[Congressional Record Volume 146, Number 136 (Thursday, October 26, 2000)]
[Senate]
[Pages S11116-S11117]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      SECTION-BY-SECTION ANALYSIS OF THE PAIN RELIEF PROMOTION ACT

  Mr. NICKLES. Mr. President, on October 25, 2000, Representative Henry 
Hyde introduced H.R. 5544, the Pain Relief Promotion Act of 2000. The 
text of the legislation is based on the Senate Judiciary committee 
substitute to H.R. 2260, the Pain Relief Promotion Act, ordered 
reported out of the Senate Judiciary Committee on April 27, 2000.
  For the information of all Members of Congress, I offer the following 
section-by-section analysis of the legislation.
  I ask unanimous consent that the material be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

 Section-by-Section Analysis--Pain Relief Promotion Act of 2000, H.R. 
                                  5544

     Section 1. Short title
       Entitles the act the ``Pain Relief Promotion Act of 2000.''
     Section 2. Findings
       Makes a series of findings about the importance of 
     emphasizing pain management and palliative care in the first 
     decade of the new millennium, the regulation of drugs with a 
     potential for abuse under the Controlled Substances Act, the 
     use of such drugs by practitioners for legitimate medical 
     purposes, especially the purpose of relieving pain and 
     discomfort even if it increases the risk of death, the need 
     for improved treatment of pain, and the fact that dispensing 
     and distributing such drugs affects interstate commerce.


                                TITLE I

     Section 101. Activities of Agency for Healthcare Research and 
         Quality
       This section amends the Public Health Services Act by 
     authorizing a program responsibility for the Agency for 
     Healthcare Research and Quality in the Department of Health 
     and Human Services to promote and advance scientific 
     understanding of palliative care. The Agency is directed to 
     collect and disseminate protocols and evidence-based 
     practices for pain management and palliative care with 
     priority for terminally ill patients.
       The section is specifically made subject to subsections (e) 
     and (f) of section 902 of the Public Health Service Act [42 
     U.S.C. 299a(e) and (f)], added by the Healthcare Research and 
     Quality Act of 1999, Public Law 106-129, which prevent the 
     mandating of national standards of clinical practice. This 
     section has a definition of pain management and palliative 
     care which is a modified version of the World Health 
     Organization's definition of palliative care.
     Section 102. Activities of Health Resources and Services 
         Administration
       This section amends the Public Health Services Act by 
     authorizing a program for education and training in pain 
     management and palliative care in the Health Resources and 
     Services Administration of the Department of Health and Human 
     Services. This section allows the Secretary, in consultation 
     with the Director of the Agency for Healthcare Research and 
     Quality to award grants, cooperative agreements and contracts 
     to health professions schools, hospices, and other public and 
     private entities to develop and implement pain management and 
     palliative care education and training programs for health 
     care professions.
       This section requires the applicant for the award to 
     include three educational informational components in the 
     program: (1) the program must have a component that addresses 
     a means for diagnosing and alleviating pain and other 
     distressing signs and

[[Page S11117]]

     symptoms of patients, especially in terminally ill patients, 
     including the use of controlled substances; (2) the program 
     must provide information and education on the applicable laws 
     on controlled substances, including those permitting 
     dispensing or administering them to relieve pain even in 
     cases wheresuch efforts may unintentionally increase the risk 
     of death, and (3) the information and education must provide 
     recent findings and developments in the improvement of pain 
     management and palliative care. Health professions schools, 
     residency training programs, continuing education, graduate 
     programs in the health professions, hospices, and other sites 
     as determined by the Secretary will be used as program sites.
       This section also requires the Secretary to evaluate the 
     programs directly or through grants or contracts and mandates 
     that the Secretary include individuals with expertise and 
     experience in pain management and palliative care for the 
     population of patients whose needs are to be served in each 
     peer review group involved in the selection of the grantees.
       Five million dollars annually are authorized to carry out 
     these programs.
     Section 103. Decade of pain control and research
       This section designates the decade beginning January 1, 
     2001, as the ``Decade of Pain Control and Research.''
     Section 104. Effective date
       This section makes title I effective on the date of 
     enactment.
     Section 201. Reinforcing existing standard for the legitimate 
         use of controlled substances
       This section amends the Controlled Substances Act to 
     establish that physicians and other licensed health care 
     professionals holding DEA registrations are authorized to 
     dispense, distribute, or administer controlled substances for 
     the legitimate medical purpose of alleviating a patient's 
     pain or discomfort in the usual course of professional 
     practice even if the use of these drugs may increase the risk 
     of death.
       Essentially, this provision makes clear that there exists a 
     ``safe harbor'' for those who dispense controlled substances 
     for pain relief and palliative care, even if such treatment 
     increases a patient's risk of death. The Department of 
     Justice (DOJ) has taken the position that the Pain Relief Act 
     ``would eliminate any ambiguity about the legality of using 
     controlled substances to alleviate the pain and suffering of 
     the terminally ill by reducing any perceived threat of 
     administrative and criminal sanctions in this context.''
       Without creating any new Federal standard, this section 
     also ensures that the new safe harbor is not construed to 
     change the proper interpretation of current law that the 
     administration, dispensing, or distribution of a controlled 
     substance for the purpose of assisting a suicide is not 
     authorized by the Controlled Substances Act. Individuals 
     covered by the CSA would not be subject to any new liability 
     under the statute--with the exception of those who would 
     attempt in the future to rely on the Oregon Act as a defense 
     to alleged violations of the CSA.
       This section further provides that the Attorney General in 
     implementing the Controlled Substances Act shall not give 
     force or effect to any State law permitting assisted suicide 
     or euthanasia. This effectively overturns the June 5, 1998 
     ruling of the Attorney General insofar as that ruling 
     concluded ``the CSA does not authorize DEA to prosecute, or 
     to revoke the DEA registration of, a physician who has 
     assisted in a suicide in compliance with Oregon law [or the 
     law of any other state that might authorize assisting suicide 
     of euthanasia.''
       This section provides that the provisions of the bill are 
     effective only upon enactment with no retroactive effect. 
     This means that the Oregon statute will serve as a defense 
     for any actions taken in complaince under the Oregon law 
     prior to the enactment of H.R. 5544.
       This section further provides that nothing in it shall be 
     construed to alter the roles of the Federal and State 
     governments in regulating the practice of medicine, affirming 
     that regardless of whether a practitioner's DEA registration 
     is deemed inconsistent with the public interest, the status 
     of the practitioner's State professional license and State 
     prescribing privileges remain solely within the discretion of 
     State authorities.
       This section also provides that nothing in the act is to be 
     construed to modify Federal requirements that a controlled 
     substance may be dispensed only for a legitimate medical 
     purpose nor to authorize the Attorney General to issue 
     national standards for pain management and palliative care 
     clinical practice, research, or quality, except that the 
     Attorney General may take such other actions as may be 
     necessary to enforce the act.
       This section provides that in any proceeding to revoke or 
     suspend a DEA registration based on alleged intent to cause 
     or assist in causing death in which the practitioner claims 
     to have been dispensing, distributing, or administering 
     controlled substances to alleviate pain or discomfort in the 
     usual course of professional practice, the burden rests with 
     the Attorney General to prove by clear and convincing 
     evidence that the practitioner's intent was to cause or 
     assist in causing the death.
     Section 202. Education and training programs
       This section directs educational and research training 
     programs for law enforcement to include means by which they 
     may better accommodate the necessary and legitimate use of 
     controlled substances in pain management and palliative care.
     Section 203. Funding authority
       This section designates the source of funds for carrying 
     out duties created under some provisions of the Controlled 
     Substances Act, as amended by H.R. 5544.
     Section 204. Effective date
       This section establishes that the effective date of the act 
     is that of its enactment.

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