36020 Federal Register / Vol. 71, No. 121 / Friday, June 23, 2006 / Rules and Regulations 

* * * * * 

[FR Doc. E6–9950 Filed 6–22–06; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 423 

[CMS–0018–IFC] 

RIN 0938–A042 

Medicare Program; Identification of 

Backward Compatible Version of 

Adopted Standard for E-Prescribing 

and the Medicare Prescription Drug 

Program (Version 8.1) 

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 

Prescriber/Pharmacist Interface SCRIPT 

Standard, Implementation Guide, 

Version 8.1 (hereafter referred to as 

‘‘Version 8.1 of the National Council for 

Prescription Drug Programs (NCPDP) 

SCRIPT Standard’’) as a backward 

compatible update of the adopted 

Version 5.0. This interim final rule with 

comment period also permits the 

voluntary use of Version 8.1 of the 

NCPDP SCRIPT Standard for conducting 

certain e-prescribing transactions for the 

electronic prescription drug program 

under Title I of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA). 

DATES: Effective date: These regulations 

are effective on June 23, 2006. The 

incorporation by reference of the 

publication listed in these regulations is 

approved by the Director of the Federal 

Register as of June 23, 2006. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

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

August 22, 2006. 

ADDRESSES: In commenting, please refer 

to file code CMS–0018–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. Click 

on the link ‘‘Submit electronic 

comments on CMS regulations with an 

open comment period.’’ (Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–0018–

IFC, P.O. Box 8015, Baltimore, MD 

21244–8015. 

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 (one 

original and two copies) to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–0018–IFC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. 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. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH 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.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Gladys Wheeler, (410) 786–0273. 

Gladys.Wheeler@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–0018–IFC 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

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://www.cms.hhs.gov/ 

eRulemaking. Click on the link 

‘‘Electronic Comments on CMS 

Regulations’’ 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 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘BACKGROUND’’ at the 

beginning of your comments.] 

A. Statutory Basis 

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 

the Voluntary Prescription Drug Benefit 

Program. Included in the provisions at 

section 1860D–4(e) of the Act is the 

requirement that any prescriptions for 

covered program (Part D) drugs 

prescribed for Part D eligible 

individuals that are transmitted 

electronically, comply with final 

standards adopted by the Secretary 

under an electronic prescription drug 

program. 

The Medicare Prescription Drug 

Benefit Program final rule, published 

January 28, 2005 (70 FR 4194), 

established cost control and quality 

improvement requirements for 

prescription drug benefit plans. Among 

those requirements, prescription drug 

plan (PDP) sponsors and Medicare 

Advantage (MA) organizations offering 

Medicare Advantage-Prescription Drug 

(MA–PD) plans must have the capacity 

to support e-prescribing programs in 

accordance with the final e-prescribing 

standards established by the Secretary. 

The requirement that PDP sponsors 

and MA organizations offering MA–PD 


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plans have the capacity to support eprescribing programs in accordance 

with final standards established by the 

Secretary does not require that 

prescriptions be written or transmitted 

electronically by physicians or 

pharmacies. However, physicians, 

pharmacies, and others in the health 

care industry that are not required to 

use the standards at the time they are 

adopted are encouraged to do so. The 

MMA directs the Secretary to 

promulgate regulations, in consultation 

with the Attorney General, which 

provide for an anti-kickback statute safe 

harbor and a Federal physician selfreferral prohibition exception for eprescribing of covered Part D drugs. 

For a more detailed discussion of the 

proposed physician self-referral 

prohibition exceptions and the 

proposed anti-kickback statute safe 

harbors, please refer to our proposed 

rules, ‘‘Medicare Program; Physicians’

Referrals to Health Care Entities With 

Which They Have Financial 

Relationships; Exceptions for Certain 

Electronic Prescribing and Electronic 

Health Records Arrangements’’ (October 

11, 2005, 70 FR 59182); and ‘‘Medicare 

and State Health Care Programs: Fraud 

and Abuse; Safe Harbor for Certain 

Electronic Prescribing Arrangements 

Under the Anti-Kickback 

Statute’’(October 11, 2005, 70 FR 

59015). 

Section 1860D–4(e) of the Act 

contains the provisions for e-prescribing 

programs. The statute specifies when 

initial standards are to be developed, 

adopted, recognized or modified (not 

later than September 1, 2005), and when 

final standards must be promulgated 

(not later than April 1, 2008) and then 

become effective (not later than 1 year 

after the date of promulgation of the 

final standards). 

The provisions at section 1860D–4(e) 

of the Act require that electronic 

transmissions of prescription and 

certain other information for covered 

Part D drugs prescribed for Part D 

eligible individuals, be transmitted in 

accordance with final standards and 

that the following requirements be met: 

• An electronic prescription drug 

program will provide for the electronic 

transmittal by the prescribing health 

care professional and the dispensing 

pharmacy and pharmacist of the 

prescription and information on 

eligibility and benefits (including the 

drugs included in the applicable 

formulary, any tiered formulary 

structure, and any requirements for 

prior authorization) and of the following 

information with respect to the 

prescribing and dispensing of a covered 

Part D drug: 

+ Information on the drug being 

prescribed or dispensed and other drugs 

listed on the medication history, 

including information on drug-to-drug 

interactions, warnings or cautions, and, 

when indicated, dosage adjustments. 

+ Information on the availability of 

lower cost and therapeutically 

appropriate alternatives (if any) for the 

drug prescribed. 

• Effective on and after a date that the 

Secretary specifies and after the 

establishment of appropriate standards, 

the program will provide for the 

electronic transmittal of information 

that relates to the medical history 

concerning the individual and related to 

a covered Part D drug being prescribed 

or dispensed, upon request of the 

professional or pharmacist involved. 

• Information will only be disclosed 

if the disclosure of this information is 

permitted under the Federal regulations 

(concerning the privacy of individually 

identifiable health information) 

established under section 264(c) of the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA). 

• To the extent feasible, the 

information exchanged will be on an 

interactive, real-time basis. 

The statute also requires the National 

Committee on Vital and Health 

Statistics (NCVHS) to develop 

recommendations for standards, in 

consultation with a specific group of 

constituencies. The Secretary will take 

into consideration NCVHS’s 

recommendation, if any, when 

developing, adopting, recognizing, or 

modifying initial uniform standards. 

The statute requires pilot testing of 

the initial standards before publishing 

the final standards in order to facilitate 

efficient implementation of the 

requirements. However, it also permits 

an exception to the pilot testing 

requirement for standards where there 

already is adequate industry experience 

with these standards, as determined by 

the Secretary after consultation with 

affected standard-setting organizations 

and industry users. Under this 

exception, standards can be proposed 

and adopted as standards through 

rulemaking without pilot testing, and 

would then become final standards. 

B. Provisions of the Final Rule 

In the final rule, Medicare Program; EPrescribing and the Prescription Drug 

Program,’’ (November 7, 2005, 70 FR 

67567), and codified at 42 CFR 

423.160(b), we adopted Version 5.0 of 

the NCPDP SCRIPT standard for the 

communication of a prescription or 

prescription-related information 

between prescribers and dispensers, for 

the following: 

• 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. 

In the preamble of the November 7, 

2005 final rule, we discussed version 

updating and maintenance of 

implementation specifications for the 

adopted standards (70 FR 67579). We 

stated that when updating a standard, 

we would look at a variety of factors to 

consider how an update should occur, 

including the significance of the 

corrections or revisions and whether the 

newer version is backward compatible 

with the previously adopted version. 

As explained in the preamble of the 

November 7, 2005 final rule, many 

commenters supported this proposed 

method of permitting voluntary 

implementation of later versions of 

adopted standards that are backward 

compatible. They also expressed 

concern that the version updating and 

maintenance process should not be 

hindered by extensive rulemaking, 

particularly when voluntary adoption of 

newer versions of standards would be 

precluded. These commenters explained 

that progress and innovation would be 

stifled if the voluntary adoption of 

backward compatible versions were to 

be prohibited. We agreed with the 

majority of commenters and intend to 

identify backward compatible version 

updates of adopted standards, which the 

industry may voluntarily implement. 

As discussed in section II. below, 

‘‘backward compatible’’ means that the 

newer version of a data transmission 

standard would retain, at a minimum, 

the full functionality of the version(s) 

previously adopted in regulation, and 

would permit the successful completion 

of the applicable transaction(s) with 

entities that continue to use the older 

version(s). 

After a review of Version 8.1 of the 

NCPDP SCRIPT Standard, and taking 

into account input from the NCVHS and 

industry stakeholders, we have 

determined that Version 8.1 of the 

NCPDP SCRIPT Standard maintains full 

functionality of version 5.0, and would 

permit the successful completion of the 


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applicable transaction with entities that 

continue to use 5.0. Therefore, Version 

8.1 of the NCPDP SCRIPT Standard is 

backward compatible with Version 5.0 

and we will permit its use to carry out 

the transactions described above. 

Furthermore, as explained in section III 

of this notice (‘‘Waiver of Proposed 

Rulemaking’’), we have found good 

cause to waive notice and comment 

rulemaking. 

In the November 7, 2005 final rule, we 

adopted specific versions of the 

foundation standards. We noted in the 

preamble of that rule that we anticipate, 

as appropriate, updating these 

foundation standards and other adopted 

standards through the incorporation by 

reference update process. When 

updating a standard, we stated that we 

would look at a variety of factors to 

consider how the update should occur. 

If the update or new version of the 

standard would impose new 

requirements on the public, we noted 

that we would initiate notice and 

comment rulemaking. If, on the other 

hand, changes to an updated version 

were not substantive and imposed no 

new requirements on the public, we 

stated that the Secretary would consider 

waiving notice and comment under an 

Administrative Procedure Act exception 

to the requirement for notice and 

comment rulemaking. This, we noted, 

would mean that compliance with 

either version for a covered transaction 

would be viewed as compliance with 

the transaction standard. However, we 

intend to permit use of an alternative 

version of a standard and must make a 

conforming change to the Code of 

Federal Regulations which reflects this 

alternative. Therefore, we are making 

this change in this interim final rule 

with comment period. If we anticipate 

mandating adoption of a new version of 

a standard or a new standard in the 

future, we will, through notice and 

comment rulemaking, provide ample 

opportunity for public comment. 

Based upon numerous testimonies 

presented to the NCVHS during their 

2005 hearings regarding e-prescribing, 

comments from the NCPDP, and CMS 

consultation with industry stakeholders 

that currently are conducting eprescribing transactions, we concluded 

that Version 8.1 of the NCPDP SCRIPT 

Standard retains the full functionality of 

Version 5.0 and would permit the 

successful completion of the applicable 

transactions with entities that continue 

to use version 5.0, without imposing 

any new regulatory burdens or costs on 

participating entities. 

II. Provisions of the Interim Final Rule 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘PROVISIONS’’ at the 

beginning of your comments.] 

Use of either Version 5.0 or Version 

8.1 of the NCPDP SCRIPT Standard for 

the covered transactions listed below 

will be permitted under 42 CFR 

423.160(b), effective June 23, 2006. 

Version 8.1 of the NCPDP SCRIPT 

Standard is an update to Version 5.0, 

and we have determined that it is 

backward compatible with the adopted 

NCPDP SCRIPT Standard Version 5.0. 

(Although Version 8.1 of the NCPDP 

SCRIPT Standard has additional eprescribing functionalities, we are not 

adopting any of these additional 

functionalities at this time.) Use of 

Version 8.1 of the NCPDP SCRIPT 

Standard for the communication of a 

prescription or prescription-related 

information between prescribers and 

dispensers, for the following functions, 

constitutes compliance with the 

adopted e-prescribing standard: 

• 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. 

According to the November 7, 2005 

final rule (70 FR 67580), entities that 

voluntarily adopt later versions of 

standards that are backward compatible 

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 eprescribing transactions may voluntarily 

adopt Version 8.1 of the NCPDP SCRIPT 

Standard, but must continue to accept 

the earlier Version 5.0 transactions 

without alteration until Version 5.0 is 

officially retired. In this interim final 

rule with comment period, we will 

revise § 423.160(b)(1) and (c) to reflect 

the voluntary use of Version 8.1 of the 

NCPDP SCRIPT Standard. We seek 

comment on permitting the voluntary 

use of the backward compatible Version 

8.1 of the NCPDP SCRIPT Standard as 

satisfying the requirements of the 

adopted standard Version 5.0. We also 

seek comment on whether and when to 

retire Version 5.0. 

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 are unnecessary because this 

interim final rule with comment period 

imposes no additional or different legal 

requirements upon entities participating 

in the e-prescribing program, but merely 

provides an additional method by 

which they may carry out the 

transactions described 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 above, this interim final rule 

with comment period imposes no new 

requirements on the public. It merely 

serves to permit the voluntary use of the 


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backward compatible Version 8.1 of the 

NCPDP SCRIPT Standard in lieu of 

Version 5.0, recognizing that the use of 

Version 8.1 constitutes compliance with 

the adopted standard for the specified eprescribing transactions. Entities that 

elect to use Version 8.1 must support 

and continue to accept NCPDP SCRIPT 

Standard Version 5.0 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 Version 8.1 of the NCPDP 

SCRIPT Standard in lieu of Version 5.0. 

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 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘IMPACT’’ at the beginning of 

your comments.] 

We have examined the impact of this 

interim final rule with comment period 

as required by Executive Order 12866 

(September 1993, Regulatory Planning 

and Review), the Regulatory Flexibility 

Act (RFA) (September 19, 1980, Pub. L. 

96–354), section 1102(b) of the Social 

Security Act, the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132. 

Executive Order 12866 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 $6 million to $29 million in any 1 

year. Individuals and States are not 

included in the definition of a small 

entity. We are not preparing an analysis 

for the RFA because we have 

determined that this interim final rule 

with comment period imposes no new 

requirements on small entities because 

use of Version 8.1 of the NCPDP SCRIPT 

Standard is voluntary and 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 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 interim 

final rule with comment period imposes 

no new requirements on small rural 

hospitals because use of Version 8.1 of 

the NCPDP SCRIPT Standard is 

voluntary and 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. 

That threshold level is currently 

approximately $120 million. This notice 

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 the use of Version 8.1 of the 

NCPDP SCRIPT Standard is voluntary 

and 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 E.O. 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 in 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: Secs 1102, 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 

revising paragraphs (b)(1) and (c) to read 

as follows: 

§ 423.160 Standards for electronic 

prescribing. 

* * * * * 

(b) Standards. (1) Prescription. The 

National Council for Prescription Drug 

Programs SCRIPT Standard, 

Implementation Guide, Version 5, 

Release 0, May 12, 2004, or Prescriber/ 

Pharmacist Interface SCRIPT Standard, 

Implementation Guide, Version 8, 

Release 1, October 2005, to provide for 

the communication of a prescription or 

prescription-related information 

between prescribers and dispensers, for 

the following: 

(i) Get message transaction. 

(ii) Status response transaction. 

(iii) Error response transaction. 

(iv) New prescription transaction. 

(v) Prescription change request 

transaction. 

(vi) Prescription change response 

transaction. 

(vii) Refill prescription request 

transaction. 

(viii) Refill prescription response 

transaction. 

(ix) Verification transaction. 

(x) Password change transaction. 

(xi) Cancel prescription request 

transaction. 

(xii) Cancel prescription response 

transaction. 

* * * * * 


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(c) Incorporation by reference. The 

Director of the Federal Register 

approves, in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51, the 

incorporation by reference of the 

National Council for Prescription Drug 

Programs SCRIPT Standard, 

Implementation Guide, Version 5, 

Release 0, May 12, 2004, excluding the 

Prescription Fill Status Notification 

Transaction (and its three business 

cases; Prescription Fill Status 

Notification Transaction—Filled, 

Prescription Fill Status Notification 

Transaction—Not Filled, and 

Prescription Fill Status Notification 

Transaction—Partial Fill), Prescriber/ 

Pharmacist Interface SCRIPT Standard, 

Implementation Guide, Version 8, 

Release 1, October 2005, excluding the 

Prescription Fill Status Notification 

Transaction (and its three business 

cases; Prescription Fill Status 

Notification Transaction—Filled, 

Prescription Fill Status Notification 

Transaction—Not Filled, and 

Prescription Fill Status Notification 

Transaction—Partial Fill); the 

Accredited Standards Committee X12N 

270/271—Health Care Eligibility Benefit 

Inquiry and Response, Version 4010, 

May 2000, 004010X092 and Addenda to 

Health Care Eligibility Benefit Inquiry 

and Response, Version 4010, October 

2002, Washington Publishing Company, 

004010X092A1, and the National 

Council for Prescription Drug Programs 

Telecommunication Standard 

Specification, Version 5, Release 1 

(Version 5.1), September 1999, and 

equivalent NCPDP Batch Standard 

Batch Implementation Guide, Version 1, 

Release 1 (Version 1.1), January 2000 

supporting Telecommunications 

Standard Implementation Guide, 

Version 5, Release 1 (Version 5.1), 

September 1999, for the NCPDP Data 

Record in the Detail Data Record. You 

may inspect copies of these materials at 

the headquarters of the Centers for 

Medicare & Medicaid Services (CMS), 

7500 Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday from 8:30 a.m. to 4 p.m. or at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at CMS, call 410–786–0273. For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. You may obtain a 

copy of the National Council for 

Prescription Drug Programs SCRIPT 

Standard, Version 5, Release 0, May 12, 

2004 or the Prescriber/Pharmacist 

Interface SCRIPT Standard, 

Implementation Guide, Version 8, 

Release 1, October 2005, from the 

National Council for Prescription Drug 

Programs, Incorporated, 9240 E. 

Raintree Drive, Scottsdale, AZ 85260–

7518; Telephone (480) 477–1000; and 

fax (480) 767–1042 or http:// 

www.ncpdp.org. You may obtain a copy 

of the Accredited Standards Committee 

X12N 270/271—Health Care Eligibility 

Benefit Inquiry and Response, Version 

4010, May 2000, Washington Publishing 

Company, 004010X092 and Addenda to 

Health Care Eligibility Benefit Inquiry 

and Response, Version 4010, 

004010X092A1, October 2002, from the 

Washington Publishing Company,301 

West North Bend Way, Suite 107, P.O. 

Box 15388, North Bend, WA 98045; 

Telephone (425) 831–4999; and fax 

(425) 831–3233 or http://www.wpcedi.com/. You may obtain a copy of the 

National Council for Prescription Drug 

Programs Telecommunication Standard 

Guide, Version 5, Release 1 (Version 

5.1), September 1999, and equivalent 

NCPDP Batch Standard Batch 

Implementation Guide, Version 1, 

Release 1 (Version 1.1), January 2000 

supporting Telecommunications 

Standard Implementation Guide, 

Version 5, Release 1 (Version 5.1), 

September 1999, for the NCPDP Data 

Record in the Detail Data Record, from 

the National Council for Prescription 

Drug Programs, Incorporated, 9240 E. 

Raintree Drive, Scottsdale, AZ 85260–

7518; Telephone (480) 477–1000; and 

FAX (480) 767–1042 or http:// 

www.ncpdp.org. 

Authority: Section 1860D–4(e) of the 

Social Security Act (42 U.S.C. 1395w–104(e)) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 30, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 22, 2006. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. E6–9521 Filed 6–22–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Parts 222 and 223 

[Docket No. 060405097–6161–02; I.D. 

033006E] 

RIN 0648–AU10 

Sea Turtle Conservation; Modification 

to Fishing Activities 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS is requiring that any 

offshore pound net leader in the 

Virginia waters of the mainstem 

Chesapeake Bay, south of 37°19.0′ N. 

lat. and west of 76°13.0′ W. long., and 

all waters south of 37°13.0′ N. lat. to the 

Chesapeake Bay Bridge Tunnel at the 

mouth of the Chesapeake Bay, and the 

James and York Rivers downstream of 

the first bridge in each tributary, during 

the period of May 6 through July 15, 

meet the definition of a modified pound 

net leader. Without this final rule, 

existing regulations would continue to 

prohibit all offshore pound net leaders 

in that area during that time frame. An 

offshore pound net leader refers to a 

leader with the inland end set greater 

than 10 horizontal feet (3 m) from the 

mean low water line. While restrictions 

promulgated in 2004 on pound net 

leaders in the Virginia waters of the 

Chesapeake Bay outside the 

aforementioned area remain in effect, 

this final rule creates an exception to 

those restrictions by allowing the use of 

modified pound net leaders in this area. 

This action, taken under the Endangered 

Species Act of 1973 (ESA), responds to 

new information generated by gear 

research. It is intended to conserve sea 

turtles listed as threatened under the 

ESA and to help enforce the provisions 

of the ESA, including the provisions 

against takes of endangered species, 

while enabling fishermen to use leaders, 

an important component of pound net 

gear, during the regulated period. 

DATES: Effective June 23, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Pasquale Scida (ph. 978–281–9208, fax 

978–281–9394), or Therese Conant (ph. 

301–713–2322, fax 301–427–2522). 

SUPPLEMENTARY INFORMATION: 

Background 

NMFS issued a final rule on May 5, 

2004 (69 FR 24997), which prohibited 

the use of offshore pound net leaders in 


rmajette on PROD1PC67 with RULES