39–010 

Calendar No. 187 

109TH CONGRESS REPORT " ! SENATE 1st Session 109–117 

NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC 

REPORTING ACT OF 2005 

JULY 29, 2005.—Ordered to be printed 

Mr. ENZI, from the Committee on Health, Education, Labor, and 

Pensions, submitted the following 

R E P O R T 

[To accompany S. 518] 

The Committee on Health, Education, Labor, and Pensions, to 

which was referred the bill (S. 518) to provide for establishment of 

a controlled substance monitoring program in each State, having 

considered the same, reports favorably thereon with an amendment 

in the nature of a substitute and recommends that the bill (as 

amended) do pass. 

CONTENTS 

Page 

I. Purpose and summary ................................................................................... 1 

II. Background and need for legislation ............................................................ 2 

III. Legislative history and committee action .................................................... 2 

IV. Explanation of bill and committee views ..................................................... 2 

V. Cost estimate .................................................................................................. 6 

VI. Application of law to the legislative branch ................................................ 7 

VII. Regulatory impact statement ........................................................................ 7 

VIII. Section-by-section analysis ............................................................................ 7 

IX. Changes in existing law ................................................................................ 10 

I. PURPOSE AND SUMMARY

The purpose of S. 518 is to combat the abuse and diversion of 

prescription drugs by establishing a grant program, to be administered by the Department of Health and Human Services, that 

would support the expansion, in number and effectiveness, of State 

prescription drug monitoring programs (PMPs). Each State operating an authorized monitoring program would be required to cover 

Schedule II, III, and IV drugs. 

2 

S. 518 will provide resources to States to establish PMPs or to 

States improving existing programs. The bill will also facilitate the 

interoperability of State systems to detect more rapidly drug diversion and abuse that crosses State lines. 

II. BACKGROUND AND NEED FOR LEGISLATION

The diversion and abuse of legally manufactured prescription 

drugs continues to be a pressing national issue. The Office of National Drug Control Policy (ONDCP) cites that in 2002, 6.2 million 

Americans abused prescription drugs. 

In the approximately 20 States currently operating some form of 

a PMP, abuse and diversion have been reduced directly, through 

the identification of high-risk patient behavior or inappropriate 

provider practices; and indirectly, as growing awareness of these 

programs serves as a deterrent for potential wrongdoers. In general, PMPs operate by collecting from dispensers a basic set of information on prescriptions that are issued for controlled substances. In the most effective programs, providers, including physicians and pharmacists, may request the prescription histories of 

patients, permitting them to avoid providing controlled substances 

to ‘‘doctor shoppers’’ seeking multiple prescriptions to feed addiction or for diversion to the black market. Physicians are also provided with an important tool for early detection of patterns of addiction, presenting a new opportunity for early intervention and 

treatment. Other appropriate authorities, including public health 

entities, professional regulatory bodies, and law enforcement, may 

also access the PMP data under certain circumstances. 

However, several issues have emerged as clear barriers to the 

full realization of these programs’ potential. It is clear that effective programs push illicit activity across State borders. At present, 

even in regions where the abuse and diversion problem is rampant, 

many States do not yet operate programs, and none have the ability to effectively share information across State lines. In addition, 

many States are finding their programs hampered by outdated design and need both the technical and the financial assistance that 

this legislation would provide in order to undertake essential upgrades. 

III. LEGISLATIVE HISTORY AND COMMITTEE ACTION

Senator Sessions introduced S. 518 on March 3, 2005, with Senators Durbin, Kennedy, and Dodd. Additional cosponsors were 

added after introduction: Senators Alexander, Burr, Talent, and 

Vitter. 

On May 25, 2005, the Senate Committee on Health, Education, 

Labor, and Pensions met in Executive Session. After accepting a 

substitute amendment offered by Senators Sessions, Kennedy, Enzi 

and Dodd by unanimous voice vote, the committee approved S. 518, 

as amended, by unanimous voice vote. 

IV. EXPLANATION OF BILL AND COMMITTEE VIEWS

The committee believes the diversion and abuse of legally manufactured prescription drugs is a pressing national issue. The purpose of the legislation is to foster the establishment of State-administered prescription drug monitoring systems to ensure that health 

3 

care providers have access to accurate, timely prescription history 

information that they may use as a tool for the early identification 

of patients at risk for addiction. With the knowledge gained, health 

care providers will be able to initiate appropriate medical intervention and avert the tragic personal, family, and community consequences of untreated addiction. This legislation will also establish, based on the experiences of existing State controlled substance 

monitoring programs, a set of best practices to guide the establishment of new State programs and the improvement of existing programs. 

The bill amends Part P of title III of the Public Health Service 

Act and adds a new Section 399O, Controlled Substance Monitoring 

Program. Under this program, the Secretary of Health and Human 

Services would award grants to States to establish and implement 

controlled substance monitoring programs or to improve existing 

programs. 

Each State receiving grant approval from the Secretary will be 

awarded a minimum grant of 1.0 percent of that fiscal year’s appropriation for the program. Additional funding allocated to each State 

will be based on a ratio of the number of pharmacies within a State 

to the total number of pharmacies in States that have approved 

monitoring programs under this section. The committee recommends that the Secretary consult with the National Association 

of Boards of Pharmacy to determine the number of pharmacies in 

each State. The Secretary may adjust each State’s allocation after 

considering cost estimates provided by the State. 

Prior to awarding a grant under this section, but not later than 

6 months after the appropriation of funds, the Secretary will develop minimum standards for grant submissions by States and recommended penalties for the unlawful provision or use of any information found in the monitoring programs. Within 2 years from the 

date the funds are first appropriated under this section, the Secretary will report to Congress on the recommended penalties and 

the extent to which existing penalties are meeting these recommendations. 

To receive a grant under this section, a State must submit an application in a time, manner, and containing such assurances and 

information that the Secretary may require. States planning to establish or implement a program must include a cost estimate, and 

proposed criteria for information security, electronic formatting, 

program access, and penalties for misuse of information in their 

application. States requesting funds for improving existing systems 

must include a cost estimate, a plan to ensure the program is in 

compliance with the standards and penalties in this section, and a 

plan to enable the State program to achieve interoperability with 

other State programs. States establishing, implementing, or improving a controlled substance monitoring program must have enacted legislation or regulations to permit the implementation of the 

program and the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained by the program. 

The Committee recognizes that persons should be able to have 

accurate information in the database, and to be able to have any 

inaccurate information removed or corrected. In existing programs, 

the physician is normally the responsible party to seek the correcVerDate Aug 04 2004 01:56 Aug 09, 2005 Jkt 039010 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\SR117.XXX SR117
4 

tion on behalf of the affected individual. It is the intent of the committee that States would address the issue of how incorrect information would be corrected as part of their responsibility to ensure 

that the information in the database is accurate. 

The committee recognizes the concerns surrounding the potential 

for unauthorized access to the database and that patients will want 

to be notified if the privacy of their records is compromised. This 

legislation allows States to exceed the minimum privacy and penalty standards as outlined in the application criteria to protect the 

integrity of their electronic database. 

In order to increase the effectiveness of these programs, the legislation requires a State submitting an application that geographically borders another State that is operating a controlled substances monitoring program to describe how it will achieve interoperability between monitoring programs of these States. 

Sharing of information among neighboring States may help prevent diversion across State lines. In response to a request from a 

practitioner, law enforcement official, or PMP from a neighboring 

State, the PMP will prepare and provide a report summarizing the 

relevant information from the database to fully respond to the request. Further, in establishing interoperability agreements, the 

committee feels that PMPs can choose not to establish and/or cancel an agreement if they are concerned about the other State’s privacy protections. 

In implementing or improving a PMP under this section, a State 

shall require all dispensers to report each dispensing in the State 

not later than 1 week after dispensing. The legislation defines a 

controlled substance as any schedule II, III, IV drug or any other 

drug identified by the State to be subject to the monitoring program. 

The direct administration of a controlled substance to an ultimate user is excluded from this reporting requirement. The State 

may also exclude reporting for the dispensing of a controlled substance in an amount adequate to treat the ultimate user for 48 

hours or less. Because the possibility for diversion is small in both 

of these instances, to require this reporting would present a significant burden on the monitoring programs without a resulting benefit. For this reason, the Secretary may also identify other exclusions from reporting requirements. 

The information that must be reported by the dispenser includes: 

(1) the Drug Enforcement Administration Number (or other identifying number used in lieu of such Registration Number) of the dispenser; (2) the Drug Enforcement Administration Registration 

Number (or other identifying number used in lieu of such Registration Number) and name of the practitioner who prescribed the 

drug; (3) the name, address, and telephone number of the ultimate 

user; (4) identification of the drug by a national drug code number; 

(5) the quantity dispensed; (6) number of refills ordered or as a 

first time request; (7) whether the drug was dispensed as a refill; 

(8) the date of dispensing; and (9) the date of origin of the prescription. 

The committee intends that States require dispensers to report 

this information in a uniform electronic format in accordance with 

the Secretary’s criteria. In implementing or improving a controlled 

substance database, a State shall establish and maintain an elecVerDate Aug 04 2004 01:56 Aug 09, 2005 Jkt 039010 PO 00000 Frm 00004 Fmt 6659 Sfmt 6602 E:\HR\OC\SR117.XXX SR117
5 

tronic database that is searchable by any field or combination of 

fields. The State shall take appropriate safeguards to ensure the 

accuracy and completeness of the database, and shall take appropriate measures to protect the integrity of, and access to, the database. 

A State may disclose the information from the database upon request from a practitioner or local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority that certifies that the information is for an individual investigation. The committee intends that the term ‘‘program authority’’ 

should be interpreted to include State Medicaid authorities, or 

other State or Federal authorities responsible for investigating 

health care fraud and abuse. 

The bill directs each State to establish a notification program to 

improve collaboration between practitioners and dispensers to identify and prevent the unlawful diversion or misuse of controlled substances. This notification program will be established in consultation with practitioners, dispensers, and other relevant and interested stakeholders. States may, to the extent permitted under 

State law, notify the appropriate authorities responsible for drug 

diversion investigations if the information in the monitoring database suggests an unlawful diversion or abuse of a controlled substance. 

The bill specifies that nothing in the legislation should be construed to restrict the ability of any authority to perform functions 

otherwise authorized by law; preempt any State law; preempt any 

State from imposing additional privacy protections; supersede Federal confidentiality requirements; or create a Federal private right 

of action. 

The bill directs the Secretary to study whether the implementation of existing State monitoring programs has had a substantial 

negative impact on patient access to treatment, pediatric access to 

treatment, or patient enrollment in research or clinical trials. If the 

Secretary determines that a substantial negative impact has been 

demonstrated with regard to one or more of these categories, the 

Secretary shall identify additional appropriate categories of exclusion from reporting. 

The legislation also directs the Secretary to complete a study on 

the progress of States in establishing and implementing controlled 

substance monitoring programs. The study shall also determine the 

progress of States in achieving interoperability between monitoring 

programs, the feasibility of implementing a real-time electronic 

monitoring program, and an analysis of the privacy protections in 

place, and the feasibility of implementing technological alternatives 

to centralized data storage, such as peer-to-peer file sharing or 

data pointer systems, in monitoring programs and the potential for 

these alternatives to enhance privacy and security of individually 

identifiable data. Additionally, the study shall evaluate the penalties that States have enacted for the unauthorized use and disclosure of information maintained in monitoring programs. The Secretary shall submit a report to Congress on the results of this 

study. 

The bill authorizes States to establish an advisory council to assist in the establishment, implementation, or improvement of the 

monitoring program, however, no funds from this grant may be 

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used to operate such council. In establishing an advisory council, 

the State should consult with appropriate professional boards and 

other interested parties. An advisory council can provide needed expertise to a drug monitoring authority, including assistance in developing standards for indicating unlawful diversion or abuse. 

The bill authorizes to be appropriated $15 million in each of fiscal years 2006 and 2007 and $10 million in each of fiscal years 

2008 through 2010. 

The committee views this bill as an important step in reducing 

substance abuse across the Nation. 

According to the National Survey on Drug Use and Health 

(NSDUH), there was a significant increase in lifetime nonmedical 

use of pain relievers between 2002 and 2003 among person aged 12 

years and older—from 29.6 million to 31.2 million. The NSDUH 

also found that while 3 million americans receive treatment in a 

year, another 19 million remain without the services they need. As 

a result, the committee believes an important component of any 

strategy relating to prescription drug monitoring programs is a 

strong link with each State’s single State Authority (SSA) for Substance Abuse—the office responsible for planning and managing 

the publicly funded substance abuse prevention and treatment 

service delivery system. This important link with the SSA will help 

provide access to clinically appropriate treatment services for persons addicted to prescription drugs and enhance opportunities to 

build a strong and comprehensive prevention portfolio related to 

the misuse of prescription drugs. 

V. COST ESTIMATE

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, June 6, 2005. 

Hon. MIKE ENZI, Chairman, Committee on Health, Education, Labor, and Pensions, 

U.S. Senate, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for S. 518, the National All Schedules Prescription Electronic Reporting Act of 2005. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Shinobu Suzuki. 

Sincerely, 

ELIZABETH M. ROBINSON

(For Douglas Holtz-Eakin, Director). 

Enclosure. 

S. 518—National All Schedules Prescription Electronic Reporting 

Act of 2005 

S. 518 would authorize the Secretary of Health and Human Services to make grants to States to establish electronic database systems for monitoring the dispensing of controlled substances. The 

database would be used to identify, and report to appropriate authorities, the potential unlawful diversion or misuse of a controlled 

substance. 

7 

The bill would authorize the appropriation of $15 million in each 

of fiscal years 2006 and 2007, and $10 million a year for fiscal 

years 2008 through 2010. Assuming appropriation of those 

amounts, and based on spending patterns for similar programs, 

CBO estimates that implementing S. 518 would cost $52 million 

over the 2005–2010 period. Enacting S. 518 would have no effect 

on direct spending or revenues. 

S. 518 contains no intergovernmental or private-sector mandates 

as defined in the Unfunded Mandates Reform Act. It would establish a grant program for States to monitor controlled substances 

and to notify authorities when they suspect that controlled substances are being improperly dispensed or used. 

The CBO staff contact for this estimate is Shinobu Suzuki. This 

estimate was approved by Peter H. Fontaine, Deputy Assistance 

Director for Budget Analysis. 

VI. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH

Section 102(b)(3) of Public Law 104–1, the Congressional Accountability Act (CAA) requires a description of the application of 

this bill to the legislative branch. This bill does not amend any act 

that applies to the legislative branch. 

VII. REGULATORY IMPACT STATEMENT

The committee has determined that the bill will not have a significant regulatory impact. 

VIII. SECTION-BY-SECTION ANALYSIS

Section 1. Short title 

National All Schedules Prescription Electronic Reporting Act of 

2005. 

Section 2. Purpose 

The purpose of the legislation is to foster the establishment of 

State-administered prescription drug monitoring systems in order 

to ensure that health care providers have access to accurate, timely 

prescription history information. This information may be used as 

a tool for the early identification of patients at risk for addiction 

in order to initiate appropriate medical intervention and avert the 

tragic personal, family, and community consequences of untreated 

addiction. This legislation will also establish, based on the experiences of existing State controlled substance monitoring programs, 

a set of best practices to guide the establishment of new State programs and the improvement of existing programs. 

Section 3. Controlled Substance Monitoring Program 

Amends Part P of title III of the Public Health Service Act by 

adding a new section 399O, Controlled Substance Monitoring Program. 

Subsection (a) tasks the Secretary of Health and Human Services 

with awarding grants to States to establish and implement controlled substance monitoring programs or to improve existing programs. Each State receiving grant approval from the Secretary will 

be awarded a minimum grant of 1.0 percent of that fiscal year’s apVerDate Aug 04 2004 01:56 Aug 09, 2005 Jkt 039010 PO 00000 Frm 00007 Fmt 6659 Sfmt 6602 E:\HR\OC\SR117.XXX SR117
8 

propriation for the program. Additional funding will be allocated to 

each State based on a ratio of the number of pharmacies within the 

State to the total number of pharmacies in all States that have approved monitoring programs. 

Subsection (b) tasks the Secretary with developing minimum 

standards for grant submissions by prior to awarding a grant. 

Subsection (c) outlines the application approval office. To receive 

a grant under this section, a State must submit an application in 

a time, manner, and containing such assurances and information 

that the Secretary may require. States planning to establish or implement a program must include a cost estimate, and proposed criteria for information security, electronic formatting, program access, and penalties for misuse of information in their application. 

States requesting funds for improving existing systems must include a cost estimate, a plan to ensure the program is in compliance with the standards and penalties in this section, a plan to enable the State program to achieve interoperability with other State 

programs, and must have enacted legislation or regulations to permit the implementation of the program. 

A State submitting an application that geographically borders 

another State that is operating a controlled substances monitoring 

program under this section on the date of such application must 

describe how it will achieve interoperability between monitoring 

programs of these States. 

If the Secretary withdraws authorization, or if the State ceases 

to operate its monitoring program, then the State must return a 

prorated portion of its grant funding to the Secretary. 

Subsection (d) specifies reporting requirements. This section requires States implementing or improving a PMP, to report each 

dispensing of a controlled substance in the State not later than one 

week after dispensing. For the purposes of this section, controlled 

substance means any schedule II, III, IV drug or any other drug 

identified by the State to be subject to the monitoring program. 

The information that must be reported by the dispenser includes: 

(1) the Drug Enforcement Administration Number of the dispenser; 

(2) the Drug Enforcement Administration Registration Number and 

name of the practitioner who prescribed the drug; (3) the name, address, and telephone number of the ultimate user; (4) identification 

of the drug by a national drug code number; (5) the quantity dispensed; (6) number of refills ordered or as a first time request; (7) 

whether the drug was dispensed as a refill; (8) the date of dispensing; and (9) the date of origin of the prescription. 

Subsection (e) requires dispensers to report this information in a 

uniform electronic format in accordance with the Secretary’s criteria. In implementing or improving a controlled substance database, a State shall establish and maintain an electronic database 

that is searchable by any field or combination of fields. The State 

shall take appropriate safeguards to ensure the accuracy and completeness of the database, and shall take appropriate measures to 

protect the integrity of, and access to, the database. 

Subsection (f) specifies that a State may disclose the information 

from the database upon request from a practitioner, or agent thereof, who certifies that the information is to be used to treat a patient. The State may also disclose the information to local, State, 

or Federal law enforcement, narcotics control, licensure, discipliVerDate Aug 04 2004 01:56 Aug 09, 2005 Jkt 039010 PO 00000 Frm 00008 Fmt 6659 Sfmt 6602 E:\HR\OC\SR117.XXX SR117
9 

nary, or program authority that certifies that the information is for 

an individual investigation. In addition, the State may disclose information to another State or group of States with whom the State 

has an interoperability agreement. The State may also disclose information to any agent of the Department of Health and Human 

Services, a State Medicaid program, a State health department, or 

the Drug Enforcement Administration who certifies that the requested information is for research purposes. 

Subsection (g) is a limitation stating that in implementing or improving a controlled substance monitoring program, a State shall 

limit the information provided to the minimum necessary to accomplish the intended request and shall not disclose any individually 

identifiable information. 

Subsection (h) tasks the Secretary with specifying a uniform electronic format for the reporting, sharing, and disclosure of information. 

Subsection (i) lists rules of construction stating this legislation 

should not be construed to restrict the ability of any authority to 

perform functions otherwise authorized by law. This legislation 

should also not be construed to preempt any other State law. Additionally, this legislation should not be construed to preempt any 

State from imposing additional privacy protections. This bill should 

not be construed to supersede Federal confidentiality requirements. 

Furthermore, nothing in this bill shall be construed to create a 

Federal private right of action. 

Subsection (j) tasks the Secretary with conducting studies and 

reports and specifies not later than 180 days after the date of enactment, the Secretary shall determine whether the implementation of existing State monitoring programs has had a substantial 

negative impact on patient access to treatment, pediatric access to 

treatment, or patient enrollment in research or clinical trials. If the 

Secretary determines that a substantial negative impact has been 

demonstrated with regard to one or more of these categories, the 

Secretary shall identify additional appropriate categories of exclusion from reporting. Not later than 3 years after the date on which 

funds are first appropriated, the Secretary shall complete a study 

on the progress of States in establishing and implementing controlled substance monitoring programs. The study shall also determine the progress of States in achieving interoperability between 

monitoring programs, the feasibility of implementing a real-time 

electronic monitoring program, and an analysis of the privacy protections in place. Additionally, the study shall evaluate the penalties that States have enacted for the unauthorized use and disclosure of information maintained in monitoring programs. The Secretary shall submit a report to Congress on the results of this 

study. 

Subsection (k) gives States the authority to establish and advisory council to assist in the establishment, implementation, or improvement of the monitoring programs. 

Subsection (l) defines ‘‘bona fide patient’’, ‘‘controlled substance’’, 

‘‘dispense’’, ‘‘dispenser’’, ‘‘interoperability’’, ‘‘nonidentifiable information’’, ‘‘practitioner’’, ‘‘State’’, and ‘‘ultimate user’’. 

Subsection (m) authorizes to be appropriated $15 million in each 

of fiscal years 2006 and 2007 and $10 million in each of fiscal years 

2008 through 2010. 

10 

IX. CHANGES IN EXISTING LAW

In compliance with rule XXVI paragraph 12 of the Standing 

Rules of the Senate, the following provides a print of the statute 

or the part or section thereof to be amended or replaced existing 

law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed 

is shown in roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

PART P—ADDITIONAL PROGRAMS 

SEC. 399L. CHILDREN’S ASTHMA TREATMENT GRANTS PROGRAM. 

(a) AUTHORITY TO MAKE GRANTS.— 

(1) IN GENERAL.—* * * 

* * * * * * * 

SEC. 399N CHILDHOOD MALIGNANCIES. 

(a) IN GENERAL.—* * * 

* * * * * * * 

(e) AUTHORIZATION OF APPROPRIATIONS.—* * * 

* * * * * * * 

SEC. 399O. CONTROLLED SUBSTANCE MONITORING PROGRAM. 

(a) GRANTS.— (1) IN GENERAL.—Each fiscal year, the Secretary shall award 

a grant to each State with an application approved under this 

section to enable the State— 

(A) to establish and implement a State controlled substance monitoring program; or 

(B) to make improvements to an existing State controlled 

substance monitoring program. 

(2) DETERMINATION OF AMOUNT.— (A) MINIMUM AMOUNT.—In making payments under a 

grant under paragraph (1) for a fiscal year, the Secretary 

shall allocate to each State with an application approved 

under this section an amount that equals 1.0 percent of the 

amount appropriated to carry out this section for that fiscal 

year. 

(B) ADDITIONAL AMOUNTS.—In making payments under a 

grant under paragraph (1) for a fiscal year, the Secretary 

shall allocate to each State with an application approved 

under this section an additional amount which bears the 

same ratio to the amount appropriated to carry out this section for that fiscal year and remaining after amounts are 

made available under paragraph (1) as the number of 

pharmacies of the State bears to the number of pharmacies 

of all States with applications approved under this section 

(as determined by the Secretary), except that the Secretary 

may adjust the amount allocated to a State under this subparagraph after taking into consideration the budget cost 

estimate for the State’s controlled substance monitoring 

program. 

11 

(3) TERM OF CERTAIN GRANTS.—Grants awarded under this 

section shall be obligated in the year in which funds are allotted. 

(b) DEVELOPMENT OF MINIMUM REQUIREMENTS.—Prior to awarding a grant under this section, but not later than 6 months after the 

date on which funds are first appropriated under this section, the 

Secretary shall identify minimum requirements for use by States in 

submitting their proposed criteria under clauses (ii), (v), (vi), and 

(vii) of subsection (c)(1)(A). 

(c) APPLICATION APPROVAL PROCESS.— (1) IN GENERAL.—To be eligible to receive a grant under this 

section, a State shall submit an application to the Secretary at 

such time, in such manner, and containing such assurances 

and information as the Secretary may reasonably require. Each 

such application shall include— 

(A) with respect to a State that intends to use funds 

under the grant as provided for in subsection (a)(1)(A)— 

(i) a budget cost estimate for the controlled substance 

monitoring program to be implemented under the 

grant; 

(ii) 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; 

(iii) an agreement to adopt health information interoperability standards, including health vocabulary and 

messaging standards, that are consistent with any 

such standards generated or identified by the Secretary 

or his or her designee; 

(iv) criteria for meeting the uniform electronic format 

requirement of subsection (h); 

(v) criteria for availability of information and limitation on access to program personnel; 

(vi) criteria for access to the database, and procedures to ensure database accuracy; 

(vii) 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); 

(viii) penalties for the unauthorized use and disclosure of information in violation of applicable State law 

or regulation; and 

(ix) assurances of compliance with all other requirements of this section; or 

(B) with respect to a State that intends to use funds 

under the grant as provided for in subsection (a)(1)(B)— 

(i) a budget cost estimate for the controlled substance 

monitoring program to be improved under the grant; 

(ii) a plan for ensuring that the State controlled substance monitoring program is in compliance with the 

criteria and penalty requirements described in clauses 

(ii) through (viii) of subparagraph (A); 

(iii) a plan to enable the State controlled substance 

monitoring program to achieve interoperability with at 

12 

least one other State controlled substance monitoring 

program; and 

(iv) assurances of compliance with all other requirements of this section or a statement describing why 

such compliance is not feasible or is contrary to the 

best interests of public health in such State. 

(2) STATE LEGISLATION.—As part of an application under 

paragraph (1), the Secretary shall require the State to have 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. 

(3) INTEROPERABILITY.—If a State that submits an application under this subsection geographically borders another State 

that is operating a controlled substances monitoring program 

under subsection (a)(1) on the date of such application, and 

such applicant State has not achieved interoperability for purposes of information sharing between its monitoring program 

and the monitoring program of such border State, such applicant State shall, as part of the plan under paragraph (1)(B)(iii), 

describe the manner in which the applicant State will achieve 

interoperability between the monitoring programs of such 

States. 

(4) RETURN OF FUNDS.—If the Secretary withdraws approval 

of a State’s application under this section, or the State chooses 

to cease to implement or improve a controlled substance monitoring program under this section, a funding agreement for the 

receipt of a grant under this section is that the State will return 

to the Secretary an amount which bears the same ratio to the 

overall grant as the remaining time period for expending the 

grant funds bears to the overall time period for expending the 

grant (as specified by the Secretary at the time of the grant). 

(d) REPORTING REQUIREMENTS.—In implementing or improving a 

controlled substance monitoring program under this section, a State 

shall comply, or with respect to a State that applies for a grant 

under subsection (a)(1)(B) submit to the Secretary for approval a 

statement of why such compliance is not feasible or is contrary to 

the best interests of public health in such State, with the following: 

(1) The State shall require dispensers to report to such State 

each dispensing in the State of a controlled substance to an ultimate user not later than 1 week after the date of such dispensing. 

(2) The State may exclude from the reporting requirement of 

this subsection— 

(A) the direct administration of a controlled substance to 

the body of an ultimate user; 

(B) the dispensing of a controlled substance in a quantity 

limited to an amount adequate to treat the ultimate user 

involved for 48 hours or less; or 

(C) the administration or dispensing of a controlled substance in accordance with any other exclusion identified by 

the Secretary for purposes of this paragraph. 

(3) The information to be reported under this subsection with 

respect to the dispensing of a controlled substance shall include 

the following: 

13 

(A) Drug Enforcement Administration Registration Number (or other identifying number used in lieu of such Registration Number) of the dispenser. 

(B) Drug Enforcement Administration Registration Number (or other identifying number used in lieu of such Registration Number) and name of the practitioner who prescribed the drug. 

(C) Name, address, and telephone number of the ultimate 

user or such contact information of the ultimate user as the 

Secretary determines appropriate. 

(D) Identification of the drug by a national drug code 

number. 

(E) Quantity dispensed. 

(F) Number of refills ordered. 

(G) Whether the drug was dispensed as a refill of a prescription or as a first-time request. 

(H) Date of the dispensing. 

(I) Date of origin of the prescription. 

(4) The State shall require dispensers to report information 

under this section in accordance with the electronic format specified by the Secretary under subsection (h), except that the State 

may waive the requirement of such format with respect to an 

individual dispenser that is unable to submit such information 

by electronic means. 

(e) DATABASE.—In implementing or improving a controlled substance monitoring program under this section, a State shall comply 

with the following: 

(1) The State shall establish and maintain an electronic database containing the information reported to the State under 

subsection (d). 

(2) The database must be searchable by any field or combination of fields. 

(3) The State shall include reported information in the database in a manner consistent with criteria established by the 

Secretary, with appropriate safeguards for ensuring the accuracy and completeness of the database. 

(4) The State shall take appropriate security measures to protect the integrity of, and access to, the database. 

(f) USE AND DISCLOSURE OF INFORMATION.— (1) IN GENERAL.—Subject to subsection (g), in implementing 

or improving a controlled substance monitoring program under 

this section, a State may disclose information from the database 

established under subsection (e) and, in the case of a request 

under subsection (f)(1)(D), summary statistics of such information, only in response to a request by— 

(A) a practitioner (or the agent thereof) who certifies, 

under the procedures determined by the State, 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; 

(B) any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, 

who certifies, under the procedures determined by the State, 

that the requested information is related to an individual 

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14 

sion or misuse of a schedule II, III, or IV substance, and 

such information will further the purpose of the investigation or assist in the proceeding; 

(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 who certifies 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; or 

(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, 

who 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 under this section. 

(2) DRUG DIVERSION.—In consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State 

receiving a grant under subsection (a)— 

(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; and 

(B) 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. 

(g) LIMITATIONS.—In implementing or improving a controlled substance monitoring program under this section, a State— 

(1) shall limit the information provided pursuant to a valid 

request under subsection (f)(1) to the minimum necessary to accomplish the intended purpose of the request; and 

(2) shall limit information provided in response to a request 

under subsection (f)(1)(D) to nonidentifiable information. 

(h) ELECTRONIC FORMAT.—The Secretary shall specify a uniform 

electronic format for the reporting, sharing, and disclosure of information under this section. 

(i) RULES OF CONSTRUCTION.— 

(1) FUNCTIONS OTHERWISE AUTHORIZED BY LAW.—Nothing in 

this section shall be construed to restrict the ability of any authority, including any local, State, or Federal law enforcement, 

narcotics control, licensure, disciplinary, or program authority, 

to perform functions otherwise authorized by law. 

(2) NO PREEMPTION.—Nothing in this section shall be construed as preempting any State law, except that no such law 

15 

may relieve any person of a requirement otherwise applicable 

under this Act. 

(3) ADDITIONAL PRIVACY PROTECTIONS.—Nothing in this section shall be construed as preempting any State from imposing 

any additional privacy protections. 

(4) CERTAIN CONFIDENTIALITY REQUIREMENTS.—Nothing in 

this section shall be construed as preempting the confidentiality 

requirements of part 2 and part 2a of title 42, Code of Federal 

Regulations. 

(5) NO FEDERAL PRIVATE CAUSE OF ACTION.—Nothing in this 

section shall be construed to create a Federal private cause of 

action. 

(j) STUDIES AND REPORTS.— 

(1) IMPLEMENTATION REPORT.— 

(A) IN GENERAL.—Not later than 180 days after the date 

of enactment of this section, the Secretary, based on a review of existing State controlled substance monitoring programs and other relevant information, shall determine 

whether the implementation of such programs has had a 

substantial negative impact on— 

(i) patient access to treatment, including therapy for 

pain or controlled substance abuse; 

(ii) pediatric patient access to treatment; or 

(iii) patient enrollment in research or clinical trials 

in which, following the protocol that has been approved 

by the relevant institutional review board for the research or clinical trial, the patient has obtained a controlled substance from either the scientific investigator 

conducting such research or clinical trial or the agent 

thereof. 

(B) ADDITIONAL CATEGORIES OF EXCLUSION.—If the Secretary determines under subparagraph (A) that a substantial negative impact has been demonstrated with regard to 

one or more of the categories of patients described in such 

subparagraph, the Secretary shall identify additional appropriate categories of exclusion from reporting as authorized under subsection (d)(2)(C). 

(2) PROGRESS REPORT.—Not later than 3 years after the date 

on which funds are first appropriated under this section, the 

Secretary shall— 

(A) complete a study that— 

(i) determines the progress of States in establishing 

and implementing controlled substance monitoring 

programs under this section; 

(ii) determines the progress of States in achieving 

interoperability between controlled substance monitoring programs, including an assessment of technical 

and legal barriers to such activities and recommendations for addressing these barriers; 

(iii) determines the feasibility of implementing a 

real-time electronic controlled substance monitoring 

program, including the costs associated with establishing such a program; 

(iv) provides an analysis of the privacy protections in 

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stance monitoring program in each State receiving a 

grant for the establishment or operation of such program, and any recommendations for additional requirements for protection of this information; 

(v) determines the feasibility of implementing technological alternatives to centralized data storage, such as 

peer-to-peer file sharing or data pointer systems, in 

controlled substance monitoring programs and the potential for such alternatives to enhance the privacy and 

security of individually identifiable data; and 

(vi) evaluates the penalties that States have enacted 

for the unauthorized use and disclosure of information 

maintained in the controlled substance monitoring program, and reports on the criteria used by the Secretary 

to determine whether such penalties qualify as appropriate pursuant to this section; and 

(B) submit a report to the Congress on the results of the 

study. 

(k) ADVISORY COUNCIL.— 

(1) ESTABLISHMENT.—A State may establish an advisory 

council to assist in the establishment, implementation, or improvement of a controlled substance monitoring program under 

this section. 

(2) LIMITATION.—A State may not use amounts received 

under a grant under this section for the operations of an advisory council established under paragraph (1). 

(3) SENSE OF CONGRESS.—It is the sense of the Congress that, 

in establishing an advisory council under this subsection, a 

State should consult with appropriate professional boards and 

other interested parties. 

(l) DEFINITIONS.—For purposes of this section: 

(1) The term ‘‘bona fide patient’’ means an individual who is 

a patient of the dispenser or practitioner involved. 

(2) The term ‘‘controlled substance’’ means a drug that is included in schedule II, III, or IV of section 202(c) of the Controlled Substance Act. 

(3) The term ‘‘dispense’’ means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order 

of, a practitioner, irrespective of whether the dispenser uses the 

Internet or other means to effect such delivery. 

(4) The term ‘‘dispenser’’ means a physician, pharmacist, or 

other person that dispenses a controlled substance to an ultimate user. 

(5) The term ‘‘interoperability’’ with respect to a State controlled substance monitoring program means the ability of the 

program to electronically share reported information, including 

each of the required report components described in subsection 

(d), with another State if the information concerns either the 

dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing of a controlled substance prescribed by a practitioner whose principal place of 

business is located in such other State. 

(6) The term ‘‘nonidentifiable information’’ means information 

that does not identify a practitioner or an ultimate user and 

with respect to which there is no reasonable basis to believe that 

17 

the information can be used to identify a practitioner or an ultimate user. 

(7) The term ‘‘practitioner’’ means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United 

States or the jurisdiction in which he or she practices or does 

research, to distribute, dispense, conduct research with respect 

to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. 

(8) The term ‘‘State’’ means each of the 50 States and the District of Columbia. 

(9) The term ‘‘ultimate user’’ means a person who has obtained from a dispenser, and who possesses, a controlled substance for his or her own use, for the use of a member of his 

or her household, or for the use of an animal owned by him or 

her or by a member of his or her household. 

(m) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there are authorized to be appropriated— (1) $15,000,000 for each of fiscal years 2006 and 2007; and 

(2) $10,000,000 for each of fiscal years 2008, 2009, and 2010.. 

* * * * * * * 

Æ