Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 9295 

(2) Section 1902(a)(19) of the Act 

requires that States provide care and 

services consistent with the best 

interests of the recipients. 

(3) Section 1902(a)(30) of the Social 

Security Act requires that State payment 

methods must be consistent with 

efficiency, economy, and quality of care. 

(b) Definitions. As used in this 

section— 

Health care-acquired condition means 

a condition identified as a HAC by the 

Secretary under section 

1886(d)(4)(D)(iv) of the Act for purposes 

of the Medicare program and other 

HACs identified in the State plan that 

the State determines meet the 

requirements described in section 

1886(d)(4)(D)(ii) and (iv) of the Act. 

Other provider-preventable condition 

means a condition occurring in any 

health care setting that meets the 

following criteria: 

(i) Could have reasonably been 

prevented through the application of 

evidence based guidelines. 

(ii) Has a negative consequence for the 

beneficiary. 

(iii) Is identified in the State plan. 

(iv) Is auditable. 

(v) Includes, at a minimum, wrong 

surgical or other invasive procedure 

performed on a patient; surgical or other 

invasive procedure performed on the 

wrong body part; surgical or other 

invasive procedure performed on the 

wrong patient. 

Provider-preventable condition means 

a condition that meets the definition of 

a ‘‘health care-acquired condition’’ or an 

‘‘other provider-preventable condition’’ 

as defined in this section. 

(c) General rules. 

(1) A State plan must provide that no 

medical assistance will be paid for 

‘‘provider-preventable conditions’’ as 

defined in this section. 

(2) Reductions in provider payment 

may be limited to the extent that the 

following apply: 

(i) The identified providerpreventable conditions would otherwise 

result in an increase in payment. 

(ii) The State can reasonably isolate 

for nonpayment the portion of the 

payment directly related to treatment 

for, and related to, the providerpreventable conditions. 

(3) FFP will not be available for any 

State expenditure for providerpreventable conditions. 

(4) A State plan must ensure that 

payment for services is sufficient to 

assure access to services for Medicaid 

beneficiaries in accordance with section 

1902(a)(30)(A) of the Act. 

(d) Reporting. State plans must 

require that providers identify providerpreventable conditions that are 

associated with claims for Medicaid 

payment or with courses of treatment 

furnished to Medicaid patients for 

which Medicaid payment would 

otherwise be available. 

Authority: Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program. 

Dated: November 17, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: December 13, 2011. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2011–3548 Filed 2–16–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 5b 

RIN 0906–AA91 

Privacy Act; Exempt Record System 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposed rule would 

exempt the system of records (09–15– 

0054, the National Practitioner Data 

Bank for Adverse Information on 

Physicians and Other Health Care 

Practitioners, HHS/HRSA/BHPr) for the 

National Practitioner Data Bank (NPDB) 

from certain provisions of the Privacy 

Act. The exemption is necessary due to 

the recent expansion of the NPDB under 

section 1921 of the Social Security Act 

to include the investigative materials 

compiled for law enforcement purposes 

reported to the Healthcare Integrity and 

Protection Data Bank (HIPDB). The 

system of records for the HIPDB has an 

exemption from certain provisions of 

the Privacy Act. In order to maintain the 

exemption for the HIPDB investigative 

materials, which are now also available 

through the NPDB, it is necessary to 

expand the same privacy act exemptions 

for the HIPDB to the NPDB. This rule 

specifically seeks public comments on 

the proposed exemption. 

DATES: To assure consideration, public 

comments must be delivered to the 

address provided below by no later than 

5 p.m. on April 18, 2011. 

ADDRESSES: You may submit comments 

in one of the three ways listed below. 

The first is the preferred method. Please 

submit your comments in only one of 

these ways, so that no duplicates are 

received. 

• Federal eRulemaking Portal. You 

may submit comments electronically to 

http://www.regulations.gov. Click on the 

link ‘‘Submit electronic comments on 

HRSA regulations with an open 

comment period.’’ Submit your actual 

comments as an attachment to your 

message or cover letter. (Attachments 

should be in Microsoft Word or 

WordPerfect; however, we prefer 

Microsoft Word.) 

• By regular, express or overnight 

mail. You may mail written comments 

to the following address only: Health 

Resources and Services Administration, 

Department of Health and Human 

Services, Attention: HRSA Regulations 

Officer, Parklawn Building Rm. 14A–11, 

5600 Fishers Lane, Rockville, MD 

20857. Please allow sufficient time for 

mailed comments to be received before 

the close of the comment period. 

• Delivery by hand (in person or by 

courier). If you prefer, you may deliver 

your written comments before the close 

of the comment period to the same 

address: Parklawn Building Room 14A– 

11, 5600 Fishers Lane, Rockville, MD 

20857. Please call in advance to 

schedule your arrival with one of our 

HRSA Regulations Office staff members 

at telephone number (301) 443–1785. 

Because of staffing and resource 

limitations, and to ensure that no 

comments are misplaced, we cannot 

accept comments by facsimile (FAX) 

transmission. 

In commenting, please refer to RIN 

0906–AA91. Comments are available for 

public viewing on the Federal 

eRulemaking portal at http:// 

www.regulations.gov. Comments 

received on a timely basis will be 

available for public inspection as they 

are received in Room 14A–11 of the 

Health Resources and Services 

Administration’s offices at 5600 Fishers 

Lane, Rockville, MD, Monday through 

Friday of each week (Federal holidays 

excepted) from 8:30 a.m. to 5 p.m. 

(phone: 301–443–1785). 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Practitioner Data 

Banks, Bureau of Health Professions, 

Health Resources and Services 

Administration, Parklawn Building, 

5600 Fishers Lane, Room 8–103, 

Rockville, MD 20857; telephone 

number: (301) 443–2300. 

SUPPLEMENTARY INFORMATION: On 

January 28, 2010, the Health Resources 

and Services Administration published 

a final rule in the Federal Register (75 

FR 4656) designed to implement section 

1921 of the Social Security Act (herein 

referred to as section 1921). Section 

1921 expands the scope of the NPDB. 

Section 1921 requires each state to 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
9296 Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 

1Subsections (c)(3), (d)(1)–(4), and (e)(4)(G) and 

(H) of the Privacy Act, in accordance with 5 U.S.C. 

552a(k)(2) and proposed 45 CFR 5b.11(b)(2)(ii)(L). 

adopt a system of reporting to the 

Secretary certain adverse licensure 

actions taken against health care 

practitioners and health care entities by 

any authority of the state responsible for 

the licensing of such practitioners or 

entities. It also requires each state to 

report any negative action or finding 

that a state licensing authority, a peer 

review organization, or a private 

accreditation entity has finalized against 

a health care practitioner or entity. 

Practically speaking, Section 1921 

resulted in, among other consequences, 

the transfer of the vast majority of 

information contained in the HIPDB to 

the NPDB. 

The HIPDB was created by the Health 

Insurance Portability and 

Accountability Act (HIPAA) of 1996, 

Public Law (Pub. L. 104–191), which 

required the Secretary, acting through 

the Office of Inspector General (OIG) 

and the United States Attorney General, 

to establish a new health care fraud and 

abuse control program to combat health 

care fraud and abuse. 

Groups that have access to this 

information include all organizations 

eligible to query the NPDB under the 

Health Care Quality Improvement Act of 

1986 (hospitals, other health care 

entities that conduct peer review and 

provide health care services, state 

medical or dental boards and other 

health care practitioner state boards), 

other state licensing authorities, 

agencies administering federal health 

care programs, including private entities 

administering such programs under 

contract, state agencies administering or 

supervising the administration of state 

health care programs, State Medicaid 

Fraud Control Units, and certain law 

enforcement agencies, and utilization 

and quality control peer review 

organizations (referred to as QIOs) as 

defined in Part B of title XI of the Social 

Security Act and appropriate entities 

with contracts under section 

1154(a)(4)(C) of the Social Security Act. 

Individual health care practitioners and 

entities can self-query. 

One of the primary purposes of these 

data will be use of this information by 

a federal or state government agency 

charged with the responsibility of 

investigating or prosecuting a case 

where there is an indication of a 

violation or potential violation of law, 

whether civil, criminal, or regulatory in 

nature. The information in this system 

may also be used in the preparation for 

a trial or hearing for such violation. 

Specifically, this proposed rule would 

exempt this data bank from certain 

provisions of the Privacy Act.1 This 

exemption is intended to protect, from 

release to the record subject, 

information on law enforcement queries 

to the data bank. It would also exempt 

the data bank from Privacy Act access 

and amendment procedures in order to 

establish access and amendment 

procedures in the NPDB regulations. 

While subjects will have access to 

information on all other queries to the 

data bank, disclosure of law 

enforcement queries could compromise 

ongoing investigation activities. The 

premature disclosure of the existence of 

a law enforcement activity to an outside 

party (who may also be the subject of 

the investigation) could lead to, among 

other things, the destruction or 

alteration of evidence and the tampering 

with witnesses. 

Record subjects are guaranteed access 

to, and correction rights for, substantive 

information reported to the NPDB. The 

procedures, appearing in 45 CFR part 

60, use the Privacy Act access and 

correction procedures as a basic 

framework while, at the same time, 

providing significant additional rights 

(such as automatic notification to the 

record subject of any report filed with 

the data bank). Data bank subjects also 

have broader rights on NPDB correction 

procedures, including the right to file a 

statement of disagreement as soon as a 

report is filed with the data bank. 

Economic and Regulatory Impact 

The Office of Management and Budget 

has reviewed this proposed rule in 

accordance with the provisions of 

Executive Order 12866 and the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), as amended by Executive 

Orders 13258 and 13422, and has 

determined that it will have no major 

effect on the economy or federal 

expenditures. Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when rulemaking is 

necessary, to select regulatory 

approaches that maximize net benefits, 

including potential economic, 

environmental, public health, safety 

distributive and equity effects. 

The Secretary has determined that 

this proposed rule is not a ‘‘major rule’’ 

within the meaning of the statute 

providing for Congressional Review of 

Agency Rulemaking, 5 U.S.C. 801, and 

has determined that it does not meet the 

criteria for a significant regulatory 

action. In addition, under the Small 

Business Enforcement Act (SBEA) of 

1996, if a rule has a significant 

economic effect on a substantial number 

of small businesses, the Secretary must 

specifically consider the economic 

effect of a rule on small business entities 

and analyze regulatory options that 

could lessen the impact of the rule. The 

Secretary has reviewed this proposed 

exemption in accordance with the 

provisions of the SBEA and certifies that 

this proposed exemption will not have 

a significant impact on a substantial 

number of small entities. Specifically, as 

indicated above, while the reports of 

adverse actions to the NPDB will be 

known to the subjects of the records in 

the data bank, the access and use of 

such information by law enforcement 

agencies would not be known to the 

subjects of the records. As a result, we 

believe that disclosure of this 

information could compromise ongoing 

law enforcement activities. 

Similarly, it will not have effects on 

state, local, and tribal governments and 

on the private sector such as to require 

consultation under the Unfunded 

Mandates Reform Act of 1995. 

The Secretary has reviewed this 

proposed rule in accordance with 

Executive Order 13132 regarding 

federalism, and has determined that it 

does not have ‘‘federalism implications.’’ 

This rule would not ‘‘have substantial 

direct effects on the states, or on the 

relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

The proposals made in this notice of 

proposed rulemaking, if implemented, 

would not adversely affect the following 

family elements: family safety, family 

stability, marital commitment; parental 

rights in the education, nurture and 

supervision of their children; family 

functioning, disposable income, or 

poverty; or the behavior and personal 

responsibility of youth, as determined 

under section 654(c) of the Treasury and 

General Government Appropriations 

Act of 1999. 

Paperwork Reduction Act 

This proposed rule does not have any 

information collection requirements. 

Dated: December 22, 2010. 

Mary Wakefield, 

Administrator, Health Resources and Services 

Administration. 

Approved: January 19, 2011. 

Kathleen Sebelius, 

Secretary. 

List of Subjects in 45 CFR Part 5b 

Privacy. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 33 / Thursday, February 17, 2011 / Proposed Rules 9297 

Accordingly, 45 CFR part 5b is 

proposed to be amended as set forth 

below: 

PART 5b—PRIVACY ACT 

REGULATIONS 

1. The authority citation for part 5b 

continues to read as follows: 

Authority: 5 U.S.C. 301, 5 U.S.C. 552a. 

2. In § 5b.11, add paragraph 

(b)(2)(ii)(L) to read as follows: 

§ 5b.11 Exempt systems. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) * * * 

(L) Investigative materials compiled 

for law enforcement purposes for the 

National Practitioner Data Bank (NPDB). 

(See § 60.16 of this title for access and 

correction rights under the NPDB by 

subjects of the Data Bank.) 

* * * * * 

[FR Doc. 2011–3513 Filed 2–16–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

[Docket No. FWS–R2–ES–2009–0014; 

92210–1117–0000–B4] 

RIN 1018–AW50 

Endangered and Threatened Wildlife 

and Plants; Proposed Designation of 

Critical Habitat for Roswell 

Springsnail, Koster’s Springsnail, 

Noel’s Amphipod, and Pecos 

Assiminea 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; revision and 

reopening of comment period. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service, announce reopening of 

the public comment period on the June 

22, 2010, proposal to revise designated 

critical habitat for the Pecos assiminea 

(Assiminea pecos), and to newly 

designate critical habitat for the Roswell 

springsnail (Pyrgulopsis roswellensis), 

Koster’s springsnail (Juturnia kosteri), 

and Noel’s amphipod (Gammarus 

desperatus), under the Endangered 

Species Act of 1973, as amended (Act). 

We also announce revisions to the 

proposed critical habitat, as it was 

described in the proposed rule 

published in the Federal Register on 

June 22, 2010 (75 FR 35375). In total, we 

are proposing to designate as critical 

habitat 520.8 acres (210.8 hectares) for 

the four species. In this proposal we 

include as critical habitat for Noel’s 

amphipod an additional 5.8 acres (2.3 

hectares) for Chaves County, New 

Mexico, as a population of amphipods 

was recently confirmed to be Noel’s 

amphipod at this location. We are 

reopening the comment period to allow 

all interested parties an opportunity to 

comment simultaneously on the revised 

proposed rule, the associated economic 

analysis, environmental assessment, and 

the amended required determinations. 

DATES: We will consider comments 

received on or before March 21, 2011. 

Comments must be received by 11:59 

p.m. Eastern Time on the closing date. 

Any comments that we receive after the 

closing date may not be fully considered 

in the final decision on this action. 

ADDRESSES: You may submit comments 

by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Search for docket 

number FWS–R2–ES–2009–0014 and 

then follow the instructions for 

submitting comments. 

• U.S. mail or hand-delivery: Public 

Comments Processing, Attn: Docket No. 

FWS–R2–ES–2009–0014; Division of 

Policy and Directives Management; U.S. 

Fish and Wildlife Service; 4401 N. 

Fairfax Drive, Suite 222; Arlington, VA 

22203. 

We will post all comments on 

http://www.regulations.gov. This 

generally means that we will post any 

personal information you provide us 

(see the Public Comments section below 

for more information). 

FOR FURTHER INFORMATION CONTACT: 

Wally ‘‘J’’ Murphy, Field Supervisor, 

U.S. Fish and Wildlife Service, New 

Mexico Ecological Services Field Office, 

2105 Osuna Rd., NE., Albuquerque, NM 

87113; telephone 505–761–4781; 

facsimile 505–246–2542. If you use a 

telecommunications device for the deaf 

(TDD), call the Federal Information 

Relay Service (FIRS) at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Public Comments 

We will accept written comments and 

information during this reopened 

comment period on our proposed 

designation of the proposed revisions to 

critical habitat for the Pecos assiminea 

(Assiminea pecos), and the proposed 

critical habitat for the Roswell 

springsnail (Pyrgulopsis roswellensis), 

Koster’s springsnail (Juturnia kosteri), 

and Noel’s amphipod (Gammarus 

desperatus) (four invertebrates) that was 

published in the Federal Register on 

June 22, 2010, (75 FR 35375), and the 

additional area proposed in this notice. 

As a result of information sent to us in 

response to our June 22, 2010, proposal 

and request for comments, we became 

aware that a population of amphipods 

was confirmed to be Noel’s amphipod 

along the Rio Hondo, on the South Tract 

of Bitter Lake National Wildlife Refuge. 

We are particularly interested in 

information on our proposed inclusion 

of this new habitat in our final critical 

habitat designation, including 

comments on the economic analysis and 

environmental assessment of the 

proposed designation related to this 

new area. We particularly seek 

comments concerning: 

(1) The reasons why we should or 

should not designate habitat as ‘‘critical 

habitat’’ under section 4 of the 

Endangered Species Act of 1973, as 

amended (Act) (16 U.S.C. 1531 et seq.), 

including whether there are threats to 

the species from human activity, the 

degree of which can be expected to 

increase due to the designation, and 

whether that increase in threat 

outweighs the benefit of designation 

such that the designation of critical 

habitat is not prudent. 

(2) Specific information on: 

(a) The amount and distribution of 

habitat for the Roswell springsnail, 

Koster’s springsnail, Noel’s amphipod, 

and Pecos assiminea; 

(b) What areas occupied at the time of 

listing and that contain features 

essential to the conservation of the 

species we should include in the 

designation and why. We are 

particularly interested in information on 

the additional habitat containing the 

recently discovered Noel’s amphipod 

population on the South Tract of Bitter 

Lake National Wildlife Refuge; 

(c) Special management 

considerations or protections for areas 

that contain the features essential to the 

conservation of the Roswell springsnail, 

Koster’s springsnail, Noel’s amphipod, 

and Pecos assiminea that have been 

identified in this proposal, including 

management for the potential effects of 

climate change; and 

(d) What areas not occupied at the 

time of listing are essential for the 

conservation of the species and why. 

(3) Land use management and current 

or planned activities in the subject areas 

and their possible impacts on proposed 

critical habitat, particularly in the area 

occupied by the recently discovered 

Noel’s amphipod population on the 

South Tract of Bitter Lake National 

Wildlife Refuge. 

(4) Any foreseeable economic, 

national security, or other relevant 

impacts of designating any area that 

may be included in the final 

designation. We are particularly 


jlentini on DSKJ8SOYB1PROD with PROPOSALS