Medicare Program; Identification of Backward Compatible Version of Adopted Standard for E-Prescribing and the Medicare Prescription Drug Program (Version 8.1), 36020-36024 [E6-9521]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Rules and Regulations]
[Pages 36020-36024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9521]


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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.

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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 https://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: https://
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

[[Page 36021]]

plans have the capacity to support e-prescribing 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 self-referral prohibition exception for e-prescribing 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; E-Prescribing 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

[[Page 36022]]

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 
e-prescribing 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 e-prescribing 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 e-prescribing 
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 
Sec.  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

[[Page 36023]]

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 e-prescribing 
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.


0
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

0
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).


0
2. Section 423.160 is amended by revising paragraphs (b)(1) and (c) to 
read as follows:


Sec.  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.
* * * * *

[[Page 36024]]

    (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 https://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 https://
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 https://www.wpc-edi.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 https://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