82 FR 48770 - Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing

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

Federal Register Volume 82, Issue 202 (October 20, 2017)

This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.

[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Rules and Regulations]
[Pages 48770-48773]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

[CMS-3271-F]
RIN 0938-AS04


Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal 
Occult Blood (FOB) Testing

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

ACTION: Final rule.

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SUMMARY: This final rule amends the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) regulations to clarify that the waived test 
categorization applies only to non-automated fecal occult blood tests.

DATES: These regulations are effective December 19, 2017.

FOR FURTHER INFORMATION CONTACT: Nancy Anderson, CDC, (404) 498-2280, 
or Daralyn Hassan, CMS, (410) 786-9360.

SUPPLEMENTARY INFORMATION: 

[[Page 48771]]

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 and 
CMS. The Food and Drug Administration (FDA) is responsible for test 
categorization.
    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, urine pregnancy tests--visual color 
comparison tests) 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 currently 97; 
consequently, the percentage of laboratories issued a COW has grown 
significantly from 20 percent to almost 72 percent of the approximate 
250,000 laboratories enrolled.
    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, as specified at Sec.  493.15(c)(1) and 
(2), respectively. The regulation specifies that waived test status is 
applicable to ``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 test was only available as a manual 
or non-automated test. However, there are now 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 was 
therefore necessary to propose amendments to the regulations to exclude 
these automated tests from the list of waived tests in the CLIA 
regulations.
    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 was our 
understanding that the non-automated hemoglobin by copper sulfate 
method at Sec.  493.15(c)(6) was no longer in use. Therefore, we 
proposed to remove the hemoglobin by copper sulfate method from the 
list of waived tests at Sec.  493.15(c)(6) if commenters confirmed that 
the method is no longer used.

II. Provisions of the Proposed Regulations

    On November 7, 2014, we published a proposed rule in the Federal 
Register (79 FR 66348 through 66350) entitled, ``Clinical Laboratory 
Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing.'' In 
that rule, we proposed to revise Sec.  493.15(c)(2) by adding the words 
``non-automated'' following ``Fecal occult blood.'' This change would 
exclude the more complex automated FOB analyzers from the list of 
waived tests in the CLIA regulations.
    In addition, we proposed to remove the hemoglobin by copper sulfate 
method from the list of waived tests at Sec.  493.15(c)(6) if we 
received public comments confirming that this method is no longer used.
    Finally, we proposed to renumber the remaining paragraphs if Sec.  
493.15(c)(6) was removed.

III. Analysis of and Responses to Public Comments

    In response to the November 7, 2014 proposed rule, we received 7 
public comments. Interested parties that submitted comments included 
blood donor centers, laboratories and accreditation organizations. A 
summary of the comments and our responses are as follows:
    Comment: One commenter supported our proposal to add the words 
``non-automated'' following ``Fecal occult blood.''
    Response: We appreciate the commenters' support. This change would 
exclude the more complex automated FOB analyzers from the list of 
waived tests in the CLIA regulations.
    Comment: In regard to our proposal to remove the hemoglobin by 
copper sulfate method from the list of waived tests if comments 
confirmed that this method is no longer used, one commenter stated that 
they collect approximately 10,000 units of blood per year and currently 
use the hemoglobin by copper sulfate method for cost reasons. Another 
commenter stated that they use the hemoglobin by copper sulfate method 
as a qualitative method to detect hemoglobin levels of 12.5g/dl or 
greater.
    Several commenters indicated that they use the hemoglobin by copper 
sulfate method to screen donors for acceptable pre-donation hemoglobin. 
Specifically, they perform approximately 20,000 to 30,000 tests per 
year.
    Response: In consideration of these public comments, which indicate 
that the hemoglobin by copper sulfate method is still in use, we are 
not finalizing our proposal to remove the hemoglobin by copper sulfate 
method from the list of waived tests at Sec.  493.15(c)(6).
    Comment: One commenter stated that it is appropriate to require 
``automated FOB tests'' to be evaluated through the CLIA waiver process 
instead of automatically waiving these devices. However, the commenter 
believed that ``waived testing'' poses risk to patients in certain 
settings and that any test that may result in harm should not be 
waived.
    Response: We appreciate the commenter's support for requiring 
``automated FOB tests'' to be evaluated through the CLIA waiver process 
instead of automatically waiving these devices. According to section 
263a(d)(3) of the CLIA statute, waived tests are simple laboratory 
examinations and procedures that have been approved by the FDA for home 
use or that, as determined by the Secretary, are simple laboratory 
examinations and procedures that have an insignificant risk of an 
erroneous result, including those that employ methodologies that are so 
simple and accurate that the likelihood of inaccurate result by the 
user is negligible, and those that the Secretary has determined pose no 
unreasonable risk of harm to the patient if performed incorrectly. 
Therefore, we believe that waived tests that are determined to have met 
the statutory criteria do not pose a significant risk of harm to 
patients.

IV. Provisions of the Final Regulations

    We are adopting as final the provision set forth in the November 7, 
2014 proposed rule (79 FR 66348 through 66350) with the following 
modifications:
     In consideration of public comments, we are not finalizing 
our proposal to remove the hemoglobin by

[[Page 48772]]

copper sulfate method from the list of waived tests at Sec.  
493.15(c)(6).
     Since we are not removing Sec.  493.15(c)(6), we are not 
finalizing our proposal to renumber the remaining paragraphs in this 
section.

V. 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 (44 U.S.C. 3501 et seq.).

VI. 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) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    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 must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
This rule does not reach the economic threshold and thus is not 
considered a major rule.
    This final rule amends the CLIA regulations at Sec.  493.15(c)(2) 
to provide that only non-automated FOB tests are waived by the 
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 the FDA demonstrating the particular test system meets 
the statutory waiver criteria of being simple and having an 
insignificant risk of an erroneous result.
    As of July 11, 2017, the FDA CLIA test categorization database 
includes 134 FOB test systems. Five 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). Only two of the five automated 
test systems are sold in the United States. Because the current 
regulation governing FOB tests does not specify automated or non-
automated FOB tests, it could be misconstrued that automated FOB test 
systems are available for use by laboratories with a COW. As amended, 
it will be clear that automated FOB test systems are not permitted 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 (which are categorized as moderate complexity tests) would 
be impacted by this rule if they are currently operating under a COW. 
According to the information on automated analyzers for FOB testing 
distributed in the United States provided by manufacturers, we estimate 
that no more than 26 laboratories would be impacted by this regulatory 
change. We developed a range of the estimated economic impact for 
changes that may result from this final rule. Our highest estimate 
totals approximately $151,000 for the first year, due to the initial 
costs required to change certificate types for all potentially impacted 
laboratories. This would decrease in years two through five, projected 
to be as low as approximately $3,000 per year in years two and four, 
when no certificate fees would be paid. Therefore, this rule does not 
meet the economic threshold to be considered a major rule.
    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 are not 
preparing an analysis for the RFA because we believe that approximately 
79 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 July 11, 2017 (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 no more than 26 
laboratories would potentially be impacted by this regulatory change. 
As its measure of significant economic impact on a substantial number 
of small entities, 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 final rule because very few small entities would 
be subject to the provisions in this rule.
    In addition, section 1102(b) of the Social Security Act (the 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 604 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area for Medicare payment regulations and 
has fewer than 100 beds. We do not expect this final rule to have a 
significant impact on a substantial number of small rural hospitals. 
The changes in this final 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 2017, that 
threshold is approximately $148 million. This rule will have no 
consequential effect on state, local, or tribal governments or on the 
private sector.
    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 regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017 (82 FR 
9339, February 3, 2017). Section 2(a) of Executive Order 13771 requires 
an agency, unless

[[Page 48773]]

prohibited by law, to identify at least two existing regulations to be 
repealed when the agency publicly proposes for notice and comment, or 
otherwise promulgates, a new regulation. In furtherance of this 
requirement, section 2(c) of Executive Order 13771 requires that the 
new incremental costs associated with new regulations shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations. OMB's interim guidance, 
issued on April 5, 2017, https://www.whitehouse.gov/the-press-office/2017/04/05/memorandum-implementing-executive-order-13771-titled-reducing-regulation, explains that for Fiscal Year 2017 the above 
requirements only apply to each new ``significant regulatory action 
that imposes costs.'' It has been determined that this final rule is 
not a ``significant regulatory action thus does not trigger the above 
requirements of Executive Order 13771.

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 amends 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 revising paragraph (c)(2) to read as 
follows:


Sec.  493.15  Laboratories performing waived tests.

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

    Dated: August 24, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: October 5, 2017.
Anne Schuchat,
RADM, U.S. Public Health Service, Principal Deputy Director, Centers 
for Disease Control and Prevention.

    Dated: October 12, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-22813 Filed 10-19-17; 8:45 am]
 BILLING CODE 4120-01-P