[Congressional Record Volume 150, Number 78 (Monday, June 7, 2004)]
[Senate]
[Pages S6490-S6491]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 AMENDING THE CONTROLLED SUBSTANCES ACT TO LIFT THE PATIENT LIMITATION 
 ON PRESCRIBING DRUG ADDICTION TREATMENTS BY MEDICAL PRACTITIONERS IN 
                            GROUP PRACTICES

  Mr. COCHRAN. I ask unanimous consent the Senate proceed to the 
immediate consideration of Calendar No. 542, S. 1887.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 1887) to amend the Controlled Substances Act to 
     lift the patient limitation on prescribing drug addiction 
     treatments by medical practitioners in group practices and to 
     amend the Controlled Substances Act, and so forth, and for 
     other purposes.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. COCHRAN. 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.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 1887) was read the third time and passed, as follows:

                                S. 1887

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. ELIMINATION OF THE 30-PATIENT LIMIT FOR GROUP 
                   PRACTICES.

       Section 303(g)(2)(B) of the Controlled Substance Act (21 
     U.S.C. 823(g)(2)(B)) is amended by striking clause (iv).
  Mr. LEVIN. 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.

[[Page S6491]]

       ``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. COCHRAN. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. CORNYN. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. CORNYN. Mr. President, I ask unanimous consent I be allowed to 
speak for 20 minutes in morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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