66348 Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Proposed Rules 

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. 

SUMMARY: This proposed rule would 

amend the Clinical Laboratory 

Improvement Amendments (CLIA) 

regulations to clarify that the waived 

test categorization applies only to nonautomated 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. 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Proposed Rules 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 nonautomated 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 

§ 493.15(c)(2) to clarify that only nonautomated 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 

§ 493.15(c)(9), it is our understanding 

that the non-automated hemoglobin by 

copper sulfate method at § 493.15(c)(6) 

may no longer be in use. Therefore, we 

are soliciting comments to determine if 

the waived test at § 493.15(c)(6) 

Hemoglobin—copper sulfate—nonautomated 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 § 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 

§ 493.15(c)(6) if commenters confirm 

that the method is no longer used. 

Finally, we propose to renumber the 

remaining paragraphs if § 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 § 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 § 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 § 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, 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
66350 Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Proposed Rules 

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 

■ 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. 

■ 2. Section 493.15 is amended by— 

■ A. Revising paragraph (c)(2). 

■ B. Removing paragraph (c)(6). 

■ C. Redesignating paragraphs (c)(7) 

through (c)(9) as paragraphs (c)(6) 

through (c)(8). 

The revision reads as follows: 

§ 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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