Federal Register / Vol. 83, No. 249 / Monday, December 31, 2018 / Notices 67723 

identified in this section. The State 

Medicaid/CHIP agency will report the 

existence of a system to collect all 

information needed to determine and 

redetermine eligibility for Medicaid and 

CHIP. The State Medicaid/CHIP agency 

will attest to using the PARIS system in 

determining beneficiary eligibility in 

Medicaid or CHIP benefit programs. 

Form Number: CMS–R–74 (OMB control 

number: 0938–0467); Frequency: 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 55; Total Annual 

Responses: 3,241; Total Annual Hours: 

1,071. (For policy questions regarding 

this collection contact Stephanie Bell at 

410–786–0617.) 

Dated: December 13, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–27337 Filed 12–28–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3356–NC] 

RIN 0938–AT56 

Medicare Program; Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) Fees 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice with comment 

period announces the increase of certain 

fees established under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). The Public Health 

Service Act (PHSA) requires the 

Secretary to impose certificate fees to 

cover the general costs of administering 

the CLIA program, as well as additional 

fees, including Inspection fees for nonaccredited laboratories. We are 

increasing these fees to cover the cost of 

administering the CLIA program as 

required by statute. We seek public 

comment regarding this increase, which 

we believe is necessary to meet the 

statutory requirements. 

DATES: Comments: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

March 1, 2019. 

ADDRESSES: In commenting, refer to file 

code CMS–3356–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three 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–3356–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–3356–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: For 

policy related questions, please contact 

Cindy Flacks, 410–786–6520, and 

Caecilia Blondiaux, 410–786–2190. 

For the Budget and Financial Impact, 

please contact Jeffrey Pleines, 410–786– 

0684. 

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. CLIA Fees 

On October 31, 1988, Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578), which 

replaced in its entirety section 353 of 

the Public Health Service Act (PHSA). 

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 and must be sufficient to 

cover the general costs of administering 

the CLIA program, including evaluating 

and monitoring approved proficiency 

testing (PT) programs and accrediting 

bodies and implementing and 

monitoring compliance with program 

requirements. Additional fees are 

imposed for inspections of nonaccredited laboratories and for the cost 

of performing PT on laboratories that do 

not participate in approved PT programs 

intended to cover the cost of evaluating 

a laboratory to determine overall if an 

accreditation organization’s standards 

and inspection process is equivalent to 

the CLIA program. These evaluations 

are referred to as validation inspections. 

The additional fees must be sufficient to 

cover, among other things, the cost of 

carrying out such inspections and PT. 

Certificate and additional fees 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, and only a nominal 

fee may be required for the issuance and 

renewal of Certificates of Waiver 

(CoWs). 

The regulations provide for a 

methodology for determining fee 

amounts (§ 493.649) and periodic 

updating of the certificate fee amounts 

(§ 493.638(b)) and compliance fee 

amounts (§ 493.643(b)). Under 

§ 493.645(b)(1), laboratories that are 

issued a certificate of accreditation 

(CoA) are assessed a fee to cover the cost 

of validation inspections. All accredited 

laboratories share in the cost of these 

inspections. These costs are the same as 

those that are incurred when inspecting 

non-accredited laboratories. 

B. CLIA Budget Process 

With the exception of the ‘‘CLIA 

Program; Fee Schedule Revision’’ notice 

published in the August 29, 1997 

Federal Register (62 FR 45815 through 

45821), the fees imposed to cover the 

costs of administering the CLIA program 

have not been updated since 1992. The 

fee amounts currently collected under 

the CLIA regulations are based on 

preliminary assumptions made in 1992 

about future program operations and 

workload requirements. After decades of 

actual program experience, we have 

determined that it is necessary to 

increase certain CLIA fees to fund 

current and future program operations 

as required by section 353(m) of the 

PHSA. Specifically, as discussed in 

section II. of this notice with comment 

period, we are increasing those CLIA 

fees collected under § 493.638(b) 

(hereinafter referred to as ‘‘Certificate 

Fees’’), with the exception of fees for 


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issuing a Certificate of Registration 

(CoR); § 493.643(b) (hereinafter referred 

to as ‘‘Compliance Fees’’); and 

§ 493.645(b)(1) (hereinafter referred to as 

‘‘Additional Fees’’) (collectively referred 

to hereinafter as ‘‘CLIA Fees’’). 

We routinely monitor incoming CLIA 

Fee collections and compare them on a 

monthly basis with the corresponding 

amounts of obligations and 

expenditures for all costs required to 

support the operation of the CLIA 

program, including state survey agency 

(SA) awards, CMS administrative costs, 

other federal agency costs, and contract 

support. Over the past several years, we 

have observed that the total amount of 

incurred obligations in a given fiscal 

year has outpaced the corresponding 

amount of CLIA Fees collected over the 

same timeframe, leading to decreases in 

the level of budgetary resources 

available to support program operations. 

Factors contributing to the increased 

obligations incurred by the CLIA 

program include an increase in the 

amount of time it takes to perform 

surveys in laboratories that are using 

more complex testing platforms and 

laboratory developed tests, as well as 

the overall inflation of the economy. 

Based on our observations, we 

performed a retrospective comparative 

analysis of federal fiscal year (FY)-end 

CLIA Fee collections and incurred 

obligations over the prior six FYs (FY 

2012 through FY 2017). As shown in 

Table 1, the amount of incurred 

obligations in each fiscal year has 

exceeded the corresponding amount of 

collected CLIA Fees. 

TABLE 1—CMS COMPARATIVE ANALYSIS FYS 2012 THROUGH 2017 

FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 

Certificate Fees Collected ........................ $36,343,753 $42,169,869 $41,173,724 $41,185,755 $42,369,451 $41,544,575 

Compliance Fees Collected ..................... 13,213,680 13,040,589 12,823,731 12,466,102 13,468,981 12,527,235 

Sequester 1 ............................................... 0 (2,760,521) (3,887,817) (3,916,586) (3,795,483) (3,730,969) 

Total, CLIA Fees Collected 2 ............ 49,557,433 52,449,907 50,109,639 49,735,271 52,042,948 50,340,842 

Total, CLIA Obligations 2 3 ................ 54,539,917 54,169,837 57,360,315 56,404,651 56,778,918 59,680,186 

Total, CLIA (Shortfall)/Surplus .......... (4,982,484) (1,719,930) (7,250,677) (6,669,380) (4,735,970) (9,339,344) 

1Sequester is a reduction in budget authority authorized by Public Law 112–25, the Budget Control Act of 2011. 

2 Collections and obligations data taken from FY-end Healthcare Integrated General Ledger Accounting System (HIGLAS) reporting. Exempt 

State Fees are categorized as Certificate Fees, because the state surveys their own laboratories and State Fees charged go to the state. 3 CLIA obligations include FY-end obligations for CMS administration (payroll, travel, training, supplies, contracts), other federal agencies 

(CDC, FDA, Treasury, DHHS/OGC), and SA awards (surveys, PT, etc.). 

Over the past few years, we have been 

diligent in controlling administrative 

costs, including use of carryover funds, 

in an attempt to avoid a fee increase. For 

example, we have controlled costs by 

enhancing monitoring and control over 

funds awarded to SAs for surveys, 

reducing federal travel and training 

expenses, as well as imposing strict 

oversight of incurred contract costs. 

Despite these efforts, a portion of CLIA’s 

administrative obligations and 

expenditures remains fixed and cannot 

be further reduced without significant 

disruption in program operations (for 

example, limiting planned regulatory 

and enforcement actions). Taking into 

account annual inflation in the overall 

economy, we anticipate that program 

costs and concurrent obligations will 

continue to increase, further 

contributing to a projected shortfall in 

collections. Moreover, our ability to 

continue using carryover funds is 

limited since we have used this 

carryover to supplement shortfalls in 

new collections over a number of years. 

We project that without a fee increase, 

the CLIA program would cease to be 

self-sustaining at some point in FY 

2020, as shown in Table 2. 

TABLE 2—CMS PROJECTIONS FYS 2018 THROUGH 2020 

[No Fee Increase] 

FY 2018 FY 2019 FY 2020 

Prior Year Carryover (SOY) 1 ...................................................................................................... $43,494,763 $29,469,649 $14,464,636 

Projected CLIA Fee Collections .................................................................................................. 51,900,306 51,900,306 51,900,306 

Projected Sequester (6.6%, 6.2%) .............................................................................................. (3,425,420) (3,217,819) (3,217,819) 

Budgetary Resources .................................................................................................................. 91,969,649 78,152,136 63,147,123 

Projected Obligations ................................................................................................................... 62,500,000 63,687,500 65,024,938 

Projected Carryover (EOY) 2 ....................................................................................................... 29,469,649 14,464,636 (1,877,815) 

1Start of year balances. 

2End of year balances. 

Based on these projections, absent a 

fee increase, our ability to maintain 

effective program operations may be 

jeopardized, potentially comprising 

public health and safety. As a result, we 

need to increase currently assessed 

CLIA Fees to ensure effective program 

operations. 

C. CLIA RFI Feedback 

In January 2018, we published the 

‘‘Request for Information: Revisions to 

Personnel Regulations, Proficiency 

Testing Referral, Histocompatibility 

Regulations and Fee Regulations under 

the Clinical Laboratory Improvement 

Amendments (CLIA) of 1988’’ (83 FR 

1004). As part of the general solicitation 

for comments related to the CLIA Fees, 

more than a few commenters noted the 

CLIA Compliance and Additional fees 

have not been updated since 1992 and 

supported increasing the fees. Some of 

these commenters suggested the CLIA 

Fees be reviewed annually and updated 

as needed to cover the program costs of 

performing biennial surveys. 

One commenter raised concerns 

related to increases to the CLIA Fees, 

linking them to the recent changes to 


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the Clinical Laboratory Fee Schedule 

(CLFS) (see 81 FR 41036). While we 

appreciate this commenter’s concerns, 

we note that changes to the CLFS are 

issued by Medicare and are separate and 

distinct from changes to CLIA Fees. 

As a result of the feedback received 

from the 2018 RFI, as well as through 

assessing the current program needs, we 

are increasing the fees as outlined in 

section II of this notice with comment 

period. Additionally, we will consider 

the comments received in response to 

the 2018 RFI as well as this notice with 

comment period in future rulemaking. 

II. CLIA Fees Increase 

For the reasons discussed in section I. 

of this notice with comment period, we 

are increasing the following CLIA Fees: 

Certificate Fees (collected under 

§ 493.638(b), with the exception of fees 

for the issuance of a CoR); Compliance 

Fees (collected under § 493.643(b)); and 

Additional Fees (collected 

under§ 493.645(b)(1)). These increases 

are based on our review of historical 

revenue and expenditure data, which 

have shown that expenditures in 

comparison to collections are 

insufficient to keep pace with the CLIA 

program costs. 

As shown in Table 1, we must close 

the $9.3 million gap between incurred 

obligations and CLIA Fee collections in 

FY 2017 to keep the program on a 

sustained solvent basis projected over 

time. To close this $9.3 million gap, we 

first determined the appropriate fee 

drivers, as shown in Table 3, and then 

added the results together, along with 

current State-Exempt Fees at about $1.1 

million, to calculate the total projected 

fees. 

TABLE 3—CMS PROJECTED LABORATORY POPULATION AND SURVEY WORKLOAD, FY 2018 

Waived PPMP1 LVA2

Schedule Codes 

Total 

A B C D E F G H I J 

Non-Accredited .. 0 0 6,466 4,245 183 2,022 249 1,493 793 497 1,721 200 167 18,036 

Accredited .......... 0 0 2,103 2,700 184 1,895 228 1,631 959 599 3,081 1,107 1,794 16,281 

Other .................. 178,616 33,411 0 0 0 0 0 0 0 0 0 0 0 212,027 

Total, CLIA 

Lab Population ........ 178,616 33,411 8,569 6,975 367 3,917 477 3,124 1,752 1,096 4,802 1,307 1,961 246,344 

Total, CLIA 

Compliance Surveys ......... 0 0 3,500 2,330 110 1,124 145 839 445 285 995 141 144 10,058 

1Provider-Performed Microscopy Procedures Laboratories (PPMP). 

2 Low-Volume Laboratory (LVA). 

For Certificate Fees, the driver used in 

our calculations is one half of the 

projected laboratory population for FY 

2018 (123,172 CLIA laboratories), 

broken out by state and laboratory 

schedule code. We used one half of the 

projected laboratory population to 

determine an average annual collection 

because all CLIA laboratories are billed 

on a biennial basis. For Compliance 

Fees, the driver used in our calculations 

is the projected number of surveys 

budgeted for FY 2018 (10,058 total 

surveys). For Additional Fees for 

accredited laboratory validation 

inspections, the driver used in our 

calculations is the projected number of 

validation surveys budgeted for FY2018 

(about 407). Using this methodology, we 

project increased CLIA Fee collections 

at $61.0 million in FY 2018, as opposed 

to the currently collected $50.8 million, 

plus the collection of $1.1 million in 

State-Exempt Fees, for a total projected 

collection of $62.1 million. 

We have projected that we need to 

increase the CLIA Fees described 

previously by at least 18.6 percent 

($9.339 million/$50.341 million, per 

Table 1). In calculating projected 

collections for FYs 2018 through 2021, 

we rounded up to a 20 percent increase 

to ensure a sufficient level of carryover 

to maintain operations in the first two 

quarters of FYs 2019 and 2020. 

Generally, carryover funds are needed to 

support program operations at the start 

of any given FY, until a sufficient 

amount of current FY collections is 

accumulated and made available for 

obligation. In rounding up to the 20 

percent increase, we projected increased 

FY 2018 collections at $62.1 million, 

enough to reasonably approximate 

projected FY 2018 obligations. To 

calculate the $62.1 million in projected 

collections, we multiplied the increased 

fees by the appropriate fee drivers, as 

shown in Table 3, and then added the 

results together, along with current 

State-Exempt Fees at about $1.1 million, 

to calculate the total projected fees. 

The total of fees collected by HHS 

must be sufficient to cover the general 

costs of administering the CLIA 

program, and as indicated in Table 4, 

upon publication of the final notice, we 

project that the 20 percent increase will 

be sufficient to fund the CLIA program 

into FY 2022. 

TABLE 4—CMS PROJECTIONS FYS 2018 THROUGH 2021 

[With 20 percent fee increase] 

FY 2018 FY 2019 FY 2020 FY 2021 

Prior Year Carryover (SOY) 1 .......................................................................... $43,494,763 $29,469,649 $20,855,892 $14,052,629 

Projected CLIA Fee Collections ....................................................................... 51,900,306 58,714,011 62,070,016 62,070,016 

Projected Sequester (6.6%, 6.2%) .................................................................. (3,425,420) (3,640,269) (3,848,341) (3,848,341) 

Budgetary Resources ...................................................................................... 91,969,649 84,543,392 79,077,566 72,274,303 

Projected Obligations ....................................................................................... 62,500,000 63,687,500 65,024,938 66,390,461 

Projected Carryover (EOY) 2 ............................................................................ 29,469,649 20,855,892 14,052,629 5,883,842 

1Start of year balances. 


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2End of year balances. 

With this notice, we are increasing all 

currently assessed CLIA Fees by 20 

percent to close the gap between current 

obligations and current collections, and 

to account for a small increase in costs 

for the current fiscal year. Fees for the 

issuance of registration certificates 

would not be increased as these 

increases would not have substantial 

impact. 

The 20 percent increase would apply 

to the following CLIA fee types: 

1. Certificate Fees—collected under 

§ 493.638(b), with the exception of fees 

for the issuance of a CoR. Under 

§ 493.638(b), the fee amount is based on 

the category of test complexity, or on 

the category of test complexity and 

schedules or ranges of annual laboratory 

test volume (excluding waived tests and 

tests performed for quality control, 

quality assurance, and PT purposes) and 

specialties tested, with the amounts of 

the fees in each schedule being a 

function of the costs for all aspects of 

general administration of CLIA as set 

forth in § 493.649(b) and (c). Under 

§ 493.649(a), the fee for issuance of a 

CoR or CoC is based on the laboratory’s 

scope and volume of testing. The 

current Certificate Fees are already 

based on each laboratory’s schedule’s 

scope and volume of testing, including 

test complexity and specialties tested. 

Following the application of a uniform 

20 percent increase to Certificate Fees 

across all schedules, with the exception 

of fees for the issuance of a CoR, the 

new Certificate Fees will continue to 

satisfy §§ 493.638(b) and 493.649(a). 

2. Compliance Fees collected under 

§ 493.643(b). Under § 493.649(a), the 

amount of the fee in each schedule for 

compliance determination inspections 

is based on the average hourly rate 

(which includes the costs to perform the 

required activities and necessary 

administration costs) multiplied by the 

average number of hours required or, if 

activities are performed by more than 

one of the entities listed in § 493.649(b), 

the sum of the products of the 

applicable hourly rates multiplied by 

the average number of hours required by 

the entity to perform the activity. 

As discussed in section I. of this 

notice with comment period, current 

Compliance Fees were established in 

1992 based on estimates as to the 

average time a survey would take, the 

cost of the surveyor salary per hour, as 

well as the size of the laboratory. Based 

on FY 2017 available compliance fee 

collections, we estimate that current 

Compliance Fee collections cover 

approximately 55 percent of current and 

future compliance determination costs. 

Following the application of a uniform 

20 percent increase to Compliance Fees 

across all schedules, in combination 

with the aforementioned increase to 

Certificate Fees, the new Compliance 

Fees will continue to satisfy 

§ 493.649(a). 

3. Additional Fees collected under 

§ 493.645(b)(1). Under § 493.645(b)(1), 

laboratories that are issued a CoA are 

assessed an additional fee to cover the 

cost of validation inspections. These 

costs are the same as those that are 

incurred when inspecting nonaccredited 

laboratories. As discussed in section I. 

of this notice with comment period, 

current Additional Fees were 

established in 1992 based on estimates 

as to the average time a survey would 

take, the cost of the surveyor salary per 

hour, as well as the size of the 

laboratory. Following the application of 

a uniform 20 percent increase to 

additional fees across all schedules, in 

combination with the aforementioned 

increases to Certificate Fees and 

Compliance Fees, the new Additional 

Fees will continue to satisfy 

§§ 493.645(b)(1) and 493.649(a). 

While we recognize that the 20 

percent increase to CLIA Fees across all 

schedule codes can be perceived as a 

major increase for laboratories, we 

intend for this approach to be a onetime adjustment to address the projected 

shortfall to ensure the program can 

remain self-sustaining into FY 2022. We 

will continue to review our obligations 

and collections and may make future 

adjustments as needed to avoid 

shortfalls. We considered multiple 

options prior to this notice with 

comment period, including limiting the 

increase to varying percentages and 

timeframes across a single fee type, 

specifically Compliance Fees. For 

example, we considered the following 

options: 

• Update the existing Compliance 

Fees by updating the hours for all 

classifications (schedules) of 

laboratories and the hourly rates for all 

states and territories. 

• A one-time 70 percent increase in 

Compliance Fees alone to meet 

projected obligations, with a phased-in 

two 35 percent Compliance Fee 

increases over a two biennial survey 

cycles. 

As discussed previously, in regard to 

the estimates established in 1992, we 

are proposing the one-time 20 percent 

increase across most CLIA Fees, 

including Certificate (excluding CoR 

fees) and Compliance Fees based on our 

comparison of FY 2017 obligations and 

collections (see Table 1). Analysis 

indicates that the difference between 

collections and obligations results 

primarily from inflationary increases 

incurred since Compliance Fees were 

set in 1992 and since Certificate Fees 

user fees were last increased in 1997. 

Furthermore, analysis shows that the 

relative proportions of the certification 

and compliance work to total program 

obligations has remained virtually 

consistent over time, at about 34 percent 

for compliance and 66 percent for 

certification. We believe the original 

methodology for calculating CLIA fees 

was reasonable at the time, with the 

exception of excluding adjustments for 

inflation, which has remained relatively 

constant. Therefore, we determined that 

a one-time 20 percent increase across 

most currently assessed fees is the most 

appropriate approach. The 20 percent 

increase also meets our policy objectives 

to keep any increase reasonably limited, 

given the elapsed time since the CLIA 

Fees were last updated. 

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 (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, if we proceed with 

a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Statement 

A. Statement of Need 

As discussed in section I. of this 

notice with comment period, when 

CLIA was enacted, and its implementing 

regulations were finalized in 1992, CLIA 

Fees were established based on 

estimates as to the average time a survey 

would take; cost of the surveyor salary 

per hour; as well as the size of the 

laboratory (schedules A, B, etc.). As 

discussed in section III. of this notice 

with comment period, we are increasing 


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certain CLIA Fees based on our analysis 

of the overall level of collections 

relative to the costs of maintaining the 

CLIA program, which project a shortfall 

to begin in calendar year 2020. 

B. Overall Impact 

We have examined the impacts 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 (the 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) and 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). Section 3(f) of Executive Order 

12866 defines a ‘‘significant regulatory 

action’’ as an action that is likely to 

result in a rule: (1) Having an annual 

effect on the economy of $100 million 

or more in any one year, or adversely 

and materially affecting a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or state, local or tribal 

governments or communities (also 

referred to as ‘‘economically 

significant’’); (2) creating a serious 

inconsistency or otherwise interfering 

with an action taken or planned by 

another agency; (3) materially altering 

the budgetary impacts of entitlement 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or (4) raising novel legal or 

policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. A regulatory impact analysis 

(RIA) is required for economicallysignificant regulatory actions that are 

likely to impose costs or benefits of 

$100 million or more in any given year. 

This notice with comment period is 

not economically significant within the 

meaning of section 3(f)(1) of the 

Executive Order since the estimated cost 

alone is not likely to exceed the $100 

million annual threshold. Our upper 

limit of estimated impact is under the 

threshold of $150 million for the year of 

2018 under Unfunded Mandates Reform 

Act (UMRA). This notice with comment 

period increases certain CLIA Fee 

requirements and will affect 

approximately 251,010 clinical 

laboratories, resulting in some budget 

implications. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities if a rule has a significant impact 

on a substantial number of small 

entities. For purposes of the RFA, we 

assume that the great majority of clinical 

laboratories are small entities, either by 

virtue of being nonprofit organizations 

or by meeting the Small Business 

Administration definition of a small 

business by having revenues of less than 

$7.5 million to $38.5 million in any one 

year. For purposes of the RFA, we 

believe that approximately 82 percent of 

clinical laboratories qualify as small 

entities based on their nonprofit status 

as reported in the American Hospital 

Association Fast Fact Sheet, updated 

January 2017 (https://www.aha.org/ 

system/files/2018-01/fast-facts-ushospitals-2017_0.pdf ). Individuals and 

states are not included in the definition 

of a small entity. We are voluntarily 

preparing a Regulatory Impact Analysis 

and are requesting public comments in 

this area to assist us in making this 

determination. 

In addition, section 1102(b) of 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 and has 

fewer than 100 beds. We do not expect 

this notice with comment period will 

have a significant impact on small rural 

hospitals. Laboratories in small rural 

hospitals are already subject to CLIA 

Fees. We are requesting public 

comments in this area to assist us in 

making this determination. 

C. Anticipated Effects 

This notice with comment period 

impacts approximately 251,010 CLIA 

certified laboratories. 

TABLE 5—CURRENT AND NEW NATIONAL AVERAGE OF COMPLIANCE FEE UPDATE

[Compliance fee updates at 20 percent increase] 

Laboratory classification 

(schedules) 

Current 

average 

(c) 

New 

average 

(n) 

LVA .......................................................................................................................................................................... $300 $360 

A ............................................................................................................................................................................... 994 1,192 

B ............................................................................................................................................................................... 1,325 1,591 

C .............................................................................................................................................................................. 1,657 1,988 

D .............................................................................................................................................................................. 1,947 2,336 

E ............................................................................................................................................................................... 2,237 2,684 

F ............................................................................................................................................................................... 2,527 3,032 

G .............................................................................................................................................................................. 2,817 3,380 

H .............................................................................................................................................................................. 3,107 3,728 

I ................................................................................................................................................................................ 3,397 4,076 

J ............................................................................................................................................................................... 3,673 4,408 

Table 5 reflects the national average of 

compliance fees for each classification 

of laboratories (schedules) that requires 

inspection. Specifically, Table 5 

represents the national average for each 

schedule for the current Compliance 

Fees (noted with a ‘‘c’’) as paid 

biennially by laboratories that hold a 

CoC and the national average for each 

schedule for the new Compliance Fees 

(noted with a ‘‘n’’) that will be paid 

biennially by laboratories that hold a 

CoC. As discussed section II. of this 

notice with comment period, Table 5 

reflects a total increase of 20 percent 

across all schedules. 


khammond on DSK30JT082PROD with NOTICES
67728 Federal Register / Vol. 83, No. 249 / Monday, December 31, 2018 / Notices 

TABLE 6—CURRENT AND NEW NATIONAL AVERAGE OF ADDITIONAL FEES FOR ACCREDITED LABORATORIES UPDATE

[Additional fee updates at 20 percent increase] 

Laboratory classification 

(schedules) 

Current 

average 

(c) 

New 

average 

(n) 

LVA .......................................................................................................................................................................... $15 $18 

A ............................................................................................................................................................................... 50 60 

B ............................................................................................................................................................................... 60 80 

C .............................................................................................................................................................................. 83 99 

D .............................................................................................................................................................................. 97 117 

E ............................................................................................................................................................................... 112 134 

F ............................................................................................................................................................................... 126 152 

G .............................................................................................................................................................................. 141 169 

H .............................................................................................................................................................................. 155 186 

I ................................................................................................................................................................................ 170 204 

J ............................................................................................................................................................................... 184 220 

Table 6 shows the national average of 

Additional Fees for each schedule of 

accredited laboratory. Specifically, 

Table 6 represents the national average 

fees for each schedule for the current 

Additional Fees (noted with a ‘‘c’’) as 

paid biennially by laboratories that hold 

a CoA and the national average for the 

new Additional Fees (noted with a ‘‘n’’) 

that will be paid biennially by 

laboratories that hold a CoA. As 

discussed in section II. of this notice 

with comment period, Table 6 reflects a 

total increase of 20 percent across all 

schedules. 

TABLE 7—CLIA BIENNIAL CERTIFICATE FEES

Type of CLIA certificate Laboratory schedule Current fee New fee 

Certificate of Waiver (CoW) ......................................... Not applicable ............................................................... $150.00 $180.00 

PPM .............................................................................. Not applicable ............................................................... 200.00 240.00 

CoC and CoA ............................................................... LVA ............................................................................... 150.00 180.00 

CoC and CoA ............................................................... A ................................................................................... 150.00 180.00 

CoC and CoA ............................................................... B ................................................................................... 150.00 180.00 

CoC and CoA ............................................................... C ................................................................................... 430.00 516.00 

CoC and CoA ............................................................... D ................................................................................... 440.00 528.00 

CoC and CoA ............................................................... E ................................................................................... 650.00 780.00 

CoC and CoA ............................................................... F .................................................................................... 1,100.00 1,320.00 

CoC and CoA ............................................................... G ................................................................................... 1,550.00 1,860.00 

CoC and CoA ............................................................... H ................................................................................... 2,040.00 2,448.00 

CoC and CoA ............................................................... I ..................................................................................... 6,220.00 7,464.00 

CoC and CoA ............................................................... J .................................................................................... 7,940.00 9,528.00 

Table 7 depicts the current and new 

Certificate Fees, which reflects the 20 

percent increase across all schedules, 

with the exception of fees for the 

issuance of a CoR. 

D. Regulatory Reform Analysis Under 

E.O. 13771 

Executive Order 13771, titled 

Reducing Regulation and Controlling 

Regulatory Costs, was issued on January 

30, 2017 and requires that the costs 

associated with significant new 

regulations ‘‘shall, to the extent 

permitted by law, be offset by the 

elimination of existing costs associated 

with at least two prior regulations.’’ It 

has been determined that this notice 

with comment period is not a 

‘‘significant regulatory action’’ under 

E.O. 12866 and thus is not considered 

regulatory action under Executive Order 

13771. 

E. Conclusion 

Although the effect of the changes 

will increase laboratory costs, 

implementation of these changes will be 

negligible in terms of workload for 

laboratories as these fee increases are 

operational and technical in nature and 

do not require additional time to be 

spent by laboratory employees. 

We have determined that this notice 

with comment period would not have a 

significant economic impact on a 

substantial number of small entities or 

a significant impact in the operations of 

a substantial number of small rural 

hospitals and for these reasons, we are 

not preparing analyses for either the 

RFA or section 1102(b) of the Act. 

In accordance with the provisions of 

Executive Order 12866, this notice with 

comment period was reviewed by the 

Office of Management and Budget. 

Dated: December 14, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: December 18, 2018. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2018–28359 Filed 12–28–18; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Physician-Focused Payment Model 

Technical Advisory Committee; 

Meetings 

ACTION: Notice of meetings. 

SUMMARY: This notice announces the 

2019 meetings of the Physician-Focused 

Payment Model Technical Advisory 

Committee (PTAC). These meetings will 

include deliberation and voting on 


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