H.R. 2260: PAIN RELIEF PROMOTION ACT
How the Substitute Transforms the Pain Relief Promotion Act:

* Increased Burden of Proof

The substitute affords additional protection for doctors who prescribe controlled drugs for pain relief by significantly raising the burden of proof before a practitioner's Drug Enforcement Administration (DEA) registration can be revoked for intentionally causing death. Under existing law, the burden of proof is a "preponderance of evidence." The substitute would require the more exacting "clear and convincing evidence."
This new burden of proof would have to be met whenever the practitioner claims that federally controlled substances were dispensed, distributed, or administered in order to alleviate pain or discomfort. It is the most protective standard of proof known to the civil law and would make it much harder than at present for the DEA to question or challenge a practitioner's prescription of federally controlled drugs for pain relief.

*Law Enforcement Training to Focus on Accommodating Pain Management

The bill's provision for training DEA and other law enforcement personnel has been substantially reworked. The training is now to be focused on how "investigation and enforcement actions by law enforcement personnel may better accommodate the necessary and legitimate use of controlled substances in pain management and palliative care." This replaces language in the original bill which had been seen as suggesting that law enforcement personnel might be "trained" in how themselves to make determinations about what is or is not appropriate pain management and palliative care.

* No Federally Mandated Clinical Standards

Ensuring that the Department of Health and Human Services does not use the Pain Relief Promotion Act as a basis to promulgate mandatory national clinical standards for pain management or palliative care was a central concern of American Medical Association delegates and other medical professionals. Therefore, a provision has been added stating "Nothing in the Pain Relief Promotion Act of 2000 (including the amendments made by such Act) shall be construed ... to provide the Attorney General with the authority to issue national standards for pain management and palliative care clinical practice, research, or quality...."
In addition, a provision in the bill providing for the collection and dissemination of protocols and evidence-based practices for pain management and palliative care has been altered. It has been made specifically subject to provisions in a new (1999) law that provide that the relevant "Agency shall not mandate national standards of clinical practice or quality health care standards. Recommendations resulting from projects funded and published by the Agency shall include a corresponding disclaimer" and state that "Nothing in this section shall be construed to imply that the Agency's role is to mandate a national standard or specific approach to quality measurement and reporting. In research and quality improvement activities, the Agency shall consider a wide range of choices, providers, health care delivery systems, and individual preferences."

* Federalism Preserved

Language has been added to clarify that the bill is not to pre- empt state laws or standards, but simply to ensure federal law is not subject to state nullification. The provision states, " Nothing in this subsection shall be construed to alter the roles of the Federal and State governments in regulating the practice of medicine. Even where the Attorney General determines pursuant to this section that a practitioner's registration is inconsistent with the public interest, it remains solely within the discretion of state authorities to determine whether action should be taken with respect to the practitioner's state professional license or state prescribing privileges."