[Congressional Record Volume 151, Number 104 (Wednesday, July 27, 2005)]
[House]
[Pages H6681-H6686]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  NATIONAL ALL SCHEDULES PRESCRIPTION ELECTRONIC REPORTING ACT OF 2005

  Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and 
pass the bill (H.R. 1132) to provide for the establishment of a 
controlled substance monitoring program in each State, as amended.
  The Clerk read as follows:

                               H.R. 1132

       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.
       ``(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);
       ``(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).
       ``(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

[[Page H6682]]

     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).
       ``(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
       ``(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.
       ``(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.

[[Page H6683]]

       ``(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 
     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.
       ``(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.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Georgia (Mr. Deal) and the gentleman from Ohio (Mr. Brown) each will 
control 20 minutes.
  The Chair recognizes the gentleman from Georgia (Mr. Deal).


                             General Leave

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days in which to revise and extend their 
remarks and to insert extraneous material on this bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?
  There was no objection.
  Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, we are facing a growing national health care crisis 
involving the abuse of prescription drugs. Earlier this month, Columbia 
University released a report that showed that more Americans are now 
abusing controlled prescription drugs than cocaine, hallucinogens, 
inhalants and heroin combined. The report also stated the number of 
Americans who admit abusing prescription drugs nearly doubled to over 
15 million from 1992 to 2003, while abuse among teens has tripled. H.R. 
1132 will provide immediate assistance to States to help them reduce 
prescription drug abuse. The bill will provide new funding to help 
States establish and operate data systems that will allow physicians to 
detect and prevent prescription drug abuse.
  Physicians are on the front line of providing care to patients and 
understand the need to stop prescription drug abuse before it starts. 
H.R. 1132 will provide physicians with the tools they need to learn 
when their patients attempt to obtain multiple prescriptions for 
addictive drugs. The bill will also allow physicians to continue to 
provide proper medication therapy to their patients. This is why groups 
like the American Medical Association, the American Society of 
Anesthesiologists, and the American Society of Interventional Pain 
Physicians all support this legislation.
  I would like to thank the gentleman from Kentucky (Mr. Whitfield), 
the gentleman from Georgia (Mr. Norwood), the gentleman from New Jersey 
(Mr. Pallone), and the gentleman from Ohio (Mr. Strickland), members of 
the Energy and Commerce Committee, for their efforts on this bill. As a 
result of their hard work, the bill has been strengthened and improved 
from last year when the House approved similar legislation by voice 
vote.
  Among the many improvements are requirements that drug monitoring 
programs meet new standards for the security of information handling, 
availability of information, limitations on access to the database, and 
procedures to ensure database accuracy.
  I would also like to thank the staff of the Energy and Commerce 
Committee for their hard work and in particular thank Ryan Long and 
John Ford for their efforts to negotiate a bipartisan agreement on this 
bill.
  H.R. 1132 will allow States to reduce the improper abuse of 
prescription drugs and ensure that monitoring programs can communicate 
with each other to stifle interstate drug diversion. I urge my 
colleagues to support this needed legislation.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3 minutes.
  Prescription pain relievers, stimulants, and other controlled 
substances play a crucial role in health care; but when misused, these 
same medicines can be enormously destructive. Some are addictive. Some 
are life-threatening. Many are both. As these medicines proliferate, 
so, unfortunately, does the risk of misuse. Over the last decade, use 
of prescription pain relievers increased by almost 200 percent while 
the use of stimulants increased by more than 150 percent. An estimated 
6.2 million Americans misuse prescription medications for nonmedicinal 
purposes.
  In 1999, a quarter of those taking prescription drugs for nonmedical 
purposes were new users. In other words, this problem is not just 
growing, it is exploding. To combat this abuse, physicians and 
pharmacists need information. This legislation, the culmination of hard 
work and compromise, as the gentleman from Georgia pointed out, by the 
gentleman from New Jersey (Mr. Pallone), the gentleman from Kentucky 
(Mr. Whitfield), the gentleman from Georgia (Mr. Norwood) who is here 
today, and the gentleman from Ohio (Mr. Strickland), will provide the 
information and coordination necessary to stem the misuse of 
prescription medicines.
  The legislation creates grants to establish State-run programs for 
prescription monitoring that will be administered and coordinated at 
the Federal level. Over 20 States currently have such a program in 
place or are working to develop one. Fighting prescription abuse and 
preventing nonmedical use is a difficult problem that requires doctors 
and law enforcement authorities to acquire and share information. For 
this reason, groups like the American Medical Association and the 
American Society of Interventional Pain Physicians have lent their 
endorsement to this bill. I believe this bill is an important step 
forward in this fight and am pleased to support it.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I yield 5 minutes to the gentleman 
from Georgia (Mr. Norwood).

[[Page H6684]]

  Mr. NORWOOD. I thank my friend for yielding me the time.
  Mr. Speaker, this is a bill that we have been working hard to get 
passed for some time now. I would like to begin by really thanking all 
the people who have helped us get this bill to the floor. The gentleman 
from Kentucky (Mr. Whitfield) and his staff have just done amazing 
work. A few years ago, I had a bill like this and the gentleman from 
Kentucky had a bill like this and it shows that we can work together. 
We merged our bill and came out with a good product today. I do 
appreciate the efforts of our Democratic cosponsors, the gentleman from 
New Jersey (Mr. Pallone) and the gentleman from Ohio (Mr. Strickland). 
I would like to also thank Chairman Barton and Chairman Deal and 
Ranking Members Dingell and Brown for recognizing the importance of 
this issue and helping us move forward.

                              {time}  1300

  Mr. Speaker, prescription drug abuse in this country is a serious 
problem. I know it. I have seen it. It is a subject with which I have 
some experience. I experienced it in Vietnam treating wounded soldiers. 
I experienced it in my dental practice. Some say there is no such thing 
as doctor-shopping. That is pure nonsense. I have seen it many times in 
my own life. I have experienced it personally after a car wreck. I feel 
strongly that we do not do a good enough job in this country to 
alleviate pain, and morally and ethically we should. But if we do not 
deal with this misuse of prescription drugs, we are going to have less 
pain relief than more.
  I also know that the drugs that relieve the most severe pain can 
always, almost always, be the most dangerous. They can create a 
dependency. They can be diverted by the abusers. We have a 
responsibility to find ways to fight drug abuse without in any way 
dampening the ability of doctors to treat their patients in severe 
pain.
  In fact, the abuse and diversion of prescription drugs is a growing 
public health issue for this Nation, and we need to recognize it and 
understand it.
  From major cities to the smallest rural towns, we have had to deal 
with the consequences of prescription drug abuse. Prescription drugs 
now rank second only to marijuana in abuse. Think about that. Over 31 
million American adults and adolescents have at one time abused pain 
relievers. Prescription medications are emerging as the drugs of choice 
for abuse by America's teenagers. According to a national study 
released earlier this year, approximately one in five teenagers, that 
is over 4 million of our sons and daughters, have abused prescription 
painkillers. Surveys also show that they abuse them because they can, 
because access is just simply too easy. Mr. Speaker, those numbers are 
appalling. But there are human faces behind each headline and report of 
abuse. Their families and their communities suffer along with those who 
become addicted.
  Those who help divert drugs allow these medications to get into the 
hands of our children as well as adults who have no medical needs. Most 
physicians have recognized the tremendous benefit State programs in 
place today are already having, and they have lined up behind our 
legislation because we could cross State lines.
  In an effort to address the problem of prescription drug abuse, 21 
States have implemented prescription drug monitoring programs. They are 
in place today. But in our case, if we have one in Georgia, right 
across the river in South Carolina we cannot deal with it. In a 
prescription drug monitoring program, pharmacists are required to 
provide a standard set of information to a State database when 
dispensing a controlled substance. The administrator of the State 
database can then alert appropriate authorities if data indicates abuse 
or diversion.
  A doctor or a pharmacist can check that database to see if a patient 
could be abusing a prescription drug. Think about it. There are other 
great consequences from that. The confidentiality of, and access to, 
the information is protected to the best of our ability, and we think 
it has been done very well. We have worked very hard on that to try to 
get privacy rights. H.R. 1132 is a bill that would allow the Secretary 
of Health and Human Services to fund more of these State-monitoring 
programs. In exchange for Federal funding, the States agree to set up 
these programs if they do not have them or, if they do have them, 
improve the ones they already have.
  But there must be some basic Federal standards. Border States must 
also be able to communicate. This closes a serious loophole in States' 
current efforts to fight drug abuse. If an abuser can simply cross a 
State line to avoid detection, the monitoring system cannot work; or if 
an abuser is doctor-shopping, as I have seen happen, it is very hard to 
catch him. Through this bill we are encouraging all the States to get 
on board with a system that works while respecting States' rights and 
people's privacy.
  I ask and encourage all of our colleagues to join us in supporting 
this very important bill.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 3 minutes to the gentleman 
from Michigan (Mr. Stupak), on the Committee on Energy and Commerce.
  Mr. STUPAK. Mr. Speaker, I thank the gentleman for yielding me this 
time.
  Since 2001, I have been an original cosponsor of the National All 
Schedules Prescription Electronic Reporting Act, or NASPER, as we call 
it; and I rise today in strong support of its passage.
  I would like to thank the gentleman from Kentucky (Mr. Whitfield), 
the gentleman from New Jersey (Mr. Pallone), the gentleman from Ohio 
(Mr. Strickland), the gentleman from Ohio (Mr. Brown), and the 
gentleman from Georgia (Mr. Norwood) for their leadership on this 
issue. I would also like to recognize the valuable input of the 
stakeholders, including the States and physician groups, including the 
American Society of Interventional Pain Physicians.
  The prescription drug abuse problem is growing at an alarming rate. 
According to a new report by Columbia University, between 1992 and 2003 
the number of people abusing controlled prescription drugs jumped 94 
percent. Prescription drugs are now the fourth most abused substance in 
America, behind only marijuana, alcohol, and tobacco.
  ``Particularly alarming,'' the authors write, ``is the 212 percent 
increase in the number of 12 to 17 year olds abusing controlled 
prescription drugs and the increasing number of teens trying these 
drugs for the first time.''
  Today, Congress has taken an important first step towards addressing 
this huge and growing problem by ensuring that all schedule II, 
schedule III and schedule IV controlled substances are prescribed 
safely.
  The NASPER Act builds on efforts already under way in many States, 
including my home State of Michigan, to create electronic monitoring 
systems. The Government Accounting Office, GAO, found in 2002 that 
these systems help health care providers ensure that patients are not 
overprescribed powerful, potentially addictive prescription drugs.
  The NASPER Act also addresses the problem of people going to other 
States to circumvent one State's tracking system. This loophole was 
also identified by the GAO. The NASPER Act will strengthen the ability 
of practitioners in other States to contact each other and make sure 
they are not overprescribing these drugs.
  To conclude, Mr. Speaker, this is a good bill. NASPER is more 
necessary than ever, and now is the time for Congress to pass it and 
for President Bush to sign it.
  Mr. DEAL of Georgia. Mr. Speaker, I yield 5 minutes to the gentleman 
from Kentucky (Mr. Whitfield), who is one of the leaders on the 
drafting of the House counterpart to this legislation.
  Mr. WHITFIELD. Mr. Speaker, I thank the gentleman for yielding me 
this time to give me an opportunity to speak on behalf of H.R. 1132, 
the National All Schedules Prescription Electronic Reporting Act of 
2005.
  Mr. Speaker, the gentleman from Georgia (Chairman Deal) referred to 
the study at Columbia University noting the increase in abuse of 
prescription drugs in this country, and I would point out that one of 
the most disturbing aspects of the report out of Columbia University 
was the finding that a 212 percent increase in the number of children 
between the ages of 12 and 17 are now abusing prescription drugs. So 
with this legislation today, we have

[[Page H6685]]

the opportunity to combat this problem not only with children but also 
with adults around the country.
  I would also mention that, and I think someone has already referred 
to this, that 20 States are already operating these programs; and with 
this legislation we establish a grant program at HHS, but more 
important than that, we provide some Federal standards on this program 
with this legislation today. In doing that, we will help foster 
interstate communication by establishing uniform standards on 
information collection and privacy protections that together will make 
it easier for States to share information.
  I think it is also important to note that the Committee on 
Appropriations has already been appropriating money for these types of 
programs. So with this legislation, the Committee on Energy and 
Commerce, which has exclusive jurisdiction in this area, we now set the 
guidelines for this, and I think it will do a tremendous job of 
improving this program and improving our health care program and giving 
doctors more information to better treat their patients.
  I want to thank the gentleman from Texas (Chairman Barton) for his 
leadership, the gentleman from Georgia (Chairman Deal) for his 
leadership, and, of course, the gentleman from Georgia (Mr. Norwood). 
We have all been working on this program for 3 years. The gentleman 
from New Jersey (Mr. Pallone) has been involved in it for 3 years, the 
gentleman from Ohio (Mr. Strickland), the gentleman from Ohio (Mr. 
Brown). So it truly is a bipartisan effort. It is going to do a 
tremendous job in improving our health care program. And I would urge 
every Member of Congress to support this important legislation.
  And I want to thank particularly Ryan Long, one of the staffers who 
has worked on this; John Ford of the minority the staff; and my 
personal staffer John Halliwell; and the many others who were involved, 
including Warren Burke, who actually wrote the legislation over at the 
legislative counsel's office.
  So after 3 years, I think we are getting ready to move this bill. We 
know that the Senate is going to take it up in its entirety. And so we 
look forward to President Bush signing this legislation and improving 
our health care system.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 3 minutes to the gentleman 
from New Jersey (Mr. Pallone), a member of the Health Subcommittee.
  Mr. PALLONE. Mr. Speaker, I thank the gentleman from Ohio (Mr. Brown) 
for yielding me this time.
  I rise in strong support of the National All Schedules Prescription 
Electronic Reporting Act, or NASPER, legislation which has been 
mentioned that the gentleman from Kentucky (Mr. Whitfield) has 
introduced, along with myself, the gentleman from Georgia (Mr. 
Norwood), and the gentleman from Ohio (Mr. Strickland).
  This critical legislation provides an avenue for addressing the 
illegal diversion and misuse of prescription drugs. Prescription drug 
abuse constitutes one of the fastest growing areas of drug abuse in our 
Nation today, affecting people of all areas of our Nation, all ages, 
and all income levels.
  Health care practitioners and pharmacists desperately need electronic 
prescription drug monitoring systems to ensure that they are only 
prescribing and dispensing schedule II, III, and IV controlled 
substances that are medically necessary. This bill provides the 
resources to States to create and operate State-based drug monitoring 
programs, allows physicians to access this information, and allows for 
States to communicate with one another. NASPER would help physicians 
prevent their patients from becoming addicted to prescription 
medications and would help law enforcement with criminal investigations 
in the illicit prescription drug market.
  NASPER legislation represents a work of great bipartisan and 
bicameral effort, and I want to thank the gentleman from Kentucky (Mr. 
Whitfield), the gentleman from Georgia (Mr. Norwood), the gentleman 
from Ohio (Mr. Strickland), obviously the gentleman from Ohio (Mr. 
Brown). And I also want to mention my staff person who is no longer 
with me, Kathy Kulkarni, but worked very hard on this legislation.
  In the other body, Senator Sessions, Senator Kennedy, and Senator 
Durbin, all of these people have been willing to move forward with this 
effort both here in the House, and it will be taken up in the Senate to 
alleviate the prescription drug abuse problem plaguing our Nation.
  In addition, I applaud the tremendous leadership of the American 
Society for Interventional Pain Physicians for working with Congress in 
this significant public health initiative.
  Mr. Speaker, I hope my colleagues will join me in supporting this 
critical measure to help our health care providers begin to stem the 
burgeoning problems of prescription drug abuse.
  Mr. MARKEY. Mr. Speaker, I rise to express my strong concerns about 
the lack of adequate patient privacy protections in H.R. 1132--the 
National All Schedules Prescription Electronic Reporting, NASPER, Act 
of 2005. H.R. 1132 is being considered on the House Floor under 
suspension of the rules; therefore it cannot be amended. Because of the 
absence of urgently needed patient privacy safeguards, I oppose this 
bill, and I urge my colleagues to vote no on this legislation.
  H.R. 1132 is intended to support States' efforts to prevent the abuse 
of certain controlled substances through the provision of Federal 
grants to the States for the purpose of establishing and implementing 
controlled substance monitoring programs. States would use the grants 
to develop and maintain an electronic database containing information 
about the type of medication prescribed, quantity dispensed, number of 
refills, and similar product information. The database also would 
collect personal information about each patient receiving prescriptions 
of the covered controlled substances, such as the patient's name, 
address and telephone number.
  The abuse of controlled substances such as oxycontin and amphetamines 
is a serious problem that plagues many Americans. In response to the 
seriousness of the problem of prescription drug abuse, more than 20 
States, including Massachusetts, have taken steps to prevent such abuse 
through the establishment of reporting requirements on pharmacists and 
the creation of drug monitoring databases similar to those contemplated 
by H.R. 1132. In Massachusetts, for example, pharmacies are required to 
report the prescriptions they fill for substances in Schedules I and II 
to the State's department of Public Health.
  The problem is that H.R. 1132 does not provide the safeguards that 
are required to shield patients--the vast majority of whom will be law-
abiding citizens receiving medications as part of a legitimate plan of 
care--from unauthorized disclosure of their personal medical 
information. Instead, the legislation provides the States broad leeway 
to establish databases of patients' private medical records with little 
guidance on the privacy protections that must be in place in order to 
quality for the grants.
  For example, H.R. 1132 permits disclosure of individually-
identifiable patient information in the database to a wide range of 
professionals in addition to practitioners and law enforcement 
personnel, including any local, State or Federal ``narcotics control, 
licensure, disciplinary or program authority'' who can make specific 
certifications as to the need for access to the information. Any 
``agent of another state'' with a monitoring program approved by the 
bill also could gain access to patient records in the database, 
provided that the purpose of the access is for ``implementing the 
state's controlled substance monitoring program.'' Such easy access 
puts the privacy of potentially hundreds of thousands of law-abiding 
citizens at risk of unauthorized disclosure.
  Additional privacy protections that are missing from H.R. 1132 
include: a requirement that States receiving grants under the terms of 
the bill periodically notify patients whose information in the database 
has been lost, stolen or used for an unauthorized purpose; a mandate 
that States inform patients before dispensing medications covered by 
the bill's reporting requirement that their name, address, and phone 
number will be stored in a State-run database, potentially in 
perpetuity, as a result of the dispensing of the medication; and a 
requirement at the States purge the database of information about any 
particular prescription after a limited amount of time.
  While I strongly support efforts to prevent the abuse of controlled 
substances, H.R. 1132 does not contain sufficient guidance to the 
states on the level of privacy protections that they must provide in 
the creation and maintenance of the databases authorized under the 
legislation. Since that breach of 145,000 personal records form the 
databases of data profiler ChoicePoint in February 2005, 50 million 
records with private information have been leaked from public 
companies, hospitals, universities and other organizations. During 
consideration of this legislation in the Energy and Commerce Committee, 
I offered a reasonable amendment to incorporate a fundamental privacy 
protection in the bill. My amendment was

[[Page H6686]]

supported by the American Conservative Union, the American 
Psychoanalytic Association, the American Psychiatric Association, the 
American Association of Practicing Psychiatrists and the Massachusetts 
Medical Society. While my amendment would have simply required patient 
notification if their information in these databases were lost, stolen 
or used for an unauthorized purpose, it was defeated.
  Without such fundamental protections for patients, this bill is not 
worthy of support. This bill--which is opposed by a broad, bipartisan 
coalition--does not belong on the suspension calendar, where it is not 
subject to amendment.
  I urge my colleagues to oppose H.R. 1132. Send it back to committee, 
where the needed privacy protections can be added. The important goals 
of this bill can be accomplished without sacrificing the privacy of 
law-abiding patients.
  Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I urge the adoption of this bill, I 
have no further requests for time, and I yield back the balance of my 
time.
  The SPEAKER pro tempore (Mr. Foley). The question is on the motion 
offered by the gentleman from Georgia (Mr. Deal) that the House suspend 
the rules and pass the bill, H.R. 1132, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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