[Federal Register Volume 75, Number 126 (Thursday, July 1, 2010)]
[Rules and Regulations]
[Pages 38026-38030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15505]


=======================================================================
-----------------------------------------------------------------------

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

[[Page 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 e-
prescribing. 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 Sec.  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 e-prescribing 
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.

[[Page 38028]]

    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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Long-Term 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

[[Page 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 e-prescribing 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 e-prescribing 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 e-
prescribing 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 e-prescribing 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 e-prescribing 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

[[Page 38030]]

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.

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:  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).


0
2. Section 423.160 is amended by--
0
A. Revising the introductory text of paragraph (b)(2)(ii).
0
B. Revising paragraph (b)(4).
0
C. Adding a new paragraph (c)(1)(v).
    The revisions and addition read as follows:


Sec.  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