PUBLIC LAW 109–60—AUG. 11, 2005 119 STAT. 1979

Public Law 109–60

109th Congress

An Act

To provide for the establishment of a controlled substance monitoring program

in each State.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘National All Schedules Prescription Electronic Reporting Act of 2005’’.

SEC. 2. PURPOSE.

It is the purpose of this Act to—

(1) foster the establishment of State-administered controlled substance monitoring systems in order to ensure that

health care providers have access to the accurate, timely

prescription history information that they may use as a tool

for the early identification of patients at risk for addiction

in order to initiate appropriate medical interventions and avert

the tragic personal, family, and community consequences of

untreated addiction; and

(2) 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.

SEC. 3. CONTROLLED SUBSTANCE MONITORING PROGRAM.

Part P of title III of the Public Health Service Act (42 U.S.C.

280g et seq.) is amended by adding after section 399N the following:

‘‘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.

42 USC 280g–3.

National All

Schedules

Prescription

Electronic

Reporting Act

of 2005.

Health and

health care.

42 USC 201 note.

42 USC 280g–3

note.

Aug. 11, 2005

[H.R. 1132]

119 STAT. 1980 PUBLIC LAW 109–60—AUG. 11, 2005

‘‘(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 subparagraph (A) 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.

‘‘(3) TERM OF 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, and not later than 6 months

after the date on which funds are first appropriated to carry out

this section, after seeking consultation with States and other

interested parties, the Secretary shall, after publishing in the Federal Register proposed minimum requirements and receiving public

comments, establish minimum requirements for criteria to be used

by States for purposes of 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 that information in the database is

accurate;

‘‘(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);

Deadline.

Federal Register,

publication.

PUBLIC LAW 109–60—AUG. 11, 2005 119 STAT. 1981

‘‘(viii) penalties for the unauthorized use and

disclosure of information maintained in the State controlled substance monitoring program in violation of

applicable State law or regulation;

‘‘(ix) information on the relevant State laws, policies, and procedures, if any, regarding purging of

information from the database; and

‘‘(x) 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 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 a State to 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.

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

that is operating a controlled substance monitoring program

under subsection (a)(1) on the date of submission 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) APPROVAL.—If a State submits an application in accordance with this subsection, the Secretary shall approve such

application.

‘‘(5) 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).

119 STAT. 1982 PUBLIC LAW 109–60—AUG. 11, 2005

‘‘(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:

‘‘(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.

‘‘(J) Such other information as may be required by

State law to be reported under this subsection.

‘‘(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).

Deadline.

PUBLIC LAW 109–60—AUG. 11, 2005 119 STAT. 1983

‘‘(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 subparagraph (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 investigation or proceeding involving the unlawful

diversion 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

Certification.

119 STAT. 1984 PUBLIC LAW 109–60—AUG. 11, 2005

‘‘(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

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) FEDERAL PRIVACY REQUIREMENTS.—Nothing in this section shall be construed to supersede any Federal privacy or

confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability

and Accountability Act of 1996 (Public Law 104–191; 110 Stat.

2033) and section 543 of the Public Health Service Act.

‘‘(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.

Records.

PUBLIC LAW 109–60—AUG. 11, 2005 119 STAT. 1985

‘‘(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) provides an analysis of the extent to which

the operation of controlled substance monitoring programs have reduced inappropriate use, abuse, or diversion of controlled substances or affected patient access

to appropriate pain care in States operating such programs;

‘‘(iii) 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;

‘‘(iv) determines the feasibility of implementing a

real-time electronic controlled substance monitoring

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

‘‘(v) provides an analysis of the privacy protections

in place for the information reported to the controlled

substance 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;

‘‘(vi) 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

‘‘(vii) 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) PREFERENCE.—Beginning 3 years after the date on which

funds are first appropriated to carry out this section, the Secretary,

in awarding any competitive grant that is related to drug abuse

(as determined by the Secretary) and for which only States are

eligible to apply, shall give preference to any State with an application approved under this section. The Secretary shall have the

discretion to apply such preference to States with existing controlled

substance monitoring programs that meet minimum requirements

Effective date.

119 STAT. 1986 PUBLIC LAW 109–60—AUG. 11, 2005

under this section or to States that put forth a good faith effort

to meet those requirements (as determined by the Secretary).

‘‘(l) 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.

‘‘(m) DEFINITIONS.—For purposes of this section:

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

is a patient of the 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, dispenser, or an

ultimate user and with respect to which there is no reasonable

basis to believe that the information can be used to identify

a practitioner, dispenser, 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.

PUBLIC LAW 109–60—AUG. 11, 2005 119 STAT. 1987

LEGISLATIVE HISTORY—H.R. 1132 (S. 518):

HOUSE REPORTS: No. 109–191 (Comm. on Energy and Commerce).

SENATE REPORTS: No. 109–117 accompanying S. 518 (Comm. on Health, Education, Labor, and Pensions).

CONGRESSIONAL RECORD, Vol. 151 (2005):

July 27, considered and passed House.

July 29, considered and passed Senate.

Æ

‘‘(n) 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.’’.

Approved August 11, 2005.