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[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Proposed Rules]
[Pages 66348-66350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26559]

[[Page 66348]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3271-P]
RIN 0938-AS04

Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult 
Blood (FOB) Testing

AGENCY: Centers for Medicare & Medicaid Services (CMS); Centers for 
Disease Control and Prevention (CDC), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would amend the Clinical Laboratory 
Improvement Amendments (CLIA) regulations to clarify that the waived 
test categorization applies only to non-automated fecal occult blood 
tests. In addition, the proposed rule would remove the hemoglobin by 
copper sulfate method from the list of waived tests if commenters 
confirm that the method is no longer used.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on January 6, 2015.

ADDRESSES: In commenting, please refer to file code CMS-3271-P. 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-3271-P, P.O. Box 8010, 
Baltimore, MD 21244-1850.
    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-3271-P, 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 prior to 
the close of the comment period: 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 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) 786-9994 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 information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Nancy Anderson, CDC, (404) 498-2280. 
Judith Yost, CMS, (410) 786-3531.

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 Web 
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

I. Background

    The Clinical Laboratory Improvement Amendments of 1988 (CLIA) 
(section 353 of the Public Health Service Act, codified at 42 U.S.C. 
263a) requires any facility performing examinations of human specimens 
(for example, tissue, blood, and urine) for diagnosis, prevention, or 
treatment purposes to be certified by the Secretary of the Department 
of Health and Human Services (HHS). The objective of the CLIA program 
is to ensure accurate and reliable laboratory testing. The Centers for 
Medicare & Medicaid Services (CMS) is responsible for the 
administration of CLIA. The Centers for Disease Control and Prevention 
(CDC) provides scientific and technical support/consultation to HHS/
CMS. The Food and Drug Administration (FDA) is responsible for test 
categorization.
    To enroll in the CLIA program, laboratories must first register by 
completing an application; pay applicable certificate fees; be 
surveyed, if applicable; and become certified. CLIA fees are based on 
the type of certificate requested by the laboratory (that is, waived, 
provider-performed microscopy (PPM), accreditation, or compliance) and, 
for laboratories that perform moderate and high complexity testing, the 
annual volume and types of testing performed. Waived and PPM 
laboratories may apply directly for their certificates, as they are not 
subject to routine surveys.
    To receive a certificate of waiver (COW) under CLIA, a laboratory 
must only perform tests listed as waived in the CLIA regulations at 42 
CFR 493.15(c) (for example, blood glucose by glucose monitoring devices 
cleared by the FDA for home use) or tests which the FDA has determined 
to be waived because they are simple with an insignificant risk of 
error. Waived tests are exempt from most CLIA requirements, and the 
laboratories that perform them receive no routine surveys.
    Waived laboratories must meet only the following requirements under 
CLIA:
     Enroll in the CLIA program;
     Pay applicable certificate fees biennially; and
     Follow manufacturers' test instructions.
    Since the implementation of the CLIA program in 1992, the types of 
tests waived under CLIA have increased from 8 to currently119 tests; 
consequently, the percentage of laboratories issued a COW has grown 
significantly from 20 percent to almost 70 percent of the approximate 
230,000 laboratories enrolled.

[[Page 66349]]

    Dipstick or tablet reagent urinalysis (non-automated) and fecal 
occult blood (FOB) are two of the original 8 waived tests published in 
the Federal Register in 1992, listed at 42 CFR 493.15(c)(1) and (c)(2). 
The regulation specifies that waived test status is applicable to the 
``non-automated'' dipstick or tablet reagent urinalysis, but it does 
not specify ``non-automated'' for FOB tests. At the time the regulation 
was adopted, the FOB was a manual or non-automated test method. 
However, there are automated FOB analyzers that use complex and 
sophisticated technology, which do not meet the CLIA criteria for 
waiver and, therefore, should not be waived. It, therefore, is 
important to clarify these tests are not included in the list of tests 
waived in the CLIA regulations. As a result, we propose to revise the 
current regulation at Sec.  493.15(c)(2) to clarify that only non-
automated FOB tests are automatically waived by regulation.
    Furthermore, since the development and proliferation of the waived 
test for hemoglobin by single analyte instruments with self-contained 
or component features, as described at Sec.  493.15(c)(9), it is our 
understanding that the non-automated hemoglobin by copper sulfate 
method at Sec.  493.15(c)(6) may no longer be in use. Therefore, we are 
soliciting comments to determine if the waived test at Sec.  
493.15(c)(6) Hemoglobin--copper sulfate--non-automated is still in use. 
If comments support the premise that this test is not in use, we 
propose to remove the test from the regulation.

II. Provisions of the Proposed Regulations

    We propose to revise Sec.  493.15(c)(2) by adding the words ``non-
automated'' following ``fecal occult blood.'' This change would clarify 
the categorization of the more complex automated FOB analyzers.
    In addition, we propose to remove the hemoglobin by copper sulfate 
method from the list of waived tests at Sec.  493.15(c)(6) if 
commenters confirm that the method is no longer used.
    Finally, we propose to renumber the remaining paragraphs if Sec.  
493.15(c)(6) is removed.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995.

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.

V. Regulatory Impact Statement

    We have examined the impact of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (Pub. L. 96-
354, September 19, 1980), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 
March 22, 1995), Executive Order 13132 on Federalism (August 4, 1999) 
and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
This rule does not reach this economic threshold and thus is not 
considered a major rule.
    This proposed rule would amend the CLIA regulations at 42 CFR 
493.15(c)(2) to clarify that only non-automated FOB tests are 
specifically waived by regulation. Automated test systems that detect 
FOB would, therefore, be subject to test categorization by the FDA as 
moderate or high complexity as described in Sec.  493.17. These test 
systems would only be considered for waiver approval if the 
manufacturer submits a waiver application to FDA demonstrating the 
particular test system meets the statutory waiver criteria of being 
simple and having an insignificant risk by the user of an erroneous 
result.
    As of April 5, 2013, the FDA CLIA test categorization database 
includes 111 FOB test systems. Two of these test systems are automated 
and are categorized by the FDA as moderate (non-waived) complexity; all 
others are waived non-automated methods (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm). However, because of the 
language in the current regulation governing FOB, it could be construed 
that automated FOB test systems are available for use by laboratories 
with a COW. If this proposed rule is finalized, these two automated 
test systems and any automated FOB systems that are developed in the 
future, will not be available for use by a laboratory with a COW under 
Sec.  493.15(c)(2). This means that testing sites using one or both of 
the two automated test systems noted above (that are categorized as 
moderate complexity tests) would be impacted by this rule if they are 
currently operating under a COW. Due to the low number of automated 
analyzers for FOB testing distributed in the United States, we estimate 
that less than 10 laboratories would be impacted by this proposed 
regulatory change.
    Furthermore, our second proposal, the removal of the provision 
governing hemoglobin by the copper sulfate method at Sec.  493.15 
(c)(6) is not expected to affect any laboratories, as we believe that 
it is no longer in use. Therefore, we believe the proposed regulatory 
changes outlined in this proposed rule would have little or no economic 
impact if they were to be finalized, and would not reach the economic 
threshold to be considered a major rule. We welcome comments and 
supporting data regarding the potential impact of this change.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.5 million to $38.5 million in any 1 year. Individuals and 
states are not included in the definition of a small entity. We believe 
approximately 73 percent of United States medical laboratories qualify 
as small entities based on their nonprofit status as reported in the 
American Hospital Association Fast Fact Sheet, updated January 3, 2013 
(http://www.aha.org/research/rc/stat-studies/fast-facts.shtml). 
However, as previously described, due to the low number of automated 
analyzers distributed in the United States, we estimate that less than 
10 laboratories would potentially be impacted by this regulatory 
change. As its measure of significant economic impact on a substantial 
number of small entities,

[[Page 66350]]

HHS uses a change in revenue of more than 3 to 5 percent. We do not 
believe that this threshold would be reached by the requirements in 
this proposed rule because very few small entities would be subject to 
the provisions in this proposed rule.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area for Medicare payment regulations and 
has fewer than 100 beds. We do not expect this proposed rule, if 
finalized, would have a significant impact on a substantial number of 
small rural hospitals. The changes proposed in this rule would apply 
only to the laboratories previously described, which do not include any 
small rural hospitals at this time. Thus, an analysis under section 
1102(b) of the Act is not required for this rulemaking.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2014, that 
threshold is approximately $141 million. This proposed rule would not 
impose any mandates on state, local, or tribal governments. The impact 
on the private sector would be less than the threshold.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. Since this proposed regulation would not impose any costs 
on state or local governments, the requirements of Executive Order 
13132 are not applicable.
    For reasons listed above, we believe this regulatory change would 
result in little or no economic impact. This proposed rule does not 
reach the economic threshold and thus is not considered a major rule. 
We are requesting comments and additional data to assist us in making a 
more thorough and accurate prediction of impact in the final rule.

List of Subjects in 42 CFR Part 493

    Administrative practice and procedure, Grant programs-health, 
Health facilities, Laboratories, Medicaid, Medicare, Penalties, 
Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR part 493 as set forth 
below:

PART 493--LABORATORY REQUIREMENTS

0
1. The authority citation for part 493 continues to read as follows:

    Authority: Sec. 353 of the Public Health Service Act, secs. 
1102, 1861(e), the sentence following sections 1861(s)(11) through 
1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 
1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)), 
and the Pub. L. 112-202 amendments to 42 U.S.C. 263a.

0
2. Section 493.15 is amended by--
0
A. Revising paragraph (c)(2).
0
B. Removing paragraph (c)(6).
0
C. Redesignating paragraphs (c)(7) through (c)(9) as paragraphs (c)(6) 
through (c)(8).
    The revision reads as follows:

Sec.  493.15  Laboratories performing waived tests.

* * * * *
    (c) * * *
    (2) Fecal occult blood-non-automated;
* * * * *

    Dated: June 18, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: June 18, 2014.
Thomas R. Frieden,
Director, Centers for Disease Control and Prevention, Administrator, 
Agency for Toxic Substances and Disease Registry.

     Dated: September 18, 2014.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2014-26559 Filed 11-6-14; 8:45 am]
BILLING CODE 4120-01-P
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