[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
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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
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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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