U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

53–359 PDF 2008

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 

( 

(II) 

COMMITTEE ON THE JUDICIARY 

PATRICK J. LEAHY, Vermont, Chairman 

EDWARD M. KENNEDY, Massachusetts 

JOSEPH R. BIDEN, JR., Delaware 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

BENJAMIN L. CARDIN, Maryland 

SHELDON WHITEHOUSE, Rhode Island 

ARLEN SPECTER, Pennsylvania 

ORRIN G. HATCH, Utah 

CHARLES E. GRASSLEY, Iowa 

JON KYL, Arizona 

JEFF SESSIONS, Alabama 

LINDSEY O. GRAHAM, South Carolina 

JOHN CORNYN, Texas 

SAM BROWNBACK, Kansas 

TOM COBURN, Oklahoma 

BRUCE A. COHEN, Chief Counsel and Staff Director 

MICHAEL O’NEILL, Republican Chief Counsel and Staff Director 

(III) 

C O N T E N T S 

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 

(1) 

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 

2 

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 

3 

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. 

4 

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. 

5 

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 twothirds, 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 

6 

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. 

7 

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. 

8 

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. 

9 

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. 

10 

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-andpen 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 

11 

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 

12 

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. 

13 

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 

14 

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 

15 

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 

16 

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— 

17 

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. 

18 

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 

19 

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. 

20 

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 

21 

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 inVerDate Nov 24 2008 09:09 Nov 25, 2009 Jkt 053359 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\53359.TXT SJUD1 PsN: CMORC
22 

formation 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 subVerDate Nov 24 2008 09:09 Nov 25, 2009 Jkt 053359 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\53359.TXT SJUD1 PsN: CMORC
23 

stances 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. 

24 

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 elecVerDate Nov 24 2008 09:09 Nov 25, 2009 Jkt 053359 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\53359.TXT SJUD1 PsN: CMORC
25 

tronically. 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. Eprescribing could help law enforcement to quickly identify in real 

time patients who doctor shop and garner multiple prescriptions for 

controlled substances. 

26 

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 builtin 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, realVerDate Nov 24 2008 09:09 Nov 25, 2009 Jkt 053359 PO 00000 Frm 00030 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\53359.TXT SJUD1 PsN: CMORC
27 

ly, 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? Realtime 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 paperbased 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. 

28 

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. 

29 

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 eprescribing 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 perVerDate Nov 24 2008 09:09 Nov 25, 2009 Jkt 053359 PO 00000 Frm 00033 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\53359.TXT SJUD1 PsN: CMORC
30 

son 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 

31 

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— 

32 

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 

33 

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 

34 

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 

35 

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 propVerDate Nov 24 2008 09:09 Nov 25, 2009 Jkt 053359 PO 00000 Frm 00039 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\53359.TXT SJUD1 PsN: CMORC
36 

er 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 

37 

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. 

38 

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. 

39 

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-tomake-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.] 

40 


53359.001
41 


53359.002
42 


53359.003
43 


53359.004
44 


53359.005
45 


53359.006
46 


53359.007
47 


53359.008
48 


53359.009
49 


53359.010
50 


53359.011
51 


53359.012
52 


53359.013
53 


53359.014
54 


53359.015
55 


53359.016
56 


53359.017
57 


53359.018
58 


53359.019
59 


53359.020
60 


53359.021
61 


53359.022
62 


53359.023
63 


53359.024
64 


53359.025
65 


53359.026
66 


53359.027
67 


53359.028
68 


53359.029
69 


53359.030
70 


53359.031
71 


53359.032
72 


53359.033
73 


53359.034
74 


53359.035
75 


53359.036
76 


53359.037
77 


53359.038
78 


53359.039
79 


53359.040
80 


53359.041
81 


53359.042
82 


53359.043
83 


53359.044
84 


53359.045
85 


53359.046
86 


53359.047
87 


53359.048
88 


53359.049
89 


53359.050
90 


53359.051
91 


53359.052
92 


53359.053
93 


53359.054
94 


53359.055
95 


53359.056
96 


53359.057
97 


53359.058
98 


53359.059
99 


53359.060
100 


53359.061
101 


53359.062
102 


53359.063
103 


53359.064
104 


53359.065
105 


53359.066
106 


53359.067
107 


53359.068
108 


53359.069
109 


53359.070
110 


53359.071
111 


53359.072
112 


53359.073
113 


53359.074
114 


53359.075
115 


53359.076
116 


53359.077
117 


53359.078
118 


53359.079
119 


53359.080
120 


53359.081
121 


53359.082
122 


53359.083
123 


53359.084
124 


53359.085
125 

Æ 


53359.086