A bill to amend the Controlled Substances Act to lift the patient limitation on prescribing drug addiction treatments by medical practitioners in group practices.

Mr. President, S. 1887, which the Senate adopted yesterday, ensures that all appropriately trained group practice physicians may prescribe and dispense certain recently approved drugs for the treatment of heroin addiction. It addresses the unintended effect of the Drug Addiction and Treatment Act of 2000, DATA, that hinders access to new treatments for thousands of individuals who seek such help.

When Congress passed DATA as Title XXXV of the Children's Health Act of 2000, Public Law 106-310, it allowed for the dispensing and prescribing of Schedule III drugs, like buprenorphine/naloxone, in an office-based setting, for the treatment of heroin addiction. As a result of DATA, access to drug addiction treatment is significantly expanded; patients no longer are restricted to receiving treatment in a large clinic setting, but now may receive such care from specifically trained physicians in an office-based setting.

DATA limits qualified individual physicians to treating no more than 30 patients at a time. This same 30-patient limit applies to medical groups as to individual physicians. For example, the physician members of the Duke University Medical School faculty practice plan may treat only 30 patients at one time, even though they may have 10 individual physicians trained and willing to treat patients and more than 30 patients would benefit from newly available treatment. The difficulties that have arisen, including the dashed hopes for treatment of many, due to the patient limitation on group practices, are detailed in a May 30 article in the Boston Globe, by Peter DeMarco. I would like to share a few excerpts from that article with my Colleagues, as follows:

When buprenorphine became available as a treatment for

OxyContin and heroin addiction 18 months ago, many medical

professionals and addicts hailed it as a miracle drug,

bringing addicts back from the brink and helping them lead

normal lives when all else had failed. But for many addicts,

buprenorphine remains one of the hardest drugs to obtain.

Approved by the Federal Food and Drug Administration in 2002,

buprenorphine is an opiate like heroin or the painkiller

OxyContin. Unlike those drugs or methadone, the prescribed

drug it's meant to replace, buprenorphine doesn't cloud the

minds of patients, allowing them to work or study as if

they're not on any drug at all. Nearly all who take

buprenorphine, meanwhile, say they lose all physical cravings

for street drugs.

But a combination of federal limits on the distribution of

buprenorphine, and reluctance on the part of some physicians

to offer it to patients has kept thousands of opiate addicts

from receiving the drug in Massachusetts and across the

country. At the heart of the issue is federal legislation

passed in 2000--two years before the drug was approved by the

FDA--that restricts individual clinical practices from

treating more than 30 patients with buprenorphine at a time.

While many substance-abuse experts say the 30-patient

figure is too low for some practices, their main quarrel with

the Drug Addiction Treatment Act of 2000 is its failure to

differentiate single-physician practices, hospitals, and

health care organizations. For example, all the doctors who

work for Tufts Health Plan can treat a combined 30 patients--

the same total as can be seen by a physician practicing

alone.

Boston health officials, along with their counterparts in

the State and Federal governments, say the Federal

legislation erred on the side of caution, and needs to be

changed to allow wider access to buprenorphine.

Boston Medical Center's main practice has 200 or more

general internal-medicine doctors, and within that practice,

we can only treat 30 people. It's the craziest loophole,''

said Colleen Labelle, nurse-manager of the hospital's Office-

Based Opioid Treatment Program. ``We get 20 calls a day from

across the state. People are begging, desperate to get

treated, who we can't treat.''

The Federal Substance Abuse and Mental Health Services

Administration has begun an internal process to increase the

30-patient cap. But because any proposed change would be

subject to the public-review process, approval could take as

long as two years, said

Nick Reuter, a senior public health analyst with the agency.

It clearly was not the intention of DATA that individuals seeking treatment have less access to new medications simply because they receive care from a physician practicing in a group, or from a group- based or mixed-model health plan. Nevertheless, this is the effect it is having and it is a severe effect. The problem is addressed by removing the 30-patient aggregate limit on medical groups. The patient limitation would remain on individual treating physicians. This is achieved in the bill, S. 1887, which I introduced along with Senators Hatch and Biden. It simply removes the statutory limit on the number of patients for whom doctors in medical groups may prescribe certain newly available, FDA-approved medications to treat heroin addiction.

I would like to close with another excerpt from Mr. DeMarco's article regarding the positive impact buprenorphine treatment has had on an individual who sought help with his addiction, and was fortunate enough not to be turned away. It is as follows:

Timothy Tigges says his addiction began after he wrenched

his back and bummed a few Percocet pills, a prescription

analgesic, from a friend to dull the pain. Before he knew it,

he was hooked on opiates, alternating between OxyContin and

shooting up heroin as his life went to pieces.

In October, Tigges, a 27-year-old East Boston carpet

installer, began taking buprenorphine, placing an orange pill

the size of a dime under his tongue until it dissolves, four

times daily. He hasn't touched an illegal drug since the day

he started the program, has put on 80 pounds from lifting

weights at the gym, and has yet to miss a day of work. For

the first time in three years, Tigges hopes to see his 5-

year-old daughter, whose mother has refused to let him visit.

I've had clean urines, 100 percent, for nine months now.

There's nothing I'm prouder of than that,'' he said, choking

back emotion. ``What I read on the front page of the paper

every day is 18- and 20-year-old kids dying of garbage drugs.

There's just no need for it. I would take every ounce of

heroin off the street and give them this stuff. You watch the

crime rate go down.

Mr. President, I thank my colleagues for their wisdom in adopting this much-needed legislation.

Mr. President, this legislation, S. 1887, ensures that all appropriately trained group practice physicians may prescribe and dispense certain recently approved drugs for the treatment of heroin addiction. It addresses the unintended effect of the Drug Abuse and Treatment Act of 2000, DATA, that hinders access to new treatments for thousands of individuals who seek such help.

When Congress passed DATA as Title XXXV of the Children's Health Act of 2000, Public Law 106-310, it allowed for the dispensing and prescribing of Schedule III drugs, like buprenorphine/naloxone, in an office-based setting, for the treatment of heroin addiction. As a result of DATA, access to drug addiction treatment is significantly expanded; patients no longer are restricted to receiving treatment in a large clinic setting, but now may receive such care from specifically trained physicians in an office-based setting.

DATA limits qualified individual physicians to treating no more than 30 patients at a time. The interpretation of the law results in the same 30-patient limit on physician groups. For example, the physician members of the Duke University Medical School faculty practice plan may treat only 30 patients at one time, even though they may have ten individual physicians trained and willing to treat patients and more than 30 patients would benefit from newly available treatment. The difficulties that have arisen, including the dashed hopes for treatment of many, due to the patient limitation on group practices, are detailed in a May 30 article in the Boston Globe, by Peter DeMarco. I would like to share a few excerpts from that article with my Colleagues, as follows:

When buprenorphine became available as a treatment for

OxyContin and heroin addiction 18 months ago, many medical

professionals and addicts hailed it as a miracle drug,

bringing addicts back from the brink and helping them lead

normal lives when all else had failed. But for many addicts,

buprenorphine remains one of the hardest drugs to obtain.

Approved by the Federal Food and Drug Administration in 2002,

buprenorphine is an opiate like heroin or the painkiller

OxyContin. Unlike those drugs or methadone, the prescribed

drug it's meant to replace, buprenorphine doesn't cloud the

minds of patients, allowing them to work or study as if

they're not on any drug at all. Nearly all who take

buprenorphine, meanwhile, say they lose all physical cravings

for street drugs.

But a combination of federal limits on the distribution of

buprenorphine, and reluctance on the part of some physicians

to offer it to patients has kept thousands of opiate addicts

from receiving the drug in Massachusetts and across the

country. At the heart of the issue is federal legislation

passed in 2000--two years before the drug was approved by the

FDA--that restricts individual clinical practices from

treating more than 30 patients with buprenorphine at a time.

While many substance-abuse experts say the 30-patient

figure is too low for some practices, their main quarrel with

the Drug Addiction Treatment Act of 2000 is its failure to

differentiate single-physician practices, hospitals, and

health care organizations. For example, all the doctors who

work for Tufts Health Plan can treat a combined 30 patients--

the same total as can be seen by a physician practicing

alone.

Boston health officials, along with their counterparts in

the State and Federal governments, say the Federal

legislation erred on the side of caution, and needs to be

changed to allow wider access to buprenorphine.

``Boston Medical Center's main practice has 200 or more

general internal-medicine doctors, and within that practice,

we can only treat 30 people. It's the craziest loophole,''

said Colleen Labelle, nurse-manager of the hospital's Office-

Based Opioid Treatment Program. ``We get 20 calls a day from

across the state. People are begging, desperate to get

treated, who we can't treat.''

The Federal Substance Abuse and Mental Health Services

Administration has begun an internal process to increase the

30-patient cap. But because any proposed change would be

subject to the public-review process, approval could take as

long as two years, said Nick Reuter, a senior public health

analyst with the agency.

It clearly was not the intention of DATA that individuals seeking treatment have less access to new medications simply because they receive care from a physician practicing in a group, or from a group- based or mixed-model health plan. Nevertheless, this is the is the effect and it is having a severe effect. The problem is addressed by removing the 30-patient aggregate limit on medical groups. The patient limitation would remain on individual treating physicians. This is achieved in the bill, S. 1887, which I introduced along with Senators Hatch and Biden. It simply removes the statutory limit on the number of patients for whom doctors in medical groups may prescribe certain newly available, FDA-approved medications to treat heroin addiction.

I would like to close with another excerpt from Mr. DeMarco's article regarding the positive impact buprenorphine treatment has had on an individual who was fortunate enough to seek and help and not be turned away. It is as follows:

Timothy Tigges says his addiction began after he wrenched

his back and bummed a few Percocet pills, a prescription

analgesic, from a friend to dull the pain. Before he knew it,

he was hooked on opiates, alternating between OxyContin and

shooting up heroin as his life went to pieces.

In October, Tigges, a 27-year-old East Boston carpet

installer, began taking buprenorphine, placing an orange pill

the size of a dime under his tongue until it dissolves, four

times daily. He hasn't touched an illegal drug since the day

he started the program, has put on 80 pounds from lifting

weights at the gym, and has yet to miss a day of work. For

the first time in three years, Tigges hopes to see his 5-

year-old daughter, whose mother has refused to let him visit.

``I've had clean urines, 100 percent, for nine months now.

There's nothing I'm prouder of than that,'' he said, choking

back emotion. ``What I read on the front page of the paper

every day is 18- and 20-year-old kids dying of garbage drugs.

There's just no need for it. I would take every ounce of

heroin off the street and give them this stuff. You watch the

crime rate go down.''

Mr. President, I ask unanimous consent that the Committee on Banking, Housing, and Urban Affairs be authorized to meet during the session of the Senate on Thursday, June 3, 2004, at 9:30 a.m. to conduct a hearing on ``Bank Secrecy Act Enforcement.''

Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet to conduct a markup on Thursday, June 3, 2004, at 9:30 a.m. in Dirksen Senate Building room 226.

Agenda

I. Nominations

Henry W. Saad to be U.S. Circuit Judge for the Sixth Circuit

II. Legislation

S. 1735, Gang Prevention and Effective Deterrence Act of 2003 [Hatch, Feinstein, Grassley, Graham, Chambliss, Cornyn, Schumer, Biden];

S. 1635, A bill to amend the Immigration and Nationality Act to ensure the integrity of the L-1 visa for intracompany transferees [Chambliss];

S. 1129, Unaccompanied Alien Child Protection Act of 2003 [Feinstein, DeWine, Feingold, Kennedy, Leahy, Specter, Edwards, Durbin, Kohl, Schumer];

S. 2013, Satellite Home Viewer Extension Act of 2004 [Hatch, Leahy, DeWine, Kohl];

S. 1887, A bill to amend the Controlled Substances Act to lift the patient limitation on prescribing drug addiction treatments by medical practitioners in group practices Act of 2003 [Hatch, Levin, Biden];

S. 2363, A bill to review and extend the Boys and Girls Clubs of America Act of 2004 [Hatch, Leahy, DeWine, Kohl, Biden];

S. Con. Res. 5, A concurrent resolution expressing the support for the celebration in 2004 of the 150th anniversary of the Grand Excursion of 1854 Act of 2003 [Grassley, Durbin, Kohl, Feingold];

S.J. Res. 4, Proposing an amendment to the Constitution of the United States authorizing Congress to prohibit the physical desecration of the flag of the United States Act of 2003 [Hatch, Feinstein, Sessions, DeWine, Grassley, Graham, Cornyn, Chambliss, Specter];

S. 1700, Advancing Justice though DNA Technology Act of 2003 [Hatch, Leahy, Biden, Specter, DeWine, Feinstein, Kennedy, Schumer, Durbin, Kohl, Edwards];

Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet to conduct a hearing on Thursday, June 3, 2004 at 2:30 p.m. on ``The Child Custody Protection Act: Protecting Parents' Rights and Children's Lives'' in the Dirksen Senate Office Building room 226. The witness list is attached.

Panel I: The Honorable John Ensign, United States Senator [R-NV].

Panel II: Mr. John C. Harrison, Professor of Law, University of Virginia School of Law, Charlottesville, VA; Mr. Peter J. Rubin, Professor of Law, Georgetown University Law Center, Washington, DC; and Ms. Teresa Stanton Collett, Professor of Law, University of St. Thomas School of Law, Minneapolis, MN.

Panel III: Ms. Joyce Farley, Victim, Dushore, PA; Ms. Crystal Lane, Victim, Dushore, PA; and the Reverend Dr. Katherine Hancock Ragsdale, St. David's Episcopal Church, Pepperell, MA.

Mr. President, I ask unanimous consent that the Subcommittee on Competition, Foreign Commerce, and Infrastructures be authorized to meet on Thursday, June 3, 2004, at 2:30 p.m. on Thread Act revisited.

I ask unanimous consent the Senate proceed to the immediate consideration of Calendar No. 542, S. 1887.

Mr. President, I ask unanimous consent the bill be read a third time and passed, the motion to reconsider be laid upon the table, and any statements be printed in the Record.

Mr. President, I suggest the absence of a quorum.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, I ask unanimous consent I be allowed to speak for 20 minutes in morning business.