[Senate Hearing 110-922]
[From the U.S. Government Publishing Office]
S. Hrg. 110-922
ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES: ADDRESSING HEALTH CARE
AND LAW ENFORCEMENT PRIORITIES
=======================================================================
HEARING
before the
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
DECEMBER 4, 2007
__________
Serial No. J-110-64
__________
Printed for the use of the Committee on the Judiciary
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COMMITTEE ON THE JUDICIARY
PATRICK J. LEAHY, Vermont, Chairman
EDWARD M. KENNEDY, Massachusetts ARLEN SPECTER, Pennsylvania
JOSEPH R. BIDEN, Jr., Delaware ORRIN G. HATCH, Utah
HERB KOHL, Wisconsin CHARLES E. GRASSLEY, Iowa
DIANNE FEINSTEIN, California JON KYL, Arizona
RUSSELL D. FEINGOLD, Wisconsin JEFF SESSIONS, Alabama
CHARLES E. SCHUMER, New York LINDSEY O. GRAHAM, South Carolina
RICHARD J. DURBIN, Illinois JOHN CORNYN, Texas
BENJAMIN L. CARDIN, Maryland SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island TOM COBURN, Oklahoma
Bruce A. Cohen, Chief Counsel and Staff Director
Michael O'Neill, Republican Chief Counsel and Staff Director
C O N T E N T S
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STATEMENTS OF COMMITTEE MEMBERS
Page
Kennedy, Hon. Edward M., a U.S. Senator from the State of
Massachusetts.................................................. 4
Specter, Hon. Arlen, a U.S. Senator from the State of
Pennsylvania................................................... 3
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 1
WITNESSES
Adams, Laura, President and CEO, Rhode Island Quality Institute,
Providence, Rhode Island....................................... 21
Hutchinson, Kevin, CEO, Sure Scripts, Alexandria, Virginia....... 23
Miller, David, Chief Security Officer, Covisint, Detroit,
Michigan....................................................... 26
Podgurski, Mike A., R.Ph., Vice President, Pharmacy Services,
Rite Aid Corporation, Camp Hill, Pennsylvania.................. 28
Rannazzisi, Joseph T., Deputy Assistant Administrator, Drug
Enforcement Administration, Office of Diversion Control,
Alexandria, Virginia........................................... 5
Trenkle, Tony, Director, Office of E-Health Standards and
Services Centers for Medicare and Medicaid Services, Baltimore,
Maryland....................................................... 7
QUESTIONS AND ANSWERS
Responses of Joseph Rannazzisi to questions submitted by Senator
Whitehouse..................................................... 40
SUBMISSIONS FOR THE RECORD
AARP, Washington, D.C., statement................................ 44
Adams, Laura, President and CEO, Rhode Island Quality Institute,
Providence, Rhode Island, statement............................ 48
American Pharmacists Association, Washington, D.C., statement.... 51
CHCC Corporate Health Care Coalitia, statement................... 55
e-Prescribing Controlled Substances Coalition, letter............ 57
Hutchinson, Kevin, CEO, Sure Scripts, Alexandria, Virginia,
statement...................................................... 75
Miller, David, Chief Security Officer, Covisint, Detroit,
Michigan, statement............................................ 84
National Association of Chain Drug Stores, Alexandria, Virginia,
statement...................................................... 92
Podgurski, Mike A., R.Ph., Vice President, Pharmacy Services,
Rite Aid Corporation, Camp Hill, Pennsylvania, statement....... 99
Rannazzisi, Joseph T., Deputy Assistant Administrator, Drug
Enforcement Administration, Office of Diversion Control,
Alexandria, Virginia, statement................................ 106
Trenkle, Tony, Director, Office of E-Health Standards and
Services Centers for Medicare and Medicaid Services, Baltimore,
Maryland, statement............................................ 115
Walgreens, Washington, D.C., statement........................... 122
ELECTRONIC PRESCRIBING OF CONTROLLED SUBSTANCES: ADDRESSING HEALTH CARE
AND LAW ENFORCEMENT PRIORITIES
----------
TUESDAY, DECEMBER 4, 2007
U.S. Senate,
Committee on the Judiciary,
Washington, DC
The Committee met, pursuant to notice, at 10 a.m., in room
226, Dirksen Senate Office Building, Hon. Sheldon Whitehouse,
presiding.
Present: Senators Kennedy, Specter, and Coburn.
OPENING STATEMENT OF HON. SHELDON WHITEHOUSE, A U.S. SENATOR
FROM THE STATE OF RHODE ISLAND
Senator Whitehouse. Welcome, everyone. I will call this
hearing of the Judiciary Committee to order.
We are here today to discuss an issue that is, as many
issues are, at the conjunction of different departments and
different responsibilities here in the government, and that is
the electronic prescription of controlled substances.
I am Sheldon Whitehouse, a member of this committee, and I
have the honor to chair this particular hearing. I am joined by
my very distinguished colleague from Massachusetts, Senator
Kennedy, and I am very thrilled that he is here today. I
appreciate it.
Senator, with your permission I'll make a brief opening
statement and then turn to you for opening remarks, then we can
go on to the witnesses.
And the Ranking Member has arrived, Senator Specter of
Pennsylvania.
Senator Specter. I arrived promptly at 10, may the record
show.
[Laughter.]
Senator Whitehouse. The committee today will consider the
question of electronic prescription of controlled substances.
Viewed up close, this issue involves technical questions about
competing information technology systems, the evidentiary needs
of law enforcement officials, and the prevention of drug
addiction in America. But it also puts at issue our struggle to
rein in exploding health care costs. Solving this e-prescribing
dilemma will help us fulfill our obligation in Congress to
provide high-quality health care to all Americans at reasonable
cost.
While electronic prescription is by no means the end-all,
be-all of health care reform, it is an important piece of the
puzzle. For starters, electronic prescription could save $20
billion per year--this is Washington, so this is a ``b'',
billion dollars per year--through reduced adverse drug events,
increased patient adherence to prescription regimens, and
improved administrative efficiency.
It is also a logical gateway for many providers to the more
comprehensive health care information technology system that we
need, one that could save, by some reports, as much as $346
billion per year, and certainly would save multiple tens of
billions of dollars per year.
But until doctors can prescribe electronically, they are
unlikely to adopt a fully integrated electronic health record
system which could decrease medical errors, better coordinate
care, particularly for high-cost, chronically ill patients, and
enhance efficiency throughout the system, though it is an
important gateway.
Indeed, to quote Department of Health and Human Services
Secretary Leavitt, ``The benefits of electronic prescribing are
unchallengeable. E-prescribing is not only more efficient and
convenient for consumers, but widespread use would eliminate
thousands of medication errors every year. E-prescribing needs
faster implementation.''
Unfortunately, there is one road block in our way: current
law does not permit the electronic prescription of schedule
drugs. A doctor can electronically prescribe medication that is
not regulated by the Drug Enforcement Administration, totaling
roughly 90 percent of prescriptions, but must rely on paper and
pen for the remaining 10 percent. The inevitable result is that
many doctors simply refuse to prescribe any medications
electronically because it is too burdensome to operate two
separate systems, an electronic one for regular prescriptions
and a paper and pen one for controlled drugs.
Imagine if you are the doctor, prescribing both controlled
and non-controlled medication to the same patient in the same
visit and having to use two systems for that, and you will
understand the confusion that this creates. Everyone seems to
support the notion that it is time for DEA to issue regulations
permitting e-prescription of controlled substances. Indeed, I
understand that the Drug Enforcement Administration itself
agrees with this notion.
Therefore, the only two questions that we have to explore
this morning are when, and how? First, the ``when''. DEA issued
e-prescription regulations 4 years ago, but they were roundly
criticized for being too restrictive and were never
implemented.
I understand the DEA has been at work on a new set of
regulations since at least 2006, but has been unwilling yet to
commit to any sort of timeline for completion and has not as
yet circulated these draft regulations outside of DEA. At this
point we could conclude the Bush administration without
progress at this rate, and so I am hoping that we can
accelerate things.
The ``how'' question is a little bit more complex. Roughly
6 million people per month, 2.5 percent of the population, use
prescription medication for non-medical purpose, and this
number has more than doubled in the last 15 years. I have been
the Attorney General of my State, I've been a U.S. Attorney. I
fully appreciate that any e-prescription must preserve the
government's ability to investigate and prosecute cases where
prescriptions are unlawfully used to acquire controlled
substances, known as diversion cases in law enforcement.
But protecting these law enforcement capabilities need not
be incompatible with giving doctors, pharmacies, and patients
the tools necessary for e-prescription. We target military
weapons. We engage in billion-dollar financial transactions. We
transmit national security information and we engage in
countless important private communications electronically every
day. I can't believe we can't figure out a way to prescribe
Vicodin electronically. Indeed, as we will hear from witnesses
on the second panel, those necessary tools do exist.
So, as President Bush said of our health care system just a
few weeks ago--not a man I frequently quote, but here we are--
``When it comes to information technology, they are light-years
behind a lot of America. Perhaps the best way to describe it is
that we still get doctors handwriting files.'' He went on to
say, ``Congress ought to focus on spreading information
technology throughout health care.''
Well, here we are today. I look forward to hearing
testimony, both from DEA and the Department of Health and Human
Services, on how they are working to help the President fulfill
this mandate. Later this morning I look forward to hearing the
perspective of doctors, pharmacists, and experts in the field
of e-prescription as well.
Our Ranking Member, Senator Specter.
STATEMENT OF HON. ARLEN SPECTER, A U.S. SENATOR
FROM THE STATE OF PENNSYLVANIA
Senator Specter. Thank you, Mr. Chairman. I note your
comment that you don't often quote the President. He is widely
quoted, occasionally favorably, by Democrats, but frequently
quoted unfavorably by the Democrats. But I don't think he's a
central party to this particular issue, and it is one of
importance.
Although I cannot stay too long, and Senator Coburn will
represent the Republican side during the course of the hearing,
I did want to come to lend my voice in support of using e-
prescriptions. We have a very distinguished array of witnesses.
We have DEA here to express their point of view, and CMS to
discuss their administration of the e-prescription program at
HHS.
I am pleased to note the presence of Mike Podgurski, who is
Vice President for Pharmacy Services for Rite-Aid, a major
Pennsylvania corporation with pharmacies all over the United
States, specifically, 5,000 in stores in 31 States. We thank
them for their participation in this hearing.
I do believe that it is time that this issue came into the
21st century. Electronic systems are in use. Having had some
experience in prosecution, I can understand DEA's interest in
having a paper trail. But these electronic transmissions are
trailable. Some of the most significant evidence these days is
dug up on e-mails, so electronic transmission would be a great
help. Since you can prescribe certain controlled substances
orally, it seems to me that using an electronic prescription
system is an equallly sound way to approach it.
Senator Whitehouse has already outlined the kinds of
savings which are involved, and I think it would be very, very
useful. So it is my hope that this hearing will shed some
significant light and give the program a push, and perhaps
motivate DEA to move forward on a timeline to set forth their
position.
Thank you, Mr. Chairman.
Senator Whitehouse. Well, I thank the distinguished Ranking
Member for honoring us with his presence today. I do appreciate
it very, very much.
I would recognize the senior Senator from Massachusetts,
Senator Kennedy.
STATEMENT OF HON. EDWARD M. KENNEDY, A U.S. SENATOR FROM THE
STATE OF MASSACHUSETTS
Senator Kennedy. Thank you very much, Senator Whitehouse,
Senator Specter. On having this hearing, I first of all want to
commend Senator Whitehouse for his interest and his knowledge
and awareness about this issue. As an Attorney General, he has
really led the country in terms of his commitment, in terms of
quality health care in the State of Rhode Island and had a
particular interest in the role of information technology. We
know we've had the various GAO studies that estimated about $30
billion a year could be saved in terms of adverse drug reaction
with the use of information technology. Thirty billion dollars
could be saved.
So, there are broad policy issues, whether the DEA is
playing the constructive role in terms of making available
needed narcotics for people that have the kinds of health
conditions where those are necessary, and also how you're going
to be able to police the fraudulent use, which is an issue and
a problem in terms of the country. It's a balance. That's what
this hearing is about. But it has broad implications as well.
In many respects, the way that the DEA goes will have an
implication in terms of where the Nation goes on issues of
information technology and the use of e-prescribing. So they
have incredible, broad health kinds of implications, these
decisions, and that's why this hearing is so important and why
I commend Senator Whitehouse for his interest. We've lagged
behind other nations in the world in terms of the use of
information technology.
Just a final point. We in Massachusetts have both
physicians and pharmacies that have already begun adopting e-
prescribing, and our patients are benefiting. Massachusetts was
recognized as the State with the highest volume of electronic
prescriptions per capita in the country. We have an
infrastructure to move forward with incorporating controlled
substances into the electronic prescribing. It's my
understanding that Massachusetts applied for a waiver from DEA
to allow them to move ahead after they had spent a great deal
of time in working through this issue. I'm disappointed to hear
that the waiver was rejected.
So, I hope that the DEA's concerns could be addressed in a
manner that would allow the health care providers, the
patients, to benefit from the advantages of electronic
prescribing. This is a very important health care issue. There
are a lot of concerns that American families have about health
care, such as access, cost, availability, dependability,
reliability, a lot of different kinds of issues. Prevention,
case management. A thousand different kinds of issues. But this
one here is of incredible importance and consequence.
I just commend the Chair for having it, and I hope the DEA
and CMS will work very closely with the Chair and others
interested in this issue so we can make progress. It's really
key in terms of quality and in terms of cost, and it seems to
me in terms of law enforcement, as has been the case by Senator
Whitehouse with his work as Attorney General, and someone who
understands this and its importance in terms of law
enforcement. That's why the Judiciary Committee is having this
hearing. I want to commend you and thank you for having it, and
look forward to working with you and our witnesses to see if we
can't make progress.
Senator Whitehouse. Well, thank you, Senator Kennedy. It's
a great honor for all of us to have you here. There is no
person in this institution who has shown more leadership on
health care than you, so we're honored that you could stop by
today. I appreciate it very much.
We have as our first panel of witnesses Joseph Rannazzisi
from the Drug Enforcement Administration; and Tony Trenkle, who
is the Director of the Office of E-Health Standards and
Services. If I might ask you gentlemen to please stand to be
sworn.
[Whereupon, the witnesses were duly sworn.]
Senator Whitehouse. Thank you very much. Please be seated.
I believe, at least in my order of proceeding, that Mr.
Rannazzisi goes first. So if you'd care to give your opening
statement now, I would appreciate it. I thank you for being
here. I understand that you oversee DEA's effort to prevent,
detect, and investigate the diversion of pharmaceutical
controlled substances and listed chemicals, so I appreciate you
taking time out of your busy work to come here. Thank you, sir.
STATEMENT OF JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT
ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION, OFFICE OF
DIVERSION CONTROL, ALEXANDRIA, VA
Mr. Rannazzisi. Thank you, Chairman Whitehouse. Good
morning. On behalf of Acting Administrator Michele Leonhart and
the men and women of the Drug Enforcement Administration, I
want to thank you for this opportunity to appear today to
discuss DEA's ongoing efforts to establish standards that will
permit electronic prescribing for controlled substances.
Before I elaborate on our progress toward this end, I want
to explain the need for ensuring the distribution system for
controlled substances, even when it includes electronic
prescription, remains a closed system as envisioned by the
Controlled Substances Act, also known as the CSA. In recent
years we've seen a remarkable reduction in the number of
individuals who abuse illicit drugs. However, we are now
fighting an alarming increase in the abuse and trafficking of
prescription medication. In just 5 years, the number of
Americans abusing prescription drugs rose more than two-thirds,
from 3.8 million abusers to nearly 7 million.
DEA is charged with the responsibility to prevent diversion
while ensuring there is an adequate, non-interrupted supply of
pharmaceutical drugs to meet legitimate medical needs. Since
passage of the CSA, there have been significant technological
advancements that affect the way DEA carries out its mission.
The information and technological revolution promotes
business models that improve efficiency, shrink costs, and
reduce paperwork. Unfortunately, DEA's investigative and
regulatory obligations must factor in an element that is not
part of such innovative business models: the criminal element.
To be effective, DEA must be able to identify, collect, and
preserve evidence for subsequent criminal, civil, and
administrative proceedings.
An area not contemplated by Congress during the creation of
the CSA was the Internet, which has drastically altered the
medical community's traditional business models. As the number
of Americans with Internet access has increased, so, too, have
the opportunities for individuals to acquire pharmaceutical
controlled substances over the Internet, both legally and
illegally.
Technology, when used appropriately, can increase
efficiency and reduce costs. However, DEA knows all too well
that individuals are more than willing to exploit weaknesses in
technology for financial gain. A small number of individuals
can wreak havoc in a very short period of time.
Let me give you an example of how technology can be
exploited, and the subsequent damage. In 2006 alone, just 34
pharmacies used the Internet to illegally divert more than 98
million dosage units of hydrocodone. Now, DEA recognizes that
there are strong societal benefits realized by enabling
individuals to fill their prescriptions over the Internet, as
long as all of the parties involved do so in accordance with
the law. However, the anonymity of the Internet and the
proliferation of Web sites that facilitate illicit transactions
for pharmaceutical controlled substances have given drug
traffickers and drug abusers the means to circumvent the law,
as well as sound medical practice.
The overwhelming majority of prescribing in America is
conducted responsibly, but a small number of unscrupulous
practitioners prescribe controlled substances improperly;
carelessly at best, knowingly at worst. Their actions help
supply America's second most widespread drug addiction problem.
In the case of electronic transmissions involving
prescriptions for controlled substances, DEA's responsibility
to identify, collect, and preserve evidence is a challenging
task. According to a recent report by the Kaiser Family
Foundation, there were more than 3.5 billion prescriptions
written in the U.S. in 2005. The report noted that this was a
71 percent increase from the number of prescriptions written in
1994, compared to a U.S. population growth of only 9 percent
during that same period. Based upon these figures, the number
of prescriptions written for controlled substances in 2005 were
between 360 and 400 million.
To meet statutory obligations, DEA must ensure that any
electronic system used for transmitting a prescription for a
controlled substance include three factors: authentication,
non-repudiation, and integrity in the recordkeeping process and
system. It is critical that we acknowledge and account for the
clear and distinct differences between the system for non-
controlled substances and one for a powerful and addictive
controlled substance.
The technology and standards which are ultimately
promulgated for the electronic prescribing of controlled
substances cannot simply be plug-and-play; a system that does
not have adequate safeguards and accountability simply provides
a plausible defense for those who would exploit such a system
to divert even more controlled substances to those willing to
abuse them.
I'd like to close by saying that DEA is committed to
establishing a system of electronic prescribing, but only a
system that's in the best interests of the American public. A
system without adequate safeguards is nothing more than an
electronic superhighway for prescriptions, with an express lane
for diversion. DEA is committed to protecting the public, first
and foremost.
On behalf of the Drug Enforcement Administration, I want to
thank you for this opportunity to appear today and I look
forward to answering any questions you may have.
[The prepared statement of Mr. Rannazzisi appears in the
appendix.]
Senator Whitehouse. Thank you.
I think what I'll do right now is actually go to the
opening statement of Mr. Trenkle, and then we can have a
discussion back and forth with both of you.
Mr. Trenkle.
STATEMENT OF TONY TRENKLE, OFFICE OF E-HEALTH STANDARDS AND
SERVICES, CENTERS FOR MEDICARE AND MEDICAID SERVICES,
BALTIMORE, MD
Mr. Trenkle. Good morning, Senator Whitehouse. I am pleased
to be here today to discuss CMS's leadership role in the
ongoing development of uniform standards for electronic
prescribing for the Medicare Part D program.
More than 43 million people are covered by Medicare alone
this year. Since the enactment of the Medicare Prescription
Drug Improvement and Modernization Act of 2003, CMS has been
working with its government partners and industry stakeholders
to develop and implement standards that would create an
infrastructure that will allow us to realize the significant
potential public health and safety benefits e-prescribing
offers for the Medicare population.
The MMA directed CMS to promulgate standards for a
voluntary e-prescribing program in the Medicare Part D
prescription drug benefit. For several years now, CMS has
pursued an incremental approach to adopting final uniform
standards for Part D e-prescribing that are consistent with the
MMA's objectives of patient safety, quality, and efficiency.
And as you mentioned, beyond Part D, facilitating the
widespread adoption of e-prescribing is one of the key action
items in the administration's effort to build a nationwide
interoperable electronic health information infrastructure.
The current handwritten medication prescription process, as
we know, is prone to errors. In addition to ineligible
prescriptions, it is estimated that some 530,000 adverse drug
events take place annually among Medicare beneficiaries alone.
The Institute of Medicine last year reported that more than 1.5
million Americans are injured each year by drug errors in
hospitals, nursing homes, and doctors' offices.
E-prescribing has the potential to empower both prescribers
and pharmacists to deliver higher quality care and improve work
flow efficiencies. For providers who choose to invest in e-
prescribing technology, quality and efficiency can improve,
resulting in better beneficiary outcomes and, more importantly,
saving lives.
We continue to make progress on the e-prescribing front. To
encourage e-prescribing in the initial year of the Part D
program, we published a final rule establishing a set of
foundation standards. The rule reflected industry consensus and
recommendations from the National Committee on Vital and Health
Statistics, which is a Federal advisory committee representing
significant experience in health information technology,
including e-prescribing. These foundation standards took effect
January 1, 2006 and they were related to transaction and
eligibility information exchanges among providers, dispensers,
and Part B plan sponsors.
In 2006, following implementation of the foundation
standards, CMS, along with another HHS agency, the Agency for
Healthcare, Research, and Quality, ARQ, conducted a series of
pilot tests to test six additional standards for potential
adoption. Results of the pilot testing were issued by the
Secretary in a report to Congress April of 2007.
Based on the pilot results, several weeks ago, November 15,
2007, we published a Notice of Proposed Rulemaking to adopt two
additional standards for e-prescribing in Part D: the first
proposed standard for formulary and benefits governs
information for prescribers about a patient's drug coverage
provided at the point of care; the second proposed standard for
medication history is intended to provide a uniform means for
prescribers, dispensers, and payors to communicate about drugs
that have been dispensed to a patient. The four remaining
standards tested during the pilot are not proposed for adoption
at this time, but may be proposed in the future.
CMS is committed to continue testing and partnerships with
all stakeholders to advance the development of secure,
scaleable, and administratively feasible e-prescribing
standards for use throughout the health care system. The
challenge moving forward is that the law does not treat all
prescriptions equally. As the e-prescribing environment
continues to evolve, we support a consistent e-prescribing
framework because we feel the alternative could slow adoption
and generate undue administrative burden, along with attendant
incremental costs.
For this reason, CMS believes that existing standards and
industry practices must be given careful consideration in
future efforts to establish e-prescribing standards, such as
those related to controlled substances.
CMS has heard from various stakeholders in both public
testimony and in written comments to proposed e-prescribing
standards regulation that the inability to prescribe controlled
substances electronically is a major inhibitor of overall
growth of e-prescribing.
In response, CMS and other parts of HHS have reached out to
the DEA to work jointly, along with appropriate stakeholders,
to identify and adopt solutions for the secure e-prescribing of
controlled substances. These solutions must be consistent and
scaleable with current mainstream practices and work flows.
In July 2006, HHS and DEA co-sponsored a public meeting on
e-prescribing of controlled substances and solicited input from
stakeholders. The stakeholders spoke from various perspectives,
but agreed that a consistent approach to e-prescribing was
critical.
Following the hearing, CMS and DEA have had further
discussions on how best to move ahead, including potential
pilot testing. Recently, because of its critical importance to
the administration's HIT agenda, we asked Dr. Robert Kolodner,
the national coordinator for health information technology, to
help broker an acceptable solution. Dr. Kolodner had agreed,
and has begun meeting with CMS and DEA.
Thank you for the opportunity to talk about CMS role in
promoting e-prescribing. We are committed to ensuring patient
safety, not only for the Medicare population, but for all
Americans. E-prescribing saves lives, and it is critical to
take all necessary steps to achieve widespread adoption of e-
prescribing. Thank you.
[The prepared statement of Mr. Trenkle appears in the
appendix.]
Senator Whitehouse. Thank you, Mr. Trenkle.
To start at a very basic level, I assume that you two know
each other?
Mr. Rannazzisi. Actually, we just met today. But I think
we've been on the phone together, and I know our staffs meet.
Mr. Trenkle. Yes. Our staffs have met and we've been on the
phone with DEA a number of times, I've mentioned.
Senator Whitehouse. And it sounds as if the entry of Dr.
Kolodner into this as a broker to force change is a welcome
development from both of your points of view?
Mr. Rannazzisi. Any new perspective, as far as electronic
prescribing, is welcomed. Yes, we welcome his perspective as
well. Also, Mr. Trenkle testified in that hearing in July, 2006
and it was a very informative hearing.
Senator Whitehouse. I've run administrative agencies and so
I have the experience of the triage of priorities that is
necessary in an administrative agency. There are those things
that sort of urgently must be accomplished, there are those
priorities that are things that would be nice to get done but
don't have that same urgency, and then there are things that
just sort of float around and they're not really urgent, and if
you can get to them some day you will, and maybe somebody will
push you a little bit to get something done, but it simply
isn't in the top first or second tier of administrative
priorities.
Where does DEA put getting this done in its hierarchy of
administrative priorities?
Mr. Rannazzisi. It's right at the top of our administrative
hierarchies. If you look, historically, back, we started an e-
commerce initiative in 1999. In 2005, we initiated a controlled
substance ordering system through the use of PKI. The second
phase of that would be the electronic prescription initiative.
Unfortunately, where CSAS has worked very well, there have been
some hang-ups with electronic prescriptions and we're trying to
work through them now. But make no mistake about it, it's right
at the top of our list of priorities. Again, we started this
back in 1999.
Senator Whitehouse. Have you heard from the White House on
this issue?
Mr. Rannazzisi. We've discussed this issue with OMB, yes.
With ONDCP, with the Department of Justice.
Senator Whitehouse. When was this?
Mr. Rannazzisi. OMB, probably within the last month. Within
the last week.
Senator Whitehouse. Oh, good.
In your testimony just a moment ago you noted that nearly 7
million Americans have used prescription medications for non-
medical purposes.
Mr. Rannazzisi. Yes.
Senator Whitehouse. And you have said that, nationally, the
misuse of prescription drugs was second only to the use of
marijuana in calendar year 2005, and far exceeds other illicit
drugs--cocaine, heroin, PCP, amphetamines.
Mr. Rannazzisi. Yes, sir.
Senator Whitehouse. Do you think that the current paper-
and-pen regime is a really good model, given that record, in
allowing you to prevent the diversion of prescribed controlled
substances? And more specifically, in evaluating what the goals
are that you seek to achieve for e-prescribing, are you
demanding a higher level of effectiveness in that dimension,
effectiveness against diversion for the new e-prescribing than
you are able to achieve right now through the pen-and-paper
system.
Mr. Rannazzisi. Let's take the second part of the question
first. Do I believe that electronic prescribing will prevent
diversion? It will prevent some diversion, absolutely, if it's
done properly. Yes. We're proponents of the two-factor
authentication system. The reason we're proponents of two-
factor authentication is because that will help us identify who
is actually writing the prescription.
Senator Whitehouse. But to your example a moment ago, you
spoke about a small number of pharmacies in which an enormous
amount of potentially illicit prescriptions were flowing of
hydrocodone, oxycodone. I forget which one you mentioned.
Mr. Rannazzisi. Right.
Senator Whitehouse. For every document that you no longer
have on paper, so your document examiners can't go in and prove
the case their way and you actually have to prove the case a
different way using electronic signatures--and there are ways
to do it. You could do both.
Mr. Rannazzisi. Right.
Senator Whitehouse. But you would have to change from one
to the other. For the inconvenience of that, isn't there a
corresponding gain in having all that information at your
fingertips and being able to say, you know, there's been a real
bulge in prescriptions at this pharmacy that we're noting
because it's coming through electronically. We're tracking that
in new ways. We can be much more proactive.
It seems to me that the gains of e-prescribing aren't just
the gains that HHS is here to advocate for, the gains of
patient safety, the gains of greater efficiency, the sort of
gateway gains of moving more rapidly to an e-health system for
America so we can get away from the health care nightmare we
have right now. Those are all enormous gains. But if you set
those aside, it seems to me, are there not also purely law
enforcement gains from going to an electronic prescription
system for controlled substances?
Mr. Rannazzisi. Well, I would be speculating now, but until
we get a system in place and a pilot in place to actually see
how the system operates, I can say probably there will be some
law enforcement gains. However, we're not just dealing now with
a doctor and a pharmacy, we're dealing with other non-regulated
entities that will be involved in the process. I don't know how
that's going to pan out. I don't know how much regulatory
control I'll have over them. I don't know how they're going to
respond to subpoenas. I don't know how the system will address
breaches in the system where orders are actually changed.
This is all new to us, and we're trying to work through it.
Again, I don't want to speculate. Do I believe that it's going
to be better for law enforcement somewhere down the line, once
we get the proper system in place? Yes, I do. But currently,
right now, I'm just not sure because I don't know what system
is in place.
Now, Senator Kennedy talked about that Massachusetts pilot
program.
Senator Whitehouse. Why was that shot down?
Mr. Rannazzisi. That was shot down, not because of the
merits of the program, not because of the protocols, but
because in their direction what they said was they were going
to create a system that would be adopted nationwide for
security and controls.
Now, on its face, that doesn't seem like a bad idea, except
that's what the rulemaking process is. For us to agree to that,
we'd be hijacking the rulemaking process. We didn't disagree
with the merits of that pilot. In fact, we're working with
Massachusetts right now for them to resubmit so we can approve
it. So it's not been shot down, we're just in the process of
trying to work with them to get their protocols back in so we
could approve it.
Senator Whitehouse. My distinguished colleague, Senator
Coburn, has joined us. I have been taking the floor for a while
now in asking a number of questions, so if you would like to
step in, Senator, I would yield the floor to you.
Senator Coburn. It's curious to me, with all the benefits
that we're going to get from e-prescriptions, why you all would
not say, here are the things we have to have as you do this. In
other words, rather than worry about the ``what ifs'', why
don't you tell us what the ``what ifs'' are and have us write
legislation that covers it? There is no question, consumers are
going to be better off in this country with the pharmacist not
reading my handwriting. There's no question about that. There
is no question that control of controlled substances is going
to be far improved with e-prescriptions. Will there be new
potentials for abuse? Yes. Will there be new loopholes?
But I think, reading the history on this last night, it
seems to me that the problem is, the DEA needs to tell us, here
are the things we're concerned about, fix that as you write
this, and you change this, rather than saying we can't get
there. We have to get there. We have a lot of problems in terms
of IT interoperability now in health care, and that's something
the administration is doing a great job on. They don't need a
piece of legislation for it. They're actually accomplishing it
under Secretary Leavitt now.
But assuming that the interoperable standards are going to
be there and that the medical community and the health care
community is going to eventually go online with medical
records, et cetera, to say that we can't come up and lead on
what is necessary--I'd just like your comment. Why wouldn't you
just give back to this committee, here's the things that we
think have to be included in anything that has to happen in
terms of e-prescriptions for controlled substances, and then
let us work with you as we formulate legislation to create that
so that we have the safeguards against abuse of controlled
substances?
Mr. Rannazzisi. Well, Senator, I believe we've gone on
record numerous times as saying the three things that we need
are authentication, non-repudiation, and a system that protects
the integrity of the recordkeeping process. The devil is in the
details. I would love to sit here and give you a laundry list
of things that we need. Technically, I'm not the person to do
that. That's what I have a technical staff for.
However, they are just as cautious of developing these
protocols as I am because they know that we have pretty much
one shot to do it right. If we don't do it right, there could
be a massive problem in the system which causes a lot of
diversion, a huge avenue of diversion. That's what a pilot
program is for. That's why this pilot is important to us. In
fact, Massachusetts' pilot was just resubmitted last Thursday
and we're in the process of reviewing it now. If we can get
that pilot up and running, we'll have a better idea of how the
system works.
Senator Coburn. There is a massive amount of diversion now.
Mr. Rannazzisi. Yes, there is. And we don't want to
contribute to that.
Senator Coburn. But not looking at the opportunity for
eliminating what's there now by going to an e-prescription
would seem to me--you have a shop. You can offer suggested
legislative language that would raise your concerns on that,
that would address every concern that the DEA would have.
Mr. Rannazzisi. Being in the rulemaking process right now
and drafting proposed regulations, I think we're requesting
more time to get this right. I would love to give you language
for legislation, but we're so far along in the rulemaking
process right now, the regulation process right now, I think if
you just give us a little more time we'll have something that
we'll all benefit from.
Senator Coburn. What is ``a little more time''?
Mr. Rannazzisi. That's the question of the decade. If the
Drug Enforcement Administration was the approving authority,
the sole approving authority for all rules and regulations, as
the head of the Office of Diversion Control I would give you a
time. But it's not. We have to go through a process of vetting
with several agencies and several different components of the
administration. If I sat here and gave you a time limit, I'd be
lying to you and I don't want to do that.
Senator Coburn. Good. Give us the time at which you will
offer that vetting to the other agencies.
Mr. Rannazzisi. At this point in time I don't believe I'm
able to do that.
Senator Coburn. Is there a time at which you will be able
to give us that?
Mr. Rannazzisi. Yes. I'd like to see, once Massachusetts is
up and running, how their program is working.
Senator Coburn. That's a little bit frustrating, just to be
quite honest with you. The fact is, you're responsible for
control of--
Mr. Rannazzisi.--Yes, I am.
Senator Coburn [continuing.] Controlled substances in this
country, and there is no question, it's an indisputable fact
that we're going to have a better handle on it if we do it in a
more advanced technological way. E-prescriptions is that way.
The idea is, you don't want to go on record to be held to
account; because somebody might hold you to account is why
we're not going to get there as soon as we should get there.
Every day we don't get there, somebody dies from an overdose.
Somebody puts somebody else onto a drug. We see more drugs on
the street. The fact is, we're talking about ways to actually
improve the DEA, the capability to enforce and do its job. I
will submit some letters, some questions in writing. But I
don't think that's an acceptable answer of not getting this
point.
Senator Whitehouse. I agree.
Senator Coburn. There ought to be a time at which you can,
with your staff, say we will have a position of DEA on e-
prescribing that raises the areas that we think are a problem,
at which time we will submit for vetting for the rest of the
administration. We'll do the oversight. I think Senator
Whitehouse has proven that he's capable of doing the oversight.
If you've submitted it and we know it, then we'll be
bringing everybody up here and saying, ``What's wrong with
it?'' The fact is, we need to get there. We're behind the rest
of the world in terms of IT and health care. This is a large
component that's going to make a big difference in terms of
offering health to people and safety to people. So, I just
think that we need to have a date from you. You all know the
process.
I'm very supportive of DEA. I know that a lot of the
problems with controlled substances is physician-based because
we don't do our job, or we don't do it the way we should. But
this is an area of expertise and of a technical nature that you
all have, and can have, and can offer. We ought to have a time
frame. My fear is, we're going to be sitting here 2 years from
now doing the same thing because the pilot didn't go as you
wanted. So what if the pilot doesn't go? If you know what you
want and you know what you need, we can solve the problem. But
we can't if we don't start. The starting point has to be with
you all saying here's what you'd like to have.
Mr. Rannazzisi. Sir, we look forward to working with this
committee, working with your staff and Senator Whitehouse's
staff. We'd be more than happy to provide briefings for you on
where we are and how we're going about the process. I regret
that I can't give you a date, a hard date. I would love to give
you a hard date. I'm a health professional. I'm a pharmacist, a
registered pharmacist by trade, so I understand the problems.
But I just think it would be foolish for me to give you even an
estimate because I'd just be speculating.
Senator Coburn. So there's nothing inside your organization
today that says ``we have a goal to get there X''?
Mr. Rannazzisi. Yes, there is.
Senator Coburn. And when is that? When is that X?
Mr. Rannazzisi. We have a goal to get to a particular
place, but we don't have a time period yet. I can tell you, we
are drafting regulations. We've been in contact with HHS. We've
discussed our regulations with the department. We've discussed
our regulations with ONDCP. It's in the process. However, I
just can't give you a hard date. Again, that would be reckless
for me to give you a hard date. When? Trust me, as soon as
possible, as far as I'm concerned.
Senator Coburn. Thank you. I don't have any other
questions.
Senator Whitehouse. Nothing that you have told Senator
Coburn about the administrative process and the accountability
for the administrative process is consistent with your earlier
testimony that this is a top priority for the Drug Enforcement
Administration. I simply can't believe that if this is
something that is viewed by the Drug Enforcement Administration
as a top priority, there isn't the kind of internal scheduling
for purpose of internal administrative accountability that you
would set up.
When I've run organizations and I want to get something
done, I lay out what I expect to get done and I tell people
it's got to be done by this date, and I can hold my staff
accountable. Accountability makes action take place in
government.
So I think for both of us to hear you say, well, we don't
know what date, we don't have a date, we're not sure, we want
generally to do it as soon as possible but nobody's actually
pinned down any accountability points for this, none of that
registers with us as resembling ``top priority''.
Mr. Rannazzisi. I don't think you compare prioritization of
tasks with a staff than with an agency that has to deal with
several other agencies, in addition to several administration
components. The fact is, when we're drafting the rules we don't
do it in a vacuum. We're in constant contact with the agencies
that we work with, bouncing things off of them.
Senator Whitehouse. But everybody else is pushing to get
this done. DHS would like to have this done yesterday. OMB
wants this to move. Somebody just assigned Dr. Kolodner to try
to solve this. I mean, it's not as if other people are holding
you back. At least, that's not the way it seems.
Mr. Rannazzisi. And obviously CMS and several different
agencies have reasons why they're pushing it, and their reasons
could be different than DEA's. The fact is, we have to protect
the public health and safety from diversion of controlled
substances, and to do that we have to--
Senator Whitehouse. Let me stop you right there.
Mr. Rannazzisi. OK.
Senator Whitehouse. Every agency has its purposes. From a
public policy point of view, we need to see that decisions are
made in the best interests overall. We can't have an agency
stopping a process because it has particular concerns, however
well founded those may be, if the externalities, the benefits
of this going forward in other areas are so enormous that, on a
cost/benefit calculation for society, for America, for people
who are out there stuck in our health care system right now,
this is a big loser. You've got to be prepared to kind of move
on and work with other people for the greater good.
If I could just, for a moment, ask Mr. Trenkle to
summarize, he touched on safety issues, he touched on
efficiency issues, he touched on improvement of care, and he
touched on this as sort of, I'm calling it the ``gateway''
factor, that this can be a progress step toward an electronic
health system for America that can reap enormous rewards, and
we're holding back on that progress here. While, on the
internal calculation with respect to DEA, whether you will do
drug diversion more effectively or not--and I suggest, given
the results we're seeing right now it's hard to imagine it's
going to turn out a whole lot worse. It's sort of the number-
one drug abuse problem in America right now, I would hazard. So
the idea that it's going to end up a whole lot worse with this
technology is a little bit hard to believe. But when you
compare it with the public benefits that HHS is arguing for, it
seems to me that it's worth taking that shot. Let's just get it
out there and cope. You do your best to make it happen, but you
don't stop all this other progress because your particular
interest isn't met.
Would you react to that?
Mr. Rannazzisi. Yes. Controlled substances are a different
type of drug than non-controlled substances, or legend drugs.
The fact is, that's why Congress created the CSA, because they
recognized the abuse potential of these drugs. That's why they
took it out of the FDCA, put it in a separate category. In my
20-plus years of law enforcement, I've never seen anybody
selling amoxicillin, Indural, or any of those other drugs out
on the street, but I do see them selling Vicodin.
And there's a reason for it, because the profit potential
and the abuse potential of those drugs are incredibly higher.
So while on the legend drug side you might not need the
security because you're not going to see the diversion, you
will see it on the controlled substances side. That's why we're
moving so cautiously.
Senator Whitehouse. My problem, Mr. Rannazzisi, is you are
answering the question in exactly the mode that I'm trying to
push back against, which is that, in this case it is all about
our diversion responsibilities, when in this case I think it's
all about a lot of other issues as well. It's all about, also,
patient safety, which will be dramatically improved if we can
get to a serious e-prescription regime.
It is all about far greater efficiency and cost when
families are out there right now getting creamed with
prescription drug costs if they have a seriously ill member of
the family. It's all about allowing our health care system to
develop into a system that is truly supported by information
technology and has comprehensive electronic health records.
All of these things are being affected by this decision.
I'd like to hear from you that, from an administrative point of
view, you recognize all of those benefits, and it's not just
about the internal balance between, is this better or worse
from our diversion point of view, but that this is a larger
issue and maybe needs a little bit more attention for that
reason.
Mr. Rannazzisi. As I said before, I think the benefits of
electronic prescribing are numerous. I understand that
electronic patient records are very important. I understand
that it's a very good cost-saving measure. I understand that it
could prevent a lot of the medication errors and interactions--
not all of them, but I'm pretty sure most of them. OK. However,
again, that aside, I have to look at other things.
Now, there's no question that there are benefits.
Senator Whitehouse. Do you look at that thing?
Mr. Rannazzisi. Yes. Absolutely. Absolutely. I just said I
did. But that's--unfortunately, there are other factors
involved that we have to look at. We're protecting the
integrity of the closed system of controlled substance
distribution, and to do that there are other factors that we
look at. I'm not saying that the electronic prescribing of
drugs in general is not beneficial universally. It is. But we
have to do it properly. We have to do it appropriately. We have
to do it so it's not going to create another avenue of
diversion.
Senator Coburn. Mr. Chairman, can I?
Senator Whitehouse. Please.
Senator Coburn. Two years from now, will we have a system?
Mr. Rannazzisi. I would hope so.
Senator Coburn. But you can't say ``yes, we will''? We're
getting to that Coburn's Theory of Bureaucracy: never do what's
best when you can do what's safe. Now, I understand you're a
safety agency. But the goal is hiding behind a message that
allows you not to step up to the line. That's what I'm hearing,
and that's what I don't like. It has nothing to do with you
personally, Mr. Administrator. It has to do with the fact that
everybody else that's sitting here watching this hearing is
saying, why couldn't they do it in 2 years? Why couldn't it get
done in 2 years?
The question is, obviously it could if people committed to
it and did it. But what we have is no commitment, which is
worrisome because we may be here 2 years from now with the
exact same problem on controlled substances. My dealings with
the DEA in the past have been very, very similar in terms of
responsiveness. So, you need at least to give the committee
some type of assurance we're going to get this problem solved
in some timeframe. If you say ``three years'', great, 3 years.
But to not say anything means that you're not going to step up
to the line and say, here's something we need to do for this
country.
Mr. Rannazzisi. Sir, I would hope that within 3 years we
have a system in place. My personal goal is quite a bit shorter
than that, but in 3 years I would hope to have some system in
place, yes. You know, obviously it's a personal goal to have it
a lot quicker. But, you know, if you're asking me, for 3 years,
I believe that in 3 years some system will be in place, yes.
Senator Coburn. Have you communicated with your staff that
this is something we're going to get done and we're going to
get it done in a certain timeframe?
Mr. Rannazzisi. My staff is right behind me here and--
Senator Coburn. No, no. I said, have you communicated to
your staff that, this is our goal, this is what we're going to
get done, and we're going to get it done in a certain
timeframe?
Mr. Rannazzisi. I've communicated to my staff that we have
a goal and we want to get to it as quickly as possible,
however, with the appropriate safeguards to protect the
integrity of the closed system. Yes.
Senator Coburn. But every agency head in this Federal
Government can answer a question that way. What I'm saying is,
have you set a goal, a time goal, within your staff to get
something done?
Mr. Rannazzisi. No, I can't set a time goal, sir.
Senator Whitehouse. Let me ask you a different question.
DEA agents out in the field. I was U.S. Attorney in Rhode
Island. We had a wonderful DEA office in that district. The
agents communicate with each other how? Do they communicate
with each other electronically?
Mr. Rannazzisi. The whole agency communicates
electronically through an e-mail system, yes. A secure e-mail
system.
Senator Whitehouse. And that system is kept secure?
Mr. Rannazzisi. There are security safeguards built within
the system, depending on the system you're using, yes.
Senator Whitehouse. And they're adequate for the DEA to
have taken that step and gone to electronic internal
communication. Correct?
Mr. Rannazzisi. Yes.
Senator Whitehouse. And highly confidential investigative
and other material is transmitted through that system between
offices and from agents back to headquarters?
Mr. Rannazzisi. Depending on the level of security of the
information, no, not necessarily. We have several different
systems to pass information depending on the level of security
necessary for that information.
Senator Whitehouse. But you're comfortable that you can
transmit electronically within DEA highly confidential
investigative information at the appropriate level of security,
correct?
Mr. Rannazzisi. Yes. Absolutely.
Senator Whitehouse. And you do that day in and day out.
It's happening right now over at the DEA.
Mr. Rannazzisi. Yes.
Senator Whitehouse. And you have a database, don't you,
that keeps track of evidence of suspected drug dealers, of
suspected drug networks, of suspected drug organizations and
how they connect, and who is involved, and how they're
financed, and all of that? You have a very extensive
intelligence aspect to try to investigate drug dealing
organizations inside and outside the country, don't you?
Mr. Rannazzisi. Yes, we have intelligence databases. Yes.
Senator Whitehouse. And you keep those databases
electronically, don't you?
Mr. Rannazzisi. Yes.
Senator Whitehouse. And you're comfortable that they can be
kept securely?
Mr. Rannazzisi. Yes.
Senator Whitehouse. All right. It would be nice to try the
same thing for a guy who wants to prescribe a bottle of
Vicodin.
Mr. Rannazzisi. I understand your concerns, sir.
Senator Whitehouse. What is the view from HHS as to where
we are procedurally on this? What are the next steps? What does
Secretary Leavitt anticipate as a deadline for this process?
When, from HHS's point of view, should we expect to have e-
prescribing in place in the United States of America for
controlled substances?
Mr. Trenkle. From the HHS perspective, obviously we're in
support of e-prescribing as much as possible, as soon as
possible. As you know, over the last 2 years we've not only
promulgated two sets of standards, we've also run five pilot
projects that report to Congress. So, we're moving as quickly
as possible to move ahead in e-prescribing and we stand here
ready to work with DEA as much as possible on a pilot project,
to assist them in providing background, feedback, anything to
support their regulations. We feel, as you know, Senator, that
this is a very major area for patient safety. It's a key
element of the interoperable network that we're pushing, both
within e-prescribing and HIT as a whole.
Senator Whitehouse. Is that, by the way, why the 2004
proposed regulations were requested by the Department of
Justice to be withdrawn, because of non-concurrence with HHS?
Is it because of the interoperability issue, and to have this
be something that can link in with the prescribing network?
Mr. Trenkle. Yes. We were concerned, as I mentioned in my
testimony. We would like to build an e-prescribing system that
incorporates what's in the current system, and in addition
takes into account DEA's requirements, but not to build
something that would potentially require two systems.
Senator Whitehouse. A parallel and independent system. Yes.
Mr. Trenkle. Correct.
Senator Whitehouse. Good. I think that's a sensible goal.
Is that a goal that DEA shares, that a doctor who's
prescribing amoxicillin and Vicodin should be able to go to the
same machine and enter the prescription when they send it down
to CVS or to Rite Aid?
Mr. Rannazzisi. Yes, sir. We don't want parallel systems.
We don't think that serves any purpose, other than to probably
push doctors away from prescribing through electronic means.
So, yes, we share that goal.
Senator Whitehouse. Good. Well, what I would like to do, is
ask a question for the record of the Administrator, the Acting
Administrator, that she provide to this committee the very best
and most concrete information that she can give us that will
answer Senator Coburn's question and my question about what the
timeframe is for the administrative process of concluding the
e-prescribing rulemaking.
That would include not only an end date by which somebody
is willing to be held accountable for saying ``I will get this
done by then'', but also any steps along the way, the
announcement of a proposed rulemaking, for instance, with the
various Administrative Procedures Act steps. If any of them are
at this point timed, or if you can get back to us with a time
that you're willing to commit to, because we really do need to
know what is going on and when this is going to happen. You've
seen intense bipartisan concern about this.
This is not an issue where we're going to go away. We'll be
back at you regularly on this subject. I think, when you
consider some of the costs that are involved here, which I
submit that you have not adequately recognized as an agency,
the costs in patient safety, the 530,000 episodes of adverse
drug interactions. Every one of them is an individual or a
family that is frightened, that is harmed, that is put at risk,
times 530,000. That's a lot of pain. We have a miserable health
care system in this country, with terrible information
technology support right now. We need to move rapidly toward
developing information technology support for our health care
system.
I think it is probably Secretary Leavitt's primary, single
goal. It's something that the President has spoken about, he's
appointed people to be in charge of. It's a very high priority
that will affect businesses across the country which are now
non-competitive with foreign manufacturers who don't have to
put that much health care into their products, and they're at a
big price disadvantage.
It's really difficult for the American families who have to
live through the tragedy of the health care system that doesn't
help them when they need it. Some of those are insured families
who find that they're in a nightmare, despite the fact that
they thought they had adequate insurance. So, there's a lot at
stake here. I think it's important that the different elements
of the administration be willing to look beyond their own brief
and consider more broadly the cost/benefit to the country of
getting past this, and move with according dispatch.
I carry a little book around and I write things in it that
interest me, that I think are useful thoughts to keep. I have
one that I will close this part of the hearing with, which is a
quotation from a decision of the U.S. Supreme Court in an
opinion authorized by the great Justice Holmes, Oliver Wendell
Holmes.
He said, ``All rights tend to declare themselves absolute
to their logical extreme, yet all, in fact, are limited by the
neighborhood of principles of policy which are other than those
on which the particular right is founded and which become
strong enough to hold their own when a certain point is
reached.'' I think we are at the point in which the
neighborhood of principles around drug diversion authority
needs to assert itself.
It's no longer appropriate for the Drug Enforcement
Administration to treat the diversion question alone as being
the absolute here in this public policy question. I appreciate
that you've come here. I appreciate, you've taken a lot of
bullets today. I know that you are the single human
representative of a large organization, and that there are some
things that are beyond your control. But we have a job here as
well. Sometimes that job is to be a thorn in the side of the
executive branch to spur activity. I'm sorry that you had to be
at the point in the body where the thorn was applied today, but
I'm sure you understand that we are here in good faith to try
to solve an important problem for our country.
Mr. Rannazzisi. I understand and respect your role,
Senator. I appreciate those words. I will take this back to the
Acting Administrator.
Senator Whitehouse. And the question for the record is one
that, if you could commit to at least a time in which that
question will be answered: 30 days, 60 days?
[Laughter.]
We'd like to leave here with at least one firm date. When
can you get back to us with the answer? Sixty days? Thirty
days? Two weeks? You name it.
Mr. Rannazzisi. To get back with the answer?
Senator Whitehouse. Yes. We're getting concurrence here.
Good.
Mr. Rannazzisi. I would say within 60 days.
Senator Whitehouse. Sixty days it is.
Mr. Rannazzisi. Yes.
Senator Whitehouse. I appreciate it. If you could make sure
that it's returned not only to me, but also to Senator Coburn,
who has shown such a distinct interest in this.
Mr. Rannazzisi. OK.
Senator Whitehouse. I thank you both for your testimony and
I look forward to working with you in the months ahead to work
our way through this quandary and get this resolved. I thank
you both kindly.
We'll take a few minute break while the next panel gathers.
We'll break for 5 minutes.
Mr. Rannazzisi. Thank you, sir.
[Whereupon, at 11:05 a.m. the hearing was recessed.]
AFTER RECESS [11:09 a.m.]
Senator Whitehouse. Let me call the hearing back to order
and welcome the second panel. I am grateful that you all are
here. I appreciate it very much. You have all been interested
in, and helpful with, this question. We look forward very much
to your guidance and advice on this important matter.
Some of you, I know already. I'm delighted to welcome Laura
Adams here from Rhode Island. She's not actually from Rhode
Island, but she works in Rhode Island and is the executive
director of an organization called the Rhode Island Quality
Institute, which has been a leadership organization in bringing
together the various stakeholders in the Rhode Island health
care system to improve information technology and explore
energetically that very special area in which improving the
quality of health care lowers the cost. It's an area well worth
mining, and she's done a wonderful job. I'm delighted that she
is here.
Kevin Hutchinson is the president and CEO of Sure Scripts.
He has worked with us in Rhode Island also. He has led the
effort to establish a neutral nationwide network for electronic
prescribing by connecting the Nation's numerous physicians'
technology applications and pharmacy software systems, enabling
physicians and pharmacies to communicate electronically.
Notably, Secretary Leavitt has selected Mr. Hutchinson to serve
as one of the 16 Commissioners of the American Health
Information Community, so he is a national leader on this issue
as well.
David Miller is the Chief Security Officer for Covisint,
where he directs and implements internal and external system
architectural security solutions for the multi-industry
exchange. In addition, Mr. Miller directs the federation and
identity management offering at Covisint, which currently
secures access for other 300,000 users across the health care
and automotive industries, as well as various public sector
initiatives.
Michael Podgurski has been at the Rite Aid Corporation
since 1987, where he current serves as Rite Aid's vice
president of Pharmacy Services. He's the past chairman of the
Pennsylvania State Board of Pharmacy, hence the appearance
today and the recognition today from your wonderful Senator,
Arlen Specter. I'm so glad that he was able to come and welcome
you.
He has served on both the Committee on Law Enforcement
Legislation and the Task Force on Pharmacy Automation at the
National Association of the Boards of Pharmacy, so he is
perfectly positioned for this discussion today.
I welcome all of the witnesses. I would ask that you stand
as a group so that I can administer the oath.
[Whereupon, the witnesses were duly sworn.]
Senator Whitehouse. Thank you very much. Please be seated.
Why don't I ask each of you to make a summary of the file
testimony rather briefly, and just go right down the table.
Then we can have a bit more of a dialog. It should be a little
bit more of an open forum than if we just go one back and
forth.
So if you don't mind, I'll ask Ms. Adams to proceed.
STATEMENT OF LAURA ADAMS, PRESIDENT AND CEO, RHODE ISLAND
QUALITY INSTITUTE, PROVIDENCE, RHODE ISLAND
Ms. Adams. Thank you, Mr. Chairman. For the record, my name
is Laura Adams and I'm the president and CEO of the Rhode
Island Quality Institute. This is a not-for-profit organization
founded 6 years ago by then-Attorney General of Rhode Island,
now U.S. Senator, Sheldon Whitehouse.
This multi-stakeholder organization, comprised of
hospitals, physicians, nurses, consumers, insurers, and
employers has the singular mission of significantly improving
the quality, safety, and value of health care in Rhode Island.
We have no other agenda and we are beholden to nobody but the
people of the State of Rhode Island.
I believe, Senator Whitehouse, I remember vividly you
putting a fine point on this about 4 years ago for the members
of the Institute when we were exploring the value of electronic
technology in health care when you pointed out to all of us
that anybody just has to go through a fast-food restaurant and
watch your order come up on the screen to realize there's more
technology in getting your hamburger from your fast-food
restaurant than there is in getting your medications to
patients. That point never left us.
I am here today to respectfully request that the committee
take action to strongly urge the Drug Enforcement
Administration and the Department of Justice to promulgate
regulations immediately for electronic prescribing of
controlled substances that are technology neutral, that build
on today's safe and secure electronic prescribing
infrastructure, allow for future changes in growth of
technology, privacy, and security safeguards in industry
expansion.
I'm going to speak about the need for those new regulations
from the perspective of our broad-based coalition that's
working together to transform the health care system in the
State of Rhode Island. The Quality Institute serves as Rhode
Island's regional health information organization, or RHIO. We
strongly believe in the value of health information technology
as an essential element of any viable proposal for addressing
the problems that plague our health care system right, left, or
center.
It's our goal to bring about the delivery of health care
system in our State, and bring it out of the paper-based
system, which we recognize as a root cause of significant waste
and harm and is a horrendous barrier to innovation.
In order for the people of our State and our Nation to
realize the promise of health information technology globally,
their providers have to adopt it and use it. Our job in Rhode
Island is to work diligently to lower these barriers to
adoption. Our Clinical IT Leadership Committee, a group of some
of the most competent and respected thought leader physicians
in Rhode Island, has identified the inability to electronically
prescribe controlled substances as a significant barrier to
adoption.
Some physicians on our committee, who devoted their scarce
and valuable time to this work for more than 3 years, have
cited this barrier as one of the primary reasons that they,
themselves, have not yet adopted electronic prescribing, even
though they're absolutely, unequivocally sure of the benefits
to patients, providers, and payors.
While approximately 12.5 percent of all prescribed drugs
are controlled substances, perhaps a more significant number is
the far higher percentage of patients that require the
prescription of controlled substances in addition to
medications that are permitted to be electronically prescribed.
For example, in the very common situation where an elderly
patient needs multiple medications to manage their chronic
illnesses and some of the drugs are controlled, it makes it far
more likely that a very busy practitioner who has adopted
electronic prescribing will default to the paper-based system
for all of the prescriptions for that particular patient than
attempt other than operating parallel systems and their very
complex office settings.
Therefore, the inability to electronically prescribe
controlled substances not only thwarts adoption in the first
place, it suppresses the total number of electronic
prescriptions written by those who have adopted and want to
electronically prescribe.
As I'm sure every member of the committee knows, research
has shown that medication errors are occurring at an alarming
rate in this country. With a staggering number of new drugs on
the market and more and more coming out all the time, it's
become all but impossible for providers to rely on their memory
for proper dosing, avoidance of drug-drug interactions, and
allergic reactions. I think David Eddie said it best when he
said that ``the complexity of modern medicine has exceeded the
capacity of the unaided human mind.''
Controlled substances include some of the most potent and
potentially harmful drugs, if given in the wrong dose or with
other drugs that result in untoward reactions. When a misplaced
decimal point or a drug interaction can be catastrophic--death
by decimal point, if you will--these patients are effectively
being denied a system that could save their lives. Patients who
require controlled substances deserve the same opportunity for
safer prescribing as all other patients.
Another problem of great concern to emergency room
physicians in Rhode Island is the electronic prescription of
controlled substances prevention. It doesn't help them prevent
``doctor shopping'', when patients with addictions or drug
dependency problems go from physician to physician to obtain
controlled substances. I was urged by the emergency room
director of our largest institution in Rhode Island to bring
this issue up today.
Electronic prescribing by emergency room physicians can
help to identify patients who doctor shop much more quickly and
efficiently than is now possible. This creates an immediate
electronic footprint or an audit trail that is documented and
time stamped through each point in the process, from the
prescriber's location to the pharmacy.
This is not simply an e-mail over the Internet, not by a
long shot. So that is not to say that electronic prescribing of
controlled substances, in every instance, could prevent drug
diversion. But it is saying that it can go a long way toward
reducing incidents of doctor shopping, reducing the rate of
those who successfully forge prescriptions, or alter the
originals.
We are asking today. The industry is ready. The need has
never been greater. We are asking for your help to bring about
the electronic prescribing of controlled substances and all the
benefits it affords consumers, providers, and payors.
Thank you for the opportunity to come before you today with
this request.
Senator Whitehouse. Thank you, Ms. Adams.
[The prepared statement of Ms. Adams appears in the
appendix.]
Senator Whitehouse. Mr. Hutchinson.
STATEMENT OF KEVIN HUTCHINSON, CEO, SURE SCRIPTS, ALEXANDRIA,
VIRGINIA
Mr. Hutchinson. Chairman Whitehouse, I thank you for the
opportunity to testify on this very important topic. We at Sure
Scripts have been interested in the implementation of
electronic prescribing for controlled substances for several
years and we're pleased to share our experiences and views on
this very important matter.
We were created by the National Community Pharmacists
Association and the National Association of Chain Drugstores in
2001. Our mission is to improve the overall prescribing process
and to ensure, among other things, neutrality, patient safety,
privacy and security, and enforce a patient's ability to choose
their pharmacy, and a physician's ability to choose the
appropriate therapy without encountering any commercial
messages along the way.
Under the leadership and with the backing of the pharmacy
industry, Sure Scripts has created a neutral and secure network
that is compatible with all major physician and pharmacy
software systems.
What is electronic prescribing? Put simply, it is not an e-
mail. It is the private and secure electronic delivery of
prescription and other health care information from a
prescriber's computer to the computer of the pharmacy, and back
again.
Allow me to point out what the term ``e-prescribing'' does
not include. It is not using a computer-generated fax. It is
not sending a prescription in an unsecure manner over the
Internet. It does not entail unlicensed or rogue Internet
pharmacies. The pharmacies that are connected to the network
are duly licensed and legitimate retail and mail-order
pharmacies.
The company's services were first put into production
sending and receiving electronic prescription transactions in
January of 2004. Today, more than 95 percent of the Nation's
pharmacies have computer systems that have been certified for
connection to the Pharmacy Health Information Technology
Exchange. Seventy percent of the Nation's pharmacies are live
on the network today.
In addition, physician software vendors, including
electronic medical record vendors and stand-alone e-prescribing
applications, whose combined customer base represents well over
150,000 prescribing physicians, have contracted and certified
their applications in the Nation's Pharmacy Health Information
Technology Exchange.
Electronic prescribing with respect to non-controlled
substances is a reality today. In 2007, 35 million prescription
transactions will have been routed electronically in the U.S.
Over 35,000 prescribers will have been utilizing e-prescribing
in the U.S., and over 40,000 pharmacies will have been e-
prescribing in the U.S. This represents 70 percent of the
pharmacies in the United States.
In fact, more prescribers electronically prescribed in the
first 10 months of 2007 than in all of 2004, 2005, and 2006
combined. There were more electronic prescriptions transmitted
in the first 8 months of 2007 than in all of 2004, 2005, and
2006 combined as well.
For 2008, Sure Scripts estimates the number of prescription
transactions routed electronically will grow to over 100
million. We estimate that in 2008, the number of electronic
prescribers will grow to approximately 85,000. Finally, for
2008, Sure Scripts estimates the number of e-prescribing
pharmacies will grow to 45,000.
Today, Sure Scripts is issuing the ``National Progress
Report on E-Prescribing'', an at-a-glance summary of key
statistics detailing the status of e-prescribing adoption and
utilization in the U.S. The deployment and use of electronic
medical records is a bipartisan priority of Congress, as well
as a priority of President Bush's administration. The
automation of the prescribing process is considered by many to
be the first step in the deployment of robust electronic
medical records. Many would argue that if we cannot get
providers to take the first step of e-prescribing, then how
will we expect them to adopt a full-fledged electronic medical
records system?
Federal policymakers and a growing number of congressional
and State legislators are calling for e-prescribing of
controlled substances to enable public and private payors,
consumers, and others to take full advantage of the safety
benefits, quality of care improvements, and increased cost
savings accruing from e-prescribing.
Adoption and utilization of e-prescribing is on the rise,
but there are still barriers to adoption. One of those
significant barriers is the fact that prescribers cannot
process controlled substances electronically. This prohibition
directly affects more than 11 to 13 percent of prescribed
medications in the U.S. today.
Prescribers want, and need, to use just one tool and one
process to prescribe their patients' medications. Using one
process for one drug and another process for a second drug is
inefficient, dangerous, and unnecessary. Consider a physician
that's about to prescribe both controlled and non-controlled
medications to his or her patient but cannot use electronic
prescribing for all of the prescriptions.
As a result, prescriptions are written electronically in
which an automatic drug interaction check is performed, and the
remaining drugs, which are controlled substances, are written
by hand and no drug interaction check is performed against
those medications, leaving the patient vulnerable to an adverse
drug event. The more likely case, is the prescriber chooses to
just use the paper and pen to issue all of the patient's
prescriptions and the advantages of automatic drug interaction
checks and use of available clinical decision support tools is
lost.
Time and time again, we hear from prescribers that they
will not e-prescribe, at all because they cannot controlled
substances electronically. Accordingly, the DEA prohibition
affects not just the 11 to 13 percent of controlled substances,
but a far greater number of prescriptions. This is truly a
barrier to adoption.
We agree that the criminal element is interested in
leveraging today's paper-based process using fraudulent means
to obtain Schedule II through V drugs, and we absolutely agree
that the DEA and other law enforcement officials need the
necessary tools to find and prosecute those who abuse drugs and
break the law.
We believe, however, the current system used for e-
prescribing supports the highly secure transmission of
prescriptions, regardless of Schedule. We believe that today's
system of e-prescribing would enhance, not deter, law
enforcement. E-prescribing is far safer and more secure than
today's paper world in which prescription pads are stolen, home
computers can easily print out counterfeit prescriptions,
signatures can be scanned and forged easily, and drug
quantities can be altered manually by patients before
prescriptions are delivered to the pharmacy.
In fact, Congress has always concluded that e-prescribing
is a substitute for paper and pen with respect to the
prevention of fraud. In Section 7002(b) of the U.S. Troop
Readiness, Veterans Care, Katrina Recovery, and Iraq
Accountability Appropriations Act of 2007, Congress mandated
the use of tamper-proof pads for all Medicaid prescriptions. It
significantly allowed for e-prescribing as an alternative to
even tamper-proof paper.
Among other things, the law aimed to prevent patients from
illegally obtaining controlled drugs. Accordingly, Congress has
also recognized that e-prescribing prevents fraud as much, if
not more than, the vulnerable paper- based system that exists
today.
The current e-prescribing system also allows for the
tracking of prescriptions on a real-time basis, which is not
possible, at least in a timely and scaleable way, with paper
processes in place today. E-prescribing could help law
enforcement to quickly identify in real time patients who
doctor shop and garner multiple prescriptions for controlled
substances.
E-prescribing, additionally, creates an immediate
electronic audit trail that is documented and time stamped
through each point in the process, from the prescribing
clinician's office to the pharmacy. These electronic audit
trails show who touched the prescription, and when.
If the prescription is created and sent electronically,
these built-in audit trails also could be used to identify drug
shopping if the patient pays cash. These electronic records,
available from the proactive process that is now live in all 50
States, including the District of Columbia, when subpoenaed,
could assist law enforcement in prosecuting diversion cases in
a much more timely and efficient manner than today's e-
prescribing process.
Accordingly, we call upon Congress to encourage the
adoption of regulations that would allow for electronic
prescribing of controlled substances. Such regulations should
set forth policy that achieves the goals and mandate of law
enforcement authorities and not mandate particular
technologies. E-prescribing, as currently conducted, not only
will enhance law enforcement, but will advance a legislative
agenda promoting electronic health records, which will save the
Federal Government millions of dollars, and will save lives.
We are Sure Scripts thank the committee for the opportunity
to share our experiences with respect to electronic health
care, and it would be my pleasure to answer any questions you
might have.
Senator Whitehouse. Thank you, Mr. Hutchinson. I appreciate
it.
[The prepared statement of Mr. Hutchinson appears in the
appendix.]
Senator Whitehouse. Mr. Miller.
STATEMENT OF DAVID MILLER, CHIEF SECURITY OFFICER, COVISINT,
DETROIT, MICHIGAN
Mr. Miller. Senator Whitehouse, I appreciate the
opportunity for myself and Covisint to be able to talk about
the issues associated with e-prescribing. Although in the last
few years Covisint has supported many doctors and pharmacies
related to things like RHIOs, and also supports the current law
enforcement information sharing program, that was not our
birth. The birth of Covisint was in 2000, really based upon the
automotive industry.
I am really here to tell you that this problem of secure
transaction sharing among large organizations that may not
trust each other, where there is the capability for fraud, has
been solved in other industries. This is not a brand-new thing.
This is not something that has never come up before.
Covisint, having to bear this problem in automotive, has
found some techniques in order to do this. The automotives,
very early on, realized that there was going to be a need to go
to electronic transactions. A large automotive manufacturer
does billions of transactions every month, and it's gotten to
the point, with global awareness, with global suppliers, that
you just can't do that with paper. You can't put pieces of
paper in an envelope and send it. So, certainly in the 1990's,
they decided to go to an electronic means.
In 2000, Covisint was started to leverage this new thing
called the Internet, to be able to make it more effective and
cheaper, really, to be able to do these type of electronic
transactions. These transactions moved to electronics. I can
tell you for a fact, having been in the automotive industry
then, that there were a lot of issues associated with security
of that type of thing.
Here's what was found out. What was found out, is that
electronic transactions have a few things that paper-based
transactions just don't have. They have easy auditability, so
they are truly auditable because you can send them through some
sort of centralized system, you can count them in the hundreds
of millions.
They are trackable in real time. So is it really effective
to be able to find out that somebody is prescribing drugs that
they weren't supposed to be prescribing 6 months after that
event occurs? Real- time action is very important.
They're transparent. And by ``transparent'' I don't mean
insecure, and I don't mean that HIPPA-based information is
exposed. By transparent, what I mean is, it is very difficult
for two parties to collude and get around the system, as it is
much easier in paper-based transactions.
You can take a look at historical information. I would
assume that there are hundreds and hundreds of millions of
transactions on controlled substances. Can you see the types of
things--doctors and pharmacists who are probably getting around
the system oftentimes use things that maybe aren't quite so
obvious. But perhaps by looking at months and months' worth of
records, or years' worth of records, you can see trends that
you wouldn't have been able to see. Automotive has been doing
this for a long time to track quality issues associated with
global suppliers.
The other thing I've found, being a security expert, is the
fact that organizations oftentimes insist on picking the most
complex, difficult, and most secure technology that is offered
at that time. Really, that problems becomes extremely difficult
then to implement those technologies. Half implementation is
almost worse than no implementation at all. As has been said
here, if people go half one way and half the other, you're
really not going to kind of get the adoption that you want.
So it's really important that you find a simple and secure
method for implementation of e-prescribing. Those types of
methods are certainly found in other areas. Again, they're
found in manufacturing and automotive, but they're certainly
found in other areas, also. For example, Web banking that we do
right now. The New York Stock Exchange does all of its
transactions electronically and they don't seem to be worried
about the fact that people could steal trillions of dollars of
information.
So what are kind of the security methodologies, at least,
that we have seen work in an industry with large constituents
that don't necessarily trust each other? The first thing is, a
secure authentication is extremely important, so something that
authenticates the user. But you don't have to go to thinks like
PKI, you don't have to go to things like issued Smart Cards.
There are other authentication mechanisms. Again, I do Web
banking with an ID and a password, some additional questions.
The world does that. It seems to be good enough for the guy
from the FDIC, so I would assume it might be good enough for
this.
Also, the idea that there are identity providers that are
already out there. Large hospital systems, large pharmacy
organizations that manage IDs today that can vouch for the
identity of an individual.
In addition, the implementation of some sort of trusted
broker is definitely something that we have seen. If you have
organizations that are working with each other--for example, a
doctor who's working with the pharmacy--they could collude, and
even in an electronic system they could find a way that nobody
might see that. If you put someone in the middle of the
transaction, some type of independent party who kind of
monitors it, it's much more difficult to collude between
organizations.
Then, last off, you really need both policy and oversight
that can be implemented in a consistent manner. Simplicity is
the most important thing here. If it's not simple, it won't be
adopted.
So in conclusion, I really think that the success of any
system that we have is really about adoption. Adoption is the
most important thing that we've seen in the automotive
industry, that we've seen in health care industries in general.
It has to be cost effective and secure. We certainly believe
that any move toward an electronic system is much superior to
the paper-based system that we have.
So, I thank you for the opportunity to testify.
Senator Whitehouse. I thank you, Mr. Miller.
[The prepared statement of Mr. Miller appears in the
appendix.]
Senator Whitehouse. Mr. Podgurski.
STATEMENT OF MIKE A. PODGURSKI, R.Ph., VICE PRESIDENT PHARMACY
SERVICES, RITE AID CORPORATION CAMP HILL, PENNSYLVANIA
Mr. Podgurski. Good morning, Senator Whitehouse. I am Mike
Podgurski. I'm vice president of Pharmacy Services for the Rite
Aid Corporation. I'm a graduate of West Virginia University's
School of Pharmacy, and I've been involved with many aspects of
the practice of pharmacy for 35 years. We thank you for this
opportunity to provide testimony today for this important
hearing regarding the electronic prescribing of controlled
substances.
Rite Aid, which is based in Camp Hill, Pennsylvania, is one
of the Nation's largest retail pharmacy chains. We operate
approximately 5,100 pharmacies in 31 States and the District of
Columbia.
Rite Aid has been involved for many years in the
development of the current electronic prescribing
infrastructure. For example, I was involved in the development
of Rite Aid's own e-prescribing system in 1998. Our company has
also been very actively involved in the development of the
Pharmacy Health Information Exchange operated by Sure Scripts.
This system currently serves as a secure platform for the
transmission of all the e-prescriptions which Rite Aid receives
today.
Rite Aid strongly supports the ability of prescribers to
send, and retail pharmacies to receive, e-prescriptions for
controlled substances in Schedules II through V. We especially
appreciate your support for this initiative, Senator
Whitehouse, as you recently expressed in a colloquy with other
Senators.
The health care system needs to increase the number of
prescriptions that are transmitted electronically. About 3.2
billion prescriptions are filled in the United States each
year. The majority of these prescriptions are still written by
prescribers on small, 3 x 5-inch pieces of paper, handed to the
patient, and brought by the patient or caregiver to the
pharmacist for dispensing.
In this day and age, the health care system can, and must,
do better in using technology in transmitting all prescriptions
to pharmacies, including controlled substances. Each of our
5,100 pharmacies across the United States is currently able to
receive e-prescriptions. These include new prescription orders,
as well as approvals to refill existing prescriptions.
These electronic transmissions have greatly enhanced the
efficiency of our pharmacists. This allows pharmacists
additional time to interact with patients and lessens the time
the pharmacist spends on the phone trying to obtain a refill
authorization or clarifying prescription orders with the
prescribers' offices.
The frequency with which prescribers are sending
prescriptions electronically is increasing, but we need to
encourage more prescribers to transmit new prescriptions and we
need to permit and encourage those who do e-prescribe today to
send all prescriptions electronically.
There are multiple health care and efficiency benefits to
e-prescribing, including those prescriptions for controlled
substances. First, e-prescriptions are easier for the
pharmacist to read, which may reduce the chances that errors
might be made in the filling of these prescriptions. It also
reduces the likelihood that a pharmacist may make a
transcription error when taking a prescriber's oral
prescription order over the telephone.
Second, before the prescriber sends an e-prescription to
the pharmacy of the patient's choosing, the prescriber is able
to perform an initial drug interaction or adverse reaction
review to make sure that the new drug being prescribed does not
conflict with a prescription drug that the patient is already
taking.
Third, e-prescribing provides significant convenience for
patients. Using this system, prescribers can transmit
prescriptions so that they are ready for pick-up when the
patient arrives at the pharmacy. However, because controlled
substance prescriptions cannot be transmitted this way, the
patient convenience and benefits of e-prescribing are
significantly reduced.
We understand and recognize the concerns of law enforcement
agencies, including the Drug Enforcement Administration, about
the need to assure that e-prescribing does not result in
additional diversion of controlled substances.
Rite Aid takes seriously our responsibilities to
appropriately dispense and account for controlled substances we
purchase and provide to our patients. However, we believe that
e-prescribing of controlled substances will reduce diversion
and abuse of controlled substances because of the significant
security features incorporated into the system.
An increase in the electronic transmission of prescriptions
may also help reduce the need for paper prescription pads.
These paper prescription pads are more subject to theft and
forgery. In addition, pharmacists make every effort to verify
the authenticity of the person communicating oral prescriptions
for controlled substances. However, the secure electronic
transmission of controlled substance prescriptions may reduce
the incidence of phony prescriptions being called into the
pharmacy.
In conclusion, we look forward to working with the Congress
and the DEA to ensure that workable regulations are developed
that would allow for the e-prescribing of controlled
substances. We believe this would enhance medical benefits to
patients, increase efficiencies in the prescribing and
dispensing of controlled substances, and reduce--not increase--
the potential for diversion and abuse of these substances.
I look forward to answering any questions you may have.
Thank you.
[The prepared statement of Mr. Podgurski appears in the
appendix.]
Senator Whitehouse. Well, thank you all for your testimony
and for your expertise and interest in this area.
The first question I'd like to ask is for Mr. Hutchinson
and Mr. Miller, and you can go back and forth in any way that
you're comfortable with. But you have handled this as a
technical question in this and in other fields. If DEA were to
come to you and to say, here's our problem: we want to make
sure people can't cut into the system and divert prescription
drugs for unauthorized purposes, what do we need to do to
accomplish that in the most sensible, thoughtful, efficient,
and effective way, what would you tell them? And particularly
with respect to you, Mr. Hutchinson. Would you tell them, use
our system? If they said, we're going to hand over to you this
question of controlled substances, would you feel that you
needed to add additional safeguards for that into the Sure
Script system as it now operates?
Mr. Hutchinson. It's a very good question, sir. I think the
response I would give, is that we feel that the systems and the
networks that are in place today in this country to process
prescriptions electronically are sufficient to process
controlled substances. In fact, if the concern is a prosecution
traceability/trackability, we've even offered up that we could
allow prescriptions to go electronically to the pharmacies, but
yet also allow the DEA to have a copy of all controlled
substances in a real-time mode where they could track
themselves the prescriptions that would go in an electronic
format.
I think, from an auditability and traceability standpoint,
it actually increases in a very real-time mode their ability to
track controlled substances and the use thereof. We have over
140 different software systems that are on the network, so the
physicians and pharmacies are able to choose their choice of
software. They are the ones that register these users on the
network and do the authentication directly of their own user
base onto the network. These are licensed pharmacies. These
are, as I mentioned in my testimony, not Internet pharmacies.
These are not rogue pharmacies. So, those systems and those
pharmacies are not on the network, and will not be on the
network.
Senator Whitehouse. In our research, my wonderful staff
found testimony from Mr. Ratliff of your organization at a
previous hearing in which he said, ``We have maintained the
confidentiality and integrity of these transmissions,'' the e-
prescribing transmissions, ``for the prescriptions that can be
transmitted electronically and have had no instances of
tampering.'' He went on to say, ``We believe that the
electronic prescribing process greatly improves security for
the prescribing of all prescriptions in comparison to today's
written and oral processes for prescription information.''
Now, this is from some time ago. Is it still valid that you
can assert that the Sure Scripts system has not been hacked and
tampered with and that you're confident in its integrity?
Mr. Hutchinson. It's absolutely valid. It was valid then,
it's valid today. We've been working on this very issue for
several years and it will maintain to be valid in the future.
Senator Whitehouse. So your answer to the question of, what
do you tell DEA, is get off the dime and use us?
Mr. Hutchinson. Absolutely.
Senator Whitehouse. Mr. Miller.
Mr. Miller. I think our answer to DEA would be very similar
to Mr. Hutchinson's answer. There is no single solution. You
need to do something. Any electronic e-prescribing methodology
is going to be more secure than a paper-based system that we
see today.
Senator Whitehouse. Any? Repeat that.
Mr. Miller. Any. Any based will be more secure than what we
have today. As I said before--
Senator Whitehouse. Can I ask you to repeat that just one
more time for effect?
[Laughter.]
Mr. Miller. Sure. Any e-prescribed based system will be
more secure than the paper-based system that is currently used
today.
Senator Whitehouse. OK. Thank you.
Mr. Miller. It is more trackable, it is more secure. It is
definitely used in other industries. Again, if this was the
leading edge thing and no one had ever even though of doing
electronic transactions over the Internet, then perhaps it
would be, we need to do a pilot and kind of try, maybe spend 3
years figuring it out. But we all trade on the Internet, we all
do banking on the Internet. I guarantee you, your health
records are going back and forth on the Internet now anyway,
even if you're not e-prescribing. So the first answer is,
really move forward with something.
The second thing, though, that is really important, is in
reality, many of the doctors that you're talking about are not
sophisticated computer users. If you pick a system that is
difficult for them to implement, they won't. The doctors that I
know are much more interested in patient care than they are
about the latest version of Windows, so you need to find
methodologies and systems that are more simple. Does that mean
that it may be a little less secure? Possibly. But again, it is
definitely more secure than the current paper-based system that
we have today.
Senator Whitehouse. Now, you say this from the position of
also being a Department of Justice vendor, are you not?
Mr. Miller. Yes. Covisint also provides electronic identity
transaction for a law enforcement sharing program that
basically allows information related to terrorist activity to
be shared both with Federal and local law enforcement. That,
today, is done--
Senator Whitehouse. That's fairly highly classified stuff
that you don't want people floating in and out of.
Mr. Miller. It is. It is definitely highly secure stuff
that you don't want people to be able to access. That
information is being transmitted today in a secure manner.
Senator Whitehouse. Without PKI technology?
Mr. Miller. Without PKI technology. As a matter of fact,
the authentication mechanism used by the FBI in their system is
also currently without PKI technology, although moving to it.
So, there are cases where the utilization of other security
technologies certainly work, again, in banking, law
enforcement. Is it possible that somebody can use this to
perhaps find a way to get around the system? Yes, anything is
possible.
But again, if you look at the system we have today, which
is little pieces of paper that are transmitted back and forth,
it certainly is more secure to be able to do it in encrypted
and tracked technology. I think that's really the big deal. In
electronic communication, I can watch all that happens. People
who are watched have a tendency to not want to break the law.
It's a lot easier if you're not watched.
Senator Whitehouse. And you can also, because the
electronic information can be easily, cheaply, quickly, and
effectively aggregated, you can very quickly detect patterns
that are inconsistent with customer use and might indicate
something is wrong so that you can make a proactive inquiry,
correct? I mean, you can set up flags that go up and various
times.
Mr. Miller. Right. Right. That's absolutely true. Not only
can you track very large patterns that you couldn't do, so you
can take a look at a doctor who consistently is over-
prescribing a medication over years of time, you also have the
ability to set up real-time flags. So, for example, if some
sort of bad guy is going to steal Oxycontin, he's not going to
steal 11 tablets, he's going to steal a million of them. Well,
no doctor prescribes a million tablets. I mean, you would see
that immediately. It would be very easy for you to be able to
identify the event that occurred and actually, you know, in
many cases stop the event before the transaction is completed.
I mean, that's how fast the electronic capability is.
Mr. Hutchinson. And imagine just the value of taking the
prescription out of the patient's hands and being between the
two providers, between the physician and the pharmacist to
avoid that kind of opportunity for fraud.
Senator Whitehouse. So the Drug Enforcement Administration,
as we all know, is a division of the Department of Justice. So
if I were to bring this question up with the new Attorney
General, Attorney General Mukasey, I could safely report to him
that this important question that is being wrestled with by his
own Drug Enforcement Administration has already been
conclusively and satisfactorily answered by other divisions of
his very organization?
Mr. Miller. Absolutely.
Senator Whitehouse. I think I might make that point.
[Laughter.]
The other thing I wanted to get into--I don't know. We're a
little bit into the technical piece of this, Mr. Podgurski, and
I'm not sure if that's where you're comfortable. But if you
wanted to add something to this, I'd be delighted to hear from
you as well.
Mr. Podgurski. No. I was just going to say, on the security
angle and the way Sure Scripts has the validation and
verification process in place, that I wasn't aware of any
breaches. I think it's the most secure system that we have for
e-prescriptions out there.
Senator Whitehouse. OK.
The other place I'd like to go with my questioning is to
try to put a little bit more of a kind of practical and human
face on some of the opportunity costs that we're missing by not
being here and by not being up to speed with e-prescribing on
controlled substances.
You can probably think of others, and if you do please
remind me, but my notes from your testimony today fall
basically into four categories. One, is patient safety, with
sort of the subcategories of accuracy of the prescription and
drug interaction alerts that can be prompted electronically.
The second would be compliance with prescription regimes, the
ability to track a little bit better what's going on.
The third would be administrative efficiency within the
system so that costs are reduced and people don't have to pay
as much for a prescription because the pharmacy industry is
able to deliver it more efficiently. The fourth would be data
gathering, not just from a fraud and abuse prevention point of
view, but also from a public health point of view. There are
four witnesses and there are four of those points, so what I
would like to do is basically target each of you with one of
them.
Ms. Adams, if I could start with you on the issue of
compliance with prescription regimes. What is the state of
knowledge about how compliant people are with prescription
regimes? How serious an issue is the non-compliance, what are
its effects, and how does e-prescribing help on the compliance
issue?
Ms. Adams. It's a serious issue in that we know that
upwards of 30 percent of all prescriptions are never filled,
than if that patient returns back--I mean, even for non-
controlled substances, it's a problem. If the patient returns
back and their blood pressure remains high, they may get an
increased dosage. Maybe this time they start taking that
prescription when they never were taking the original
prescription but the prescriber thought they were. So the
percentage is very high, surprisingly high.
Senator Whitehouse. When we're asked by our doctors if we
actually picked up the prescription?
Ms. Adams. Oftentimes we are not. That assumption has been
made. In fact, I think it's just now becoming new knowledge to
providers that their patients aren't taking their
prescriptions. We're finding that out through what? Electronic
prescribing, because we now have records of whether or not
patients pick up those prescriptions. The pharmacy never knows
if a doctor writes something on a piece of paper and the
patient never brings it to them. So, we have that capability of
discovering something new.
The point that I was making earlier about the advancement
of innovation, this is exactly what we're talking about here,
when that prescriber can know that that patient never picked it
up. There are other issues around compliance. It's not just
that somebody decided not to do it. It could be that they don't
have the money to pay for that prescription. But they'll suffer
the consequences, and so will society down the line. We'll
still pay for that patient's condition, but only after they've
had their heart attack because they're not taking their beta
blocker or something of that nature.
So, it once again contributes to hospitalizations,
contributes to visits to the doctor's office, it contributes to
the overall cost structure and the harm structure that goes on
because the physician is not able to have that discussion with
the patient: ``Gee, I see that you didn't pick up the
prescription.'' ``Well, you know what? I didn't have
transportation this week.'' ``Oh, OK. Well, we're going to
solve that problem with your case manager.'' We won't have that
information otherwise. That is afforded to us through
electronic prescribing.
Senator Whitehouse. So it's not just not picking up the
prescription the first time when you go, have a single
prescription. It also applies to people who have chronic
illnesses and require consistent prescription drug support and
the doctor can get a flag when a regularly collected medicine
is not picked up and can intervene at that point.
Ms. Adams. Correct.
Senator Whitehouse. And that person is totally missed right
now by the health care system.
Ms. Adams. So we'll know if that patient that needs that
for correct management of their chronic illness isn't taking
enough of that drug, because by now had they been taking the
prescription as prescribed, it should be renewed. We wouldn't
know that otherwise. Through the electronic system, we have
information that, now it's time for that patient to be
renewing. If they're not, we need to be connecting with them to
find out why they're not getting their next scheduled renewal
of that drug.
Senator Whitehouse. Valuable public health information.
Ms. Adams. Absolutely.
Senator Whitehouse. Mr. Hutchinson, let me ask you about
the safety questions of the accuracy of the transmission
between Dr. Coburn deciding that this is the prescription he
intends for the patient to take with what the pharmacist ends
up reading and dispensing, and also with respect to the drug
interaction. How significant are those, from a public health
point of view? What are the costs? Put kind of a human and
practical face on those, if you would.
Mr. Hutchinson. I'll give you a bonus, because I'll add a
little bit more color to the issue around adherence as well.
Senator Whitehouse. Please.
Mr. Hutchinson. Something that should be pointed out, is
that Walgreen's and IMS just concluded a study that looked at
physicians prior to adopting e-prescribing and physicians post
e-prescribing. One of the major concerns the pharmacy industry
had is restocking charges. Am I going to get all these
prescriptions electronically that patients aren't going to come
in and pick up, and now I'm having to restock these
prescriptions on the shelves?
In fact, they found the exact opposite. Once they go to
electronic prescribing to patients, they dispensed 11 percent
more prescriptions on a per-physician basis once it goes to e-
prescribing, which means that patients are more compliant with
physicians' orders once they know that the drugs have been sent
electronically. That goes directly to patient safety as well,
because if the patients are not taking their medications as
prescribed by their physicians, then in fact what happens is
they end up back in the physician's office, or in an emergency
room, or in a hospitalization.
There's a wonderful, wonderful study that's out there now--
we have plenty of studies on this topic, by the way. We don't
need any more pilots or any more studies. The Henry Ford
Medical Center just published some recent results that showed
that they were able to cut their hospitalizations and their
emergency room visits in half, and one-third of those cuts in
those visits were directly attributable to electronic
prescribing and the avoidance of drug interactions associated
with that, because they're able to track the original order
that a physician was going to prescribe, and then, post drug
interaction, the change of that medication to a safer
medication according to that drug interaction alert that was
given.
Senator Whitehouse. And their result was--repeat that for
me. A third of--
Mr. Hutchinson. They cut their hospitalizations due to
adverse drug events, and their ER visits due to adverse drug
events, in half. They attributed 33 percent of those cuts
directly to the fact that they were electronically prescribed
medications.
Senator Whitehouse. So of the 530,000 adverse drug events
that Mr. Trenkle referred to earlier in his testimony, a sixth
of that would be eliminated just by e-prescribing alone without
further--
Mr. Hutchinson. That's exactly right. A percentage of
those--
Senator Whitehouse. Three thousand folks.
Mr. Hutchinson [continuing]. Would be direct to
hospitalization or admission to hospitals, and a percentage of
those would also be attributed to potentially an emergency room
visit due to that drug interaction, and they were able to cut,
due to the implementation of electronic prescribing, those
hospitalizations due to ADEs, and emergency room visits due to
ADEs, in half.
Senator Whitehouse. And what can you tell us, kind of from
a practical point of view, about the accuracy issue, about the
extent to which errors occur because, famously, physicians'
handwriting is illegible, decimals are misplaced, and so forth?
Is there any information on how big a role that simple issue of
inaccuracy and illegibility impacts on Americans' health?
Mr. Hutchinson. Yes. There are a lot of studies that relate
to this very matter. The practical example that I will give you
is, so long as it is actually truly electronically prescribed
as defined by the standards that HHS has established in the
Medicare Modernization Act, then you will see a significant
improvement in that legibility, because we need to eliminate
the fax as well. You need duplication of entry into the
computer. Whatever is entered into the physician's computer is
exactly what shows up in the pharmacy's computer.
Why that is important, is even in a faxed prescription
environment, sometimes a milligrams of 1.0 may be misread or
misentered as 10. When it comes from application to
application, the computer does not misintepret the decimal
symbol, so we actually have proper and accurate prescriptions.
Whatever the physician orders is exactly what the pharmacy
dispenses.
Senator Whitehouse. And how often does an inaccuracy result
in a missed prescription or a health care problem for people in
America? Is that a rare and unusual problem? Is it a
significant problem?
Mr. Hutchinson. It's a significant problem. I don't have a
number at my fingertips to be able to give you today.
Senator Whitehouse. If you find one, could I make that a
question for the record so you could get back to us before the
hearing record concludes?
Mr. Hutchinson. I will, yes.
Senator Whitehouse. Thank you.
[The information appears in the appendix.]
Senator Whitehouse. Mr. Miller, my question for you has to
do with the data gathering and the sort of public health aspect
of it. I guess, beyond what we talked about earlier, do you see
public health value from being able to sort of track,
ultimately even around the country, where a prescription for a
particular type of drug is, for instance, suddenly ballooning
or where associations can be developed between a particular
drug and a condition that may emerge weeks later after the use?
Is there public health value here to this?
Mr. Miller. Absolutely. So if you take a look at a parallel
effort, which is really the ability to do electronic health
records, those electronic health records, along with a robust
e-prescribing program, would allow you to see certain drug
interactions, not only with other drugs, but drug interactions
in general with patients that you may not have seen before. So
not only do you see that Oxycontin is being prescribed, but
what you do see, is you see the number of hospital visits, for
example, that occur. You can only do that if you can marry
those two electronic transactions together as opposed to paper-
based.
Senator Whitehouse. If you have to do it with paper, you'd
go--
Mr. Miller. Well, you'd employ a lot of people, I suppose.
Senator Whitehouse. At vast expense.
Mr. Miller. The other thing that is interesting, and it's
an interesting parallel, is that what we're seeing in health
care in general is the old days of me going to the same
physician all the time, where, to be honest, the reason why
there weren't drug interactions and he knew what I was taking,
is he's the only person who ever prescribes me anything, and by
the way, probably going to the same pharmacist down the road.
Those days are gone. They're either gone because you travel so
much that you go lots of places, or more tragically, that you
don't have health insurance, so what you do is you go to free
clinics and you go to the ER, where, to be honest, that doctor
basically has absolutely no idea what you have been doing, or
haven't been doing.
Senator Whitehouse. Or you're chronically ill and have five
or six specialists all working on you at once.
Mr. Miller. Or you're chronically ill and you have fix or
six specialists. Those things are the things, really, that
electronic prescribing allows the doctor to be able to
understand all the prescriptions that you are currently taking.
So I actually have a personal experience, where my mother went
into the hospital last summer and she couldn't remember whether
or not she had filled her prescription for her heart
medication.
The ER doctor said, I need to know, because if you have
filled it and taken it I can't give you this drug, and if you
haven't, then I need to give you this drug. Well, she couldn't
remember. Without electronic prescriptions, there really was no
way to tell. It was kind of more of a crap shoot. So, those
are, I think, some of the things that are just really important
with that.
Senator Whitehouse. The last point was the internal
efficiency. Nobody could be more knowledgeable about that than
you, Mr. Podgurski. Could you kind of quantify, from an
industry point of view, what benefits do you see if we move
from a paper system and are able to eliminate it and go fully
to an e-prescribing system in terms of your ability to make
this transaction more efficient and reduce costs for American
consumers?
Mr. Podgurski. Well, the thing is, with the efficiencies,
these prescriptions come directly into the computer so you
don't have to do a data entry. They still go through adverse
drug reactions at the pharmacy, but they automatically come
into the system and print a hard copy, which is still required,
and are identified as e-Rxs. They also have an electronic
signature on them that makes them valid for the secure
purposes.
There's a pharmacist shortage across this Nation. Many
pharmacists work in different pharmacies today. No longer will
you see many of the same people continually only working in one
store. Those individuals used to be able to identify a doctor's
signature, a doctor's nurse calling in. Those days have gone by
the wayside.
E-prescriptions would bring an authenticity to that.
Pharmacists still have a duty to make sure that the
prescription is valid, and the State Boards of Pharmacy have
given them the authority to use their professional judgment in
dispensing medications. So looking at, if it's an out-of-the-
area prescriber, a new patient that's out of the area, those
things won't go by the wayside when looking at the
authenticity, even if it's an electronic prescription. They
still have a duty to verify those.
Senator Whitehouse. Good. Well, this hearing was scheduled
to end at noon and we've come to the noon hour. If anybody has
a closing point of any kind they would like to make, I'm not in
any particular rush and I'd welcome any final point, if anybody
has something they'd like to make.
Ms. Adams. Senator Whitehouse, I'd just like to add one
statistic to that--
Senator Whitehouse. Please.
Ms. Adams [continuing]. That Mr. Miller was referencing,
that notion of, in this day and age, multiple providers.
Studies have shown that Medicare beneficiaries see anywhere
from 1.5 to 13.8 unique providers each year, 13.8 unique
providers, none of whom are able to talk to each other if
everybody is using a paper-based system. The issue is serious.
Senator Whitehouse. So the electronic e-prescribing system
really becomes the safety net under that circumstance with
respect to their prescriptions.
Ms. Adams. That's right. You're not the only doctor they're
seeing, the only pharmacy that's filling your prescriptions;
13.8 doctors are making prescriptions here, and the drug
interaction potential is horrendous.
Senator Whitehouse. Well, thank you very much. I will call
this hearing very shortly to its end. We will leave the record
of the hearing open for 7 days, so the questions that have been
asked for the record, we'd like to have within 7 days, with the
exception, in DEA's case, of the 60 days that we granted you.
But the record of this particular hearing will close then.
I want to thank all of you for your travel here, for your
very helpful and thoughtful testimony. I know you've come a
considerable distance and you all have very busy lives. It has
been very helpful to me, and I hope to my colleagues, to have
you here. I think it will make a difference if we can push
through this problem.
I would like to, I guess, close with one observation, to
put this into some context as to why I called this hearing and
why I think it's so important. I also serve on the Budget
Committee with Senator Conrad, who is a brilliant chairman of
the Budget Committee and a very able and sensible person,
certainly not anyone who is any kind of an hysteric.
The information that we have received in the Budget
Committee, and the conclusions that he, I, and others have
drawn about them, show that we are headed for a real potential
disaster in our health care system. There is what he has
described as a tsunami of cost coming at us in the American
health care system. The people who will receive that medical
care have already been born. They are here. We can't do
anything about their presence. Time makes them older, second by
second. We can't do anything about the passage of time.
Aging human beings require more health care services than
younger ones. That is a fact of life. I don't know that we can
do much about that. Unless we can do something about the
efficiency with which we deliver that health care to those
people, the combination of those factors will make our already
wasteful health care system unaffordable. If our health care
system becomes unaffordable, then the only place we have to go
is to cut people off of it: seniors, working families,
children. That is not acceptable.
The alternative, the only alternative, is to get ahead now
while we have the time to make it work and build the
infrastructure that can make our health care system
sufficiently efficient to continue to serve Americans the way
they expect, to actually improve the health care service that
America gets, but to do it at a cost that America can afford.
It is the electronic health infrastructure that is our best
avenue to accomplishing that goal.
Now, this is kind of a macro point. It's probably going to
take 10, 15, 20 years for all this to play out. But as time
goes by and we lose the opportunity to get in ahead and build
this into place, the potential costs on the back end to people
who will pay the price in lowered health care services is a
very, very real one, and a very human one, and a very tragic
one. So, 3 years is more than we have to wait on this. We have
got to get going now, because e-prescribing is a gateway to
this. Many of you have said it.
I think it's really important not just from a diversion
point of view, not just from a wow-isn't-this-a-wonderful-
gizmo-it's-going-to-make-people-get-their-prescriptions-more-
efficiently point of view, but from a point of view of where
our American health care system goes. This has been a really
important point for us to tackle, so your effort in coming here
is much, much appreciated.
This was my first hearing--I'm a new Senator--the first one
that I've called and held. So I want to also, on the record,
express my appreciation to the brilliant staffers: Jordana
Levinson, my health care staffer, and Sam Goodstein, my
Judiciary staffer who have prepared me for this and worked with
all of you to get here today. So, with my thanks to them and a
reminder that 7 days is when the hearing record will close, we
are adjourned.
[Whereupon, at 12:09 p.m. the hearing was adjourned.]
[Questions and answers and submissions for the record
follow.]
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