Request for Comment on Minimum Requirements for Criteria in Grant Applications Under the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER), 19566-19570 [E9-9854]
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19566
Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Treating and Preventing
Inflammatory Bowel Disease (IBD)
Involving Interleukin-13 (IL–13) and
Natural Killer T (NKT) Cells
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AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in PCT Patent Application
No. PCT/US02/18790, filed June 14,
2002, which published as WO 2004/
001655 on December 31, 2003, now
expired, entitled ‘‘Method of Treating
and Preventing Colitis Involving IL–13
and NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–PCT–01];U.S. Patent
Application No. 10/517,898, filed
December 13, 2004, which was
published as US–2006–0024306 A1 on
February 2, 2006, entitled ‘‘A Method of
Treating Inflammatory Bowel Disease
(IBD)’’ [HHS Ref. No. E–131–2002/0–
US–02]; European Patent Application
No. 02742057.9, filed June 14, 2002,
which published as 1552462 on July 13,
2005, entitled ‘‘Method of Treating and
Preventing Colitis Involving IL–13 and
NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–EP–08]; Australian Patent
Application No. 2002315115, filed June
14, 2002, entitled ‘‘Method of Treating
and Preventing Colitis Involving IL–13
and NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–AU–05]; Japanese Patent
Application No. 2004515561, filed June
14, 2002, entitled ‘‘Method of Treating
and Preventing Colitis Involving IL–13
and NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–JP–04]; New Zealand Patent
Application No. 537726, filed June 14,
2002, entitled ‘‘Method of Treating and
Preventing Colitis Involving IL–13 and
NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–NZ–06]; Hong Kong Patent
Application No. 05112119.6, filed June
14, 2002, entitled ‘‘Method of Treating
and Preventing Colitis Involving IL–13
and NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–HK–09]; South African Patent
Application No. 2005/00375, filed June
14, 2002, entitled ‘‘Method of Treating
and Preventing Colitis Involving IL–13
and NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–ZA–07]; Canadian Patent
Application No. 2489540, filed June 14,
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2002, entitled ‘‘Method of Treating and
Preventing Colitis Involving IL–13 and
NK–T Cells’’ [HHS Ref. No. E–131–
2002/0–CA–03]; U.S. Provisional Patent
Application No. 60/671,624, filed April
15, 2005, now abandoned, entitled
‘‘Treatment and prevention of IBD using
Mutant and Chimeric IL–13 Molecules’’
[HHS Ref. No. E–003–2005/0–US–01];
PCT Patent Application No. PCT/US06/
014393, filed April 14, 2006, now
expired, entitled ‘‘Methods of Treating
and Preventing Inflammatory Bowel
Disease Involving IL–13 and NKT
Cells,’’ which published as WO 2006/
113614 on October 20, 2006 [HHS Ref.
No. E–003–2005/0–PCT–02]; European
Patent Application No. 06750435.7,
filed November 12, 2007, entitled
‘‘Methods of Treating and Preventing
Inflammatory Bowel Disease Involving
IL–13 and NKT Cells,’’ which published
as 1877074 on January 16, 2008, [HHS
Ref. No. E–003–2005/0–EP–04]; and
U.S. Patent Application No. 11/918,711,
filed April 14, 2006, entitled ‘‘Treatment
and Prevention of Inflammatory Bowel
Disease (IBD) Using Mutant and
Chimeric IL–13 Molecules’’ [HHS Ref.
No. E–003–2005/0–US–03] to Innate
Immune, Inc. which has an office in
Stanford, California, U.S.A. The patent
rights in these inventions have been
assigned to the United States of America
and Brigham and Women’s Hospital.
The prospective exclusive license
territory may be ‘‘worldwide’’, and the
field of use may be limited to ‘‘the use
of agents that modulate Natural Killer T
cell (NKT cell) activity and/or NKT cell
number a) by interaction with antigenpresenting cells expressing CD1d family
of proteins, and/or b) by interaction
with NKT cell receptors that bind to
antigen-presenting cells expressing
CD1d family of proteins, as therapeutics
for the treatment or prevention of
inflammatory bowel disease (IBD),
including ulcerative colitis and Crohn’s
disease.’’
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before June
29, 2009 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Suryanarayana (Sury)
Vepa, Ph.D., J.D., Licensing and
Patenting Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5020; Facsimile:
(301) 402–0220; E-mail:
vepas@mail.nih.gov.
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The
subject technology is directed to
methods of treating inflammatory bowel
disease (IBD), more specifically
Ulcerative Colitis (UC). The inventors of
this technology have used a mouse
model of experimental colitis (OC) to
show that Interleukin (IL)-13, a Th2
cytokine, is a significant pathologic
factor in OC and that neutralizing IL–13
in these animals effectively prevents
colitis (Immunity (2002) 17, 629–638).
The subject technology provides for
methods of treating UC by reducing
NKT cell activity. This reduction in
NKT cell activity can be accomplished
by inhibition of the cytokine IL–13 or its
receptor, IL–13R, or through modulation
of another NKT cell surface receptor,
such as the T-cell receptor. The T-cell
receptor is activated by the
glycoprotein, CD1d, which is expressed
on the surface of antigen-presenting
cells.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within sixty (60) days from the date of
this published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
SUPPLEMENTARY INFORMATION:
Dated: April 23, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E9–9856 Filed 4–28–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Request for Comment on Minimum
Requirements for Criteria in Grant
Applications Under the National All
Schedules Prescription Electronic
Reporting Act of 2005 (NASPER)
AGENCY: Substance Abuse and Mental
Health Services Administration, HHS.
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Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices
SUMMARY: This notice is to request
comments from interested parties
regarding criteria for grants issued
under NASPER (42 U.S.C. 280g–3).
NASPER establishes a formula grant
program for States to establish or
improve State controlled substance
monitoring systems (‘‘prescription
monitoring programs,’’ or ‘‘PMPs’’).
Under NASPER, the Secretary will
award grants to qualifying States,
defined in the legislation as the 50
States and the District of Columbia (42
U.S.C. 280g–3(i)(8)). This notice is
required under NASPER and comments
received in response to this notice will
be evaluated and as appropriate,
included in public announcements for
grants under this law.
SAMHSA will be issuing a Request
for Applications (RFA) for formula grant
awards under the NASPER program in
Federal fiscal year (FFY) 2009.
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Authority: Section 399O, of the Public
Health Service Act, as amended.
DATES: The closing date to submit
comments will be May 29, 2009. The
Administrator believes that this limited
comment period is necessary and
justified to comply with the timelines
necessary to announce, submit, review
and award grants before the end of the
fiscal year, September 30, 2009.
ADDRESSES: To assure proper handling
of comments, please reference ‘‘Docket
No. CSAT 002’’ on all written and
electronic correspondence. Written
comments may be submitted to the
Division of Pharmacologic Therapies,
Center for Substance Abuse Treatment,
1 Choke Cherry Road, Room 2–1063,
Rockville, MD 20857; Attention: DPT
Federal Register Representative.
Alternatively, comments may be
submitted directly to SAMHSA by
sending an electronic message to
dpt_interimrule@samhsa.hhs.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the https://
www.regulation.gov Web site. SAMHSA
will accept attachments to electronic
comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file
formats only. SAMHSA will not accept
any file formats other than those
specifically listed here.
Please note that SAMHSA is
requesting that electronic comments be
submitted before midnight Eastern time
on the day the comment period closes
because https://www.regulations.gov
terminates the public’s ability to submit
comments at midnight Eastern time on
the day the comment period closes.
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Commenters in time zones other than
Eastern time may want to consider this
so that their electronic comments are
received. All comments sent via regular
or express mail will be considered
timely if postmarked on the day the
comment period closes.
Posting of Public Comments: Please
note that all comments received are
considered part of the public record and
made available for public inspection
Online at https://www.regulations.gov
and in the SAMHSA’s public docket.
Such information includes personal
identifying information (such as your
name, address, etc.) voluntarily
submitted by the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘Personal Identifying
Information’’ in the first paragraph of
your comment. You must also place all
the personal identifying information
you do not want posted Online or made
available in the public docket in the first
paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘Confidential Business
Information’’ in the first paragraph of
your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted Online or made
available in the public docket.
Personal identifying information and
confidential business information
identified and located as set forth above
will be redacted and the comment, in
redacted form, will be posted online and
placed in the SAMHSA’s public docket
file. Please note that the Freedom of
Information Act applies to all comments
received. If you wish to inspect the
agency’s public docket file in person by
appointment, please see the ‘‘For
Further Information’’ paragraph.
FOR FURTHER INFORMATION CONTACT:
Nicholas Reuter, Center for Substance
Abuse Treatment (CSAT), Division of
Pharmacologic Therapies, SAMHSA, 1
Choke Cherry Road, Room 2–1063,
Rockville, MD 20857, (240) 276–2716, email: Nicholas.Reuter@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
The National All Schedules
Prescription Electronic Reporting Act of
2005, (‘‘NASPER’’ Pub. L. 109–60)
enacted August 11, 2005, created a
formula grant program under the
authority of the Secretary for Health and
Human Services (‘‘the Secretary’’) for
State controlled substance monitoring
systems (‘‘prescription monitoring
programs,’’ hereinafter, ‘‘PMPs’’). The
intent of this new law is to foster the
establishment or enhancement of Stateadministered controlled substance
monitoring systems in order to ensure
that health care providers and law
enforcement officials and other
regulatory bodies have access to
accurate, timely prescription history
information. In addition, the expansion
and establishment of prescription
monitoring systems has the potential for
assisting in the early identification of
patients at risk for addiction.
Although NASPER authorized
funding, an appropriation for NASPER
was not available until March 11, 2009.
The Omnibus Spending Act of 2009
appropriated $2 million to SAMHSA for
‘‘prescription monitoring programs
(NASPER)’’ for fiscal year 2009.
According to the National Alliance of
Model State Drug Laws (NAMSDL), as
of February 2009, 32 States have
operational prescription monitoring
programs (PMPs). An additional 6 States
have enacted legislation and 5 States
have pending legislation to start a PMP.
Although there is considerable
variation, the programs essentially
require that pharmacies, physicians, or
both, submit information on
prescriptions dispensed for certain
controlled substances as mandated by
State law. Prescriber and patient
information relating to prescriptions
issued for controlled stimulants,
sedatives/depressants, anxiolytics,
narcotics, etc., is transmitted to a central
office within each State.
NASPER establishes the authority for
a grant program with the Secretary,
HHS, wherein a State may submit an
application to implement a new
controlled substance prescription
monitoring system, or to make
improvements upon an existing State
controlled substance monitoring system.
In addition, the legislation includes
provisions for standardization that will
enable and require the sharing of
information between States with
programs. The State application for a
grant must include measures to prevent
unauthorized disclosures. This is
important as State PMPs include
personal patient health information on
both individuals who receive and fill
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controlled substance prescriptions and
those who have had a controlled
substance dispensed to them beyond a
48-hour supply.
To be eligible to receive a grant under
NASPER, the State must demonstrate
that the State has enacted legislation or
regulations to permit the
implementation of the State controlled
substance monitoring program and the
imposition of appropriate penalties for
the unauthorized use and disclosure of
information maintained in such
program. Additional requirements for
applications are set forth under 42
U.S.C. 280g–3(c), and include budget
cost estimates, interoperability
standards, uniform electronic formats,
access to information, penalties for
unauthorized disclosures and other
issues. SAMHSA will issue a formal
request for applications in the next
several weeks that will specify State
application requirements.
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II. Request for Comments
Before awarding grants to States
under NASPER, the Secretary is
required, after consultating with States
and other interested parties, to seek
public comment on proposed minimum
requirements. Under 42 U.S.C. 280g–
3(b), the criteria to be used by States
relate to the following four purposes:
1. Criteria for security for information
handling and for the database
maintained by the State under
subsection (e) generally including
efforts to use appropriate encryption
technology or other appropriate
technology to protect the security of
such information (42 U.S.C. 280g–
3(c)(1)(A)(ii));
2. Criteria for availability of
information and limitation on access to
program personnel (42 U.S.C. 280g–
3)(c)(1)(A)(v));
3. Criteria for access to the database,
and procedures to ensure that
information in the database is accurate
(42 U.S.C. 280g–3(c)(1)(A)(vi));
4. Criteria for the use and disclosure
of information, including a description
of the certification process to be applied
to requests for information under
subsection (f) (42 U.S.C. 280g–
3)(c)(1)(A)(vii)).
A. Consultation With States and Other
Interested Parties
Prescription monitoring programs
(‘‘PMPs’’) have been in place for
decades. In addition, the Federal
Government has supported the
development, enhancement, and
expansion of these State programs for
several years under the ‘‘Harold Rogers
Prescription Drug Monitoring Grant
Program,’’ which is administered by the
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Department of Justice, Bureau of Justice
Assistance (DOJ/BJA). In fiscal year (FY)
2009, the Harold Rogers Grant Program
will operate concurrently with the
NASPER grant program. Since FY 2003,
BJA has provided training and technical
assistance to grantees and to States
which are planning to implement a
program. BJA training and technical
assistance partners have included the
National Alliance for Model State Drug
Laws, the IJIS Institute, the National
Conference of State Legislatures, the
Addiction Technology Transfer Center,
Brandeis University, and the Alliance of
States with Prescription Drug
Monitoring Programs.
In developing these proposed
minimum standards, SAMHSA has
consulted with DOJ/BJA and the
Alliance of States with Prescription
Drug Monitoring Programs to obtain
information about their experience with
PMP operating requirements. In
addition, SAMHSA has discussed
NASPER provisions with individual
States with PMPs, and entities such as
the Institute of Justice Information
Systems, which have provided technical
assistance to State PMPs on interstate
information sharing. SAMHSA has
reviewed the Model State PMP law, the
Harold Rogers Grant Program grant
solicitations, as well as numerous
reports, survey results, and published
articles in prepared proposed minimum
requirements. While additional time
may have permitted a more extensive
and formal level of consultation,
SAMHSA believes that taken together,
the approach outlined above provides a
sufficient level of consultation for the
minimum requirements proposed for
comment in this notice.
B. Proposed Minimum Requirements
Overall, the Administrator’s intent in
proposing the minimum standards
below is to facilitate the stated goals of
NASPER—to foster establishment of
PMPs that provide timely information to
health care providers and others, and,
over time, to guide the improvement of
PMPs with best practices. In addition,
the Administrator strives with these
proposed minimum requirements to
balance the need to advance PMPs with
what States applying for NASPER grants
could be realistically expected to
achieve in a relatively short period of
time.
1. Criteria for security for information
handling and for the database
maintained by the State under
subsection (e) generally including
efforts to use appropriate encryption
technology or other appropriate
technology to protect the security of
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such information (42 U.S.C. 280g–
3(c)(1)(A)(ii));
State PMPs include personal patient
health information on both individuals
who receive and fill controlled
substance prescriptions and those who
have had a controlled substance
dispensed to them beyond a 48-hour
supply. In addition, PMPs need to
collect identification information on
prescribers and dispensers. Finally, the
systems need to collect information that
identifies the types and quantities of the
prescribed/dispensed substances. The
information collection requirements
under NASPER are set forth under 42
U.S.C. 280g–3(d)(3)(A).
Information from PMPs must be
stored and protected in an electronic
manner that, at a minimum, is at least
equivalent to the standards set forth in
regulations promulgated under section
262 of the Health Insurance Portability
and Accountability Act of 1996 (Pub. L.
104–191; 110 Stat. 2033). This would
include the technical safeguards
standards of the HIPAA Security Rule
under 45 CFR 164.312. ‘‘Technical
safeguards’’ is defined at 45 CFR
164.304 as, ‘‘the technology and the
policy and procedures for its use that
protect electronic protected health
information and control access to it.’’
These HIPAA security regulations
include technical safeguards for access
control, audit controls, integrity, person
or entity authentication, and
transmission security. The access
control standards require, at a
minimum, unique user identification,
and an emergency access procedure,
with automatic logoff and encryption/
decryption as addressable
implementation specifications.
In addition, NASPER does not
supersede the requirements of the
Federal substance abuse confidentiality
law (42 U.S.C. 290dd–2) and regulations
under 42 CFR part 2.
The Administrator is proposing as a
minimum requirement that PMP
databases are stored on separate servers,
physically secured with firewall
protections. These databases must
provide for backup and restore needs in
the event of disasters. These back up
systems must conform to the same
security requirements.
As discussed in more detail below,
information from these electronic
prescription drug monitoring databases
is released to certain entities upon
request (solicited), or without request
(unsolicited). The transmission of this
information must also be secure to
prevent inadvertent disclosure. The
Administrator understands that many of
these releases are conducted by webbased applications. At a minimum, the
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Secretary is proposing to require that
such web-based releases are encrypted
with 128-bit Secure Socket Logic
technology.
2. Criteria for availability of
information and limitation on access to
program personnel (42 U.S.C. 280g–
3(c)(1)(A)(v));
For the purposes of organization, the
Administrator will address ‘‘criteria for
availability of information’’ under item
four, below. ‘‘Limitation on access to
program personnel’’ will be interpreted
for the purposes of this notice to mean
limiting access to individuals within the
State PMP program to the PMP database
and the PMP data itself.
The Administrator is proposing that
each PMP have a ‘‘Master
Administrator.’’ The master
administrator is an individual with the
responsibility of controlling and
monitoring access to the PMP database
itself. This individual has the
responsibility for assigning usernames
and passwords to those who are granted
access to PMP data (both State
employees and non-State employees
who are certified to receive PMP data
notices.) A second key responsibility of
the master administrator is the ability to
maintain a log that accurately details
those who have accessed and received
data from the PMP database. The
Administrator is proposing that this log
requirement would not have to provide
‘‘per record’’ detail information. In other
words, the master administrator log
would need to detail who accessed the
system when, but not each record
received.
3. Criteria for access to the database,
and procedures to ensure that
information in the database is accurate
(42 U.S.C. 280g–3(c)(1)(A)(vi));
For the purposes of organization, the
Administrator will address ‘‘criteria for
access to the database’’ under sections
two and four, and proposed minimum
standards here (section 3) relating to
procedures to ensure that information in
the database is accurate.
Based upon consultations with States
and other entities, the Administrator
believes that the procedures applied by
PMPs to ensure accuracy have evolved
over the years. Indeed, electronic PMPs
rely on much of the same technology for
transmission of prescription drug data
as that used by the private and public
insurance systems. As such, these
electronic data transmission switches
have evolved procedures and safeguards
to help assure that the information is
accurate for reimbursement purposes.
The Administrator proposes for
comment the following minimum
requirements for accuracy. First, PMPs
must adopt the most recent version of
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the American Society for Automation in
Pharmacy (ASAP) standard for
electronic prescription formatting.
Adoption of the minimum, which the
Administrator believes is almost
universally in place will help ensure
that gross formatting errors in
identification numbers, NDC codes, etc.,
are minimized. In addition, the
Administrator is proposing as a
minimum requirement that PMPs
applying for NASPER grants must have
a mechanism for correcting inaccuracies
when notified by physicians,
pharmacists, patients, and others.
4. Criteria for the use and disclosure
of information, including a description
of the certification process to be applied
to requests for information under
subsection (f) (42 U.S.C. 280g–
3(c)(1)(A)(vii)).
The intent of this provision is to limit
the disclosure of information from a
State PMP to that necessary for public
health and law enforcement purposes.
NASPER envisions two types of
disclosures from PMPs—solicited
disclosures and unsolicited disclosures.
Solicited Disclosure of Information
from PMP. Under 42 U.S.C. 280g–3(f)(1),
a State may disclose information from
the PMP only in response to a request
(‘‘a solicited request’’) by five entities:
(a) A practitioner (or the agent thereof),
(b) any local, State, or Federal law
enforcement, narcotics control,
licensure, disciplinary, or program
authority, (c) the controlled substance
monitoring program of another State or
group of States with whom the State has
established an interoperability
agreement, (d) any agent of the
Department of Health and Human
Services, a State Medicaid program, a
State health department, or the Drug
Enforcement Administration, and (e) an
agent of the State agency or entity of
another State that is responsible for the
establishment and maintenance of that
State’s controlled substance monitoring
program. The Administrator views
solicited requests for information as a
two component process. First, the
individual or entity requesting
information from the PMP must be
authorized (‘‘authentication’’) to receive
the information. Next, the authorized
individual or entity must provide a need
(‘‘certification’’) for the requested
information.
The Administrator is proposing
minimum authentication and
certification requirements for solicited
disclosures from PMPs for the five
entities listed in NASPER.
(a) A practitioner (or the agent thereof,
including pharmacist) must submit a
hard copy written, signed, and notarized
request to the designated State agency,
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which in turn, verifies the information
before providing a username and
password to the practitioner. The
request must include the practitioner’s
name and date of birth, a corresponding
DEA registration number, and State
medical license number. In soliciting
information from the State PMP
database, the practitioner must certify
that the requested information is for the
purpose of providing medical or
pharmaceutical treatment or evaluating
the need for such treatment to a bona
fide current patient. The Administrator
envisions that such requests/
certifications can be conducted by webbased procedures.
(b) A local, State, or Federal law
enforcement, narcotics control,
licensure, disciplinary, or program
authority must submit a hard copy
written signed and notarized request to
the designated State agency, which in
turn, verifies the information before
providing a username and password to
the practitioner. The request must
include the agency name and the
individuals who will be authorized to
request access within the agency. The
requestor must certify for each
disclosure that the requested
information is related to an individual
investigation or proceeding involving
the unlawful diversion or misuse of a
schedule II, III, or IV substance, and that
such information will further the
purpose of the investigation or assist in
the proceeding. Such requests shall
include an active case number or
provide other assurance that the request
is pursuant to the law enforcement
agency’s official duties and
responsibilities.
(c) The controlled substance
monitoring program of another State or
group of States must have an
established, signed interoperability
agreement in place before interstate
patient information sharing (but not
anonymous, aggregate data) can
proceed. The Administrator notes that
there is considerable activity underway
between States, including ‘‘pilot
studies’’ to explore interoperability
technical and other issues. As such, at
this time the Administrator is proposing
that any interoperability agreements that
meet the requirements of the individual
State PMPs, and the general
requirements established by this notice,
should be acceptable. This means, for
example, that if the ultimate
information requestor is a law
enforcement entity, each State PMP
must meet the authentication and
certification requirements proposed
under (b), above.
(d) Any agent of the Department of
Health and Human Services, a State
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Medicaid program, a State health
department, or the Drug Enforcement
Administration must submit a written
request to the State PMP that identifies
the summary statistics sought. The
requesting Department, program,
administration, etc., must certify that
the requested information is necessary
for research to be conducted by such
department, program, or administration,
respectively, and the intended purpose
of the research is related to a function
committed to such department,
program, or administration by law that
is not investigative in nature.
(e) An agent of the State agency or
entity of another State that is
responsible for the establishment and
maintenance of the State’s controlled
substance monitoring program must
submit a written request on Agency
letterhead that identifies the requestor
as the person responsible for that State’s
controlled substance monitoring
program. After authentication by the
disclosing State PMP, the requesting
State certifies that (i) the State has an
application approved under this section;
and (ii) the requested information is for
the purpose of implementing the State’s
controlled substance monitoring
program.
Patients. The Administrator notes that
NASPER does not specifically designate
disclosures to patients as a category for
minimum requirements, perhaps
because HIPAA and other patient
information access provisions already
permit sufficient patient access to their
own controlled prescription drug
information. The Administrator invites
specific comment on this issue.
Unsolicited Disclosures of
Information from PMPs. Practitioners
and Dispensers. Under 42 U.S.C. 280g–
3(f)(2)(A), NASPER requires that ‘‘[I]n
consultation with practitioners,
dispensers, and other relevant and
interested stakeholders, a State
receiving a grant under subsection (a)
* * * shall establish a program to notify
practitioners and dispensers of
information that will help identify and
prevent the unlawful diversion or
misuse of controlled substances * * *.’’
The Administrator understands that
notifying prescribers and dispensers
when PMP activity suggest drug
diversion, or identifying individuals
who may need substance abuse
treatment, is important to reducing
substance abuse and reducing illicit
distribution of controlled prescription
substances. In addition, the
Administrator is aware that many States
have established ‘‘thresholds’’ that
trigger such notifications. States have
considerable latitude in establishing
such programs; and, at a minimum
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17:48 Apr 28, 2009
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States must establish and articulate the
criteria for such thresholds. For
example: The threshold for notifying
prescribers and dispensers is when an
individual has filled five or more
controlled substance prescriptions from
five different prescribers, or five
different dispensers in the State, within
a six month period.
Drug Diversion Investigators—Under
42 U.S.C. 280g–3(f)(2)(B) a State PMP
‘‘may, to the extent permitted under
State law, notify the appropriate
authorities responsible for carrying out
drug diversion investigations if the State
determines that information in the
database maintained by the State under
subsection (e) indicates an unlawful
diversion or abuse of a controlled
substance.’’
The Administrator notes that the
language in NASPER clearly indicates
that the provision for PMP to notify law
enforcement officials of potentially
criminal violations is voluntary. It is
likely that most States with existing
PMPs have established procedures and
thresholds for these types of unsolicited
disclosures. The Administrator
understands that minimum required
thresholds and procedures would be
quantitatively and qualitatively different
from those proposed for practitioners
and dispensers, above. At this time, the
Administrator is not proposing
minimum requirements for unsolicited
disclosures to drug diversion
investigators; however, the
Administrator invites comment on this
issue.
Eric B. Broderick,
Acting Administrator, Assistant Surgeon
General, Substance Abuse and Mental Health
Services Administration.
[FR Doc. E9–9854 Filed 4–28–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number 105–A]
Updating the List of Hazardous Drugs
for the NIOSH Alert: Additions and
Deletions to the NIOSH Hazardous
Drug List
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of draft document
available for public comment.
PO 00000
Frm 00086
Fmt 4703
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SUMMARY: The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the availability of the
following draft document available for
public comment entitled ‘‘Updating the
List of Hazardous Drugs for the NIOSH
Alert: Additions and Deletions to the
NIOSH Hazardous Drug List.’’ The
document and instructions for
submitting comments can be found at
https://www.cdc.gov/niosh/review/
public/105a/.
DATES: Comments must be postmarked
by June 30, 2009.
ADDRESSES: You may submit comments
to nioshdocket@cdc.gov or to the NIOSH
Docket Office, Robert A. Taft
Laboratories, MS–C34, 4676 Columbia
Parkway, Cincinnati, OH 45226 or by
facsimile (513) 533–8285. Comments
should be in Microsoft Word format and
should reference NIOSH docket number
105–A. NIOSH includes all comments
received without change in the docket,
including any personal information
provided. After the comment period has
closed, comments will be able to be
accessed electronically at https://
www.cdc.gov/NIOSH under the link to
the NIOSH docket. As appropriate,
NIOSH will post comments with the
commenters’ names, affiliations and
other information, on the Internet.
Background: The ‘‘NIOSH Alert:
Preventing Occupational Exposures to
Antineoplastic and Other Hazardous
Drugs in Health Care Settings’’ was
published in September 2004 (https://
www.cdc.gov/niosh/docs/2004–165/).
Since that time, approximately 60 new
drugs have received FDA approval and
approximately 60 drugs have received
special warnings (usually black box
warnings) based on reported adverse
effects in patients. An additional 18
drugs were included from the updated
National Institutes of Health (NIH)
Hazardous Drug List. From this list of
approximately 150 drugs, 62 drugs were
determined to have one or more
characteristic of a hazardous drug and
published for comment in NIOSH
docket number 105.
After review by experts, public review
and comment, input from stakeholders
and review of the scientific literature,
NIOSH has proposed a second draft list
of hazardous drugs. A number of drugs
were removed from the initial proposed
list based on comments from the various
groups and organizations. The second
draft list identifies 24 drugs that fit the
NIOSH definition of hazardous drugs.
Based on comments received by NIOSH,
Bacillus Calmette-Guerin (BCG) will be
removed from Appendix A in the 2004
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]]>Agencies
[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19566-19570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9854]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Request for Comment on Minimum Requirements for Criteria in Grant
Applications Under the National All Schedules Prescription Electronic
Reporting Act of 2005 (NASPER)
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
[[Page 19567]]
SUMMARY: This notice is to request comments from interested parties
regarding criteria for grants issued under NASPER (42 U.S.C. 280g-3).
NASPER establishes a formula grant program for States to establish or
improve State controlled substance monitoring systems (``prescription
monitoring programs,'' or ``PMPs''). Under NASPER, the Secretary will
award grants to qualifying States, defined in the legislation as the 50
States and the District of Columbia (42 U.S.C. 280g-3(i)(8)). This
notice is required under NASPER and comments received in response to
this notice will be evaluated and as appropriate, included in public
announcements for grants under this law.
SAMHSA will be issuing a Request for Applications (RFA) for formula
grant awards under the NASPER program in Federal fiscal year (FFY)
2009.
Authority: Section 399O, of the Public Health Service Act, as
amended.
DATES: The closing date to submit comments will be May 29, 2009. The
Administrator believes that this limited comment period is necessary
and justified to comply with the timelines necessary to announce,
submit, review and award grants before the end of the fiscal year,
September 30, 2009.
ADDRESSES: To assure proper handling of comments, please reference
``Docket No. CSAT 002'' on all written and electronic correspondence.
Written comments may be submitted to the Division of Pharmacologic
Therapies, Center for Substance Abuse Treatment, 1 Choke Cherry Road,
Room 2-1063, Rockville, MD 20857; Attention: DPT Federal Register
Representative. Alternatively, comments may be submitted directly to
SAMHSA by sending an electronic message to dpt_interimrule@samhsa.hhs.gov. Comments may also be sent electronically
through https://www.regulations.gov using the electronic comment form
provided on that site. An electronic copy of this document is also
available at the https://www.regulation.gov Web site. SAMHSA will accept
attachments to electronic comments in Microsoft Word, WordPerfect,
Adobe PDF, or Excel file formats only. SAMHSA will not accept any file
formats other than those specifically listed here.
Please note that SAMHSA is requesting that electronic comments be
submitted before midnight Eastern time on the day the comment period
closes because https://www.regulations.gov terminates the public's
ability to submit comments at midnight Eastern time on the day the
comment period closes. Commenters in time zones other than Eastern time
may want to consider this so that their electronic comments are
received. All comments sent via regular or express mail will be
considered timely if postmarked on the day the comment period closes.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection Online at https://www.regulations.gov and in the SAMHSA's
public docket. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``Personal Identifying Information'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted Online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``Confidential
Business Information'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted Online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the SAMHSA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the ``For Further Information'' paragraph.
FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance
Abuse Treatment (CSAT), Division of Pharmacologic Therapies, SAMHSA, 1
Choke Cherry Road, Room 2-1063, Rockville, MD 20857, (240) 276-2716, e-
mail: Nicholas.Reuter@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The National All Schedules Prescription Electronic Reporting Act of
2005, (``NASPER'' Pub. L. 109-60) enacted August 11, 2005, created a
formula grant program under the authority of the Secretary for Health
and Human Services (``the Secretary'') for State controlled substance
monitoring systems (``prescription monitoring programs,'' hereinafter,
``PMPs''). The intent of this new law is to foster the establishment or
enhancement of State-administered controlled substance monitoring
systems in order to ensure that health care providers and law
enforcement officials and other regulatory bodies have access to
accurate, timely prescription history information. In addition, the
expansion and establishment of prescription monitoring systems has the
potential for assisting in the early identification of patients at risk
for addiction.
Although NASPER authorized funding, an appropriation for NASPER was
not available until March 11, 2009. The Omnibus Spending Act of 2009
appropriated $2 million to SAMHSA for ``prescription monitoring
programs (NASPER)'' for fiscal year 2009.
According to the National Alliance of Model State Drug Laws
(NAMSDL), as of February 2009, 32 States have operational prescription
monitoring programs (PMPs). An additional 6 States have enacted
legislation and 5 States have pending legislation to start a PMP.
Although there is considerable variation, the programs essentially
require that pharmacies, physicians, or both, submit information on
prescriptions dispensed for certain controlled substances as mandated
by State law. Prescriber and patient information relating to
prescriptions issued for controlled stimulants, sedatives/depressants,
anxiolytics, narcotics, etc., is transmitted to a central office within
each State.
NASPER establishes the authority for a grant program with the
Secretary, HHS, wherein a State may submit an application to implement
a new controlled substance prescription monitoring system, or to make
improvements upon an existing State controlled substance monitoring
system. In addition, the legislation includes provisions for
standardization that will enable and require the sharing of information
between States with programs. The State application for a grant must
include measures to prevent unauthorized disclosures. This is important
as State PMPs include personal patient health information on both
individuals who receive and fill
[[Page 19568]]
controlled substance prescriptions and those who have had a controlled
substance dispensed to them beyond a 48-hour supply.
To be eligible to receive a grant under NASPER, the State must
demonstrate that the State has enacted legislation or regulations to
permit the implementation of the State controlled substance monitoring
program and the imposition of appropriate penalties for the
unauthorized use and disclosure of information maintained in such
program. Additional requirements for applications are set forth under
42 U.S.C. 280g-3(c), and include budget cost estimates,
interoperability standards, uniform electronic formats, access to
information, penalties for unauthorized disclosures and other issues.
SAMHSA will issue a formal request for applications in the next several
weeks that will specify State application requirements.
II. Request for Comments
Before awarding grants to States under NASPER, the Secretary is
required, after consultating with States and other interested parties,
to seek public comment on proposed minimum requirements. Under 42
U.S.C. 280g-3(b), the criteria to be used by States relate to the
following four purposes:
1. Criteria for security for information handling and for the
database maintained by the State under subsection (e) generally
including efforts to use appropriate encryption technology or other
appropriate technology to protect the security of such information (42
U.S.C. 280g-3(c)(1)(A)(ii));
2. Criteria for availability of information and limitation on
access to program personnel (42 U.S.C. 280g-3)(c)(1)(A)(v));
3. Criteria for access to the database, and procedures to ensure
that information in the database is accurate (42 U.S.C. 280g-
3(c)(1)(A)(vi));
4. Criteria for the use and disclosure of information, including a
description of the certification process to be applied to requests for
information under subsection (f) (42 U.S.C. 280g-3)(c)(1)(A)(vii)).
A. Consultation With States and Other Interested Parties
Prescription monitoring programs (``PMPs'') have been in place for
decades. In addition, the Federal Government has supported the
development, enhancement, and expansion of these State programs for
several years under the ``Harold Rogers Prescription Drug Monitoring
Grant Program,'' which is administered by the Department of Justice,
Bureau of Justice Assistance (DOJ/BJA). In fiscal year (FY) 2009, the
Harold Rogers Grant Program will operate concurrently with the NASPER
grant program. Since FY 2003, BJA has provided training and technical
assistance to grantees and to States which are planning to implement a
program. BJA training and technical assistance partners have included
the National Alliance for Model State Drug Laws, the IJIS Institute,
the National Conference of State Legislatures, the Addiction Technology
Transfer Center, Brandeis University, and the Alliance of States with
Prescription Drug Monitoring Programs.
In developing these proposed minimum standards, SAMHSA has
consulted with DOJ/BJA and the Alliance of States with Prescription
Drug Monitoring Programs to obtain information about their experience
with PMP operating requirements. In addition, SAMHSA has discussed
NASPER provisions with individual States with PMPs, and entities such
as the Institute of Justice Information Systems, which have provided
technical assistance to State PMPs on interstate information sharing.
SAMHSA has reviewed the Model State PMP law, the Harold Rogers Grant
Program grant solicitations, as well as numerous reports, survey
results, and published articles in prepared proposed minimum
requirements. While additional time may have permitted a more extensive
and formal level of consultation, SAMHSA believes that taken together,
the approach outlined above provides a sufficient level of consultation
for the minimum requirements proposed for comment in this notice.
B. Proposed Minimum Requirements
Overall, the Administrator's intent in proposing the minimum
standards below is to facilitate the stated goals of NASPER--to foster
establishment of PMPs that provide timely information to health care
providers and others, and, over time, to guide the improvement of PMPs
with best practices. In addition, the Administrator strives with these
proposed minimum requirements to balance the need to advance PMPs with
what States applying for NASPER grants could be realistically expected
to achieve in a relatively short period of time.
1. Criteria for security for information handling and for the
database maintained by the State under subsection (e) generally
including efforts to use appropriate encryption technology or other
appropriate technology to protect the security of such information (42
U.S.C. 280g-3(c)(1)(A)(ii));
State PMPs include personal patient health information on both
individuals who receive and fill controlled substance prescriptions and
those who have had a controlled substance dispensed to them beyond a
48-hour supply. In addition, PMPs need to collect identification
information on prescribers and dispensers. Finally, the systems need to
collect information that identifies the types and quantities of the
prescribed/dispensed substances. The information collection
requirements under NASPER are set forth under 42 U.S.C. 280g-
3(d)(3)(A).
Information from PMPs must be stored and protected in an electronic
manner that, at a minimum, is at least equivalent to the standards set
forth in regulations promulgated under section 262 of the Health
Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191;
110 Stat. 2033). This would include the technical safeguards standards
of the HIPAA Security Rule under 45 CFR 164.312. ``Technical
safeguards'' is defined at 45 CFR 164.304 as, ``the technology and the
policy and procedures for its use that protect electronic protected
health information and control access to it.'' These HIPAA security
regulations include technical safeguards for access control, audit
controls, integrity, person or entity authentication, and transmission
security. The access control standards require, at a minimum, unique
user identification, and an emergency access procedure, with automatic
logoff and encryption/decryption as addressable implementation
specifications.
In addition, NASPER does not supersede the requirements of the
Federal substance abuse confidentiality law (42 U.S.C. 290dd-2) and
regulations under 42 CFR part 2.
The Administrator is proposing as a minimum requirement that PMP
databases are stored on separate servers, physically secured with
firewall protections. These databases must provide for backup and
restore needs in the event of disasters. These back up systems must
conform to the same security requirements.
As discussed in more detail below, information from these
electronic prescription drug monitoring databases is released to
certain entities upon request (solicited), or without request
(unsolicited). The transmission of this information must also be secure
to prevent inadvertent disclosure. The Administrator understands that
many of these releases are conducted by web-based applications. At a
minimum, the
[[Page 19569]]
Secretary is proposing to require that such web-based releases are
encrypted with 128-bit Secure Socket Logic technology.
2. Criteria for availability of information and limitation on
access to program personnel (42 U.S.C. 280g-3(c)(1)(A)(v));
For the purposes of organization, the Administrator will address
``criteria for availability of information'' under item four, below.
``Limitation on access to program personnel'' will be interpreted for
the purposes of this notice to mean limiting access to individuals
within the State PMP program to the PMP database and the PMP data
itself.
The Administrator is proposing that each PMP have a ``Master
Administrator.'' The master administrator is an individual with the
responsibility of controlling and monitoring access to the PMP database
itself. This individual has the responsibility for assigning usernames
and passwords to those who are granted access to PMP data (both State
employees and non-State employees who are certified to receive PMP data
notices.) A second key responsibility of the master administrator is
the ability to maintain a log that accurately details those who have
accessed and received data from the PMP database. The Administrator is
proposing that this log requirement would not have to provide ``per
record'' detail information. In other words, the master administrator
log would need to detail who accessed the system when, but not each
record received.
3. Criteria for access to the database, and procedures to ensure
that information in the database is accurate (42 U.S.C. 280g-
3(c)(1)(A)(vi));
For the purposes of organization, the Administrator will address
``criteria for access to the database'' under sections two and four,
and proposed minimum standards here (section 3) relating to procedures
to ensure that information in the database is accurate.
Based upon consultations with States and other entities, the
Administrator believes that the procedures applied by PMPs to ensure
accuracy have evolved over the years. Indeed, electronic PMPs rely on
much of the same technology for transmission of prescription drug data
as that used by the private and public insurance systems. As such,
these electronic data transmission switches have evolved procedures and
safeguards to help assure that the information is accurate for
reimbursement purposes.
The Administrator proposes for comment the following minimum
requirements for accuracy. First, PMPs must adopt the most recent
version of the American Society for Automation in Pharmacy (ASAP)
standard for electronic prescription formatting. Adoption of the
minimum, which the Administrator believes is almost universally in
place will help ensure that gross formatting errors in identification
numbers, NDC codes, etc., are minimized. In addition, the Administrator
is proposing as a minimum requirement that PMPs applying for NASPER
grants must have a mechanism for correcting inaccuracies when notified
by physicians, pharmacists, patients, and others.
4. Criteria for the use and disclosure of information, including a
description of the certification process to be applied to requests for
information under subsection (f) (42 U.S.C. 280g-3(c)(1)(A)(vii)).
The intent of this provision is to limit the disclosure of
information from a State PMP to that necessary for public health and
law enforcement purposes. NASPER envisions two types of disclosures
from PMPs--solicited disclosures and unsolicited disclosures.
Solicited Disclosure of Information from PMP. Under 42 U.S.C. 280g-
3(f)(1), a State may disclose information from the PMP only in response
to a request (``a solicited request'') by five entities: (a) A
practitioner (or the agent thereof), (b) any local, State, or Federal
law enforcement, narcotics control, licensure, disciplinary, or program
authority, (c) the controlled substance monitoring program of another
State or group of States with whom the State has established an
interoperability agreement, (d) any agent of the Department of Health
and Human Services, a State Medicaid program, a State health
department, or the Drug Enforcement Administration, and (e) an agent of
the State agency or entity of another State that is responsible for the
establishment and maintenance of that State's controlled substance
monitoring program. The Administrator views solicited requests for
information as a two component process. First, the individual or entity
requesting information from the PMP must be authorized
(``authentication'') to receive the information. Next, the authorized
individual or entity must provide a need (``certification'') for the
requested information.
The Administrator is proposing minimum authentication and
certification requirements for solicited disclosures from PMPs for the
five entities listed in NASPER.
(a) A practitioner (or the agent thereof, including pharmacist)
must submit a hard copy written, signed, and notarized request to the
designated State agency, which in turn, verifies the information before
providing a username and password to the practitioner. The request must
include the practitioner's name and date of birth, a corresponding DEA
registration number, and State medical license number. In soliciting
information from the State PMP database, the practitioner must certify
that the requested information is for the purpose of providing medical
or pharmaceutical treatment or evaluating the need for such treatment
to a bona fide current patient. The Administrator envisions that such
requests/certifications can be conducted by web-based procedures.
(b) A local, State, or Federal law enforcement, narcotics control,
licensure, disciplinary, or program authority must submit a hard copy
written signed and notarized request to the designated State agency,
which in turn, verifies the information before providing a username and
password to the practitioner. The request must include the agency name
and the individuals who will be authorized to request access within the
agency. The requestor must certify for each disclosure that the
requested information is related to an individual investigation or
proceeding involving the unlawful diversion or misuse of a schedule II,
III, or IV substance, and that such information will further the
purpose of the investigation or assist in the proceeding. Such requests
shall include an active case number or provide other assurance that the
request is pursuant to the law enforcement agency's official duties and
responsibilities.
(c) The controlled substance monitoring program of another State or
group of States must have an established, signed interoperability
agreement in place before interstate patient information sharing (but
not anonymous, aggregate data) can proceed. The Administrator notes
that there is considerable activity underway between States, including
``pilot studies'' to explore interoperability technical and other
issues. As such, at this time the Administrator is proposing that any
interoperability agreements that meet the requirements of the
individual State PMPs, and the general requirements established by this
notice, should be acceptable. This means, for example, that if the
ultimate information requestor is a law enforcement entity, each State
PMP must meet the authentication and certification requirements
proposed under (b), above.
(d) Any agent of the Department of Health and Human Services, a
State
[[Page 19570]]
Medicaid program, a State health department, or the Drug Enforcement
Administration must submit a written request to the State PMP that
identifies the summary statistics sought. The requesting Department,
program, administration, etc., must certify that the requested
information is necessary for research to be conducted by such
department, program, or administration, respectively, and the intended
purpose of the research is related to a function committed to such
department, program, or administration by law that is not investigative
in nature.
(e) An agent of the State agency or entity of another State that is
responsible for the establishment and maintenance of the State's
controlled substance monitoring program must submit a written request
on Agency letterhead that identifies the requestor as the person
responsible for that State's controlled substance monitoring program.
After authentication by the disclosing State PMP, the requesting State
certifies that (i) the State has an application approved under this
section; and (ii) the requested information is for the purpose of
implementing the State's controlled substance monitoring program.
Patients. The Administrator notes that NASPER does not specifically
designate disclosures to patients as a category for minimum
requirements, perhaps because HIPAA and other patient information
access provisions already permit sufficient patient access to their own
controlled prescription drug information. The Administrator invites
specific comment on this issue.
Unsolicited Disclosures of Information from PMPs. Practitioners and
Dispensers. Under 42 U.S.C. 280g-3(f)(2)(A), NASPER requires that
``[I]n consultation with practitioners, dispensers, and other relevant
and interested stakeholders, a State receiving a grant under subsection
(a) * * * shall establish a program to notify practitioners and
dispensers of information that will help identify and prevent the
unlawful diversion or misuse of controlled substances * * *.''
The Administrator understands that notifying prescribers and
dispensers when PMP activity suggest drug diversion, or identifying
individuals who may need substance abuse treatment, is important to
reducing substance abuse and reducing illicit distribution of
controlled prescription substances. In addition, the Administrator is
aware that many States have established ``thresholds'' that trigger
such notifications. States have considerable latitude in establishing
such programs; and, at a minimum States must establish and articulate
the criteria for such thresholds. For example: The threshold for
notifying prescribers and dispensers is when an individual has filled
five or more controlled substance prescriptions from five different
prescribers, or five different dispensers in the State, within a six
month period.
Drug Diversion Investigators--Under 42 U.S.C. 280g-3(f)(2)(B) a
State PMP ``may, to the extent permitted under State law, notify the
appropriate authorities responsible for carrying out drug diversion
investigations if the State determines that information in the database
maintained by the State under subsection (e) indicates an unlawful
diversion or abuse of a controlled substance.''
The Administrator notes that the language in NASPER clearly
indicates that the provision for PMP to notify law enforcement
officials of potentially criminal violations is voluntary. It is likely
that most States with existing PMPs have established procedures and
thresholds for these types of unsolicited disclosures. The
Administrator understands that minimum required thresholds and
procedures would be quantitatively and qualitatively different from
those proposed for practitioners and dispensers, above. At this time,
the Administrator is not proposing minimum requirements for unsolicited
disclosures to drug diversion investigators; however, the Administrator
invites comment on this issue.
Eric B. Broderick,
Acting Administrator, Assistant Surgeon General, Substance Abuse and
Mental Health Services Administration.
[FR Doc. E9-9854 Filed 4-28-09; 8:45 am]
BILLING CODE 4162-20-P
