National All Schedules Prescription Electronic Reporting Act of 2004

Mr. Speaker, I rise to express my strong concerns about the lack of adequate patient privacy protections in H.R. 3015, the National All Schedules Prescription Electronic Reporting Act of 2004.

H.R. 3015 is intended to support states' efforts to prevent the abuse of certain controlled substances through the provision of federal grants to the states for the purpose of establishing and implementing controlled substance monitoring programs. States would use the grants to develop and maintain an electronic database containing information about the type of medication prescribed, quantity dispensed, number of refills, and similar product information. The database also would collect personal information about each patient receiving prescriptions of the covered controlled substances, such as the patient's name, address and telephone number.

The abuse of controlled substances such as oxycontin and amphetamines is a serious problem that plagues many Americans. In response to the seriousness of the problem of prescription drug abuse, more than 20 states, including Massachusetts, have taken steps to

prevent such abuse through the establishment of reporting requirements on pharmacists and the creation of drug monitoring databases similar to those contemplated by H.R. 3015. In Massachusetts, for example, pharmacies are required to report the prescriptions they fill for substances in Schedules I and II to the state's department of Public Health.

The problem is that H.R. 3015 does not provide the safeguards that are required to shield patients--the vast majority of whom will be law- abiding citizens receiving medications as part of a legitimate plan of care--from unauthorized disclosure of their personal medical information. Instead, the legislation provides the states broad leeway to establish databases of patients' private medical records with little guidance on the privacy protections that must be in place in order to qualify for the grants.

For example, H.R. 3015 does not require states to limit access to the database information to a finite and identifiable number of individuals. Instead, the bill permits disclosure of individually- identifiable patient information in the database to a wide range of professionals in addition to practitioners and law enforcement personnel, including any local, state or federal ``narcotics control, licensure, disciplinary or program authority'' who can make specific certifications as to the need for access to the information. Any ``agent of another state'' with a monitoring program approved by the bill also could gain access to patient records in the database, provided that the purpose of the access is for ``implementing the state's controlled substance monitoring program.'' Such easy access puts the privacy of potentially hundreds of thousands of law-abiding citizens at risk of unauthorized disclosure.

Additional privacy protections that are missing from H.R. 3015 include: a requirement that states receiving grants under the terms of the bill periodically purge the database of information about any particular prescription after a limited amount of time; unambiguous language stipulating that the bill does not override established standards of medical ethics relating to privacy; establishment of specific penalties for unauthorized access and redisclosure; and a provision making clear that the term ``minimum necessary'' as it relates to the limitation of information to the ``minimum necessary'' needed to comply with a request for patient data be interpreted as defined under the Amended Privacy Rule.

While I strongly support efforts to prevent the abuse of controlled substances, H.R. 3015 does not contain sufficient guidance to the states on the level of privacy protections that they must provide in the creation and maintenance of the databases authorized under the legislation. The potential for the invasion of patient privacy resulting from such databases is not merely theoretical. The New York Times reported on October 1, 2004 that confidential records of nearly 4,000 abused and foster children in Central Florida were available to the public on the Internet for at least four months because of a security breach in a child welfare computer system. The records included the children's names, photographs, Social Security numbers, case histories and locations of the foster homes they were in, and were accessible on a Web site of a private children's agency under contract with the Department of Children and Families. I am including a copy of this article for inclusion in the Record.

Now that H.R. 3015 has been approved by the House, I urge the Senate to strengthen the privacy provisions in the legislation so that the important goal of preventing prescription drug abuse can be advanced without sacrificing the privacy of law-abiding patients.

[From the New York Times, Oct. 1, 2004]

Confidentiality for Foster Children Is Broken

(By Terry Aguayo)

Miami, Sept. 30.--Confidential records of nearly 4,000

abused and foster children in Central Florida were available

to the public on the Internet for at least four months

because of a security breach in a child welfare computer

system, the Department of Children and Families said on

Thursday.

The records included the children's names, photographs,

Social Security numbers, case histories and locations of the

foster homes they were in, and were accessible on the Web

site of Kids Central, a private children's agency under

contract with the Department of Children and Families, the

state's child welfare agency.

In April or May, Kids Central began using a computer system

designed to let private caseworkers review state child

welfare records through the Internet, said to Janice Johnson,

chief executive of Kids Central in Ocala. Although a user

name and a password were needed to reach the records, some

passwords and user names became available online in

unrestricted files created when caseworkers sought technical

help with the system.

``Confidentiality is critical,'' said Don Thomas, district

administrator for the Department of Children and Families in

Central Florida. ``If these kids are in the child welfare

system to begin with, they have a far from ideal life, and if

their personal information is available to those who don't

have to know, it violates their privacy.''

Department administrators ordered the Web site shut down on

Wednesday after a reporter for The Miami Herald, which first

reported the problem, informed them of the flaw. It was back

up Thursday morning after the security issues were resolved,

Mr. Thomas said.

Mr. Thomas said he knew of no one, other than the reporter,

who gained access to the records because of the flaw.

``A child's case record is a child's life. It should be

treated as sacred,'' said Richard Wexler, executive director

of the National Coalition for Child Protection Reform and a

strong critic of the department. ``Given the kind of

information, I think there is a clear danger, particularly

since the locations of these children were made available to

anyone.''

The Department of Children and Families has been afflicted

by numerous problems that surfaced after it lost track of a

4-year-old foster child, Rilya Wilson, and did not notice she

was missing until 15 months later, in April 2002. She remains

unaccounted for. Jerry Regier, the department's secretary,

resigned in August as a result of accusations that he and two

top aides took favors from contractors.

Mr. Speaker, I rise in opposition to H.R. 3015, the National All Schedules Prescription Electronic Reporting Act. This bill is yet another unjustifiable attempt by the Federal government to use the war on drugs as an excuse for invading the privacy and liberties of the American people and for expanding the Federal government's disastrous micromanagement of medical care. As a physician with over 30 years experience in private practice, I must oppose this bill due to the danger it poses to our health as well as our liberty.

By creating a national database of prescriptions for controlled substances, the Federal government would take another step forward in the war on pain patients and their doctors. This war has already resulted in the harassment and prosecution of many doctors, and their staff members, whose only ``crime'' is prescribing legal medication, including opioids, to relieve their patients' pain. These prosecutions, in turn, have scared other doctors so that they are unwilling to prescribe an adequate amount of pain medication, or even any pain medication, for their suffering patients.

Doctors and their staffs may even be prosecuted because of a patient's actions that no doctor approved or even knew about. A doctor has no way of controlling if a patient gives some of the prescribed medication away or consumes a prescribed drug in a dangerous combination with illegal drugs or other prescription drugs obtained from another source. Nonetheless, doctors can be subjected to prosecution when a patient takes such actions.

Applying to doctors laws intended to deal with drug kingpins, the government has created the illusion of some success in the war on drugs. Investigating drug dealers can be hard and dangerous work. In comparison, it is much easier to shut down medical practices and prosecute doctors who prescribe pain medication.

A doctor who is willing to treat chronic pain patients with medically justified amounts of controlled substances may appear at first look to be excessively prescribing. Because so few doctors are willing to take the drug war prosecution risks associated with treating chronic pain patients, and because chronic pain patients must often consume significant doses of pain medication to obtain relief, the prosecution of one pain doctor can be heralded as a large success. All the government needs to do is point to the large amount of patients and drugs associated with a medical practice.

Once doctors know that there is a national database of controlled substances prescriptions that overzealous law enforcement will be scrutinizing to harass doctors, there may be no doctors left who are willing to treat chronic pain. Instead of creating a national database, we should be returning medical regulation to local control, where it historically and constitutionally belongs. Instead of drug warriors regulating medicine with an eye to maximizing

prosecutions, we should return to State medical boards and State civil courts review that looks to science-based standards of medical care and patients' best interests.

H.R. 3015 also threatens patients' privacy. A patient's medical records should be treated according to the mutual agreement of the patient and doctor. In contrast, H.R. 3015 will put a patient's prescriptions on a government-mandated database that can be accessed without the patient's permission.

Instead of further eroding our medical privacy, Congress should take steps to protect it. Why should someone not be able to deny the government and third parties access to his medical records without his permission or a warrant?

One way the House can act to protect patients' privacy is by enacting my Patient Privacy Act (H.R. 1699) that repeals the provision of Federal law establishing a medical ID for every American. Under the guise of ``protecting privacy,'' the Health and Human Services' so- called ``medical privacy'' regulations allow medical researchers, insurance agents, and government officials access to your personal medical records--without your consent. Congress should act now to reverse this government-imposed invasion of our medical privacy.

Please join me in opposing H.R. 3015--legislation that, if enacted, will make us less free and less healthy.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3015) to amend the Public Health Service Act to establish an electronic system for practitioner monitoring of the dispensing of any schedule II, III, or IV controlled substance, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks on this legislation and to insert extraneous material on the bill.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in very strong support of H.R. 3015. All of us have deep concerns about the abuse of prescription drugs. Whether after surgery or in the treatment of chronic pain, ensuring that patients receive proper pain management is a critical component in the provision of health care. However, these medications can and sometimes are abused. The Committee on Energy and Commerce has heard about the problems prescription drug abuse has created in our communities throughout America. In some areas, the nonmedical use of prescription drugs presents a bigger problem than even cocaine and heroin. This is a serious issue that cannot be addressed through traditional drug control programs. We need to find a balanced approach that does not interfere with the doctor-patient relationship but also ensures that these potentially addictive drugs are not abused. Prescription drug monitoring programs can be a part of the solution to this public health challenge.

These programs help physicians better serve their patients because they can review the patient's prescription drug history. Drug interactions can often lead to adverse events for patients so that these monitoring programs serve as an additional safety check.

Only 21 States have implemented drug monitoring programs. While this is a good start, problems arise because illicit drug use shifts to contiguous States without monitoring programs. H.R. 3015 will strengthen prescription drug monitoring programs to eliminate gaps in systems between States and ensure that programs are interoperable so information is readily available across State lines.

I would like to thank the distinguished gentleman from Kentucky (Mr. Whitfield), the distinguished gentleman from New Jersey (Mr. Pallone), the distinguished gentleman from Georgia (Mr. Norwood) and the distinguished gentleman from Ohio (Mr. Strickland), all members of the Committee on Energy and Commerce, for their hard work on this legislation.

At the appropriate time after the debate, I would urge that all of my colleagues support it.

Mr. Speaker, I reserve the balance of my time.

Mr. Speaker, I yield myself such time as I may consume.

I am going to yield to the gentleman from Kentucky (Mr. Whitfield), but before I do that I would like to announce to the House that one of the other cosponsors of this important legislation, the gentleman from Georgia (Mr. Norwood), as we speak, is awaiting a lung transplant, which may very well occur this afternoon and this legislation would have not gotten to the floor of the House without his strong commitment to it. So I would encourage all my colleagues to pray for the gentleman from Georgia (Mr. Norwood) that his surgery goes well and that he is back amongst us as soon as possible.

Mr. Speaker, I yield 4 minutes to the distinguished gentleman from Kentucky (Mr. Whitfield).

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. Speaker, I believe that H.R. 3015, legislation to support State controlled substance monitoring programs, is well intentioned. Non-medical use of controlled substances is a serious problem. Establishing State databases that contain information on prescriptions for such substances may help stem the practice of individuals seeking prescriptions from multiple providers for the purpose of non-medical use.

However, as we forge policies to facilitate controlled substance prescription information sharing among providers, States, and others, we must carefully consider the privacy implications of such steps. The databases H.R. 3015 supports potentially will contain a vast amount of personal medical information--including individually identifiable data regarding many individuals who are given prescriptions for legitimate medical reasons such as recovery from surgery. The last thing we want to do is deter individuals from seeking medical care out of fear that the privacy of their health information will not be protected.

I am pleased that, following up on concerns I expressed when the bill was under consideration in committee, sponsors of the measure agreed to add language that is a step forward

from earlier versions of the bill with respect to privacy protection. This language includes (1) a requirement that the Secretary of Health and Human Services study and report to Congress on the privacy protections regarding each State database that receives funding under the bill; and (2) requirements that the State grant applications submitted to the Secretary of HHS propose standards regarding redisclosure of information, penalties for illegal redisclosure of information, and other privacy related standards. These provisions increase focus by States and HHS on the privacy issues raised by the State controlled substance monitoring programs.

However, H.R. 3015's State-to-State disclosure and uniform electronic format provisions promote the development of, in essence, a national prescription database network. As such, it is particularly important that Congress work to ensure that appropriate privacy standards apply to databases in the network. The bill does not accomplish this task. It contains no minimum Federal standards or even a requirement that the HHS Secretary develop publicly reviewable criteria for assessing the sufficiency of the privacy standards that States must propose for their programs when applying for grants under the bill.

I do want to recognize and acknowledge the efforts of the sponsors to respond to the privacy concerns that I raised, particularly the efforts of Mr. Pallone, Dr. Norwood, and Mr. Whitfield. And while I cannot support this bill at this point, I hope that with further consideration by the Senate and ultimately in conference, Members will carefully consider the privacy ramifications of controlled substance monitoring systems and make improvements in this area before the bill is enacted.

Mr. Speaker, I thank the chairman for yielding me this time.

We are excited today to have on the floor this legislation relating to prescription drug abuse in the United States, which has reached epidemic proportions. Recent statistics show that 6.2 million Americans abuse prescription drugs. To help combat this problem, many States, such as my own State of Kentucky and about 20 others, have adopted prescription drug monitoring programs to assist physicians and law enforcement officials stop the abuse and prosecute those individuals who are breaking the law.

The cornerstone of most existing drug-monitoring programs is that they allow physicians access to the information before writing a prescription for a controlled substance. Physicians tell us that it is an invaluable tool in treating their patients. However, there is one glaring problem, and that is that these programs operate only intra- state. And as the gentleman from Texas (Chairman Barton) mentioned, it is essential that we have an inter-state program.

To that end, I have been pleased to work with the gentleman from New Jersey (Mr. Pallone), the gentleman from Georgia (Mr. Norwood), the gentleman from Ohio (Mr. Strickland), my colleagues on both sides of the aisle, on legislation to address this issue. This legislation, H.R. 3015, the National All Schedules Prescription Electronic Reporting Act, creates a grant program housed at the Department of Health and Human Services which will fund the establishment and operation of State-run prescription drug monitoring programs. It establishes standards for reporting data and governs who has access to such information and under what circumstances because of the privacy issues. From the beginning our goal has been to give physicians the tool they need to treat patients, which also provides a better mechanism to prosecute individuals who are allegedly using illegal controlled substances.

I believe this is a good bill, a balanced bill, and one that will provide States with an important tool to curb prescription drug abuse.

I would like at this time to thank all of the cosponsors and give particular thanks to the gentleman from Texas (Chairman Barton) and the gentleman from Florida (Chairman Bilirakis); the gentleman from Michigan (Mr. Dingell), ranking member; and the gentleman from Ohio (Mr. Brown), without all of whom we would not have been successful without their efforts to get this legislation through the Committee on Energy and Commerce.

I would also like to recognize the hard work of our committee staff, particularly Chuck Clapton and Ryan Long and John Halliwell on my staff; and, of course, we could not have done it without the Democratic committee staff, and I would also like to thank them.

I would urge all Members to vote for this important legislation.