our current policy requires onsite revisits for condition 
level citations. The current policy governing revisit surveys is 
described in our online state operations manual. We will, however, 
consider policy issues raised by several of the commenters for future 
reconsideration. Some professional discretion on the part of State 
survey agencies will always be required. CMS provides review and 
oversight of State survey agencies through the CMS regional offices. 
Our internal quality assurance system provides for regional office up-
front input or subsequent review when there is concern regarding 
whether the revisit survey should be conducted onsite or offsite. 
However we have always maintained that a condition level citation 
requires an onsite revisit survey. ``G'' level deficiencies in nursing 
homes are serious and are cited only when one or more nursing home

[[Page 53636]]

residents have been harmed. We will continue to conduct revisits in 
such circumstances.
2B. Survey Process: Hospitals, Home Health Agencies, Hospices, 
Ambulatory Surgical Centers, Rural Health Clinics, and End-Stage Renal 
Disease Centers
    Comment: One commenter felt that although survey teams work off the 
same worksheets, there is variation in how different survey teams 
assess similar situations. Therefore, the commenter felt that requiring 
a ``revisit'' fee for all resurveys (either onsite or offsite) will 
increase the number of times that home health agencies will contest the 
survey findings, which then they may enter into an informal dispute 
resolution process not only to avoid the revisit fee but also to 
respond to the issue of survey variation.
    Response: CMS continuously works with States to ensure that surveys 
are as consistently applied as possible. CMS also operates a national 
internal consistency program in which validation surveys are conducted 
by Federal surveyors to promote optimum consistency. It is possible 
that the revisit user fees may have the ancillary effect of increasing 
the extent to which providers or suppliers dispute the findings of 
surveys or complaint investigations. We believe this may occur whether 
the revisits are offsite or onsite. We will monitor the effect of the 
revisit fees to determine if any future adjustments are advisable.
    Comment: One commenter requested clarification on whether user fees 
will be imposed on accredited providers or suppliers for a revisit 
following a sample validation survey.
    Response: We will not charge a fee for a validation survey of a 
provider or supplier that has been duly accredited by a CMS-approved 
accrediting organization and deemed to meet Medicare requirements. 
While we believe that a revisit fee pursuant to a validation survey has 
basis, it is absent in the language of the Continuing Resolution. We 
would view this as similar to a revisit survey conducted for a non-
accredited provider; we did not however specify such a charge in the 
proposed rule. We will therefore not charge a revisit user fee in this 
final rule for a revisit that follows a validation survey, provided 
that the deemed status of the provider or supplier has not been removed 
by CMS. However, any survey, including a validation survey, that finds 
noncompliance with a Condition (compared to just a Standard), typically 
requires removal of deemed status and a full survey of a provider. When 
an accredited facility is found not to be in substantial compliance 
with the Medicare Conditions of Participation or Conditions for 
Coverage, it must remain under the jurisdiction of the State Survey 
Agency until the State Survey Agency verifies through revisits that the 
facility has corrected its deficiencies and demonstrated substantial 
compliance. We believe in this case, the removal of deemed status that 
initiated with a validation survey, that then remains under the 
jurisdiction of the State survey agency is equivalent to any other 
provider or supplier seeking recertification. In this case a provider 
or supplier cited for a deficiency during a recertification survey that 
requires a revisit survey would be assessed a revisit user fee.
    Comment: One commenter requested clarification as to whether a full 
survey following a substantiated complaint survey in a deemed provider 
or supplier is a revisit as defined in proposed Sec.  488.30(a).
    Response: A full survey that is conducted pursuant to a complaint 
investigation of an accredited facility that has fou