38026 Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Rules and Regulations 

chapter 51.352, and attachments 4 and 

5. 

(3) Health and Safety Code (2009): 

Division 26, Part 1, Chapter 2, section 

39032.5; Part 5, Chapter 5 (Motor 

Vehicle Inspection Program), Articles 1– 

9. 

(4) Business and Professions Code 

(2008): Division 3, Chapter 20.3 

(Automotive Repair), Article 4, sections 

9886, 9886.1, 9886.2, 9886.3, 9886.4. 

(5) Vehicle Code (2009): Division 3, 

Chapter 1 (Original and Renewal of 

Registration; Issuance of Certificates of 

Title), Article 1, sections 4000.1, 4000.2, 

4000.3, 4000.6. 

(373) The following revisions to the 

California Motor Vehicle Inspection and 

Maintenance Program were submitted 

on October 28, 2009, by the Governor’s 

Designee. 

(i) [Reserved] 

(ii) Additional material. 

(A) California Air Resources Board. 

(1) California I/M Program SIP 

Revision—Additional Enhanced I/M 

Performance Modeling, Tables of 

Results, excluding New Mobile 6 Input 

and Output Files and New Registration 

Distribution Files. 

* * * * * 

■ 3. Section 52.241 is revised to read as 

follows: 

§ 52.241 Inspection and maintenance 

program. 

(a) [Reserved] 

(b) Approval. On June 5, 2009, the 

California Air Resources Board 

submitted a revision to the California 

Motor Vehicle Inspection and 

Maintenance Program (2009 I/M 

Revision) to satisfy the requirements for 

basic and enhanced motor vehicle 

inspection and maintenance (I/M) in 

applicable ozone nonattainment areas. 

On October 28, 2009, the California Air 

Resources Board amended the 2009 I/M 

Revision to include revised enhanced 

performance program evaluations for six 

nonattainment areas. Approved 

elements of the 2009 I/M Revision, as 

amended on October 28, 2009, include 

a discussion of each of the required 

design elements of the I/M program; 

description of the current geographic 

coverage of the program; I/M-related 

statutes and regulations; enhanced I/M 

performance standard evaluations for 

the urbanized areas within six 

California ozone nonattainment areas 

(South Coast Air Basin, San Joaquin 

Valley, Sacramento Metro, Coachella 

Valley, Ventura County, and Western 

Mojave Desert); basic I/M performance 

standard evaluation for the urbanized 

area within the San Francisco Bay Area 

ozone nonattainment area; and emission 

analyzer specifications and test 

procedures, including BAR–97 

specifications. The 2009 I/M Revision, 

as amended on October 28, 2009, meets 

the requirements of sections 182(a)(2)(B) 

and 182(c)(3) of the Clean Air Act, as 

amended in 1990, and 40 CFR part 51, 

subpart S and is approved as a revision 

to the California State Implementation 

Plan. 

[FR Doc. 2010–16028 Filed 6–30–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 423 

[CMS–0023–IFC] 

RIN 0938–AP49 

Medicare Program; Identification of 

Backward Compatible Version of 

Adopted Standard for E–Prescribing 

and the Medicare Prescription Drug 

Program (NCPDP SCRIPT 10.6) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period identifies the National 

Council for the Prescription Drug 

Programs (NCPDP) Prescriber/ 

Pharmacist Interface SCRIPT standard, 

Implementation Guide, Version 10, 

Release 6 (Version 10.6), hereafter 

referred to as ‘‘NCPDP SCRIPT 10.6,’’ as 

a backward compatible update of the 

adopted NCPDP SCRIPT 8.1. This 

interim final rule with comment period 

therefore permits the voluntary use of 

NCPDP SCRIPT 10.6 for conducting 

certain e-prescribing transactions for the 

Medicare Part D electronic prescription 

drug program. 

DATES: Effective date: These regulations 

are effective on July 1, 2010. The 

incorporation by reference of the 

publication listed in these regulations is 

approved by the Director of the Federal 

Register as of July 1, 2010. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. 

Eastern Daylight Time (e.d.t.) on August 

30, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–0023–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions for ‘‘Submitting a 

Comment’’. 

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–0023–IFC, P.O. Box 8013, 

Baltimore, MD 21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address only: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–0023–IFC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–8013. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

7195 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by following 

the instructions at the end of the 

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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Rules and Regulations 38027 

‘‘Collection of Information 

Requirements’’ section in this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Morgan, (410) 786–2543 or 

andrew.morgan@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://regulations.gov. 

Follow the search instructions on that 

Web site to view public comments. 

Comments received timely will be 

also available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Section 101 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173) amended Title XVIII of the 

Social Security Act (the Act) to establish 

a voluntary prescription drug benefit 

program. Prescription Drug Plan (PDP) 

sponsors, Medicare Advantage (MA) 

organizations offering Medicare 

Advantage-Prescription Drug Plans 

(MAPDs) and other Medicare Part D 

sponsors are required to establish 

electronic prescription drug programs to 

provide for electronic transmittal of 

certain information to the prescribing 

provider, dispensing pharmacy and the 

dispenser. This includes information 

about eligibility, benefits (including 

drugs included in the applicable 

formulary, any tiered formulary 

structure and any requirements for prior 

authorization), the drug being 

prescribed or dispensed and other drugs 

listed in the medication history, as well 

as the availability of lower cost, 

therapeutically appropriate alternatives 

(if any) for the drug prescribed. Section 

101 of the MMA established section 

1860D–4(e) of the Act, which directed 

the Secretary to promulgate standards 

for the electronic transmission of such 

data. 

There is no requirement that 

prescribers or dispensers implement eprescribing. However, prescribers and 

dispensers who electronically transmit 

prescription and certain other 

prescription-related information for 

Medicare Part D covered drugs 

prescribed for Medicare Part D eligible 

individuals, directly or through an 

intermediary, are required to comply 

with any applicable final standards that 

are in effect. 

Section 1860D–4(e)(4)(A) of the Act 

required the Secretary to develop, 

adopt, recognize or modify ‘‘initial 

standards’’ for Part D e-prescribing. The 

Secretary identified six such standards. 

(For more information on these 

standards see the Report to Congress on 

the pilot project at http:// 

www.cms.hhs.gov/EPrescribing/ 

Downloads/E-RxReporttoCongress.pdf.) 

Section 1860D–4(e)(4) of the Act 

generally required the Secretary to 

conduct a pilot project to test these six 

initial standards that were recognized 

under section 1860D–4(e)(4)(A) of the 

Act. Based on the results of that pilot 

testing, the Secretary could then adopt 

these standards as final standards in 

accordance with section 1860D– 

4(e)(4)(D) of the Act. Section 1860D– 

4(e)(4)(C)(ii) of the Act created an 

exception to the requirement for pilot 

testing of initial standards where, after 

consultation with the National 

Committee on Vital and Health 

Statistics (NCVHS), the Secretary 

determined that there already was 

adequate industry experience with the 

standards. Such initial standards could 

be recognized by the Secretary and 

adopted through notice and comment 

rulemaking as final standards without 

pilot testing. 

We exercised this option in the 

‘‘Medicare Program; E-Prescribing and 

Prescription Drug Program’’ final rule, 

published on November 7, 2005 (70 FR 

67568). In that final rule we adopted 

three ‘‘foundation standards’’ that met 

the criteria for adoption without pilot 

testing. Those foundation standards 

included a standard for communicating 

prescription or prescription related 

information between the prescriber and 

dispensers for the transactions listed at 

§ 423.160(b)(2). That standard was 

entitled ‘‘the National Council for 

Prescription Drug Programs (NCPDP) 

SCRIPT standard, Implementation 

Guide, Version 5, Release 0 (Version 

5.0),’’ hereinafter referred to as ‘‘NCPDP 

SCRIPT 5.0.’’ 

The November 7, 2005 final rule (70 

FR 67579) also established a means of 

addressing the industry’s desire for a 

streamlined standards updating and 

maintenance process that could keep 

pace with changing business needs. 

That process provided for when a 

standard could be updated with a newer 

‘‘backward-compatible’’ version of the 

adopted standard, and identified 

whether and when the update/ 

maintenance would necessitate notice 

and comment rulemaking. In instances 

in which the user of the later version 

can accommodate users of the earlier 

version of the adopted standard without 

modification, notice and comment 

rulemaking could be waived, and use of 

either the new or old version of the 

adopted standard would be considered 

compliant upon the effective date of the 

newer version’s incorporation by 

reference in the Federal Register. This 

‘‘Backward Compatible’’ version 

updating process allows for the 

standards’ updating/maintenance to 

correct technical errors, eliminate 

technical inconsistencies, and add 

optional functions that provide optional 

enhancements to the specified eprescribing transaction standard. 

Subsequent industry input indicated 

that the adopted e-prescribing standard 

(NCPDP SCRIPT 5.0) should be updated 

to permit the use of either NCPDP 

SCRIPT 5.0 or a later version of the 

standard, NCPDP SCRIPT standard, 

Implementation Guide, Version 8, 

Release 1 (Version 8.1), October 2005, 

hereinafter referred to as NCPDP 

SCRIPT 8.1. 

Using the streamlined process 

established in the November 7, 2005 

final rule (70 FR 67568), we published 

an interim final rule with comment 

period on June 23, 2006, updating the 

adopted NCPDP SCRIPT standard, 

thereby permitting either NCPDP 

SCRIPT 5.0 or 8.1 to be used. (For more 

information, see the April 7, 2008 final 

rule (73 FR 18918) and the June 23, 

2006 interim final rule with comment 

period (71 FR 36020).) 

As noted previously, three of the six 

initial standards were adopted without 

pilot testing. The remaining standards 

were tested in a pilot project during 

calendar year (CY) 2006. Based upon the 

evaluation of the pilot project, the 

Secretary issued a report to Congress on 

the pilot results on April 1, 2007. For 

more information on the content, the 

report to Congress can be viewed at 

http://www.cms.hhs.gov/EPrescribing/ 

Downloads/E-RxReporttoCongress.pdf. 

Sections 1860D–4(e)(1) and 1860D– 

4(e)(4)(D) of the Act provided that 

successfully pilot tested initial 

standards were to be adopted through 

notice and comment rulemaking no later 

than April 1, 2008, and made effective 

no later than 1 year after the date of that 

final rule. 

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38028 Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Rules and Regulations 

Based on the pilot results in the report 

to Congress, we issued a notice of 

proposed rulemaking on November 16, 

2007 (72 FR 64900) and solicited 

comments from stakeholders and other 

interested parties on industry 

experience with certain standards. In 

that proposed rule (72 FR 64906 through 

64907), we also solicited comments 

regarding the impact of adopting NCPDP 

SCRIPT 8.1 and retiring NCPDP SCRIPT 

5.0. 

In the April 7, 2008 Federal Register 

(73 FR 18918), we published a final rule 

that responded to comments, adopted 

several new Part D e-prescribing 

standards, finalized the identification of 

the NCPDP SCRIPT 8.1 as a backward 

compatible update of the NCPDP 

SCRIPT 5.0, and, effective April 1, 2009, 

retired NCPDP SCRIPT 5.0 and adopted 

NCPDP SCRIPT 8.1 as the official Part 

D e-prescribing standard for 

communicating prescription or 

prescription related information 

between the prescriber and dispensers 

for the transactions listed at 

§ 423.160(b)(2). 

II. Provisions of the Interim Final Rule 

A. Voluntary Use of NCPDP Script 10.6 

On February 26, 2009, NCVHS heard 

testimony from industry representatives 

who requested the adoption of the 

current balloted NCPDP SCRIPT 10.6 as 

an adopted standard for e-prescribing 

under Medicare Part D. NCVHS also 

heard testimony from industry stating 

that NCPDP SCRIPT 10.6 was backward 

compatible to the current adopted 

e-prescribing standard NCPDP SCRIPT 

8.1. Industry also noted that they are 

ready to move to the new balloted 

NCPDP version of the SCRIPT standard. 

Based upon stakeholder testimony 

presented to the NCVHS during their 

2008 hearings regarding e-prescribing, 

the NCVHS recommendations that 

derived from their 2008 hearings, 

testimony from the NCPDP detailing 

NCPDP SCRIPT 10.6’s backward 

compatibility to NCPDP SCRIPT 8.1, 

and information received by CMS from 

industry stakeholders who currently 

conduct e-prescribing transactions, we 

conclude that the recognition of NCPDP 

SCRIPT 10.6 as a backward compatible 

version of the adopted standard (NCPDP 

SCRIPT 8.1) is desirable, that NCPDP 

SCRIPT 10.6 retains the full 

functionality of NCPDP SCRIPT 8.1 and 

would permit the successful completion 

of the applicable e-prescribing 

transactions with entities that continue 

to use NCPDP SCRIPT 8.1, and that use 

of the streamlined process to recognize 

NCPDP SCRIPT 10.6 as a backward 

compatible version of the adopted 

standard (NCPDP SCRIPT 8.1) would be 

appropriate. We anticipate proposing 

the adoption of NCPDP SCRIPT 10.6 as 

an adopted standard at a later date in a 

future notice of proposed rulemaking. 

At that time we would propose to adopt 

NCPDP SCRIPT 10.6 and retire the 

current adopted standard. 

We have also reviewed NCPDP 

SCRIPT 10.6, and the July 1, 2009 

NCVHS letter to the Secretary 

recommending, based on input from 

industry stakeholders, the adoption of 

NCPDP SCRIPT 10.6 in Medicare Part D 

e-prescribing (http:// 

www.ncvhs.hhs.gov). We have 

determined that NCPDP SCRIPT 10.6 

maintains full functionality of NCPDP 

SCRIPT 8.1, and would permit the 

successful completion of the applicable 

transactions with entities that continue 

to use NCPDP SCRIPT 8.1 for Part D 

e-prescribing transactions. 

NCPDP SCRIPT 10.6 also has a 

number of new functionalities that, if 

users elect to use them, will mesh with 

their use of the recently adopted NCPDP 

Prescriber/Pharmacist Interface SCRIPT 

standard, Version 8, Release 1 and its 

equivalent NCPDP Prescriber/ 

Pharmacist Interface SCRIPT 

Implementation Guide, Version 8, 

Release 1 (hereinafter referred to as the 

medication history standard), which 

was adopted in the April 7, 2008 

e-prescribing final rule (73 FR 18918). 

These new functions would allow users 

to provide prescriber order numbers, 

drug NDC source information, pharmacy 

prescription fill numbers and date of 

sale information that could then be used 

in a medication history response. These 

added functionalities would therefore 

be expected to facilitate better record 

matching, the identification and 

elimination of duplicate records, and 

the provision of richer information to 

the prescriber between willing trading 

partners. 

We are revising § 423.160(b)(2)(ii) to 

specify that providers and dispensers 

may use NCPDP SCRIPT 10.6 or 8.1 in 

electronic transactions that convey 

prescription or prescription related 

information for the following 

transactions: 

• Get message transaction. 

• Status response transaction. 

• Error response transaction. 

• New prescription transaction. 

• Prescription change request 

transaction. 

• Prescription change response 

transaction. 

• Refill prescription request 

transaction. 

• Refill prescription response 

transaction. 

• Verification transaction. 

• Password change transaction. 

• Cancel prescription request 

transaction. 

• Cancel prescription response 

transaction. 

• Fill status notification transaction. 

We are also revising § 423.160(b)(4) to 

specify that entities may use either 

NCPDP SCRIPT 10.6 or 8.1 for the 

communication of Medicare Part D 

medication history among sponsors, 

prescribers, and dispensers. 

In addition, we are adding a new 

§ 423.160(c)(1)(v) to specify the 

incorporation by reference of NCPDP 

SCRIPT 10.6. 

In accordance with the streamlined 

process established in the November 7, 

2005 final rule (70 FR 67580), entities 

that voluntarily adopt later versions of 

standards that are backward compatible 

to the adopted standard must still 

accommodate the earlier adopted 

version without modification. Since 

both versions of the standard would be 

compliant, trading partners who wish to 

conduct standard e-prescribing 

transactions may voluntarily adopt 

NCPDP SCRIPT 10.6, but must continue 

to accept transactions using the earlier 

NCPDP SCRIPT 8.1 standard without 

alteration, and they must be able to 

generate transactions that can be 

processed or read by those using the 

NCPDP SCRIPT 8.1 standard until 

NCPDP SCRIPT 8.1 is officially retired. 

We seek comment on recognizing 

NCPDP SCRIPT 10.6 as a backward 

compatible version of the adopted 

NCPDP SCRIPT 8.1 standard. We also 

seek comment on the voluntary use of 

the backward compatible NCPDP 

SCRIPT 10.6. Furthermore, we seek 

comment on whether and when to retire 

NCPDP SCRIPT 8.1. 

B. NCPDP SCRIPT 10.6 and the LongTerm Care Setting Exemption 

During the NCVHS testimony, 

industry also stated that the changes 

that were present in NCPDP SCRIPT 

10.6 created an environment where 

long-term care (LTC) facilities could 

carry out e-prescribing under Medicare 

Part D. They asked the NCVHS to 

recommend the adoption of NCPDP 

SCRIPT 10.6 and also to recommend the 

lifting the NCPDP SCRIPT standard 

‘‘LTC exemption’’ at 42 CFR 

423.160(a)(3)(ii). 

In the November 16, 2007 proposed 

rule (72 FR 64902), we noted that 

NCPDP SCRIPT 5.0 was not proven to 

support the workflows and legal 

responsibilities in the LTC setting. To 

accommodate entities transmitting 

prescriptions or prescription-related 

information where the prescriber is 

required by law to issue a prescription 

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Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Rules and Regulations 38029 

for a patient to a non-prescribing 

provider (such as a nursing facility) that 

in turn forwards the prescription to a 

dispenser (‘‘three-way prescribing 

communications’’ between facility, 

physician, and pharmacy), we provided 

an exemption from the requirement to 

use the adopted NCPDP SCRIPT 

standard in transmitting such 

prescriptions or prescription-related 

information. We also noted the results 

of the calendar year (CY) 2006 eprescribing pilot relative to the use of 

NCPDP SCRIPT 8.1 in the LTC setting, 

namely that workarounds were still 

needed to accommodate the unique 

workflow needs in LTC setting. 

As a result of the 2006 pilot findings 

and other industry and stakeholder 

input, NCPDP added other segments to 

subsequently developed versions of its 

NCPDP SCRIPT standard to enhance its 

use in e-prescribing in the LTC setting. 

Many of these enhancements first 

appeared in NCPDP SCRIPT 10.2 and 

appear in the subsequent higher 

versions of the transaction standard. We 

believe that the shortcomings that were 

identified in NCPDP SCRIPT 8.1 for use 

in LTC settings in the 2006 CMS eprescribing pilot are now fully 

addressed in NCPDP SCRIPT 10.6. 

On July 1, 2009, the NCVHS sent a 

letter to the Secretary of HHS. It 

recommended the recognition of NCPDP 

SCRIPT 10.6 as a backward compatible 

version of the adopted standard (NCPDP 

SCRIPT 8.1) through the ‘‘streamlined 

process.’’ It also recommended 

elimination of the LTC exemption for 

use of the NCPDP SCRIPT standard. 

The LTC setting issues are addressed 

in NCPDP SCRIPT 10.2 and subsequent 

versions. It would not be appropriate to 

lift the LTC exemption prior to retiring 

any NCPDP SCRIPT versions prior to 

NCPDP SCRIPT 10.2. As the retirement 

of NCPDP SCRIPT 8.1 and the 

elimination of the LTC exemption will 

be substantive changes to the Part D eprescribing regulations, we will need to 

use notice and comment rulemaking to 

effectuate these changes. We anticipate 

proposing these changes at a later date 

in a notice of proposed rulemaking. 

More information on the testimony 

given to, and the recommendations 

given by NCVHS, can be found at the 

NCVHS Web site http:// 

www.ncvhs.hhs.gov/. 

III. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

IV. Waiver of Proposed Rulemaking 

and Delay in Effective Date 

The adoption of a standard ordinarily 

requires notice and comment 

rulemaking, and a 30-day delay in 

effective date. A notice of proposed 

rulemaking is published in the Federal 

Register to invite public comment on 

the proposed rule, and generally 

includes a reference to the legal 

authority under which the rule is 

proposed, the provisions of the 

proposed rule and a description of the 

subjects and issues addressed by the 

proposed rule. Notice and comment 

rulemaking procedure can be waived, 

however, if an agency finds good cause 

that a notice-and-comment procedure is 

impracticable, unnecessary, or contrary 

to the public interest, and incorporates 

a statement of a finding and its reasons 

in the final notice or rule that is issued. 

In this case, we find that notice and 

comment rulemaking is unnecessary 

because this interim final rule with 

comment period imposes no additional 

or different legal requirements upon 

entities participating in the Part D eprescribing program. It merely provides 

an additional method by which entities 

may carry out transactions using the 

standards adopted in regulations. 

Moreover, we ordinarily provide a 30- 

day delay in the effective date of the 

provisions of a rule in accordance with 

the Administrative Procedure Act (APA) 

(5 U.S.C. 553(d), which requires a 30- 

day delayed effective date, and the 

Congressional Review Act (5 U.S.C. 

801(a)(3), which requires a 30-day 

delayed effective date for non-major 

rules. However, we can waive the delay 

in effective date if the Secretary finds, 

for good cause, that such delay is 

impracticable, unnecessary, or contrary 

to the public interest, and incorporates 

a statement of the finding and the 

reasons in the rule issued. (5 U.S.C. 

553(d)(3); 5 U.S.C. 808(2)). 

As noted previously, this interim final 

rule with comment period imposes no 

new requirements on the public. It 

merely serves to permit the voluntary 

use of the backward compatible NCPDP 

SCRIPT Standard, NCPDP SCRIPT 10.6, 

in lieu of the adopted NCPDP SCRIPT 

8.1 standard. The use of NCPDP SCRIPT 

10.6 constitutes compliance with the 

adopted standard for the specified eprescribing transactions. Entities that 

elect to use NCPDP SCRIPT 10.6 must 

support and continue to accept NCPDP 

SCRIPT Standard Version 8.1 

transactions. 

For all these reasons, we believe that 

a notice and comment period and 30- 

day delay in the effective date would be 

unnecessary and contrary to the public 

interest. We therefore find good cause 

for waiving the notice and comment 

period 30-day delay in the effective date 

for the voluntary use of the backward 

compatible NCPDP SCRIPT Standard 

NCPDP SCRIPT 10.6 in lieu of NCPDP 

SCRIPT 8.1. 

V. 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. 35). 

VI. Regulatory Impact Statement 

We have examined the impact of this 

interim final rule with comment period 

as required by Executive Order 12866 

on Regulatory Planning and Review 

(September 30, 1993), 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 Order 12866 (as amended 

by Executive Orders 13258 and 13422) 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

This interim final rule with comment 

period does not reach the economic 

threshold and, thus, is not considered a 

major rule. Therefore, an RIA has not 

been prepared. 

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. We are not preparing an analysis 

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38030 Federal Register / Vol. 75, No. 126 / Thursday, July 1, 2010 / Rules and Regulations 

for the RFA because we have 

determined, and the Secretary certifies, 

that this interim final rule with 

comment period imposes no new 

requirements on small entities because 

use of NCPDP SCRIPT NCPDP SCRIPT 

10.6 is voluntary, and as such, it will 

not have a significant economic impact 

on a substantial number of 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 for final 

rules 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 interim final rule with 

comment period imposes no new 

requirements on small rural hospitals, 

because use of NCPDP SCRIPT 10.6 is 

voluntary and as such, it will not have 

a significant economic impact on a 

substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2010, that threshold level is currently 

approximately $135 million. This rule 

will have no consequential effect on 

State, local, or tribal governments, or on 

the private sector because we have 

determined that this interim final rule 

with comment period imposes no new 

requirements on State, local, or tribal 

governments or on the private sector, 

because use NCPDP SCRIPT 10.6 is 

voluntary and as such, it will not have 

a significant economic impact on State, 

local, or tribal governments or on the 

private sector. 

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 interim final rule with 

comment period does not impose any 

costs on State or local governments, the 

requirements of Executive Order 13132 

are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this interim 

final rule with comment period was 

reviewed by the Office of Management 

and Budget. 

List of Subjects 42 CFR Part 423 

Administrative practice and 

procedure, Emergency medical services, 

Health facilities, Health maintenance 

organizations (HMO), Health 

professions, Incorporation by Reference, 

Medicare, Penalties, Privacy, Reporting 

and recordkeeping requirements. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR part 

423 as follows: 

PART 423–VOLUNTARY MEDICARE 

PRESCRIPTION DRUG BENEFIT 

■ 1. The authority citation for part 423 

continues to read as follows: 

Authority: Sections 1102, 1106, 1860D–1 

through 1860D–42, and 1871 of the Social 

Security Act (42 U.S.C. 1302, 1395w–101 

through 1395w–152, and 1395hh). 

■ 2. Section 423.160 is amended by— 

■ A. Revising the introductory text of 

paragraph (b)(2)(ii). 

■ B. Revising paragraph (b)(4). 

■ C. Adding a new paragraph (c)(1)(v). 

The revisions and addition read as 

follows: 

§ 423.160 Standards for electronic 

prescribing. 

* * * * * 

(b) * * * 

(2) * * * 

(ii) The National Council for 

Prescription Drug Programs SCRIPT 

standard, Implementation Guide 

Version 10.6, approved November 12, 

2008 (incorporated by reference in 

paragraph (c)(1)(v) of this section), or 

the National Council for Prescription 

Drug Programs Prescriber/Pharmacist 

Interface SCRIPT Standard, 

Implementation Guide, Version 8, 

Release 1 (Version 8.1), October 2005 

(incorporated by reference in paragraph 

(c)(1)(i) of this section), to provide for 

the communication of a prescription or 

prescription-related information 

between prescribers and dispensers, for 

the following: 

* * * * * 

(4) Medication history. The National 

Council for Prescription Drug Programs 

Prescriber/Pharmacist Interface SCRIPT 

Standard, Implementation Guide 

Version 8, Release 1 (Version 8.1), 

October 2005 (incorporated by reference 

in paragraph (c)(1)(v) of this section) or 

the National Council for Prescription 

Drug Programs SCRIPT Standard, 

Implementation Guide Version 10.6, 

approved November 12, 2008 

(incorporated by reference in paragraph 

(c)(1)(v) of this section) to provide for 

the communication of Medicare Part D 

medication history information among 

Medicare Part D sponsors, prescribers, 

and dispensers. 

(c) * * * 

(1) * * * 

(v) National Council for Prescription 

Drug Programs SCRIPT Standard, 

Implementation Guide Version 10.6, 

approved November 12, 2008. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 4, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: May 26, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–15505 Filed 6–28–10; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 660 

[Docket No. 090428799–9802–01] 

RIN 0648–BA00 

Magnuson-Stevens Act Provisions; 

Fisheries Off West Coast States; 

Pacific Coast Groundfish Fishery; 2010 

Harvest Specifications for Yelloweye 

Rockfish and In-Season Adjustments 

to Fishery Management Measures 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule; in-season 

adjustments to biennial groundfish 

management measures; request for 

comments. 

SUMMARY: This final rule revises the 

2010 harvest guidelines for yelloweye 

rockfish and makes in-season 

adjustments to trawl fishery 

management measures for several 

groundfish species taken in the U.S. 

exclusive economic zone (EEZ) off the 

coasts of Washington, Oregon, and 

California. These actions, which are 

authorized by the Pacific Coast 

Groundfish Fishery Management Plan 

(FMP), are intended to prevent 

exceeding the 2010 OYs for yelloweye 

WReier-Aviles on DSKGBLS3C1PROD with RULES