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Electronic Prescriptions for Controlled Substances; Notice of
Meeting
FR Doc E6-7302 [Federal Register: May 15, 2006 (Volume 71, Number 93)]
[Notices] [Page 28052-28054] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my06-70]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-218N] RIN 1117-AA61
Electronic Prescriptions for Controlled Substances; Notice of Meeting
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of meeting.
SUMMARY: The Drug Enforcement Administration (DEA), in conjunction
with the Department of Health and Human Services (HHS), is conducting a public
meeting to discuss electronic prescriptions for controlled substances.
Specifically, this meeting is intended to allow industry-- prescribers,
pharmacies, software/hardware vendors, and other interested third parties--to
address how electronic prescribing systems can meet DEA's prescription
requirements under the Controlled Substances Act, without unduly burdening the
parties to electronic prescribing transactions.
DATES: This meeting will be held Tuesday, July 11, 2006, and
Wednesday, July 12, 2006, 8:30 a.m. until 5:30 p.m. Registration will begin at
7:30 a.m. This meeting will be held at the Marriott Crystal City at Reagan
National Airport, 1999 Jefferson-Davis Highway, Arlington, VA 22202; (703)
413-5500. The meeting will take place in the Crystal Forum amphitheatre,
adjacent to the hotel.
Meeting Attendance: To ensure proper handling, please reference "Docket
No. DEA-218N'' on all written and electronic correspondence regarding this
meeting. Persons wishing to attend this meeting, space permitting, must provide
attendee information to the Liaison and Policy Section, Office of Diversion
Control, Drug Enforcement Administration, via e-mail to dea.diversion.policy@usdoj.gov,
or via facsimile, (202) 353-1079, as specified below. Persons wishing to attend
the meeting must provide this information to the Liaison and Policy Section no
later than June 26, 2006.
Comments: All written comments will be made available at the Diversion
Control Program Web site, http://www.deadiversion.usdoj.gov prior to the public
meeting. Therefore, as this is a public meeting, confidential business
information or other proprietary information SHOULD NOT be presented at this
meeting.
Persons wishing to provide written comments must do so no later than June 26,
2006. To ensure proper handling of
[[Page 28053]]
comments, please reference "Docket No. DEA-218N'' on all written and
electronic correspondence. Written comments being sent via regular mail should
be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA Federal
Register Representative/ODL. Written comments sent via express mail should be
sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL,
2401 Jefferson- Davis Highway, Alexandria, VA 22301. Comments may be directly
sent to DEA electronically by sending an electronic message to
dea.diversion.policy@usdoj.gov. DEA will accept attachments to electronic
comments in Microsoft word, WordPerfect, Adobe PDF, or Excel file formats only.
DEA will not accept any file format other than those specifically listed here.
This meeting will consist of panel presentations. There will be limited
opportunities for attendees to make oral comments at the meeting.
FOR FURTHER INFORMATION, CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537, telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION: Many within the health care industry are
encouraging the adoption of electronic prescriptions because such prescriptions
would improve patient safety by eliminating medical errors that arise from
misread or misunderstood handwritten prescriptions. These parties also focus on
the potential cost savings, both to industry and the public, realized from,
among other benefits: fewer medical errors and adverse drug events; fewer
callbacks from pharmacies to practitioners to clarify handwritten prescription
information; and reduced ability and opportunity to commit fraud and diversion
of prescription medications. The focus of these parties is to facilitate
adoption of electronic prescribing as quickly as possible to obtain the benefits
that are expected to follow.
Both the Drug Enforcement Administration (DEA) and the Department of Health
and Human Services (HHS) have an interest in electronic prescribing. DEA is
responsible for enforcing the Controlled Substances Act, including the
prescribing and dispensing of controlled substances to the public by
DEA-registered practitioners and pharmacies. Such enforcement includes the
writing and signature of prescriptions and retention of prescription records.
The Department of Health and Human Services has a statutory mandate to
facilitate adoption of electronic prescribing. The Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 requires that "prescriptions * * *
for covered Part D drugs prescribed for Part D eligible individuals that are
transmitted electronically shall be transmitted only in accordance with such
standards under an electronic prescription drug program'' that meets the
requirements of the MMA (Pub. L. 108-173). HHS is required to promulgate
transmission standards for the Medicare electronic prescription drug program.
HHS adopted foundation standards regarding transmission of electronic
prescriptions for covered Part D drugs prescribed for Part D eligible
individuals by publication of a Final Rule which became effective January 1,
2006 (70 FR 67567, November 7, 2005).
HHS also has a statutory mandate under the Health Insurance Portability and
Accountability Act (HIPAA), the Administrative Simplification provisions of
which require HHS to adopt standards for the electronic transmission of health
information contained in certain financial and administrative transactions.
HIPAA also requires HHS to adopt standards for the security of electronic health
information, and, in consultation with the Department of Commerce, to adopt
standards for electronic signatures for certain HIPAA transactions. These
regulations and standards are applicable to all health plans (including federal
health programs), healthcare clearinghouses, and all health care providers who
conduct electronic transactions.
Therefore, DEA, in conjunction with HHS, is conducting a public meeting to
allow the public, including prescribers, pharmacies, software/hardware vendors,
and other interested third parties, to identify electronic signature solutions
for electronic prescribing which mitigate, to the greatest extent possible, any
cost and burdens associated with adoption of the new technology while addressing
the security and accountability requirements under the Controlled Substances Act
of 1970 as they relate to controlled substances. Specific questions which
persons are encouraged to address are as follows:
- What is your perception of the current risks associated with electronic
prescribing?
- How did you identify those risks?
- How does your electronic prescribing system address those risks?
- Are risks pertaining to prescriptions for controlled substances different
from prescriptions for non-controlled substances? Please explain.
- What additional modifications would be necessary for your system to be
used for electronic prescribing of controlled substances? Please be specific
as to how this would be done, and the burden (cost or otherwise) this would
entail.
- How does your system authenticate the person signing the prescription?
- How does your system ensure the integrity of the prescription records?
- What current and future threats (e.g., eavesdropping, man- in-the-middle
attack, hijacking, impersonation) to system-wide security have you
considered during your design, development, and implementation?
- If smart cards, open networks or other methods of transmission are used to
facilitate electronic prescribing, can your system work within those
environments? Please specifically explain how it can or why it cannot.
Meeting Participation
This meeting is open to the public. Persons and organizations representing
prescribers, pharmacies, and vendors who design, develop, or market electronic
prescribing software or hardware/software used to permit electronic prescribing
[authenticate individuals or used to sign or secure electronic documents] may be
particularly interested in this meeting. Persons wishing to attend this meeting,
space permitting, must provide the following information to the Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement Administration, no
later than June 26, 2006 via e-mail or facsimile using the contact information
listed above:
Name:-----------------------------------------------------------------
Title:----------------------------------------------------------------
Company/Organization:-------------------------------------------------
Address:--------------------------------------------------------------
Telephone:------------------------------------------------------------
E-mail address:-------------------------------------------------------
Persons needing accommodations (e.g., sign language interpreter) are
requested to notify DEA with their accommodation request no later than June 26,
2006.
This meeting will consist of panel presentations. There will be limited
opportunities for attendees to make oral comments at the meeting.
Persons wishing to provide written comments may do so no later than June 26,
2006. All written comments will be made available at the
[[Page 28054]]
http://www.deadiversion.usdoj.gov prior to the public meeting. Therefore, as
this is a public meeting, confidential business information or other proprietary
information SHOULD NOT be presented at this meeting. Please see the "Comments''
section above for further information regarding providing written comments.
Dated: May 9, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E6-7302 Filed 5-12-06; 8:45 am]
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