Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices 67743 

pseudomallei (formerly Pseudomonas 

pseudomallei); Hendra virus; Nipah virus; Rift 

Valley fever virus; Venezuelan Equine Encephalitis 

virus. 

25Section 2695B [42 U.S.C. 300ff–133]. 

26For example: 

Siegel JD, Rhinehart E, Jackson M, Chiarello L, 

and the Healthcare Infection Control Practices 

Advisory Committee. 2007 Guideline for Isolation 

Precautions: Preventing Transmission of Infectious 

Agents in Healthcare Settings. 

CDC. Updated U.S. Public Health Service 

Guidelines for the Management of Occupational 

Exposures to HIV and Recommendations for 

Postexposure Prophylaxis. MMWR 2005;54 (No. 

RR–9):1–17. 

toxins that have the potential to pose a 

severe threat to human health and that 

may be used for or adapted for 

bioterrorist attacks. There are special 

reporting requirements for Select 

Agents, as detailed in 42 CFR part 73. 

Those agents included on the HHS 

Select Agents List that are routinely 

transmitted person to person and for 

which natural transmission remains a 

significant concern are categorized in 

the ‘‘List of Potentially Life-Threatening 

Infectious Diseases to Which Emergency 

Response Employees May be Exposed,’’ 

Part I above, according to their modes of 

transmission. The remaining agents on 

the Select Agent List would not 

typically exhibit human-to-human 

transmission or be considered 

contemporary contagious threats. 

However, in the setting of potential 

intentional modification to artificially 

increase transmissibility and/or lethality 

(‘‘weaponization’’) and deployment as 

bio-weapons (potentially in quantities 

far greater than would naturally be 

encountered), atypical pathways of 

transmission may occur. In this case, 

EREs may be exposed by entering 

contaminated environments to care for 

victims and by exposure to 

contaminated individuals from those 

environments. 

Part III. Guidelines Describing the 

Manner in Which Medical Facilities 

Should Make Determinations for 

Purposes of Section 2695B(d) [42 U.S.C. 

300ff–133(d)] 

Section 2695B(d) [42 U.S.C. 300ff– 

133(d)] specifies that medical facilities 

must respond to appropriate requests by 

making determinations about whether 

EREs have been exposed to infectious 

diseases included on the list issued 

pursuant to sec. 2695(a)(1) [42 U.S.C. 

300ff–131(a)(1)]. A medical facility has 

access to two types of information 

related to a potential exposure incident 

to use in making a determination. First, 

the request submitted to the medical 

facility contains a ‘‘statement of the 

facts collected’’ about the ERE’s 

potential exposure incident.25

Information about infectious disease 

transmission provided in relevant CDC 

guidance documents 26 or in current 

medical literature should be considered 

in assessing whether there is a realistic 

possibility that the exposure incident 

described in the statement of the facts 

could potentially transmit an infectious 

disease included on the list issued 

pursuant to sec. 2695(a)(1) [42 U.S.C. 

300ff–131(a)(1)]. 

Second, the medical facility possesses 

medical information about the victim of 

an emergency transported and/or treated 

by the ERE. This is the medical 

information that the medical facility 

would normally obtain according to its 

usual standards of care to diagnose or 

treat the victim, since the Act does not 

require special testing in response to a 

request for a determination. As stated in 

sec. 2695G(b) [42 U.S.C. 300ff–138(b)], 

‘‘this part may not, with respect to 

victims of emergencies, be construed to 

authorize or require a medical facility to 

test any such victim for any infectious 

disease.’’ 

Information about the potential 

exposure incident and medical 

information about the victim should be 

used in the following manner to make 

one of the four possible determinations 

as required by sec. 2695B(d) [42 U.S.C. 

300ff–133(d)]: 

(1) The ERE involved has been 

exposed to an infectious disease 

included on the list: 

—Facts provided in the request 

document a realistic possibility that 

an exposure incident occurred with 

potential for transmitting a listed 

infectious disease from the victim of 

an emergency to the involved ERE; 

and 

—The medical facility possesses 

sufficient medical information 

allowing it to determine that the 

victim of an emergency treated and/or 

transported by the involved ERE had 

a listed infectious disease that was 

possibly contagious at the time of the 

potential exposure incident. 

(2) The ERE involved has not been 

exposed to an infectious disease 

included on the list: 

—Facts provided in the request rule out 

a realistic possibility that an exposure 

incident occurred with potential for 

transmitting a listed infectious disease 

from the victim of an emergency to 

the involved ERE; or 

—The medical facility possesses 

sufficient medical information 

allowing it to determine that the 

victim of an emergency treated and/or 

transported by the involved ERE did 

not have a listed infectious disease 

that was possibly contagious at the 

time of the potential exposure 

incident. 

(3) The medical facility possesses no 

information on whether the victim 

involved has an infectious disease 

included on the list: 

—The medical facility lacks sufficient 

medical information allowing it to 

determine whether the victim of an 

emergency treated and/or transported 

by the involved ERE had, or did not 

have, a listed infectious disease at the 

time of the potential exposure 

incident. 

—If the medical facility subsequently 

acquires sufficient medical 

information allowing it to determine 

that the victim of an emergency 

treated and/or transported by the 

involved ERE had a listed infectious 

disease that was possibly contagious 

at the time of the potential exposure 

incident, then it should revise its 

determination to reflect the new 

information. 

(4) The facts submitted in the request 

are insufficient to make the 

determination about whether the ERE 

was exposed to an infectious disease 

included on the list: 

—Facts provided in the request 

insufficiently document the exposure 

incident, making it impossible to 

determine if there was a realistic 

possibility that an exposure incident 

occurred with potential for 

transmitting an infectious disease 

included on the list issued pursuant 

to Section 2695(a)(1) [42 U.S.C. 300ff– 

131(a)(1)] from the victim of an 

emergency to the involved ERE. 

Dated: October 26, 2011. 

James W. Stephens, 

Director, Office of Science Quality, Office of 

the Associate Director for Science, Centers 

for Disease Control and Prevention. 

[FR Doc. 2011–28234 Filed 11–1–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6049–N] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Provider 

Enrollment Application Fee Amount for 

Calendar Year 2012 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

$523 calendar year (CY) 2012 


emcdonald on DSK5VPTVN1PROD with NOTICES
67744 Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices 

application fee for institutional 

providers that are initially enrolling in 

the Medicare or Medicaid programs or 

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, 2012 and on or before 

December 31, 2012. 

DATES: Effective Date: This notice is 

effective on December 2, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Frank Whelan, (410) 786–1302 for 

Medicare enrollment issues. Claudia 

Simonson, (312) 353–2115 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 Children’s Health 

Insurance Program (CHIP) provider 

enrollment processes. Specifically, and 

as indicated 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 an enrollment 

application submitted on or after March 

25, 2011. An ‘‘institutional provider’’ is 

defined at 42 CFR 424.502 as— 

Any 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 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. 

In the March 23, 2011 Federal 

Register (76 FR 16422), we published a 

notice announcing— 

• A $505 calendar year (CY) 2011 

application fee for institutional 

providers that are initially enrolling in 

the Medicare, Medicaid, or CHIP 

program; revalidating their enrollment; 

or adding a new Medicare practice 

location; 

• That institutional providers are 

required to submit the $505 fee with 

enrollment applications submitted on or 

after March 25, 2011 and on or before 

December 31, 2011; and 

• That prospective or re-enrolling 

Medicaid or CHIP providers must 

submit the application fee unless: (1) 

The provider is an individual physician 

or non-physician practitioner; or (2) the 

provider 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. Current Fee Amount 

As noted in section I. of this notice, 

the fee amount for the period of March 

25, 2011 through December 31, 2011 is 

$505. 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) for the 12-month period ending 

with June of the previous year. 

• The CPI increase for CY 2011, 

which was calculated to be 1.0 percent, 

was based on data obtained from the 

Bureau of Labor Statistics. This resulted 

in an application fee for CY 2011 of 

$505 (or $500 × 1.01). For more detailed 

information on the CPI and the 

calculation of the application fee, see 

the February 2, 2011 final rule with 

comment period (76 FR 5955) and the 

March 23, 2011 notice (76 FR 16423). 

B. Fee Amount for Calendar Year 2012 

The CPI increase for the period of July 

2010 through June 2011 was 3.54 

percent, based on data obtained from 

the Bureau of Labor Statistics. (This 

percentage is higher than the 2.0 percent 

CPI increase that we estimated for CY 

2012 in the February 2, 2011 final rule 

with comment period (76 FR 5955).) 

This results in a projected application 

fee amount for the period of January 1, 

2012 through December 31, 2012 of 

$522.87 (or $505 × 1.0354). However, in 

the preamble to the February 2, 2011 

final rule with comment period (76 FR 

5907), we stated that ‘‘(t)o ease the 

administration of the fee, if the 

adjustment sets the fee at an uneven 

dollar amount, we will round the fee to 

the nearest whole dollar amount.’’ 

Therefore, the projected application fee 

amount for CY 2012 will be rounded to 

the ‘‘nearest whole dollar amount,’’ 

which is $523.00. This represents an 

$8.00 difference from the $515 fee that 

we had originally projected for CY 2012. 

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 previously approved 

information collections. As stated in 

section I. of this notice, the forms CMS– 

855A, CMS–855B, and CMS–855I are 

approved under OMB control number 

0938–0685; the 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 (February 2, 

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, 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 rule. 


emcdonald on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices 67745 

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 $7.0 million to $34.5 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) and the 

regulatory impact statement of the 

March 23, 2011 notice (76 FR 16423), 

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 

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 2011, that 

threshold is approximately $136 

million. This notice does not mandate 

such expenditures by States and local 

governments. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed 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 2012. In the RIA for the 

February 2, 2011 final rule with 

comment period (76 FR 5955 through 

5958), we estimated the total amount of 

application fees for CYs 2011 through 

2015. For 2012, and based on a $515 

application fee, we projected in Tables 

11 and 12 (76 FR 5955 and 5956) a total 

cost in fees of $71,803,875 for Medicare 

institutional providers (or 139,425 

providers × $515). In the February 2, 

2011 final rule with comment period (76 

FR 5957 and 5958), we estimated the 

total cost in CY 2012 for Medicaid 

providers to be $12,944,010 (or 25,134 

providers × $515), as indicated in Tables 

13 and 14. 

We are retaining the figure of 25,134 

Medicaid providers for purposes of this 

notice. However, we are changing the 

Medicare provider estimate based on 

our plan to revalidate all Medicare 

providers and suppliers– even if the 

revalidation is considered ‘‘off-cycle’’ 

per 42 CFR 424.515(e). 

1. Medicare 

For purposes of this notice only, we 

estimate that approximately 840,000 

Medicare providers and suppliers will 

be subject to revalidation in CY 2012. Of 

this total, we believe that roughly 80 

percent 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 168,000 

revalidating providers and suppliers 

that will have to pay the fee. 

In the February 2, 2011 final rule with 

comment period (76 FR 5955), we 

estimated that 31,200 newly-enrolling 

institutional providers would be subject 

to the application fee in CY 2012. We 

stand by this projection for purposes of 

this notice. Using a figure of 199,200 

providers and suppliers (168,000 + 

31,200), we estimate an increase in the 

cost of the Medicare application fee 

requirement in CY 2012 of $1,593,600 

(or 199,200 × $8.00). 

2. Medicaid and CHIP 

In the February 2, 2011 final rule with 

comment period (76 FR 5957 and 5958), 

we estimated that 25,134 (8,438 newly 

enrolling + 16,696 re-enrolling) 

Medicaid and CHIP providers would be 

subject to an application fee in CY 2012. 

This results in an increase in the cost of 

the Medicaid and CHIP application fee 

requirement in CY 2012 of $201,072 (or 

25,134 × $8.00). 

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 2012 to 

be $1,794,672. 

In accordance with the provisions of 

Executive Order 12866, this notice 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 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 30, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–28424 Filed 11–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Descriptive Study of Tribal 

Temporary Assistance for Needy 

Families (TANF) Programs. 

OMB No.: New Collection. 

Description: The Administration for 

Children and Families (ACF) is 

proposing an information collection 

activity as part of the Descriptive Study 

of Tribal TANF Programs. The proposed 

information collection consists of semistructured interviews and focus groups 

with key Tribal TANF respondents on 

questions of Tribal TANF 

administration, policies, service 

delivery, and program context. Through 

this information collection, ACF seeks 

to gain an in-depth, systematic 

understanding of program 

implementation, operations, outputs 

and outcomes in selected sites, and 

identify promising practices and other 

areas for further study. 

Respondents: Tribal TANF 

administrators, staff and participants, 

and staff of related programs. 


emcdonald on DSK5VPTVN1PROD with NOTICES