Pros and Cons of the Pain Treatment Bill Pending in Congress

The “Pain Relief Promotion Act” working its way through Congress would in effect overturn a 1998 ruling by Attorney General Janet Reno stating that Oregon’s “Death with Dignity Act” does not conflict with the federal Controlled Substances Act.

The bill, which has already been passed by the House, would not directly overturn Oregon law, but instead would prevent physicians from using controlled substances “for the purpose of causing death or assisting another person in causing death.” This is not the first time the Oregon law has been debated. In 1997, the U.S. Supreme Court ruled that the Constitution does not provide Americans with a right to die as they see fit. In Oregon, voters approved assisted suicide laws in 1994 and again in 1997.

Opponents of the Pain Relief Promotion Act say misleading statements in the bill could cause physicians to fail to treat patients’ pain aggressively out of fear that the government would second-guess their motives. For example, if a court were to determine, in error, that a physician’s motive was to cause death, the physician could face 20 years in federal prison. In addition, opponents say the insertion of drug enforcement personnel at the bedsides of dying patients would have the de facto effect of criminalizing the use of opioids at the end of life.

Proponents of the bill say the language would make it harder for state medical boards and the Drug Enforcement Administration to punish physicians who use controlled substances to alleviate pain. According to Thomas R. Reardon, MD, president of the American Medical Association, “The Pain Relief Promotion Act presents a significantly improved bill that strikes a fair balance between opposing assisted suicide and reaffirming physicians’ ability to aggressively manage patients’ pain and discomfort.”

Susan Tolle, MD, director of the Center for Ethics in Health Care at Oregon Health Sciences University, believes the bill is already having an effect in her state. She said, “We’re getting anecdotal reports of frightened doctors not giving as much pain medication to dying patients.”

With undertreatment of pain already an issue in nursing facilities, the Clinton administration and the Justice Department support the bill’s palliative care provisions and the “safe harbor” clarifying the appropriate use of controlled substances to relieve pain, but they oppose the provisions relating to assisted suicide.

Proposed FDA Rule Would Limit Citizen Petitions

Current regulations require the FDA to respond to citizen petitions within 180 days. Last year when representatives of the Office of the Inspector General of the U.S. Department of Health and Human Services reviewed the citizen petition process, they suggested limiting the subject of the petitions to reduce the number of petitions received by more than 30%.

Citizen petitions may now only refer to subjects usually dealt with via regulation. The proposal limits subjects of citizen petitions to:

• Requests that FDA amend, issue, or revoke a regulation
• Requests that FDA amend or revoke an order that has been published
• Requests that FDA take an action as specifically authorized by another FDA regulation

Agency representatives say phone calls and meetings are more expeditious but less formal methods of addressing concerns with the agency. In addition, the FDA maintains that narrowing the focus of citizen petitions it will address “does not reduce or curtail access to or discussions with the agency.”

What’s In a Name? California Pharmacists Get New Identity

The opinion of the Legislative Counsel now reads: “The term ‘health care provider’ includes a licensed pharmacist who provides nondispensing services that are within a pharmacist’s scope of practice, except as may otherwise be provided in a specific law or contract.” By identifying pharmacists as health care providers, pharmacists may look forward to more opportunities to provide services beyond dispensing medications.

CPhA leaders are hopeful that this change in designation will convince payers to recognize pharmacists for their cognitive services and allow them to bill separately for those services. According to CPhA Chief Executive Officer Carlo Michelotti, the change in designation should open pharmacists up to whole new ways to help patients—the ultimate beneficiaries of the change.

Michelotti plans to take the case to the federal level and provide agencies such as the U.S. Department of Health and Human Services with evidence of the value of pharmacists’ disease management and counseling services. At last, the valuable role that pharmacists play in helping patients manage chronic conditions is being recognized.

Window to the Future? Japan’s ‘Gold Plan’ Japan’s “Public Long-Term Care Insurance Act” was passed in November 1997 and will be implemented on April 1 of this year. The measure provides: Universality of coverage Freedom of choice Reliance on a service market Availability of comprehensive care Two categories of eligibles will be determined by municipal committee, as follows: All people aged 65 and older People aged 40-64 who have had a stroke or are suffering from dementia and need long-term care services Beneficiaries will be classified into one of six levels of care, according to need. The person’s income and family situation will not be considered in determining level of care. The program will be financed through mandatory insurance premiums (50%) and public tax revenues (50%). Premiums paid by beneficiaries will be deducted from their old-age or retirement pensions, with the amount determined by their income. The average premium is estimated at $19 per month (U.S. dollars), and there is a 10% co-payment for all incurred expenses. Long-term care expenditures in 2000 are expected to total $33.8 billion (U.S. dollars); by 2010, that figure is expected to rise to $80.8 billion. Criticisms of the Gold Plan include a lack of infrastructure in the form of significant shortages of institutional and home care services and staff trained in community-based work, and the absence of a cash option for beneficiaries to pay family members or friends to provide the care. U.S. researchers will study successes and failures of this publicly funded universal program for long-term care.

JCAHO Raises Fees for First Time Since 1994

The overall fee for a full JCAHO survey is derived from a base fee, a service volume–related fee, and the application of a survey price ceiling. For long-term care pharmacy, the base fee is determined by the annual daily census of patients served. The base fee and service-volume fee will not increase for long-term care pharmacy.

Long-term care pharmacy did not escape completely without a fee increase, though, says JCAHO Associate Director for Ambulatory Infusion Centers Darryl Rich. In the new budget, the survey price ceiling for ambulatory care, home care, and long-term care pharmacy programs was increased $5, from $3,770 to $3,775 per surveyor day. In addition, a site fee (similar to that assessed on home care providers) was added to the long-term care pharmacy accreditation program.

The fees for a full survey are paid every three years. For a fee estimate, contact the JCAHO pricing unit at 630-792-5115.

Surgeon General Urges Better Care for Depressed Elderly

His report is critical of efforts to date to bring mental health into the mainstream of health care, and he wants to continue the efforts of other researchers who have tried to mend the destructive split between mental and physical health.

Satcher also has begun a suicide prevention campaign emphasizing the need to target the elderly in prevention initiatives. At a recent briefing, Satcher said pharmacists and other workers who come in contact with the elderly need education to help treat the continually growing onslaught of depressed elderly. At the same briefing, Charles Reynolds, MD, associate medical dean at the University of Pittsburgh, said primary care providers need much more education on diagnosing and treating the depressed elderly.

According to Satcher, an educational effort does not call for massive budgets; “rather, it calls for the willingness of each of us to educate ourselves and others about mental health and mental illness, and thus to confront the attitudes, fear, and misunderstanding that remain as barriers before us.”

ASCP supports Satcher’s resolve to invest in an educational effort to learn more about how to prevent mental illness and promote mental health. For information on how consultant pharmacists can take part in this educational process, visit ASCP’s Web site (www.ascp.com), scroll down to “What’s Hot,” and click on the link “Guidelines for Use of Psychotherapeutic Medications in Older Adults.”

Michigan Medicaid Recipients Are Being Denied Mental Illness Treatment, Study Finds

Forty-nine CMHSPs in Michigan were surveyed and reported widespread denials and restriction of access to mental illness medication by the “Qualified Health Plans” (QHPs) that receive funds from the state to pay for the cost of the medication. Specific medications being denied include many new drugs, such as atypical antipsychotics to treat schizophrenia and the newer antidepressants. Eighty-eight percent of the CMHSPs said access to prescribed medications was denied by the QHPs through prior authorization, prior notification, or other requirements.

In response to the survey, Ann Arbor-based psychiatrist Oliver Cameron, MD, said, “Medications are an essential tool in treating mental illness. Timely and uninterrupted access to medications, particularly the newer drugs which are safer and less likely to produce adverse side effects, is essential for the care, treatment, and quality of life for people with mental illnesses.”

In an effort to help ensure that Medicaid recipients receive necessary medications, CMHSPs used a variety of techniques to overcome the denial of medications. Despite these efforts, 50% of CMHSPs reported that recipients were harmed when they were denied access to prescribed medications for the treatment of mental illness.

Michigan Governor John Engler (R) announced a policy change slated for February. The Mental Health Association in Michigan and the Michigan Psychiatric Society, however, are concerned that the executive branch may not target accurate and sufficient funding for mental illness medications.

Barbara Eilenfield
Senior Editor