[Federal Register Volume 83, Number 6 (Tuesday, January 9, 2018)]
[Proposed Rules]
[Pages 1004-1009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3326-NC]
RIN 0938-ZB40


Request for Information: Revisions to Personnel Regulations, 
Proficiency Testing Referral, Histocompatibility Regulations and Fee 
Regulations Under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA)

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

ACTION: Request for information.

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SUMMARY: This request for information seeks public comment regarding 
several items related to Clinical Laboratory Improvement Amendments of 
1988 (CLIA) personnel requirements and histocompatibility requirements, 
which, with minor exception, have not been updated since 1992. We are 
also seeking public comment regarding the flexibility to impose 
alternative sanctions for laboratories issued a Certificate of Waiver 
(CoW) determined to have participated in proficiency testing (PT) 
referral. In addition, we are seeking public comment related to 
appropriate sanctions in situations where we determine that a 
laboratory has referred its PT samples to another laboratory and has 
reported the other laboratory's result as their own.
    This request for information also seeks public comment regarding 
the updating of fees for determination of program compliance and 
additional fees for laboratories established under the CLIA 
regulations. We are also seeking public comment regarding the 
collection of other fees we are authorized to collect such as fees for 
revised certificates, post survey follow-up visits, complaint 
investigations, and activities related to imposition of sanctions.
    We intend to consider public comments (including information such 
as evidence, research, and trends) received in response to this request 
for information when we draft proposals, in consultation, as 
appropriate, with the Centers for Disease Control and Prevention (CDC), 
to update the existing CLIA regulations through future rulemaking. We 
are also soliciting public comment on other areas of CLIA which should 
be reviewed and potentially updated.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on March 12, 2018.

ADDRESSES: In commenting, refer to file code CMS-3326-NC. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3326-NC, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3326-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses:
    a. For delivery in Washington, DC-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not

[[Page 1005]]

readily available to persons without Federal government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.

FOR FURTHER INFORMATION CONTACT: 
    For general questions, please contact Caecilia Blondiaux, 410-786-
2190.
    For personnel requirements, please contact Sarah Bennett, 410-786-
3354.
    For proficiency testing referral, please contact Sarah Bennett, 
410-786-3354.
    For histocompatibility, please contact Penelope Meyers, 410-786-
3366.
    For CLIA fees, please contact Cindy Flacks, 410-786-6520.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

I. Background

A. Personnel Requirements

    Generally, the Clinical Laboratory Improvement Amendments of 1988 
(CLIA) regulations related to personnel requirements have not been 
updated since 1992, with the exception of minor changes to doctoral 
high complexity laboratory director qualifications in 2003 (see 68 FR 
3713). We are soliciting public comments (including information such as 
evidence, research, and trends) and intend to draft proposals, to 
update the existing CLIA personnel regulations through future 
rulemaking. The topics listed in this request for information are areas 
that the Centers for Disease Control and Prevention (CDC), CMS, 
stakeholders and State Agency surveyors identified as concepts that 
should be relevant to our efforts to update the CLIA personnel 
requirements to better reflect current knowledge, changes in the 
academic context and advancements in laboratory testing. Therefore, 
prior to starting the rulemaking process, we are seeking public 
comments (including information such as evidence, research, and 
trends), including stakeholder and surveyor feedback, specific to the 
topics discussed in this request for information. We intend to consider 
any such comments when we draft proposals to update the existing CLIA 
personnel regulations to better protect public health and safety and 
reflect current knowledge, changes in the academic context, and 
advancements in laboratory testing.
1. Nursing Degrees
    As noted in Survey & Certification Letter 16-18-CLIA\1\, we 
currently consider a bachelor's degree in nursing to be equivalent to a 
bachelor's degree in biological science for purposes of the educational 
requirements for moderate and high complexity testing personnel under 
CLIA. We are considering drafting proposals to amend 42 CFR 493.1411 
(moderate complexity technical consultant), 493.1423 (moderate 
complexity testing personnel), and 493.1489 (high complexity testing 
personnel) to expressly reflect that policy. We are also considering 
whether a nursing degree should be considered as a separate qualifying 
degree, as opposed to the equivalent of a biological science degree, 
for purposes of meeting the educational requirements for moderate and 
high complexity testing personnel and technical consultants. As such, 
we are also considering proposing to amend Sec. Sec.  493.1411, 
493.1423, and 493.1489 to add a nursing degree as a separate qualifying 
degree to the current list of qualifying degrees for the moderate and 
high complexity testing personnel and technical consultants.
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    \1\ Survey & Certification Letter 16-18-CLIA SC 16-18-CLIA, S&C 
website: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html
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    We are seeking public comments (including information such as 
evidence, research, and trends) related to whether, for purposes of 
meeting the educational requirements for moderate complexity technical 
consultants and testing personnel and high complexity testing 
personnel, Sec. Sec.  493.1411, 493.1423, and 493.1489 should be 
amended: (1) To expressly reflect that a nursing degree is equivalent 
to a biological science degree; or (2) to add nursing degrees as a 
separate qualifying degree (as opposed to the equivalent of a 
biological science degree) to the current list of qualifying degrees.
2. Physical Science Degrees
    Due to variation in usage and the absence of universally accepted 
definitions, a ``physical science degree'' is difficult to define for 
regulatory purposes. We note, however, that physical science is a broad 
discipline often described as the study of non-living systems, such as 
astronomy, physics, and earth sciences. Generally, these types of 
degrees are not related to clinical laboratory testing. We note that in 
some instances, individuals with these types of degrees have been able 
to qualify as high complexity testing personnel under Sec.  493.1489.
    We are seeking public comments (including information such as 
evidence, research, and trends) on what is considered a physical 
science degree and whether any physical science degree(s) should be 
considered as educational background(s) appropriate for qualifying to 
meet the CLIA educational requirements at Sec. Sec.  493.1405, 
493.1411, 493.1423, 493.1443, 493.1449, 493.1461, and 493.1489.
3. Personnel Competencies
    We recognize that the personnel qualifications for general 
supervisors may be less stringent than those of technical consultants. 
However, the current CLIA regulations allow general supervisors with 
associate's degrees (Sec.  493.1461) to perform competency assessment 
on high complexity testing personnel (see Sec. Sec.  493.1461(c)(2), 
493.1489(b)(2)(i)), but because the personnel requirements for moderate 
complexity testing do not include the general supervisor category, the 
same general supervisors cannot perform competency assessment on 
moderate complexity testing personnel unless they can meet the 
regulatory qualifications of a technical consultant (Sec.  493.1411). 
Technical consultants, at a minimum, are required to have a bachelor's 
degree in chemical, physical, or biological science or medical 
technology. We recognize that high complexity testing is inherently 
more involved than moderate complexity testing. We have received 
feedback from laboratories and other stakeholders that the difference 
in degree requirements to qualify to assess competency presents 
staffing challenges in laboratories. We are seeking public comments 
(including information such as evidence, research, and trends) 
regarding whether general

[[Page 1006]]

supervisors, with associate's degrees, should be allowed to perform 
competency assessment for moderate complexity testing personnel in 
laboratories that perform both moderate and high complexity testing.
4. Personnel Experience, Training and Skills
    Currently, when we refer to laboratory training, experience and/or 
skills,\2\ we mean that the individual qualifying has the training in 
and the experience with non-waived clinical laboratory testing or in 
the specialties and subspecialties in which the individual is 
performing testing. Generally, the type of training and experience 
required under the current CLIA personnel regulation at part 493, 
subpart M, is clinical in nature. This means examination and test 
performance on human specimens for purposes of obtaining or providing 
information for the diagnosis, treatment, and monitoring of patients.
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    \2\ See Sec. Sec.  493.1405, 493.1406, 493.1411, 493.1423, 
493.1443, 493.1449, 493.1461, 493.1489, 493.1491.
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    We are seeking public comments (including information such as 
evidence, research, and trends) on what should be considered 
appropriate laboratory training, experience and skills when determining 
the qualifications necessary for all \3\ personnel to meet CLIA 
requirements, and what comprises appropriate documentation to verify 
the training, experience and skills for all personnel positions in part 
493, subpart M.
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    \3\ See Sec. Sec.  493.1405, 493.1406, 493.1411, 493.1423, 
493.1443, 493.1449, 493.1461, 493.1489, 493.1491.
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5. Non-Traditional Degrees
    Several current CLIA personnel requirements allow a position to be 
filled by an individual with a degree in a ``chemical, physical, 
biological or clinical laboratory science, or medical technology.'' \4\ 
We recognize there are non-traditional degrees (for example, Regents 
Bachelor of Arts) that may include job experience in lieu of coursework 
and that typically do not include a major concentration of study (for 
example, biology or chemistry), but are instead classified as general 
education degrees.
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    \4\ See Sec. Sec.  493.1405, 493.1411, 493.1423, 493.1449(c) 
through (j) and (n) through (q), 493.1461, 493.1489.
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    We are seeking public comments (including information such as 
evidence, research, and trends) related to such non-traditional 
degrees, specifically whether these types of degrees should be 
considered to meet the requirements for a chemical, physical, 
biological or clinical laboratory science, and/or medical technology 
degrees.\5\
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    \5\ See Sec. Sec.  493.1405, 493.1411, 493.1423, 493.1449(c) 
through (j) and (n) through (q), 493.1461, 493.1489.
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B. Proficiency Testing Referral

    The Taking Essential Steps for Testing Act (``TEST Act'') (Pub. L. 
112-202, enacted on December 4, 2012) amended section 353 of the Public 
Health Service Act (PHSA) to provide the Secretary with discretion as 
to which sanctions may be applied to cases of intentional PT referral. 
Such discretion may in some circumstances replace the automatic 
revocation of the laboratory's CLIA certificate and subsequent 
imposition of the 2-year ban on the laboratory's owner or operator, 
which would prevent them from owning or operating a CLIA-certified 
laboratory for 2 years.
1. Discretion for Category 1 PT Referral
    The final rule entitled, ``Medicare Program; Prospective Payment 
System for Federally Qualified Health Centers; Changes to Contracting 
Policies for Rural Health Clinics; and Changes to Clinical Laboratory 
Improvement Amendments of 1988 Enforcement Actions for Proficiency 
Testing Referral'', published in the May 2, 2014 Federal Register (79 
FR 25463 through 25467 and 25480 through 25481), amended the 
regulations to implement the TEST Act and provide the prescriptive 
framework for the application of sanctions in PT referral cases (see 
also 79 FR 27106). These regulations allow for a more appropriate 
enforcement action based upon the nature and extent of an intentional 
PT referral violation and the penalties that are imposed. These 
regulations include three categories of sanctions for a PT referral to 
be applied under certain specified conditions, based on the severity 
and extent of the violation. These categories reserve revocation and 
the resulting laboratory director/owner/operator prohibition for the 
most egregious violations while permitting less serious sanctions in 
cases where circumstances warrant.
    ``Category 1'', found at Sec.  493.1840(b)(1), is for the most 
egregious violations, encompassing cases of repeat PT referral, 
regardless of circumstances revolving around the violation, and cases 
where a laboratory reports another laboratory's PT results as its own 
to the PT program. This category includes the revocation of the 
laboratory's CLIA certificate for at least 1 year, bans the owner and 
operator from owning or operating a CLIA-certified laboratory for at 
least 1 year, and may include the imposition of a civil money penalty 
(CMP). The application of the owner exemption from the ban is 
determined on a case-by-case basis (see Sec.  493.1840(b)(1)(ii)).
    We are seeking public comment related to applying discretion in 
situations where we determine that a laboratory has referred its PT 
samples to another laboratory and has reported the other laboratory's 
PT results as its own, and under what circumstances the discretion 
should be applied.
2. Alternative Sanctions for PT Referral by CoW Laboratories
    Section 353(d)(2)(C) of the PHSA states that laboratories issued a 
CoW are only exempt from subsections (f) and (g) of the statute. All 
other subsections apply, including the prohibition against PT referral 
in subsection (i), which refers to ``any laboratory'' that the 
Secretary determines has intentionally referred its PT samples. 
Therefore, CoW laboratories that participate in PT are not exempt from 
the ban against PT referral. Per Sec.  493.1775(b), CoW laboratories 
may be inspected to determine if the laboratory is operated and testing 
is performed in a manner that does not constitute an imminent and 
serious risk to public health, evaluate a complaint, determine whether 
the laboratory is performing tests beyond the scope of its certificate, 
or to collect information regarding the appropriateness of tests 
specified as waived tests. In addition, Sec.  493.1775(c) requires the 
laboratory to comply with the basic inspection requirements of Sec.  
493.1773. However, the CLIA regulations at Sec.  493.1804(c)(1) state 
that we do not impose alternative sanctions on CoW laboratories because 
those laboratories are not inspected for compliance with condition-
level requirements. Therefore, our only recourse in cases of PT 
referral found at CoW laboratories are principal sanctions (that is, 
revocation, suspension, or limitation).
    We are seeking public comments (including information such as 
evidence, research, and trends) to determine if alternative sanctions 
instead of principal sanctions should be an option in these cases in 
order to create parity for all certificate types for laboratories 
determined to have participated in PT referral.

C. Histocompatibility

    Generally, the CLIA regulations related to histocompatibility have 
not been updated since 1992, with the exception of certain changes in 
2003 (see 68 FR 3640). We are soliciting

[[Page 1007]]

public comment and intend to draft proposals, to update the existing 
CLIA histocompatibility regulations through future rulemaking. The 
topics listed in this request for information are areas that CDC, CMS, 
the Clinical Laboratory Improvement Amendments Advisory Committee 
(CLIAC), and stakeholders identified as concepts that should be 
relevant to our efforts to update the CLIA histocompatibility 
requirements to better reflect current knowledge, changes in transplant 
medicine, and advancements in laboratory testing. We intend to consider 
any such information when we draft proposals to update the existing 
CLIA histocompatibility requirements to better protect the public 
health and safety and reflect current knowledge, changes in transplant 
medicine, and advancements in laboratory testing.
1. Crossmatching
    As a result of changes in histocompatibility testing technology and 
practices, as well as advances in organ transplantation since 1992, we 
believe that some of the requirements found at Sec.  493.1278 have 
become outdated and may preclude the use of current transplantation 
practices. For example, in some cases, performing a ``virtual 
crossmatch'' has replaced the use of a ``physical crossmatch'' to 
determine compatibility between the donor and recipient.
    The CLIA regulations require a crossmatch to be performed as part 
of the laboratory testing process (see 42 CFR 493.1278(e)). Although 
not specified in the regulation, the crossmatching procedures in use in 
1992 were physical crossmatches (also referred to as serologic 
crossmatches), that is, a mixing of specimens from donor and recipient 
to check for compatibility. We understand that these regulations are 
viewed by the transplantation community as a barrier to modernized 
decision-making approaches on organ acceptability based on risk 
assessment.
    Virtual crossmatching generally refers to an assessment of 
immunologic compatibility based on the patient's alloantibody profile 
compared to the donor's histocompatibility antigens. In virtual 
crossmatching, laboratory test results already performed on donors and 
recipients are compared in order to predict compatibility and determine 
whether an organ is acceptable for a patient.
    The CLIAC Virtual Crossmatch Workgroup was convened to gather 
information on the acceptability and application of virtual 
crossmatching in lieu of serologic crossmatching for transplantation.
    The workgroup reported on advances in the field of transplantation 
since the CLIA regulations were published in 1992. These advances have 
made the physical crossmatching less significant or even obsolete in 
some cases. Specifically:
    <bullet> Histocompatibility testing has evolved from cell based 
assays to molecular typing and solid phase platforms for antibody 
detection, leading to improved accuracy, sensitivity, specificity.
    <bullet> Significant changes have occurred in the clinical practice 
of transplantation (for example, immunosuppression, desensitization 
practices), and improvements in anti-rejection therapies have led to 
improved outcomes and mitigation of risk due to antibodies against 
human leukocyte antigens (HLA).
    These advances have made virtual crossmatching a viable alternative 
to physical crossmatching. The Virtual Crossmatch Workgroup presented a 
report called the Acceptability and Application of Virtual 
Crossmatching in lieu of Serologic Crossmatching for 
Transplantation,\6\ to the full CLIAC at its November 2014 meeting. 
CLIAC deliberated on the report and recommended that we explore:
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    \6\ The Acceptability and Application of Virtual Crossmatching 
in lieu of Serologic Crossmatching for Transplantation (2014) 
https://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac1114/8_BRAY_Virtual_Crossmatch_Workgroup_Report_Nov-2014.pdf.
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    <bullet> Regulatory changes or guidance(s) that would allow virtual 
crossmatching to replace physical crossmatching as a pre-requisite for 
organ transplant.
    <bullet> Appropriate criteria and decision-making algorithms, based 
on the Virtual Crossmatch Workgroup input provided to CLIAC, under 
which virtual crossmatching would be an appropriate substitute for 
physical crossmatching. The determination of appropriate criteria and 
decision-making algorithms should involve a process that includes an 
open comment period.
    We are seeking public comments (including information such as 
evidence, research, and trends) related to these two CLIAC 
recommendations; that is, whether virtual crossmatching should be an 
acceptable alternative to physical crossmatching, and under what 
criteria and decision-making algorithms virtual crossmatching would be 
an appropriate substitute for physical crossmatching.
2. Updating the Histocompatibility Requirements
    Since the CLIA specialty requirements for histocompatibility 
testing were initially finalized in 1992, there have been many 
advancements in laboratory testing. We believe that some of the 
requirements found at Sec.  493.1278 other than those related to 
crossmatching may also be outdated or are redundant with other 
requirements found in subpart K of the regulations. We are seeking 
public comments (including information such as evidence, research, and 
trends) related to any histocompatibility regulations that have become 
outdated, and suggestions for updating the histocompatibility 
regulations to align with current laboratory practice.

D. CLIA Fees

    With the exception of the certificate fees notice which was 
published in the August 29, 1997 Federal Register (62 FR 45915 through 
45821), the CLIA regulations related to fees have not been updated 
since 1992, and we intend to update the CLIA regulations with regard to 
fees. These fee updates would include the determination of program 
compliance fees for laboratories holding a Certificate of Compliance 
(CoC), additional fees for laboratories holding a Certificate of 
Accreditation (CoA), fees for revised certificates, follow-up visits, 
complaint investigations, and activities related to the imposition of 
sanctions.
    Section 353(m) of the PHSA requires the Secretary to impose two 
separate types of fees: ``certificate fees'' and ``additional fees.'' 
Certificate fees are imposed for the issuance and renewal of 
certificates (except that only a nominal fee may be required for the 
issuance and renewal of CoWs) and must be sufficient to cover the 
general costs of administering the CLIA program, including and 
evaluating and monitoring approved PT programs and accrediting bodies 
and implementing and monitoring compliance with program requirements. 
Additional fees are imposed for inspections of non-accredited 
laboratories and for the cost of performing PT on laboratories that do 
not participate in approved PT programs. The additional fees must be 
sufficient to cover, among other things, the cost of carrying out such 
inspections and PT. Certificate and additional fees must vary by group 
or classification of laboratory, based on such considerations as the 
Secretary determines are relevant, which may include the dollar volume 
and scope of the testing being performed by the laboratories. The 
regulations provide for a methodology for determining

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compliance fee amounts (Sec.  493.649) and periodic updating of the 
certificate fee amounts (Sec.  493.638(b)).
1. Fees for Revised Certificate
    The regulations also allow for collection of fees for revised 
certificates (Sec.  493.639). We are exploring an appropriate 
methodology for determining a fair and reasonable fee to support these 
requests. At present, laboratories may request a revised certificate 
due to a change in name, location, director, services offered (for 
example, specialty or subspecialty), or certificate type (for example, 
CoC to Certificate of Provider-performed Microscopy (PPM) Procedures). 
There is a cost associated with such a request, including staff time to 
verify and make the edits in the data system, the contractor's time to 
print the revised certificate, and the supplies required to print the 
revised certificate. The fee for revised certificate would likely be a 
standard nominal fee for such requests.
2. Compliance Determination, Additional Fees, and Methodology for 
Determining Fee Amounts
    Laboratories holding a CoC are subject to fees for determination of 
program compliance according to the regulations at Sec.  493.643(b). 
Laboratories that hold a CoA are subject to additional fees as outlined 
in Sec.  493.645(b). As noted in this request for information, the 
statute requires certificate and additional fees to vary by group or 
classification of laboratory, based on such considerations as the 
Secretary determines are relevant, which may include the dollar volume 
and scope of the testing being performed by the laboratories. Section 
493.643(c) lists the classifications, or schedules, of laboratories 
based on the laboratory's scope and volume of testing. These schedules 
are used to determine the fee amount a laboratory is assessed and will 
not be revised. The compliance determination fees have not been 
increased since the final rule was published in 1992. The cost of 
conducting compliance determination activities (for example, surveys, 
PT reviews, and evaluating personnel) has increased over the life of 
the CLIA program.
    The regulations allow for us to collect fees for follow-up visits 
post survey, complaint investigations, and activities associated with 
imposing sanctions. Such fees for laboratories holding a CoC are 
outlined in Sec. Sec.  493.643(b) and 493.643(d), while laboratories 
holding a CoA, CoW and a PPM Certificate are subject to Sec. Sec.  
493.645(b)(2) and 493.645(c), as applicable. We are exploring 
methodology for assessing a fair fee for these compliance determination 
activities.
    The methodology for determining fee amounts is found in Sec.  
493.649. The amount of the fee in each schedule for compliance 
determination inspections is based on the average hourly rate for each 
entity, which includes costs to perform required activities and 
necessary administration costs. The hourly rate is multiplied by the 
average number of hours required to perform these activities. We are 
seeking public comments (including information such as evidence, 
research, and trends) on an alternate method to calculate the average 
hourly rate for each entity as outlined in Sec.  493.649(b). We are 
also seeking information on whether the method should be standardized 
and updated annually or as needed.
    We are therefore soliciting public comments (including information 
such as evidence, research, and trends) on the best method for 
instituting this regulatory authority to collect CLIA fees.

II. Solicitation of Comments

    This is a request for information only. Respondents are encouraged 
to provide complete but concise responses to the questions listed in 
the sections outlined below. Please note that a response to every 
question is not required. This RFI is issued solely for information and 
planning purposes; it does not constitute a Request for Proposal, 
applications, proposal abstracts, or quotations. This RFI does not 
commit the Government to contract for any supplies or services or make 
a grant award. Further, we are not seeking proposals through this RFI 
and will not accept unsolicited proposals. Responders are advised that 
the U.S. Government will not pay for any information or administrative 
costs incurred in response to this RFI; all costs associated with 
responding to this RFI will be solely at the interested party's 
expense. Not responding to this RFI does not preclude participation in 
any future procurement, if conducted. It is the responsibility of the 
potential responders to monitor this RFI announcement for additional 
information pertaining to this request. Please note that we will not 
respond to questions about the policy issues raised in this RFI. We may 
or may not choose to contact individual responders. Such communications 
would only serve to further clarify written responses. Contractor 
support personnel may be used to review RFI responses. Responses to 
this notice are not offers and cannot be accepted by the Government to 
form a binding contract or issue a grant. Information obtained as a 
result of this RFI may be used by the Government for program planning 
on a non-attribution basis. Respondents should not include any 
information that might be considered proprietary or confidential. This 
RFI should not be construed as a commitment or authorization to incur 
cost for which reimbursement would be required or sought. All 
submissions become Government property and will not be returned. We may 
publically post the comments received, or a summary thereof.
    We are soliciting public input on the following areas:

A. Clarifications of Degree(s)

    <bullet> We are seeking public comment related to whether a 
bachelor's degree in nursing should be considered equivalent to a 
bachelor's degree in biological science or should be considered a 
qualifying degree to meet the CLIA requirements for moderate and high 
complexity testing personnel as well as for technical consultants.
    <bullet> We are seeking public comment on what is considered a 
physical science degree and if a physical science degrees have the 
educational backgrounds such that all or some should to be considered a 
qualifying degree to meet the intent of the CLIA requirements at 
Sec. Sec.  493.1405, 493.1411, 493.1423, 493.1443, 493.1449, 493.1461, 
and 493.1489.
    <bullet> We are seeking public comment related to non-traditional 
degrees (for example, Regents Bachelor of Arts) specifically whether 
any of these types of degrees should be considered to meet the 
requirements for a chemical, physical, biological or clinical 
laboratory science, and/or medical laboratory technology degrees.

B. Other Requirements for CLIA Personnel Categories

    <bullet> We are seeking public comment regarding whether general 
supervisors should be allowed to perform competency assessment for 
testing personnel performing moderate complexity testing in 
laboratories that perform both moderate and high complexity testing.
    <bullet> We are seeking public comment on what is appropriate 
laboratory training, experience and skills when qualifying all 
personnel to meet CLIA requirements, and what comprises appropriate 
documentation to verify the training, experience and skills for all 
personnel positions in part 493, subpart M.

[[Page 1009]]

C. Proficiency Testing Referral

    <bullet> We are seeking public comment regarding the feasibility of 
applying alternative sanctions in cases of PT referral that involve 
waived testing.
    <bullet> We are seeking public comment related to applying 
discretion in situations where we determine that a laboratory has 
referred its proficiency testing samples to another laboratory and has 
reported those results from another laboratory as their own, and under 
what circumstances should that discretion be applied.

D. Histocompatibility

    <bullet> Virtual crossmatching: We are seeking public comment on 
the acceptability and application of virtual crossmatching in lieu of 
physical crossmatching for transplantation.
    <bullet> Criteria and decision making algorithms: We are seeking 
public comment on appropriate criteria and decision algorithms under 
which virtual crossmatching would be an appropriate substitute for 
physical crossmatching. We are also seeking public comment on the 
existence of commonly accepted current guidelines for virtual 
crossmatching in histocompatibility.
    <bullet> Updating histocompatibility regulations: We are seeking 
public comment on histocompatibility regulations that are no longer 
necessary because they are obsolete or redundant with requirements 
found in other sections of the CLIA regulations. We are also seeking 
public comment on any histocompatibility regulations that should be 
modified to reflect current practices.

E. CLIA Fees

    <bullet> We are seeking public comments (including information such 
as evidence, research, and trends) on an alternate method to calculate 
the average hourly rate for each entity as outlined in Sec.  
493.649(b). We are also seeking comment on whether the method should be 
standardized and updated annually or as needed.
    <bullet> We are seeking public comment on a methodology that would 
set a fair and reasonable fee for revised certificate requests. We also 
seek comment as to whether fees should be nominal and, if nominal, 
whether such fee would cover the costs associated with the task.
    <bullet> We are seeking public comment to update the fees for 
determination of program compliance as well as additional fees to 
accredited laboratories as outlined in Sec. Sec.  493.643(b) and 
493.645(b) respectively. We are also seeking comment on whether fees 
collected should be subject to the same ten schedules at Sec.  
493.643(c), and whether they should change based on any updates to the 
methodology for determining the average hourly rate.
    <bullet> We are seeking public comment on exploring an appropriate 
methodology for assessing a fair fee for other compliance determination 
activities to include performing follow-up visits, complaint 
investigations, and activities associated with imposition of sanctions.
    We are also soliciting general feedback from stakeholders on what 
other areas of CLIA they would potentially have recommendations for 
changing.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. However, section II of this document does contain a 
general solicitation of comments in the form of a request for 
information. In accordance with the implementing regulations of the 
Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), 
this general solicitation is exempt from the PRA. Facts or opinions 
submitted in response to general solicitations of comments from the 
public, published in the Federal Register or other publications, 
regardless of the form or format thereof, provided that no person is 
required to supply specific information pertaining to the commenter, 
other than that necessary for self-identification, as a condition of 
the agency's full consideration, are not generally considered 
information collections and therefore not subject to the PRA. 
Consequently, there is no need for review by the Office of Management 
and Budget under the authority of the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

IV. Response to Comments

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

    Dated: August 18, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: December 20, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-27887 Filed 1-5-18; 11:15 am]
 BILLING CODE 4120-01-P