Pain Management Legislation Hearing

presented by
Howard S. Smith, M.D.,
Albany Medical College

January 26, 2005
The New York State Society of Anesthesiologists, Inc. (NYSSA) appreciates the opportunity to present comments to the Pain Management Legislation Hearing concerning New York State Assembly Bill 10407. Our Society consists of physicians engaged in the medical specialty of anesthesiology, and one of our Society’s primary objectives is to enhance the standards and practice of the specialty through education, research, and scientific investigations in an effort to improve quality and safety of patient care not only within the membership but also nationwide and extending to the international community. (Statement of Educational Mission adopted by the NYSSA’s Board of Directors 2004). We are encouraged to see that the legislation at issue today addresses many of the challenges faced by pain management physicians who endeavor to improve the quality of life of the citizens of this State in the areas of acute, chronic and end-of-life pain.

The testimony presented today represents responses to the issues raised in the Notice of Public Hearing regarding the subject legislation from some of our Society’s members with individual expertise in pain medicine (whether acute, chronic or end-of-life) who are from different practice settings and locations.

Thank you for the opportunity to present our views on this important legislation.

1. DIFFERENT PAIN DISCIPLINES CALL FOR DIFFERENT APPROACHES. The legislation at issue refers to pain (acute and chronic) and palliative medicine interchangeably. While some physicians are certified in both, many are not. In addition, the education involved and approach to each pain discipline varies significantly. Acute pain deals usually with an identifiable source of tissue trauma or a known organic disease. It is usually self-limiting (lasting only a few days), and the therapy involves mostly treating the cause of the pain and reducing (usually pharmacologically) the input from the peripheral pain receptors. On the other hand, chronic pain is usually part of a syndrome which has been lasting for many months, for which the precise etiology is usually unknown, and which has no identifiable nociceptive input. The treatment is not only aimed at symptom reduction, which means pain reduction, but is also aimed at the recovery of a level of functional activity acceptable to the patient and society. It is exceptional to cure a person with this condition. The therapeutic approach to these patients is largely different from the one required for acute pain management. In addition to these two conditions, there are special pathologies which require specific management, such as cancer pain or pain in AIDS or pain treatment in palliative care or in the hospital environment. All of these different pain management situations require further training and an individual logistic which addresses the specific needs of the patient.

There are multi-level differences in acute, chronic and cancer pain management. Treating patients with pain involves a multi-disciplinary approach that considers the medical, psychological, and social needs of the patient. A pain treatment service should involve both in-patient and out-patient services. Treatment options for acute, chronic and terminal illness care are different because the causes, duration, psychological and social aspects are different. Briefly:

Acute: When evaluating the therapeutic responses to acute pain treatment, the physician focuses on both improved pain relief and improved function (i.e. mobility) equally.

Chronic: When assessing chronic pain management therapy, the physician often (but not always) focuses on restoration of function to a greater degree than pain relief. Thus, if a person is able to perform tasks to a greater degree than prior to instituting therapy and still has pain, the therapeutic response may be considered successful.

Cancer and Terminal: Finally, when assessing cancer pain therapies, the primary focus is pain reduction to improve a quality of life. However, bodily function and even consciousness may be sacrificed to achieve pain relief in special cases of terminal care.

As discussed in point “3”, below, the educational requirements of providers in these three different pain management disciplines vary substantially. In addition, the management of pain is quite different in these three areas. Thus, any legislation and regulations concerning pain management must recognize these three pain disciplines and each of their unique needs.

2. ADVISORY COMMITTEE ON PAIN MANAGEMENT: NYSSA agrees with the proposal in the legislation at issue for an Advisory Committee on pain management, as long as all relevant pain disciplines are represented, namely: acute, chronic and palliative care practitioners. As discussed in point “1”, above, these areas of pain management differ from one another substantially, and the education and approach of practitioners in these areas is quite varying.

3. MANDATORY PAIN MANAGEMENT EDUCATION: The Bill at issue requires specific documentation concerning relevant course work completed. This pain management education documentation will either be a mandatory component of the hospital credentialing process, or the practitioner must submit documentation directly to the Department of Health. The exemption provision of the Bill appears to apply to the Department of Health submission. As such, NYSSA interprets this provision to mean that an anesthesiologist, for example, must demonstrate to the hospital credentialing committee, in accordance with Section 2805-k of the Public Health Law, that he or she has satisfied the pain management education requirements.

Notwithstanding the fact that most members of our Society would likely except “out” of these general requirements by the very language of the legislation, we would not support a general pain management course for all practitioners. However, if the language concerning mandatory continuing medical education in the subject of pain management remains in the Bill, we would propose that the requirement be satisfied by taking course work sponsored by professional organizations that are accredited by the Accreditation Council for Continuing Medical Education, such as NYSSA. This would encourage these organizations to focus on topics in pain management and would also alleviate some of the burden from the Department of Health in approving appropriate programs.

4. ADDITION TO EDUCATION LAW CONCERNING PHYSICIAN MISCONDUCT: The Bill proposes amending Section 6530 of the Education Law to add an additional section illustrating Physician Misconduct, defined as “Failure to adequately order, prescribe, administer or dispense pain-relieving medication, for the relief of pain in accordance with a reasonable standard of care, including an accepted guideline, pursuant to article twenty-eight-E of the public health law.” Section 6530 of the Education Law, along with its defining regulations, is extremely comprehensive. The goals of this section of the Bill are already adequately addressed by the relevant section concerning Physician Misconduct. Attempting to add to this section seems unnecessary and confusing in its potential application. In addition, of the existing 47 sections of Section 6530 of the Education law, none apply specifically to a standard of care in a particular area of medicine in the same manner in which the proposed section “48” would. Therefore, this new section would potentially and, in our opinion, inappropriately heighten the standard for pain management physicians in a way far different from other medical disciplines. Thus, generally, our Society does not see a need to amend Section 6530 of the Education Law in the manner suggested by the legislation at issue. If the language does remain in the legislation, our Society remains uncomfortable with the wording of same.

5. FUTURE EFFECT OF FEDERAL LAW: The Drug Enforcement Administration (DEA) is clearly making an increased number of arrests of pain management physicians. Because physicians prescribing narcotic pain medications are in a somewhat unique position wherein the DEA can construe what it believes to be over-prescribing as “drug trafficking”, pain management physicians can easily be targeted for criminal liability. All the DEA must prove is that the physicians are operating outside the course of legitimate medical practice in order to convict them. While the Assembly Bill at issue appears to adhere to the same standard of care, federal law may ultimately pre-empt any resulting New York State statute.

The DEA’s regulatory policies have already affected patient treatment in this regard. In the past, physicians have been reluctant to prescribe due to triplicate prescription forms and other regulatory policies concerning the administration of narcotics. While the new law regarding controlled substances in this state ameliorates much of this particular issue, allowing for single prescription forms and more standardization for monitoring of all drugs, the DEA’s approach toward pain management has been sluggish. Electronic monitoring of all drugs, not just opiates, will enhance surveillance of potentially abused drugs. In addition, partial filling of prescriptions will increase timely availability of drugs and reduce costs for end of life care. Less acetaminophen containing opiate compounds would be prescribed as a result of this action, possibly reducing the patient’s risks for renal and hepatic intoxication. However, even under the new New York State Law, partial filling of prescriptions is only permitted for the terminally ill and Residential Health Care Facility patients.

In the past ten years, a number of state medical boards have published guidelines which address the prescribing of opiates for chronic pain (cancer or non-malignant). However, cancer pain, acute pain and chronic non-malignant pain remain seriously under treated. Attitudes toward opiates (particularly in New York City) are mostly emotional and not based on medical evidence. The prescription of methadone, for instance, is incredibly difficult. Although this is an excellent analgesic and may possibly be one of the least addictive narcotic drugs, patients will often identify the drug with addiction and decline to take it or pharmacists may not carry high dosage formulation. A common error which exists is confusing medical prescription of opiates with drug abuse, and this significantly limits our ability to treat our patients appropriately.

The DEA may have a different philosophy than many pain management physicians regarding the standard of care for treatment of chronic and end-of-life pain. Bills such as the one at issue are a positive step toward improving awareness concerning certain aspects of pain management. Ultimately, even though much of the DEA prosecution of pain management physicians has resulted in vindicating the physicians involved, who were turned in by insurance companies, etc., it has still caused a chilling effect on pain research studies and patient care. The patients have suffered.