[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]
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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.
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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
[email protected].
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]
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