Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Notices 72089 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6051–N] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Provider 

Enrollment Application Fee Amount for 

Calendar Year 2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

$542.00 calendar year (CY) 2014 

application fee for institutional 

providers that are initially enrolling in 

the Medicare or Medicaid program or 

the Children’s Health Insurance 

Program (CHIP); revalidating their 

Medicare, Medicaid or CHIP enrollment; 

or adding a new Medicare practice 

location. This fee is required with any 

enrollment application submitted on or 

after January 1, 2014 and on or before 

December 31, 2014. 

DATES: Effective Date: This notice is 

effective on January 1, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Frank Whelan, (410) 786–1302 for 

Medicare enrollment issues. Alvin 

Anderson, (410) 786–2188 for Medicaid 

and CHIP enrollment issues. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the February 2, 2011 Federal 

Register (76 FR 5862), we published a 

final rule with comment period entitled 

‘‘Medicare, Medicaid, and Children’s 

Health Insurance Programs; Additional 

Screening Requirements, Application 

Fees, Temporary Enrollment Moratoria, 

Payment Suspensions and Compliance 

Plans for Providers and Suppliers.’’ This 

rule finalized, among other things, 

provisions related to the submission of 

application fees as part of the Medicare, 

Medicaid, and CHIP provider 

enrollment processes. As stated in 42 

CFR 424.514, ‘‘institutional providers’’ 

that are initially enrolling in the 

Medicare, Medicaid or CHIP program, 

revalidating their enrollment, or adding 

a new Medicare practice location are 

required to submit a fee with their 

enrollment application. An 

‘‘institutional provider’’ is defined at 42 

CFR 424.502 as ‘‘(a)ny provider or 

supplier that submits a paper Medicare 

enrollment application using the CMS– 

855A, CMS–855B (not including 

physician and non-physician 

practitioner organizations), CMS–855S, 

or associated Internet-based PECOS 

enrollment application.’’ As we 

explained in the February 2011 final 

rule (76 FR 5914), ‘‘In addition to the 

providers and suppliers subject to the 

application fee under Medicare, 

Medicaid-only and CHIP-only 

institutional providers include nursing 

facilities, intermediate care facilities for 

persons with mental retardation (ICF/

MR), psychiatric residential treatment 

facilities, and may include other 

institutional provider types designated 

by a State in accordance with their 

approved State plan.’’. 

As indicated in 42 CFR 424.514 and 

455.460, the application fee is not 

required for either of the following: 

• A Medicare physician or nonphysician practitioner submitting a 

CMS–855I. 

• A prospective or re-enrolling 

Medicaid or CHIP provider— 

++ Who is an individual physician or 

non-physician practitioner; or 

++ That is enrolled in Title XVIII of 

the Act or another state’s Title XIX or 

XXI plan and has paid the application 

fee to a Medicare contractor or another 

state. 

II. Provisions of the Notice 

A. CY 2013 Fee Amount 

In the November 30, 2012 Federal 

Register (77 FR 71423), we published a 

notice announcing a fee amount for the 

period of January 1, 2013 through 

December 31, 2013 of $532.00. This 

figure was calculated as follows: 

• Section 1866(j)(2)(C)(i)(I) of the 

Social Security Act (the Act) established 

a $500 application fee for institutional 

providers in CY 2010. 

• Consistent with section 

1866(j)(2)(C)(i)(II) of the Act, 42 CFR 

424.514(d)(2) states that for CY 2011 

and subsequent years, the fee will be 

adjusted by the percentage change in the 

consumer price index (CPI) for all urban 

consumers (all items; United States city 

average, CPI–U) for the 12-month period 

ending in June of the previous year. 

• The CPI–U increase for CY 2011 

was 1.0 percent, based on data obtained 

from the Bureau of Labor Statistics 

(BLS). This resulted in an application 

fee amount for CY 2011 of $505 (or $500 

× 1.01). 

• The CPI–U increase for the period 

of July 1, 2010 through June 30, 2011 

was 3.54 percent, based on BLS data. 

This resulted in an application fee 

amount for CY 2012 of $522.87 (or $505 

× 1.0354). In the aforementioned 

February 2, 2011 final rule, we stated 

that if the adjustment sets the fee at an 

uneven dollar amount, we would round 

the fee to the nearest whole dollar 

amount. Accordingly, the application 

fee amount for CY 2012 was rounded to 

the nearest whole dollar amount, or 

$523.00. 

• The CPI–U increase for the period 

of July 1, 2011 through June 30, 2012 

was 1.664 percent, based on BLS data. 

This resulted in an application fee 

amount for CY 2013 of $531.70 ($523 × 

1.01664). Rounding this figure to the 

nearest whole dollar amount resulted in 

a CY 2013 application fee amount of 

$532.00. 

B. CY 2014 Fee Amount 

Using BLS data, the CPI–U increase 

for the period of July 1, 2012 through 

June 30, 2013 was 1.8 percent. This 

results in a CY 2014 application fee 

amount of $541.576 ($532 × 1.018). As 

we must round this to the nearest whole 

dollar amount, the resultant application 

fee amount for CY 2014 is $542.00. This 

represents a $6.00 difference from the 

$536 application fee amount that we 

had originally projected for CY 2014 in 

the February 2, 2011 final rule. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). However, it does 

reference currently approved 

information collections. Form CMS– 

855A, and CMS–855I are approved 

under OMB control number 0938–0685. 

Form CMS–855B is approved under 

OMB control number 0938–1198. Form 

CMS–855S is approved under OMB 

control number 0938–1056. 

IV. Regulatory Impact Statement 

We have examined the impact of this 

notice 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), 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, 


emcdonald on DSK67QTVN1PROD with NOTICES
72090 Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Notices 

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). As 

explained in this section of the notice 

(section IV.), we estimate that the total 

cost of the increase in the application 

fee will not exceed $100 million. This 

notice therefore does not reach the $100 

million economic threshold and is not 

considered a major notice. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. 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 $7.0 million to $35.5 

million in any 1 year. Individuals and 

states are not included in the definition 

of a small entity. As we stated in the 

RIA for the February 2, 2011 final rule 

with comment period (76 FR 5952), we 

do not believe that the application fee 

will have a significant impact on small 

entities. 

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 for 

Medicare payment regulations and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined, 

and the Secretary certifies, that this 

notice would not have a significant 

impact on the operations of a substantial 

number of small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

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 2013, that 

threshold is approximately $141 

million. The Agency has determined 

that there will be minimal impact from 

the costs of this notice, as the threshold 

is not met under the UMRA. 

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 notice does not impose 

substantial direct costs on state or local 

governments, the requirements of 

Executive Order 13132 are not 

applicable. 

The costs associated with this notice 

involve the increase in the application 

fee that certain providers and suppliers 

must pay in CY 2014. As indicated 

earlier, in the RIA for the February 2, 

2011 final rule, we estimated the total 

amount of application fees for CYs 2011 

through 2015. For CY 2014, and based 

on a $536 application fee amount, we 

projected in Tables 11 and 12 (76 FR 

5955 and 5956) a total cost in fees of 

$62,189,400 ($16,723,200 + 

$45,466,200) for 116,025 affected 

Medicare institutional providers (31,200 

newly enrolling + 84,825 re-enrolling). 

We also projected in Tables 13 and 14 

(76 FR 5957 and 5958) a total cost in CY 

2014 application fees of $13,471,824 

($4,522,768 + $8,949,056) for 25,134 

affected Medicaid and CHIP providers 

(8,438 newly enrolling + 16,696 reenrolling). 

In the November 30, 2012 application 

fee notice, we stated in part that we 

were— 

• Increasing the estimated number of 

affected Medicaid and CHIP providers 

in CY 2013 from 25,134 to 27,859, based 

on CY 2009 and CY 2010 data furnished 

by State Medicaid agencies through the 

annual State Program Integrity 

Assessment; and 

• Reducing the estimated number of 

affected Medicare institutional 

providers from 116,025 to 84,120. This 

was due to a much-lower-than-expected 

number of affected newly-enrolling 

institutional providers. We had 

projected in the February 2, 2011 final 

rule that 31,200 newly-enrolling 

institutional providers would be subject 

to an application fee in CY 2013. We 

reduced this figure to 4,120 based on 

CMS data. 

Our statistics indicate that roughly the 

same number of Medicaid and CHIP 

providers that we projected in the 

November 30, 2012 fee notice would be 

subject to an application fee in CY 2013 

will be similarly affected in CY 2014. 

We will therefore use the CY 2013 

figures in our calculations of the fee 

costs for CY 2014. However, as 

explained later in this section, we 

project that the number of affected 

Medicare institutional providers in CY 

2014 will be higher than the CY 2013 

projection we used in the November 30, 

2012 fee notice. 

1. Medicare 

a. Newly-Enrolling Institutional 

Providers 

Based on CMS statistics for the final 

quarter of CY 2012, we estimate that 

4,800 newly-enrolling institutional 

providers will be subject to an 

application fee in CY 2014. This 

represents an increase of 670 from the 

CY 2013 projection we used in the 

November 30, 2012 fee notice. 

b. Revalidating Institutional Providers 

Again based on CMS data, we 

estimate that approximately 580,000 

Medicare providers and suppliers will 

be subject to revalidation in CY 2014. 

(This represents an increase of 180,000 

from the CY 2013 projection we used in 

the November 30, 2012 fee notice.) Of 

this total, and based on our experience, 

we believe that roughly 80 percent of 

them will be exempt from the 

application fee requirement because the 

provider or supplier: (1) Is of a type (for 

example, a physician) that is exempt 

from the requirement; or (2) qualifies for 

a hardship exception under 42 CFR 

424.514(c). This leaves 116,000 

revalidating institutional providers that 

will have to pay the fee. Using a figure 

of 120,800 (116,000 revalidating + 4,800 

newly-enrolling) institutional providers, 

we estimate an increase in the cost of 

the Medicare application fee 

requirement in CY 2014 of $ 724,800 (or 

120,800 x $6.00) from the CY 2014 

projections we had made in the 

February 2, 2011 final rule. 

2. Medicaid and CHIP 

We estimate that 27,859 (8,438 newly 

enrolling + 19,421 re-enrolling) 

Medicaid and CHIP providers would be 

subject to an application fee in CY 2014. 

Using this figure, we estimate an 

increase in the cost of the Medicaid and 

CHIP application fee requirements in 

CY 2014 of $167,154 (27,859 x $6.00) 

from the CY 2014 projections we had 

made in the February 2, 2011 final rule. 

3. Total 

Based on the foregoing, we estimate 

the total increase in the cost of the 

application fee requirement for 

Medicare, Medicaid, and CHIP 

providers and suppliers in CY 2014 to 

be $891,954 ($724,800 + $167,154) from 

the CY 2014 projections we had made 

in the February 2, 2011 final rule. 

In accordance with the provisions of 

Executive Order 12866, this 

notice was/was not reviewed by the 

Office of Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Notices 72091 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 7, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–28733 Filed 11–29–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0719] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Planning for the Effects of 

High Absenteeism To Ensure 

Availability of Medically Necessary 

Drug Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 2, 

2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0675. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Planning for 

the Effects of High Absenteeism To 

Ensure Availability of Medically 

Necessary Drug Products—(OMB 

Control Number 0910–0675)—Extension 

The guidance recommends that 

manufacturers of drug and therapeutic 

biological products and manufacturers 

of raw materials and components used 

in those products develop a written 

Emergency Plan (Plan) for maintaining 

an adequate supply of medically 

necessary drug products (MNPs) during 

an emergency that results in high 

employee absenteeism. The guidance 

discusses the issues that should be 

covered by the Plan, such as: (1) 

Identifying a person or position title (as 

well as two designated alternates) with 

the authority to activate and deactivate 

the Plan and make decisions during the 

emergency; (2) prioritizing the 

manufacturer’s drug products based on 

medical necessity; (3) identifying 

actions that should be taken prior to an 

anticipated period of high absenteeism; 

(4) identifying criteria for activating the 

Plan; (5) performing quality risk 

assessments to determine which 

manufacturing activities may be 

reduced to enable the company to meet 

a demand for MNPs; (6) returning to 

normal operations and conducting a 

post-execution assessment of the 

execution outcomes; and (7) testing the 

Plan. The guidance recommends 

developing a Plan for each individual 

manufacturing facility as well as a 

broader Plan that addresses multiple 

sites within the organization. For 

purposes of this information collection 

analysis, we consider the Plan for an 

individual manufacturing facility as 

well as the broader Plan to comprise one 

Plan for each manufacturer. Based on 

FDA’s data on the number of 

manufacturers that would be covered by 

the guidance, we estimate that 

approximately 70 manufacturers will 

develop a Plan as recommended by the 

guidance (i.e., one Plan per 

manufacturer to include all 

manufacturing facilities, sites, and drug 

products), and that each Plan will take 

approximately 500 hours to develop, 

maintain, and update. 

The guidance also encourages 

manufacturers to include a procedure in 

their Plan for notifying the Center for 

Drug Evaluation and Research (CDER) 

when the Plan is activated and when 

returning to normal operations. The 

guidance recommends that these 

notifications occur within 1 day of a 

Plan’s activation and within 1 day of a 

Plan’s deactivation. The guidance 

specifies the information that should be 

included in these notifications, such as 

which drug products will be 

manufactured under altered procedures, 

which products will have 

manufacturing temporarily delayed, and 

any anticipated or potential drug 

shortages. We expect that approximately 

2 notifications (for purposes of this 

analysis, we consider an activation and 

a deactivation notification to equal one 

notification) will be sent to CDER by 

approximately 2 manufacturers each 

year, and that each notification will take 

approximately 16 hours to prepare and 

submit. 

The guidance also refers to previously 

approved collections of information 

found in FDA regulations. Under the 

guidance, if a manufacturer obtains 

information after releasing an MNP 

under its Plan, leading to suspicion that 

the product might be defective, CDER 

should be contacted immediately at 

drugshortages@fda.hhs.gov in 

adherence to existing recall reporting 

regulations (21 CFR 7.40; OMB control 

number 0910–0249), or defect reporting 

requirements for drug application 

products (21 CFR 314.81(b)(1)) and 

therapeutic biological products 

regulated by CDER (21 CFR 600.14) 

(OMB control numbers 0910–0001 and 

0910–0458, respectively). 

In addition, the following collections 

of information found in FDA current 

good manufacturing practice (CGMP) 

regulations in part 211 (21 CFR part 

211) are approved under OMB control 

number 0910–0139. The guidance 

encourages manufacturers to maintain 

records, in accordance with the CGMP 

requirements (see, e.g., § 211.180) that 

support decisions to carry out changes 

to approved procedures for 

manufacturing and release of products 

under the Plan. The guidance states that 

a Plan should be developed, written, 

reviewed, and approved within the 

site’s change control quality system in 

accordance with the requirements in 

§§ 211.100(a) and 211.160(a); execution 

of the Plan should be documented in 

accordance with the requirements 

described in § 211.100(b); and standard 

operating procedures should be 

reviewed and revised or supplementary 

procedures developed and approved to 

enable execution of the Plan. 

In the Federal Register of June 21, 

2013 (78 FR 37548), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

information collection as follows: 


emcdonald on DSK67QTVN1PROD with NOTICES