[Congressional Record Volume 150, Number 79 (Tuesday, June 8, 2004)]
[Senate]
[Pages S6624-S6625]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




        ELIMINATION OF THE 30-PATIENT LIMIT FOR GROUP PRACTICES

  Mr. LEVIN. 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

[[Page S6625]]

     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.

                          ____________________