END OF LIFE CARE AMENDMENTS

Health care professionals and the general public tend to conceive of the ultimate purpose of health care in "curative" terms. In other words, people think that doctors and nurses are supposed to diagnosis medical problems and extirpate the cause of those problems at their source. In recent years, many health care professionals have stressed the need for the medical profession and the general public to acknowledge that there are some problems that medicine simply cannot solve. This is not primarily a function of the contemporary state of health care. Although there is good reason to believe that the art and science of medicine will progress in finding cures for individual ailments and diseases, there is equally good reason to believe that medicine will never reach the point at which it is capable of curing all ailments and diseases. In recognition of this ultimate "Achilles heel," which requires all human beings to confront their own mortality, medical professionals, as well as religious leaders and ethicists, have begun to focus heightened attention on the need to promote acceptance of "palliative" care as an essential component of high quality health care. Palliative care mitigates the symptoms or effects of a disease-pain, in particular-once health care professionals and their patients have come to terms with the difficulty or impracticability of finding a cure. In colloquial terms, if there is a problem, then doctors, pharmacists, and nurses should try to fix it; however, while they are trying to fix the problem, or if they come to the realization that they cannot fix it, they should at least try to alleviate the problem's effects. Although it may ultimately be less satisfying than care that cures a patient of his or her condition, palliative care may significantly enhance a patient's quality of life, when futile attempts to cure might give the patient a false sense of hope and prevent him or her from coming to terms with the condition.

Proponents of palliative care argue that effective pain and symptom management is important regardless of the specific ailment or disease. Nevertheless, advocates are well aware that patients nearing the end of life have special needs. In June 1999, Governor Engler issued an executive order establishing the Michigan Commission on End of Life Care. Originally, the commission was to be composed of 17 members and was to complete its work within 15 months. In January 2000, however, the governor changed the number of members to 12 and extended the time frame for the commission's work. The commission's membership included doctors, nurses, social workers, administrators, lawyers, a professor of spirituality and ethics in medicine, a professor who serves as the director of a palliative care education and research program, two directors of state executive departments responsible for administering health care programs, and a state representative. In general, the commission was charged with identifying, compiling, considering recommendations for improving end of life care from public and private organizations and making its own recommendations on the basis of its discoveries.

Before it began its work, the members of the commission were well aware that attempts to promote high quality health care have wide-ranging effects throughout society. Advocating palliative care may seem like an indisputably worthy cause, in itself, but one of the primary means of effectively managing pain-the use of controlled substances-has always generated controversy. By definition, controlled substances have some potential to cause physical and/or psychological dependence, and even when they do not do so, they can significantly impair mental and bodily functioning. Although these undesired effects can largely be avoided through careful monitoring of the amount and dosage of medication and open dialogue regarding side effects, and a healthy doctor-patient relationship involves such monitoring and dialogue, such considerations ignore the widespread illicit use of controlled substances. Despite a marked tendency to focus on the abuse of drugs like heroin and LSD, whose distribution and consumption is strictly prohibited, Americans have increasingly come to realize that much drug abuse and misuse involves drugs that are available by prescription. This is true not just of drugs such as cocaine, whose legal use has long been overshadowed in the public's view by its illegal, recreational use, but also of drugs whose legitimate and illegitimate use are often less clearly distinguished, such as Demerol and Valium, Ritalin and Oxycontin. Some people who abuse or misuse these more commonly prescribed controlled substances are lured into a false sense of security by the very fact that they are so readily available by prescription. Disregarding the expertise of medical professionals who must make difficult judgments about the appropriateness of prescribing such substances, some abusers and misusers of prescription drugs wonder how dangerous they can be, given that they are (or seem to be) so widely prescribed. Add to this a small contingent of unscrupulous medical professionals who knowingly supply drugs to "doctor shoppers" and other abusers and misusers, and a small, but vocal minority of "conscientious objectors" to the "War on Drugs" who advocate the right to self-prescribe as integral to a truly free society, and the complexity of the controversy becomes clear.

Conceptually, the problem is how to promote the legitimate use of controlled substances, for controlling pain and other symptoms of disease and other medical conditions, without contributing to their illegitimate use. Historically, these issues came to the fore in Michigan during the 1980's. According to the Office of Substance Abuse of the Macomb County Department of Community Mental Health, Michigan became known as the "Miami of prescription drugs" in the 80's because prescription drug abuse had reached such epidemic proportions. In the latter part of the decade, the state legislature initiated what ultimately turned out to be a largely successful attempt to curb the diversion of those prescription drugs with the highest incidence of abuse and misuse-schedule 2 controlled substances. (See BACKGROUND INFORMATION for more information on controlled substances, in general, and schedule 2 controlled substances in particular.) After requiring that such prescriptions be written in triplicate and that one of the copies be forwarded to the state, Michigan virtually eliminated the problem of forged, fraudulent, and altered prescriptions for schedule 2 drugs. Scheduled to be revisited in the mid-1990's, the program came to be known as the Official Prescription Form Program (OPP) and was extended indefinitely. However, the triplicate prescription requirement was dropped in favor of a single-copy, serially numbered form and revised reporting requirements, which included revised requirements for allowing electronic reporting of prescription data to the state.

While taking heart in the OPP's successes, some people have expressed concern that focusing attention on schedule 2 controlled substances may lead to an unwelcome side-effect: an increase in the abuse and misuse of certain schedule 3, 4, and 5 drugs. (In 1997, the Controlled Substances Advisory Commission noted an increase in the availability of these other drugs, though it did not draw a causal connection between the focus on schedule 2 drugs and the increased use of drugs on other schedules.) Such abuse and misuse becomes all the more dangerous when it involves concoctions of narcotics and drugs like acetaminophen, whose misuse may lead to kidney and liver damage; Tylenol #3 is an example of such a schedule 3 drug. Some people believe that an electronic system that effectively monitored the prescription of all controlled substances would provide authorities with additional means of eliminating their misuse use and abuse.

Having identified numerous barriers to quality end of life care ("EOL care") in the areas of professional education, pain management, consumer empowerment, and insurance and regulations, the commission presented its final report to the governor in August 2001. (See the report of the Department of Community Health web site, www.mdch.state.mi.us/eol/EOLreport.) Perhaps most controversially, the commission found that the Official Prescription Form Program, in its current form, impairs access to effective pain management without a corresponding benefit in the control of prescription drug diversion or quality of pain management. Many people have raised concerns with the program's primary focus on schedule 2 controlled substances, which they believe may lead to a shift in the misuse and abuse of other controlled substances available by prescription. Moreover, the "paper" reporting system makes it very difficult for anyone to assimilate data pertaining to prescriptions, and so it is unclear whether anyone really knows that certain aspects of the OPP are as successful as its defenders suggest. One particular area of controversy involves the state-issued form, currently required, and whether it is truly preventing forged, fraudulent, and altered prescriptions.

The commission also found problems with various references in statute and insurance policies to terminally ill patients. For instance, many people believe that the overall strategy of broadening acceptance of palliative care will only work if people accept the need for all individuals suffering from pain-not just those who are suffering from terminal diseases or "intractable" pain-to receive treatment. Moreover, the commission argued that hospice care may be underutilized not only because insurers frequently restrict coverage to patients with a six month life expectancy or less, but also because patients and physicians are not sufficiently educated about hospice care. Many practitioners who do know about hospice care are reluctant to refer patients too early in the progression of a patient's condition. Finally, the commission reported that physicians and patients are not effectively communicating about-and that patients do not have sufficient means for implementing-certain "tools" for planning for the end of life that are already available, such as advance directives and do-not-resuscitate orders.

Legislation has been proposed based in part on the commission's recommendations. However, the package of legislation reflects not only the work of the Michigan Commission on End of Life Care, but also the input of members of a workgroup consisting of various other members of the health care profession and industry who were not members of the commission, and the suggestions of the Health Policy committee and those who attended committee meetings.

THE CONTENT OF THE BILLS:

House Bill 5266. Public Act 222 of 1972 allows an individual who does not have a valid operator's or chauffeur's licensed to apply for a state personal identification card, whose form is prescribed by the secretary of state. Currently, the act specifies that an applicant must pay the secretary of state a $6 fee for each original or renewal state identification card plus a $1 service fee. However, the $1 service fee is scheduled to be eliminated on January 1, 2002.

House Bill 5266 would amend the law (MCL 28.292) to require that the secretary of state designate a space on the card where the applicant could place a sticker or decal of a uniform size-determined by the secretary of state-to indicate that the cardholder carried a separate emergency medical information card. The sticker or decal could also be used to indicate that the cardholder had designated one or more patient advocates, in accordance with the Estates and Protected Individuals Code. Any person, hospital, school, medical group, or association interested in assisting in implementing the emergency medical information card could provide the sticker or decal, but the sticker or decal would have to meet the secretary of state's specifications. The (separate) emergency medical information card could contain certain information pertinent to an individual's indication of willingness to have his or her name placed on the organ donor registry and information concerning the licensee's patient advocate designation. It could also contain other emergency medical information or an indication as to where the cardholder had stored or registered emergency medical information. The bill would also eliminate the January 1, 2002 "sunset date" for the $1 service fee for the state identification card; thus, the $1 itself would become a permanent addition to the $6 fee for the original or renewal card.

House Bill 5255. Part 215 of the Public Health Code provides for the licensing and regulation of hospitals. House Bill 5255 would amend this part of the code (MCL 333.21534) to specify that, upon the request of a patient, a hospital would have to provide patients with oral and written information on hospice care and palliative care services and the availability of hospice care in the area. A patient's physician, a member of the patient's family, the patient's designated patient advocate, or the patient's legal guardian would be authorized to request-and would have to be provided with-the information as well.

House Bill 5258. The Michigan Dignified Death Act, which is Part 56a of the Public Health Code, contains various references to "terminal illness" and "terminally ill patients." "Terminal illness" is defined as "a disease or condition due to which, in the opinion of a physician, a patient's death is anticipated within six months after the date of the physician's opinion." House Bill 5258 would amend the Michigan Dignified Death Act (MCL 333.5652 et al.) to change references to "terminally ill" patients to patients who "have a reduced life expectancy due to an advanced illness." The bill would also revise certain provisions that specify what information physicians must provide to such patients. (House Bill 5257, which is also pending before the House, would revise a requirement that the Department of Community Health develop and publish a standardized, written summary containing information specified in a provision that would be amended by House Bill 5258. The bills are tie-barred.) A detailed account of changes that House Bill 5258 would make is provided below, and a summary of relevant changes to House Bill 5257 is also provided for the purposes of clarification.

House Bill 5258 would eliminate the definition of "terminal illness" from the Michigan Dignified Death Act altogether. The act currently contains a statement of the legislature's findings with respect to terminally ill patients, and the bill would revise several of these findings so that they referred to "patients having a reduced life expectancy due to an advanced illness" rather than to "terminally ill patients." The bill would also add the legislature's finding that health care providers should be encouraged to discuss medical directives during initial consultations, annual examinations, and hospitalizations, as well as when a patient is diagnosed with a chronic illness and when a patient transfers from one health care setting to another. One finding that would retain a reference to "terminal illness" currently acknowledges that patients face a unique set of circumstances and decisions once they have been diagnosed as having a terminal illness. The bill would, however, revise this finding to state that patients who had been diagnosed as having a terminal or advanced illness face a unique set of circumstances and decisions. The bill would also specify that it should not be construed as creating a new mandated benefit for any coverage issued under the Insurance Code of 1956, the Nonprofit Health Care Corporation Reform Act, or any other health care payment or benefits plan. Changes specific to the act's information requirements are summarized below.

Requirements that physicians orally inform patients of certain options. Currently the act requires a physician to provide certain information to a patient (or representative) when recommending medical treatment for a patient who has been diagnosed as having a terminal illness. (The act also allows the physician to inform the patient's surrogate or the patient's designated advocate, in the event that the patient is unable to participate in medical treatment decisions, of the patient's options.) Specifically, the act requires the physician to orally inform the patient (or other representative) about the recommended medical treatment for the illness and about alternatives to the recommended medical treatment. The physician must also orally inform the patient about the advantages, disadvantages, and risks of the recommended medical treatment and each alternative medical treatment. House Bill 5258 would make the following changes to these requirements. To begin with, the bill would require a physician who had diagnosed a patient as having a reduced life expectancy due to an advanced illness and was recommending medical treatment for the patient to inform the patient of his or her options. This reflects two basic changes. First, the bill would refer to a physician who had diagnosed a patient as opposed to a physician who had been diagnosed, and second the bill would refer to a patient having a reduced life expectancy due to an advanced illness rather than a patient with a terminal illness. The bill would also require the physician to inform a patient (or representative) orally about medical treatment for the illness and about alternatives to medical treatment for the illness. The bill would, however, continue to require the physician to orally inform the patient about the advantages, disadvantages, and risks of the medical treatment and of each alternative medical treatment. (The bill would not explicitly require a physician to inform the patient about the advantages, disadvantages, and risks of alternatives to medical treatment.)

Requirements that physicians inform patients of certain options both orally and in writing. The act specifies further information that a physician must provide to a patient (or representative) whom the physician has diagnosed as having a terminal illness and for whom the physician is recommending medical treatment. In general, this further information must be provided to the patient both orally and in writing. The bill would add a requirement that a physician inform a patient with a reduced life expectancy due to an advanced illness, both orally and in writing, that he or she may choose adequate and appropriate pain and symptom management as a basic and essential element of medical treatment.

House Bill 5257. (House Bill 5257 was reported out of the Health Policy committee on October 23, 2001 and remains under consideration by the House at this time. The following information is provided to help clarify changes that would be made by House Bill 5258.) House Bill 5257 would amend the Michigan Dignified Death Act (MCL 333.5656 et al.) to change references to "terminally ill" patients to patients who "have a reduced life expectancy due to an advanced illness." As described above, the act currently requires-and the House Bill 5258 would require-that a physician must provide certain information to a patient both orally and in writing. However, the act also required the Department of Community of Health to develop and publish a written summary containing this information by the end of May 1997, allowing a physician to give patients a copy of the summary instead of notifying them of their options both orally and in writing. House Bill 5257 would require the department to develop and publish a new summary containing the (revised) information that a physician must provide to a patient both orally and in writing. The new report would have to be developed and published by January 1, 2002. The bill would continue to allow a physician to give a patient a copy of the department's summary instead of notifying the patient of his or her options orally and in writing.

Effective dates. The changes allowing a physician to provide a patient with a copy of the department's written summary instead of informing the patient both orally and in writing (House Bill 5257) and the changes to the information requirements-oral only and oral and written-(House Bill 5258) would take effect on March 1, 2002. The other changes to the act would take effect on the bills' effective date.

House Bills 5260 - 5262. Article 7 of the Public Health Code regulates controlled substances and, among other things, provides for an "official prescription form program," or "OPP." Article 15 of the code regulates health care occupations, and the general provisions of Article 15 set forth several legislative findings and directives concerning the OPP, controlled substances, and the treatment of "intractable" pain. Among other things, the general provisions of Article 15 state that the OPP "was created to prevent the abuse and diversion of controlled substances included in schedule 2 . . . and not to prevent or inhibit the legitimate, medically recognized use of those controlled substances to treat patients with cases of intractable pain, especially long-term treatment. It is the intent of the legislature to permit and facilitate adequate treatment for intractable pain by licensed health professionals, including, but not limited to, the prescription or dispensing of controlled substances included in schedule 2 . . ., when medically appropriate."

House Bills 5260 - 5262 would amend various provisions in Articles 7 and 15 of the Public Health Code. House Bill 5260 would replace the official prescription form program for schedule 2 controlled substances with an electronic reporting system for the prescription of all controlled substances. House Bill 5261 would amend Article 15 to abolish the Official Prescription Form Program Fund and create a Controlled Substances Electronic Monitoring Fund and a Pain Management Education and Controlled Substances Antidiversion Fund. House Bill 5262 would revise several definitions relating to prescriptions in the general provisions of Article 7; these revisions include a requirement that prescriptions for controlled substances and other prescription drugs be written on secure, tamper-resistant material. The bills are tie-barred.

House Bill 5260 would amend Articles 7 and 15 of the Public Health Code (MCL 333.7333 et al.) to eliminate the official prescription form program. The bill would replace a statement providing explicit justification for creating the OPP with a statement that the legislature intended, in addition to permitting and facilitating adequate pain management, to enable regulatory and law enforcement agencies to prevent the abuse and diversion of controlled substances by creating an electronic monitoring system. The bill would eliminate references to the official prescription form and the OPP throughout Articles 7 and 15 and would provide for an electronic system for monitoring schedule 2, 3, 4, and 5 controlled substances. The bill would also eliminate a definition of "intractable pain" and various references to intractable pain in the general provisions of Article 15. Finally, the bill would eliminate a definition of and references to "androgenic anabolic steroids." (According to committee testimony, androgenic anabolic steroids are now included on the list of schedule 3 drugs.)

Electronic reporting system. The Department of Community Health would have to establish, by rule, an electronic system for monitoring schedule 2, 3, 4, and 5 controlled substances that were dispensed in the state by veterinarians, pharmacists, and dispensing "prescribers" or that were dispensed to an address in the state by a pharmacy licensed in the state. (Note: Apparently, it is intended that the Department of Consumer and Industry Services administer this provision; a floor amendment is expected to be offered to reflect this intent.) The rules would have to provide an appropriate electronic format for the reporting of data including patient identifiers, the name of the controlled substance dispensed, the date of dispensing, the quantity dispensed, the prescriber, and the dispenser. The rules would not require a veterinarian, pharmacist, or dispensing prescriber to pay a new fee dedicated to the operation of the system, and DCH would be responsible for the transmission costs of the system. The bill would specify that the rules would exempt from the reporting requirements the administration of a controlled substance directly to a patient. Moreover, a prescriber dispensing a controlled substance in a quantity adequate to treat a patient for up to 48 hours from a licensed health facility or agency would be exempt from the reporting requirements. Otherwise, reporting would be mandatory for a pharmacist, veterinarian, and dispensing prescriber. However, the department could issue a written waiver for use of the electronic system to any pharmacist, veterinarian, or dispensing prescriber who established grounds that he or she was unable to use the electronic system. The department would have to require the applicant for the waiver to report the required information in a manner approved by the department.

The department could provide data to all of the following: a designated representative of a board responsible for the licensure, regulation, or discipline of practitioners, pharmacists, or other person who was authorized to prescribe, administer, or dispense controlled substances and who was involved in a bona fide specific investigation involving a designated person; a state, federal, or municipal officer whose duty was to enforce state or federal laws relating to drugs and who was engaged in a bona fide specific investigation involving a designated person; a state-operated Medicaid program; a properly convened grand jury pursuant to a properly issued subpoena for the records; a practitioner or pharmacist who requested information and certified that the requested information was for the purpose of providing medical or pharmaceutical treatment to a bona fide current patient. The bill would also specify that a person who received data or any report containing any patient identifiers of the system from the department could not provide it to any other person or entity except by order of a court of competent jurisdiction. The Controlled Substances Advisory Commission would have to include in its annual report, as provided for elsewhere in Article 7, information on the implementation and effectiveness of the system. The department, all law enforcement officers, all officers of the court, and all regulatory agencies and officers, in using data for investigative or prosecution purposes, would have to consider the nature of the prescriber's and dispenser's practice and the condition for which the patient was being treated. The data and any report containing any patient identifiers obtained from the data would not be a public record and would not be subject to the Freedom of Information Act.

Schedule 2 controlled substances. Currently, the code prohibits, with some exceptions, the dispensing of a schedule 2 controlled substance or an androgenic anabolic steroid without the written prescription of a licensed practitioner. The prescription must be written on an official prescription form. The bill would change this qualified prohibition to specify only that a schedule 2 controlled substance could not be dispensed without the prescription of a licensed practitioner on a "prescription form." (See below House Bill 5262's proposed revision to the code's definition of "prescription form.") The bill would also prohibit a practitioner from issuing more than one prescription for a schedule 2 controlled substance on a single form. Further, the bill would change the period during which a prescription for a schedule 2 controlled substance had to be filled from five to sixty days from the prescription's issuance; this provision currently does not apply-and still would not apply-to terminally ill patients whose terminal illness was documented by the pharmacist. Finally, the bill would eliminate a prohibition on the refilling of prescriptions for a schedule 2 controlled substance or for an androgenic anabolic steroid, other than methyltestosterone, testosterone, or fluoxymensterone.

Schedule 3 or 4 controlled substances. Currently a prescription for a schedule 3 or 4 controlled substance may not be filled or refilled later than six months after the date of the prescription or be refilled more than five times, unless renewed by the practitioner in accordance with rules promulgated by the Michigan Board of Pharmacy or its designated or established authority. The bill would state that a prescription for schedule 3 or schedule 4 controlled substances could not be filled or refilled more than five times in that time frame, unless renewed by the "prescriber." (See below the definition of "prescriber" that would be added by House Bill 5262.)

Expansion of provision specific to written prescriptions. In general, controlled substances must be prescribed in writing, but the code does provide for cases in which a prescriber may need to prescribe a controlled substance orally-e.g., emergency situations. Currently, the code requires that a prescription that must be written must contain the quantity of the controlled substance or androgenic anabolic steroid prescribed, in both written and numerical terms. The bill would state instead that if a prescription was required, the prescription would have to contain the quantity of the controlled substance prescribed in both written and numerical terms.

Postdating prescription forms. Currently, the code prohibits a prescribing practitioner from postdating an official prescription form or from signing an official prescription form on a day other than the day the prescription is issued. The bill would eliminate these references to the official prescription form and specify instead that a prescribing practitioner could not postdate a prescription form that contained a prescription for a controlled substance. A prescriber could transmit a prescription by facsimile and by electronic transmission of a printed prescription form, as long as it was not prohibited by federal law. If a prescription was electronically transmitted, it would be transmitted directly to the pharmacy, and the data could not be altered, modified, extracted, viewed, or manipulated in the transmission process.

Transition period. The bill provides for the repeal of certain provisions of Article 7 and Article 15 as soon as the department promulgated the rules for the electronic monitoring system and the secretary of state received written notice from the director of CIS that the system was operational. The notice to the secretary of state would have to include a statement that CIS was able to receive data from at least 80 percent of those required to report and was able to respond to requests for data from persons authorized to make such requests and to review and utilize the data. The changes to Article 7 would take effect at the same time as the repeals. Other changes would take place on the bill's effective date.

House Bill 5261 would amend Article 15 of the Public Health Code (MCL 333.16315) to abolish the Official Prescription Form Program Fund and create a Controlled Substances Electronic Monitoring Fund and a Pain Management Education and Controlled Substances Antidiversion Fund. The bill would create both funds within the state treasury, and the treasurer would be responsible for directing the investment of both funds. Interest and earnings from investment of each fund would be credited to that fund, and the unencumbered balance in each fund at the close of the fiscal year would remain in that fund rather than reverting to the general fund. Each fund could receive gifts and devises and other money as provided by law.

The Controlled Substances Electronic Monitoring Fund. The state treasurer would be directed to transfer the money remaining in the Official Prescription Form Program Fund on the bill's effective date to the Controlled Substances Electronic Monitoring Fund. The department of treasury could only use the fund in connection with developing and maintaining the electronic monitoring system.

The Pain Management Education and Controlled Substances Antidiversion Fund. Currently, the law states that the Department of Consumer and Industry Services is to deposit with the state treasurer $20 of the fee for a license to engage in manufacturing, distributing, prescribing, dispensing, or conducting research on controlled substances. The treasurer is directed to credit the $20 (per license fee) to the Official Prescription Form Program Fund. The bill would direct the treasurer to deposit the $20 to the Pain Management Education and Controlled Substances Antidiversion Fund instead. The department could only used this fund in connection with programs relating to pain management education for health professionals, preventing the diversion of controlled substances, and maintenance of the electronic monitoring system.

House Bill 5262 would amend Article 7 of the Public Health Code (MCL 333.7104 et al.) to revise several definitions. To begin with, the bill would eliminate the definition of "official prescription form," in conjunction with House Bill 5260's elimination of the OPP, and modify the definition of "prescription form." The law currently defines a prescription form as a printed form that was authorized and intended for use by a prescribing practitioner to prescribe controlled substances or prescription drugs. The bill would retain the current requirement that the prescription form meet requirements of rules promulgated by the Michigan Board of Pharmacy or its designated or established authority. However, the bill would add a requirement that prescriptions for controlled substances or other prescription drugs be written on secure, tamper-resistant material. Additionally, the bill would require that a prescription form do the following: bear the preprinted, stamped, typed, or manually printed name, address, and telephone number or pager number of the prescribing practitioner; include the manually printed name of the patient, the address of the patient, the prescribing practitioner's signature, and the prescribing practitioner's Drug Enforcement Administration registration number; and state the quantity of the prescription drug prescribed in both written and numerical terms.

The bill would also add a definition of "sign," meaning to affix one's signature manually to a document or to use an "electronic signature." An "electronic signature would mean an "electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record." Further, the bill would incorporate a definition of "prescriber" by reference to the part of Article 15 that regulates occupations involving pharmacy practice and drug control. (As defined in that part, "prescriber" means "a licensed dentist, a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, a licensed doctor of podiatric medicine and surgery, a licensed optometrist certified . . . to administer and prescribe therapeutic pharmaceutical agents, a licensed veterinarian, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.") Finally, the bill would revise the definition of "counterfeit prescription form" by eliminating reference to the official prescription form and recognizing as counterfeit a prescription form that had been electronically transmitted without the prescriber's knowledge or permission.

Transition period. The changes would take effect as soon as the department promulgated the rules for the electronic monitoring system and the secretary of state received written notice from the director of CIS that the electronic monitoring system was operational. As described for House Bill 5260, the director of CIS would have notify the secretary of state that CIS was able to receive data from at least 80 percent of those required to report and was able to respond to requests for data from persons authorized to make such requests and to review and utilize the data.

BACKGROUND INFORMATION:

Controlled substances. Following federal law, the Public Health Code classifies controlled substances under one of five "schedules." By definition, all scheduled drugs have the potential for abuse, where the abuse is "associated with" a stimulant or depressive effect on the central nervous system. Further, scheduled drugs are either illegal and without any medically accepted use in the United States (all schedule 1 drugs) or prescription drugs with medically accepted uses in the U.S. but that have a potential for psychological or physical dependence (schedules 2, 3, 4, and 5). Schedule 1 and schedules 2 drugs are both defined as having a "high risk" of abuse, and drugs on schedule 2-5 have successively reduced potential for leading to dependence. In other words, schedule 3 drugs have a lower risk of causing dependence than schedule 2 drugs, schedule 4 drugs have a lower risk of leading to dependence than schedule 3 drugs, and schedule 5 drugs have a lower risk of leading to dependence than schedule 4 drugs. Alternatively, a drug may be placed on schedule 5 if "the incidence of abuse is such that the substance should be dispensed by a practitioner."

Schedule 2 prescription drugs. Drugs included on schedule 2 include opium and its derivatives, (e.g., codeine, morphine, and oxycodone, which is the active ingredient of Oxycontin), opium poppy and straw, other opiates (e.g., fentanyl, methadone, and pethidine), coca leaves and derivatives, such as cocaine, and methylphenidate-the active ingredient of Ritalin. Schedule 2 also includes substances containing any quantity of such drugs as amphetamine and methamphetamine (also known as "speed"), methaqualone (known by its trade name Quaalude), and barbiturates, such as amobarbital, pentobarbital, and secobarbital (a.k.a. "downers").

Schedule 3, 4, and 5 prescription drugs. Schedule 3 includes, among other things, substances with any quantity of a derivative of barbituric acid and drugs containing limited quantities of opium, codeine, or morphine. Schedule 4 includes drugs such as diazepam (known by its brand name Valium), barbital, chloral hydrate, lorazepam, meprobamate, and phenobarbital. Loperamide (Imodium AD) is an example of a Schedule 5 drug.

Governor's charge to the Michigan Commission on End of Life Care. The governor's June 1999 executive order charged the Michigan Commission on End of Life Care with the following nine responsibilities:

· Identifying, compiling, and considering recommendations for improving end of life care from the state's public and private organizations;

· Recommending model state and institutional policies with respect to end of life care, including an examination and compilation of the best ideas of multiple groups currently engaged in examining end of life issues;

· Coordinating their efforts with other groups actively engaged in addressing end of life issues;

· Identifying, evaluating, and making recommendations with respect to any existing barriers that result in inadequate end of life care;

· Evaluating the adequacy of, and making recommendations for improving, education associated with end of life care provided in medical schools, nursing schools, and other health professional education programs;

· Evaluating the adequacy of the level and degree of, and making recommendations for improving, graduate medical education training provided in residency programs associated with end of life care;

· Surveying the availability and cost of public and private insurance coverage for hospice, pain management, and palliative care (see Appendix B of the report);

· Recommending state policies concerning end of life care related to continuing medical education for licensed health professionals; and

· Inventorying existing resources available to citizens for end of life planning and producing a guide of these resources for the general public (see the summary of Appendix C below).

Appendix C: Barriers to end-of-life care. In the course of its study, the commission determined that barriers to providing appropriate EOL care stem primarily from limited resources, shortcomings in the health care system, and society's difficulties in dealing with end of life issues. Although there are many barriers to appropriate EOL care, the commission focused its discussion of barriers that need to be addressed and eliminated around four themes: professional education, pain management, consumer empowerment, and insurance and regulations.

Professional education barriers. Barriers in the area of professional education include: lack of professional training and continuing education of health care professionals in diagnosing and treating patients with life-threatening conditions and identifying when a condition or illness is nearing the terminal stage; failure to offer patients both curative and palliative choices; lack of competency and experience in compassionate dialogue with patients and families in EOL care issues; and lack of understanding of basic patient rights of informed consent, including the right to accept or reject specific types of care.

Pain management barriers. Barriers in the area of pain management include: lack of knowledge on the part of clinicians and patients that patients have a right to have their pain assessed, treated, and relieved; lack of understanding by patients of how to communicate pain (and the appropriateness of doing so; lack of knowledge by professionals of how to elicit and measure patients' reports of pain and pain relief; lack of knowledge of the full range of pharmacologic and nonpharmacologic pain treatments; and inadequate understanding of the side effects of pain medication and misconceptions concerning potential addiction. Specific to health care providers, the commission found the following barriers: insufficient education in palliative care, insufficient knowledge about symptoms of the end of life other than pain, frequent failure to conform to current standards and clinical practice guidelines for pain assessment and relief, and fear of regulatory scrutiny for prescribing controlled substances, among other things.

Consumer empowerment barriers. In the area of consumer empowerment, the commission determined that the single most significant barrier is the lack of education in EOL issues such as patient rights, advance directives, designation of surrogates for EOL decision-making, and the options for treatment, including hospice and palliative care. Further, the commission found that patients often lack access to palliative care specialists, do not understand the relationship between curative and palliative care, and do not know that pain and symptoms can be managed without foregoing all options for curative care. Finally, the commission found that physicians fail to present all options to patients and that physicians and surrogates often did not sufficiently understand patients' goals and preferences.

Insurance and regulations barriers. Among the many barriers to reimbursement, the commission emphasized the lack of-or gaps in-insurance coverage for some EOL services based on current models of care and today's finances, the inadequacy of hospice reimbursement for palliative care, and eligibility restrictions for appropriate but expensive therapies. The commission noted special concern with Medicare's requirement that coverage of hospice care begin after a prognosis of six months or less of life remaining, which is ultimately based on cancer research, as opposed to research on a wide variety of "terminal" illnesses. Regulatory issues include the limitations of EOL care for terminally ill patients in state mental hospitals, limitations on EOL care treatment options placed on providers by MCO's, inadequate dissemination of available knowledge by payors on EOL issues, and the absence of processes designed to encourage the beneficiary to keep advance directives current. Quality assurance issues include lack of consistent reporting of EOL care data, lack of benchmarks for measuring and evaluating patient quality-of-care outcomes near the end of life, and lack of consistency in standards of care across the continuum.

Recommendations. Having identified the barriers to quality end of life care, the commission issued four general recommendations: (1) the governor and legislature should adopt several specific principles for formulating public policy for end of life care; (2) the governor, the Department of Community Health (MDCH), and the Department of Consumer and Industry Services (CIS) should initiate a statewide awareness and educational campaign for the public and for health care professionals; (3) the MDCH should nurture an ongoing coalition of public and private stakeholders to reshape health care delivery systems to provide appropriate and competent curative and palliative care services; and (4) the MDCH and CIS should develop public policy and draft regulations for EOL care based on standards developed by experts in the field in order to promote competent and appropriate care for Michigan residents living and dying with advanced illness.

The committee also issued a number of specific recommendations, including: three recommendations in the area of professional education, twelve recommendations on pain and symptom management, five concerning reimbursement, two regarding long-term care, four with respect to end of life decision-making, and one recommendation on family issues. With respect to family issues, the commission specifically recommended that, in the interest of promoting the health and well-being of Michigan citizens, the governor and MDCH encourage provision of competent respite care to reduce caregiver burden and encourage health plans and other payors to provide adequate reimbursement for such service. The other specific recommendations are listed below in the order that they appear in the report's "executive summary of recommendations," except that recommendations for legislative action that directly relate to bills in the End of Life Care package have been moved to the top of the list, within each category.

Professional education recommendations. In the area of professional education, the commission recommended that:

1. Health professional schools or educational programs include in their core curricula content on EOL care appropriate to each discipline. More specifically they should:

· Charge at least one faculty member with developing the curriculum.

· Regularly assess and evaluate curriculum content, consider the professional expertise of faculty involved in EOL care education, support faculty development, and draw on the experience of community professionals.

· Collaborate with other schools within each discipline and within the larger educational institution to enhance instruction in EOL care.

· Develop new models of education that incorporate adult learning principles and interactive learning to improve the abilities of health care professionals as they care for dying persons.

2. MDCH take a leadership role in exploring options for EOL care education innovation grants to support curriculum assessment, development, and evaluation by individual schools and educational programs; and for development of interdisciplinary and inter-institutional efforts to improve EOL education.

3. MDCH, CIS, and all applicable health profession licensing boards promote and advance the art and science of EOL care education and promote palliative care as a defined area of expertise, education, and research.

Pain and symptom management recommendations. In the area of pain and symptom management the commission recommended that:

1. The legislature repeal the OPP because in its current form the OPP impairs access to effective pain management without a corresponding benefit in the control of prescription drug diversion or quality of pain management. (See House Bills 5260-5262.)

2. The legislature replace the OPP with a system that supports electronic monitoring; is balanced in its approach to high-quality pain management and its desire to limit prescription drug diversion; requires no additional special prescription form; is efficient and invisible to the patient and practitioner; and provides information that is well understood and available to all those who need it. (See House Bills 5260-5262.)

3. The legislature amend the Michigan Dignified Death Act to eliminate the terminology "life expectancy of less than six months" and replace it with language to require physicians who identify a patient with limited life expectancy due to advanced illness to provide the patient with information about pain and symptom management options. (See House Bills 5257 and 5258.)

4. The legislature amend the "Policy on Patient and Resident Rights and Responsibilities" within the Public Health Code stating that all patients have the right to adequate pain and symptom management and palliative and hospice care. (See House Bill 5259.)

5. The legislature amend all statutes to eliminate the use of the term "intractable pain" or amend it to read "pain" as appropriate. (See House Bills 5263-5265.)

6. The legislature, MDCH, and CIS minimize state regulatory impediments to effective pain medications and work with the Michigan Congressional delegation and federal officials to minimize federal regulatory impediments concerning prescriptions.

7. CIS adopt licensing requirements for health facilities and agencies that promote education programs for health professionals on effective pain and symptom management.

8. CIS and MDCH adopt by regulation and monitor the progress of licensed health facilities and agencies in implementing the Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) pain treatment requirements in order to improve individual and timely assessment and treatment of pain.

9. All applicable health profession licensing boards adopt and disseminate the Federation of State Medical Boards' "Model Guidelines for the Use of Controlled Substances for the Treatment of Pain" and adopt policy declaring that inappropriate undertreatment of pain will be scrutinized.

10. CIS develop a system and promulgate rules that require pharmacies to help patients find adequate supplies of pain medications when the pharmacy is unable fill a valid prescription.

11. MDCH and the Office of Financial and Insurance Services (OFIS) encourage health plans and payors to minimize co-pays, deductibles, and other restrictions on reimbursement for opioids prescribed for pain and symptom management.

12. MDCH, CIS and the Department of Environmental Quality (DEQ) explore ways to improve disposition of pharmaceuticals when no longer required for home use-e.g., requiring that in settings that have a central point of control, unused pharmaceuticals be retrieved and redistributed to other patients with legitimate prescriptions.

Reimbursement recommendations. In the area of reimbursement, the commission recommended that:

1. MDCH assess and validate existing state data to determine how to optimize EOL care by analyzing, redistributing, and redesigning incentives in order to provide more options concerning type and settings of care.

2. The governor, MDCH, and CIS work with the Michigan Congressional delegation and federal agencies to further understand and explore current or proposed federal laws and regulations for Medicare and Medicaid to determine their impact and make changes in the following areas:

· Development of an "outlier" formula for large-scale hospice programs whose patients need higher-cost services or require services in settings where significant transportation costs exist.

· Development of an acuity-based reimbursement formula for the first and last days in hospice in light of the rapidly declining length of stay, which creates an increasing proportion of high-cost days.

· Amending the twenty percent limit on inpatient hospice days in relation to total hospice days for programs that can document service to a disproportionately large number of high-acuity patients.

· Modifying the Medicare hospice benefit by creating a financially neutral reimbursement methodology for nursing home hospice care so that Medicare beneficiaries may choose hospice care without penalty to the nursing home or eligible residents.

· Reimbursing palliative care providers as appropriate to meet patients' and families' EOL care needs.

3. MDCH review the final report of the Hospice Residence Research Project to determine if funding the room-and-board component of inpatient hospice residences is a cost-neutral means of delivering patient care.

4. The legislature encourage and consider funding research projects designed to evaluate the hypothesis that offering both curative and palliative services concurrently is cost-effective.

5. Health plans and payors be encouraged to pay the reasonable cost of pain and symptom management, palliative care consultations, and non-pharmacological treatment of pain and symptoms by all types of providers.

Long-term care recommendations. In the area of long-term care, the commission recommended that:

1. CIS and the Michigan Long Term Care Work Group (LTCWG), together with providers of long-term care, continue to address barriers that interfere with the deliver of quality EOL care, including:

· Confusion and conflict concerning the interpretation and enforcement of regulations dealing with avoidable and unavoidable decline and the reluctance to use medications that are perceived to interfere with function-e.g., psychotropic or opiate medications-for terminally ill patients.

· Lack of adequate pain and symptom management.

· A focus on restorative and rehabilitative care as opposed to palliative care or comfort care.

· Disincentives for long-term care facilities to offer hospice and palliative services to residents.

· Absence of best-practice models for palliative EOL care within long-term care settings.

2. CIS and the LTCWG develop educational and training opportunities in EOL care for state surveyors of long-term care facilities, particularly on issues concerning avoidable and unavoidable decline related to the naturalness of dying.

Decision-making for the end of life. In the area of decision-making for the end of life, the commission recommended that:

1. The Michigan Dignified Death Act be amended to provide that regardless of whether a patient is terminally ill, physicians should engage in discussions about advance directives during initial consultations, periodic examinations, in-hospital consultations upon admission to or transfer from one health care setting to another, and at diagnosis of a chronic illness. (See House Bill 5258.) In conjunction with this recommendation, the commission recommended that:

· Studies be conducted to determine the best practices for involving physicians in effective discussions with patients about advance directives and actual implementation of advance directives.

· Managed care organizations, health plans, and other payors be encouraged to include medical-record documentation of physicians' discussions with patients as a quality indicator for physician practice.

2. Driver's licenses and other identification cards clearly denote when a person has executed a do-not-resuscitate order and whether a person has an advance directive (and where it can be found). (See House Bills 5148 and 5266.)

3. The state court administrator's office take a leadership role in seeing that courts, court personnel, guardians ad litem, and others are well prepared to administer, enforce, and provide education about the guardianship reform laws passed in 2000.

4. The MDCH director establish a working group of advocates, interested parties, and health care professionals to work toward assessing the numerous issues associated with EOL decision-making for persons who have never been competent and who are terminally ill.

"End of Life Care package". In October 2001, an "End of Life Care" package, consisting of seven resolutions and thirteen bills, was introduced in the House. The resolutions and twelve of the bills, House Bills 5255-5266, were referred to the Health Policy committee. House Bill 5254, which would amend the General Sales Tax Act, was referred to the Tax Policy committee and remains under consideration by that committee at this time. Although House Bill 5148 had been introduced earlier in the month, and thus was not introduced under the auspices of the End of Life Care package, it deals with the same issues covered by House Bill 5266, and thus falls within the general rubric of end of life care legislation. For the purposes of this analysis, the "End of Life Care package" (or "EOL package") refers to House Bills 5148 and 5255-5266. (On October 30, House Bills 5256 (Substitute H-1), 5259, and 5263-5265 were passed by the House.)

Even a fairly close examination of the bills composing the EOL package might not make obvious the bills' focus on end of life care issues. Indeed, the bills seem to cluster around several conceptual themes, which might be arranged from least clearly related to end of life care issues to most clearly specific to such issues, as follows: pain and symptom management (in general); requirements relating to the prescription of controlled substances; the accessibility of information concerning end of life care (e.g., advance directives, the designation of patient advocates, and emergency medical information); the treatment of patients with a reduced life expectancy due to an advanced illness; and hospice care. Undergirding this broad thematic spectrum, however, lies the prehistory of other legislative attempts to address such complexly interwoven phenomena as patterns of drug abuse and misuse, perceptions about the proper goal(s) of medicine, attitudes about death and dying, notions of individual autonomy and societal and familial obligations. Two significant episodes in this prehistory are the implementation of what eventually came to be known as the Official Prescription Form Program (OPP) and Michigan's confrontation with the reality of assisted suicide.

History of the Official Prescription Form Program

Michigan in the 1980's. During the 1980's, Michigan ranked first in the nation in the consumption of several schedule 2 prescription drugs, which have recognized medical uses, for which they may be prescribed legally, but are considered the most highly addictive of the controlled substances. In 1983, for example, Michigan reportedly received 35 percent of the methamphetamine consumed in the United States. In the same year, the state was also the top consumer of Ritalin, Preludin, and Dilaudid. After two years of special enforcement activity and revised rules, the consumption in Michigan of certain schedule 2 drugs, such as methamphetamine and phenmetrazine (Preludin), dropped considerably, but consumption of other schedule 2 drugs remained high. Reportedly, many of the drugs were "diverted" from legal channels to illegal and abusive distribution channels through forged and stolen prescription pads and forms; dishonest doctors, pseudo-doctors, and pharmacists who prescribed and/or dispensed the drugs for illegitimate purposes; and duped, troubled, and out-of-date practitioners who wrote prescriptions for "doctor shoppers" and other abusing patients. A 1989 pharmacist survey estimated that approximately 104,000 forged and/or altered prescriptions for schedule 2 drugs were presented to pharmacists annually.

Public Act 60 of 1988. In 1987, legislation was introduced by the Senate to address these and related problems. Enacted as Public Act 60 of 1988, the law created a Controlled Substances Advisory Commission and required the use of triplicate prescription forms for the dispensing of certain controlled substances, among other things.

Controlled Substances Advisory Commission. The Controlled Substances Advisory Commission ("CSAC") was-and still is-required to monitor indicators of controlled substance abuse and diversion. The CSAC was originally housed in the Department of Licensing and Regulation, but is now located within the Department of Consumer and Industry Services. If the data shows that the state exceeds the national average per capita consumption of a controlled substance, the CSAC must investigate and determine whether there is a legitimate reason for the excess consumption. If it determines that there is not a legitimate reason for the excess consumption, the CSAC must recommend a plan of action for overcoming the problem to the drug control administrator appointed by the Michigan Board of Pharmacy. It may also recommend action if other indicators show that a special problem is developing with any controlled substance available by prescription.

CSAC annual report. The CSAC was-and still is-required to issue an annual report on the current status of the abuse and diversion of controlled substances in the state, and the report must identify existing efforts to overcome that abuse and diversion and make recommendations for needed legislative, administrative, and interagency activities. The CSAC may also include recommendations for action involving licensing, law enforcement, substance abuse treatment and prevention, education, professional associations, pharmaceutical manufacturers, and other relevant individuals and agencies.

Official triplicate prescription ("trip scrip") form program. Prior to the enactment of Public Act 60 of 1988, the law stated merely that a schedule 2 controlled substance could not be dispensed without the written prescription of a licensed practitioner. (Exceptions were made for emergencies, as long as the prescription was promptly put into writing and filed by the dispensing pharmacy.) In general, Public Act 60 of 1988 required that prescriptions for schedule 2 substances be written on an official prescription form and prohibited the recording of more than one prescription on a single form. An "official prescription form" was defined as a prescription form that was numbered serially, was in triplicate, and contained spaces for the following information: the date the prescription was written and the date it was filled; the controlled substance prescribed, the dosage, and instructions; the name, address, and federal Drug Enforcement Administration (DEA) number of the dispensing pharmacy and the initials of the pharmacist who filled the prescription; the name, address, and age of the person for whom the substance was prescribed; and the name, address, and age of the ultimate user's "authorized agent," if any.

A person who prescribed schedule 2 controlled substances was required to fill in all three copies of the prescription form and include all of the information listed above, except the name, address, and DEA number of the dispensin