[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19566-19570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9854]


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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 [email protected]. Comments may also be sent electronically 
through http://www.regulations.gov using the electronic comment form 
provided on that site. An electronic copy of this document is also 
available at the http://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 http://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 http://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: [email protected].

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

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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 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