Request for Comment on Minimum Requirements for Criteria in Fiscal Year 2011 Grant Applications Under the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER), 19409-19413 [2010-8560]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Substance Abuse and Mental Health Services Administration

[Federal Register Volume 75, Number 71 (Wednesday, April 14, 2010)]
[Notices]
[Pages 19409-19413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8560]


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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 
Fiscal Year 2011 Grant Applications Under the National All Schedules 
Prescription Electronic Reporting Act of 2005 (NASPER)

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

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(m)(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) 
2010.
    Authority: Section 399O, of the Public Health Service Act, as 
amended.

DATES: The closing date to submit comments will be May 14, 2010. 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, 2010.

ADDRESSES: To assure proper handling of comments, please reference 
``Docket No. CSAT 003'' 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 2-1084, 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 and https://www.regulations.gov will not accept comments after 
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 
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 CONTACT paragraph.

FOR FURTHER INFORMATION CONTACT: Jennifer Fan, Center for Substance 
Abuse Treatment (CSAT), Division of Pharmacologic Therapies, SAMHSA, 1 
Choke Cherry Road, Room 2-1084, Rockville, MD 20857, (240) 276-1759, e-
mail: Jennifer.Fan@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 law is to foster the

[[Page 19410]]

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 as permitted by law. 
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 was authorized in 2005, 
an appropriation to fund the Federal grant program was not available 
until March 2009. Subsequently, the Consolidated Appropriations Act of 
2010 appropriated $2 million to SAMHSA for the NASPER program.
    According to the Alliance of States with Prescription Monitoring 
Programs (Alliance), as of February 2010, 35 States have operational 
PMPs. An additional 5 States have enacted legislation and 2 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 established 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.
    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 for 2010 
funding.
    The field of electronic patient health records is dynamic. The 
Administrator understands that there are several initiatives being 
conducted by the Office of the National Coordinator for Health 
Information Technology (ONC) under the Health Information Technology 
for Economic and Clinical Health Act (HITECH Act) of 2009. ONC supports 
the coordination of nationwide efforts to implement and use the most 
advanced health information technology and electronic exchange of 
health information such as the use of electronic health records (EHR). 
The ONC initiative is complemented by a grant program funded by the 
American Recovery and Reinvestment Act (ARRA) that accelerates the 
development and utilization of standardized EHR systems. In addition, 
the Drug Enforcement Administration (DEA) issued a notice of proposed 
rulemaking that, if finalized, would permit electronic prescribing of 
the controlled substances that are subject to PMPs, 73 FR 36722 (27 
June 2008).\1\ The Administrator believes that the future changes in 
health information technology and EHRs will have a significant impact 
on PMPs.
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    \1\ ``Electronic Prescriptions for Controlled Substances, 
Proposed Rule.'' Federal Register 73:125 (27 June 2008) p. 36722.
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    SAMHSA is currently involved in discussion with the Department of 
Health and Human Services (HHS) on Health Information Technology (HIT) 
and will monitor the implication for PMPs.

II. Request for Comments

    Before awarding grants to States under NASPER, the Secretary is 
required, after consulting 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)).
    In a Federal Register notice published April 29, 2009, 74 FR 81 (29 
April 2009), SAMSHA proposed minimum standards in accordance with 
NASPER.\2\ SAMHSA received several comments in response to that notice. 
These comments, the 2009 Request for Application (RFA), as well as a 
document that summarizes how the comments were addressed can be viewed 
by searching ``HHH-OS-2009-0006'' at the https://www.regulations.gov 
website. The comments were considered and reflected in the 2009 RFA. 
SAMHSA received and funded 13 grants to States in 2009. The minimum 
standards contained in the 2009 RFA remain in effect unless 
specifically modified as a result of this current process.
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    \2\ ``Request for Comment on Minimum Requirements for Criteria 
in Grant Applications Under the National All Schedules Prescription 
Electronic Reporting Act of 2005 (NASPER).'' Federal Register 74:81 
(29 April 2009) p. 19566.
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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). 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 revisions to the 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

[[Page 19411]]

the Institute of Justice Information Systems, which have provided 
technical assistance to State PMPs on interstate information sharing. 
SAMHSA has also reviewed the Model State PMP law, the Harold Rogers 
Grant Program grant solicitations as well as numerous reports, survey 
results, and published articles. 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.
    In addition from these consultations, SAMHSA understands that 
standards are not uniform from State to State. However, while some 
States have, or will adopt the minimum standards proposed in the 
notice, other States will consider the need to modify their systems 
substantially in order to conform with the new standards.

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.
    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 
individuals who receive and fill controlled substance prescriptions as 
well as 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)-(J).
    The Administrator is not proposing any new minimum standards for 
security under this system. The standards have not changed from those 
incorporated into the Fiscal Year 2009 RFA. To summarize, 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.
    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 section 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 not proposing any new minimum standards under 
this section.
    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 section four, and the 
revised 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.
    From the 2009 RFA, existing PMPs must adopt the 1995 or higher 
version of the American Society for Automation in Pharmacy (ASAP) 
standard for electronic prescription formatting to ensure the accuracy 
of the information in the PMP database, while PMPs that are being 
established and implemented must adopt the most current ASAP version 
(i.e., ASAP 2007). However, the Administrator proposes for comment the 
following new minimum requirements for accuracy. Existing PMPs must 
adopt the 2007 version of the ASAP standard for electronic prescription 
formatting by September 30, 2011. The Administrator believes the 
adoption of the minimum will help ensure that gross formatting errors 
in identification numbers, NDC codes, etc., are minimized. In addition, 
using the most recent version of the ASAP standard may enhance the 
potential for increased State-to-State interoperability, the potential 
to collect information on cash purchases, and the potential for ``real 
time'' reporting.
    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'') from any of 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.

[[Page 19412]]

    The Administrator is proposing minimum authentication and 
certification requirements for solicited disclosures from PMPs for the 
five entities listed in NASPER. These authentication requirements are 
proposed to bring PMPs into compliance with National Institute of 
Standards and Technology (NIST) 800-63.
    (a) A practitioner or dispenser (pharmacist) must submit a hard 
copy written, signed, and notarized request every three years 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. Such requests/certifications can be 
conducted by web-based procedures. In the 2009 RFA, States have until 
September 30, 2010 to apply this minimum requirement. This minimum 
requirement procedure must now be utilized by States at the time of 
funding. States, or their agents, must comply with level 2 authority 
verification and authorization mechanism level 2 as set forth in the 
NIST Electronic Authentication Guideline of April 2006.\3\
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    \3\ ``National Institute of Standards and Technology. Electronic 
Authentication Guideline. [Online] April 2006. Gaithersburg, MD: 
NIST Special Publication 800-63 Version 1.0.2. https://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf (accessed February 
18, 2010).
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    In addition, the Administrator recognizes that a number of States 
allow prescribers to enlist the assistance of agents who can retrieve 
patient information on behalf of the prescriber. The Administrator 
proposes the authorization of one PMP subaccount per prescriber, if 
permitted by State law. The dispenser would not be permitted to obtain 
subaccounts.
    (b) The Administrator is not proposing any new minimum standards 
under this section with respect to local, State, or Federal law 
enforcement, narcotics control, licensure, disciplinary, or program 
authorities.
    (c) The Administrator is not proposing any new minimum standards 
under this section with respect to the controlled substance monitoring 
program of another State or a group of States.
    (d) The Administrator is not proposing any new minimum standards 
under this section with respect to any agent of the Department of 
Health and Human Services, a State Medicaid program, a State health 
department, or the Drug Enforcement Administration.
    (e) The Administrator is not proposing any new minimum standards 
under this section with respect to 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.
    Patients: The Administrator is not proposing any new minimum 
standards under this section.
    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 identifies individuals who may need 
substance abuse treatment, or suggests drug diversion, is important to 
reducing substance abuse and reducing illicit distribution of 
controlled prescription substances.
    Prescription drug abuse and prescription drug mortality continue to 
present a significant public health problem. A recent Centers for 
Disease Control and Prevention Information Brief indicates that from 
1999 through 2006, the number of fatal poisonings involving opioid 
analgesics more than tripled from 4,000 to 13,800 deaths. That same 
report indicates that opioid analgesics were involved in almost 40% of 
all poisoning deaths in 2006.
    According to SAMHSA's 2008 National Survey on Drug Use and Health 
(NSDUH 2008), individuals age 12 and over initiate abuse of 
prescription controlled substance pain relievers at approximately the 
same rate as marijuana. That same report indicates that 55.9% of those 
individuals obtain the abused prescription drug free from a friend or 
relative. In turn, those friends or relatives obtained the prescription 
controlled substance from one doctor almost 80% of the time, and from 
one or more doctors 3.4% of the time. Clearly, there is a need to 
better inform prescribing physicians on how their patients are 
obtaining prescription controlled substances for potentially non-
medical uses.
    The inappropriate use of controlled prescription drugs is also 
taxing public insurance. According to the September 2009 U.S. 
Government Accountability Office (GAO) Report titled ``Medicaid: Fraud 
and Abuse Related to Controlled Substances Identified in Selected 
States,'' which looked at potential Medicaid fraud in California, 
Illinois, New York, North Carolina, and Texas, indicated that during 
fiscal years 2006 and 2007, ``doctor shopping'' activities involving 
controlled substances resulted in $63 million in Medicaid payments, not 
including medical costs related to getting prescriptions.\4\
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    \4\ U.S. Government Accountability Office. Medicaid: Fraud and 
Abuse Related to Controlled Substances Identified in Selected 
States, GAO-09-957. Washington, DC: Government Accountability 
Office, September 2009. https://www.gao.gov/new.items/d09957.pdf 
(accessed February 23, 2010).
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    The GAO Report also examined the use of PMPs in reducing fraud, 
abuse, and diversion of controlled substances. The GAO concluded that:

    For PDMPs to be useful, health care providers and pharmacies 
must use the data. Officials from the five selected states said that 
physician participation in the PDMP is not widespread and not 
required. In fact, one state did not have a Web-based PDMP; a health 
care provider has to put in a manual request to the agency to have a 
controlled substance report generated.

    SAMHSA agrees that PMPs are most effective when prescribers have 
information on patients; however, prescribers do not request or receive 
information from PMPs with acceptable frequency.\5\
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    \5\ Tribble SJ. (2010, January 20). Ohio lawmakers want to 
mandate prescription monitoring by doctors. Cleveland.com [Online] 
January 20, 2010. https://www.cleveland.com/healthfit/index.ssf/2010/01/lawmakers_want_to_mandate_pres.html (accessed February 23, 
2010).
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    Some States have enacted laws that require prescribers to solicit 
information on patients before prescribing. The Administrator is aware 
that many States have established ``thresholds'' that trigger 
unsolicited notifications to prescribers and in some cases 
dispensers.\6\
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    \6\ Katz N et al. Usefulness of prescription monitoring programs 
for surveillance--analysis of Schedule II opioid prescription data 
in Massachusetts, 1996-2006. Pharmacoepidemiology and Drug Safety 
2010; 19: 115-123.
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    In the 2009 RFA, the unsolicited notification minimum requirement 
was met by the State if the State established a plan and articulated a 
threshold for notifying practitioners and dispensers of information 
that will help identify and prevent unlawful diversion or misuse of 
controlled drugs. A threshold example

[[Page 19413]]

was provided of an individual who has filled five or more controlled 
substance prescriptions from five different prescribers or five 
different dispensers in the State within a six month period. After 
proposing this a minimum requirement in 2009, SAMHSA did receive a 
comment that this threshold would create a resource burden on States. 
Due to this, SAMHSA considered alternative notification plans.
    SAMHSA realizes that in the September 2009 GAO report, a threshold 
of patients using six or more physicians in a year to obtain controlled 
substances was used while a threshold of four or more physicians and 
four or more pharmacies in the span of one year was used by Katz et al 
in examining the data in Massachusetts.4 6 In addition, CDC 
recommended PMPs provide ``reports to providers on patients less than 
65 years old if they are being treated with opioids for more than 6 
weeks by two or more providers or if there are signs of inappropriate 
use of controlled substances.'' \7\ These thresholds have not been 
validated; however the GAO report found that approximately 65,000 
Medicaid beneficiaries in the five states investigated visited six or 
more doctors to acquire prescriptions for the same type of controlled 
substances in the selected states during fiscal years 2006 and 2007. In 
light of the above regarding the effectiveness of PMPs when prescribers 
and dispensers have access to PMP data as well as the burden on States 
with such disclosures, the Administrator is proposing as a minimum 
standard the following threshold: Any individual that has filled six or 
more controlled substance prescriptions from six different prescribers, 
or six different dispensers in the State, within a six month period 
shall be the subject of a report from the prescription drug monitoring 
program to each prescriber. This higher threshold for unsolicited 
reporting will reduce the burden to States from what was proposed in 
2009. To further mitigate the burden to States for unsolicited 
reporting to prescribers, the Administrator also proposes that reports 
must be sent to at least ten percent of the registered prescribers in 
the State in one calendar year.
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    \7\ Centers for Disease Control and Prevention. CDC's Issue 
Brief: Unintentional Drug Poisoning in the United States. [Online] 
March 2010. Atlanta, GA: https://www.cdc.gov/HomeandRecreationalSafety/pdf/poision-issue-brief.pdf (accessed 
April 5, 2010).
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    Drug Diversion Investigators: The Administrator is not proposing 
any new minimum standards under this section.

Pamela S. Hyde,
Administrator, Substance Abuse and Mental Health Services 
Administration.

[FR Doc. 2010-8560 Filed 4-13-10; 8:45 am]
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