CALIFORNIA
EFFECTIVE PAIN MANAGEMENT – A LEGAL UPDATE
From Action Report, a publication of the Medical Board of California
The problem of chronic pain and questions surrounding prescribing for pain were issues of note throughout the 1990s, and are receiving continued scrutiny today. The Medical Board of California has been actively addressing these issues since 1994, when the Board held its “Summit on Effective Pain Management: Removing the Impediments to Appropriate Prescribing.” The result of this work was the formal adoption by the Board in July 1994 of its Guidelines for the Treatment of Intractable Pain, created to complement new law, Business and Professions Code section 2241.5, which established California public policy as supportive of the responsible practice of pain management. These guidelines are intended to reassure physicians that they are free to use their best professional judgment, consistent with established medical standards, when treating patients for pain, rather than on a fear of discipline by the Medical Board.
During the 1990s, the legislature passed 6 bills of particular note dealing with pain management. They, too, are briefly summarized in this article to remind physicians of these laws and of the legislature’s ongoing interest in this matter of utmost importance to California patients and their families.
The Medical Board employs multifaceted approaches to promote the ability of physicians to provide appropriate pain relief treatment as established by emerging community standards. The Board recognizes that discipline of physicians for the under-treatment of pain is, by itself, ineffectual as an incentive to effective pain management. Patient protection, the primary role of the Medical Board, should also include the promotion of good medical practice by positive means. Therefore, the Medical Board of California is actively engaged in encouraging the dissemination of the latest information and education resources to promote appropriate pain relief.
The first step was the creation and publication of the pain relief guidelines of 1994. The Board has repeatedly informed physicians that if they follow these guidelines, they should not fear charges from the Medical Board that they have engaged in illegal over-prescribing.
The Board also has worked with the Physician Assessment and Clinical Education program at the University of California, San Diego, to make widely available its Physician Prescribing course, which provides expanded education in the latest standards of prescribing, including prescribing for pain management. This course provides invaluable information to assist in educating physicians regarding the latest in prescribing practices.
The Board sponsors its own Pain Management Seminar, certified for category I CME, which provides both medical and regulatory perspectives on this subject and educates attendees about how to identify patients who need management of their pain as distinct from those who are engaged in illegal drug-seeking behavior.
Finally, the Board is developing enhanced communication efforts to bring the latest concepts in pain management to its more than 109,000 physicians. These efforts will include enhanced links from its Web site and expanded discussions on pain management in future newsletters.
Recently Passed Pain Management Laws
SB 402 (Green, Chapter 839, Statutes of 1997, Health and Safety Code section 124961) established the “Pain Patient’s Bill of Rights.” Physicians may refuse to prescribe opioid medication for patients who request the treatment for severe chronic intractable pain; however, they must inform the patient that other physicians specialize in the treatment of such pain with methods that include the use of opiates.
AB 2305 (Runner, Chapter 984, Statutes of 1998, Business and Professions Code section 725, Health and Safety Code section 1367.215) Physicians who are in compliance with the California Intractable Pain Act will not be subject to disciplinary action. Health care service plans must approve or deny coverage for terminally ill enrollees within 72 hours of receipt of the information.
AB 2693 (Migden, Chapter 789, Statutes of 1998, Health and Safety Code section 11159.2) Prescriptions for Schedule II controlled substances used by terminally ill patients are exempt from the use of a triplicate form. Prescriptions falling under this exemption must contain the phrase “11159.2 exemption.”
SB 1140 (Committee on Health and Human Services, Chapter 791, Statues of 1998, Business and Professions Code sections 2191 and 2196.2) requires the Medical Board and the Board of Registered Nursing to consider including a course on pain management in their continuing education requirements. The Medical Board must periodically develop and disseminate information and education material regarding pain management techniques and procedures to each licensed physician and surgeon and to each general acute care hospital, and must consult with the Department of Health Services in developing materials to be distributed.
AB 791 (Thomson, Chapter 403, Statutes of 1999, Business and Professions Code section 2089) Pain management and end-of-life care are now parts of the curriculum requirements for students entering medical school on or after June 1, 2000.
AB 2018 (Thomson, Chapter 1092, Statutes of 2000, Health and Safety Code sections 111761 and 11164) allows physicians to request from the Department of Justice a sufficient supply of triplicate prescription forms to meet the needs of their patient population. Physicians or employees may complete the forms, provided the physician signs it. Pharmacists are allowed to notify the prescriber of an unintended error on the form and obtain approval for correction, so the patient does not have to return to the office for the corrected prescription, as long as a corrected copy is sent or faxed from the physician to the pharmacist within 7 days.
MARYLAND
MEDCHI PANEL URGES OVERHAUL OF PHYSICIAN REGULATION
From MedChi, a publication of the Maryland State Medical Society
A Medical and Chirurgical Faculty task force is recommending a total overhaul of Maryland’s system of physician regulation to enhance patient safety. If adopted, Maryland would become the first state to embrace the Institute of Medicine’s concept that improving patient safety entails a non-punitive environment for quality assurance.
Key elements of the plan include creating an entity separate from the Board of Physician Quality Assurance that would not only assess quality assurance data on behalf of the Board, but also would engage in interventions with physicians for quality improvement.
Envisioned as a “medical quality institute,” the new entity would operate in a manner similar to the MedChi Physician Rehabilitation Program. Physicians who it identifies as needing intervention would contract with it to implement a quality improvement plan and achieve a designated outcome. So long as the physician adhered to the plan, the intervention would not be discipline, and it would remain confidential. However, failure to cooperate with the entity would result in referral to the BPQA to compel action pursuant to the adversarial disciplinary process.
The plan supports mandatory reporting of medical errors to the “medical quality institute.” This mechanism would follow a recommendation of the Institute of Medicine, which already has been adopted in legislation. A bill passed the General Assembly earlier this year directing the Maryland Health Care Commission to develop a plan for mandatory reporting by 2003.
In order to achieve meaningful reporting of errors, the task force plan proposes an explicit policy that an individual act of medical negligence should never be the subject of discipline, so long as it is reported voluntarily. This means that interventions would only occur where the deficiency in quality is not an aberration, but instead involves a pattern of errors or a fundamental deficiency of some kind. With mandatory reporting, the deficiencies are likely to surface that involve issues far beyond physician competency, including practice setting, case selection, relationships with other professionals, and the like.
ATTORNEY GENERAL EXPRESSES CAUTION ON OXYCONTIN ABUSE
Police departments and prosecutors are alarmed at growing abuse of the prescription pain medication Oxycontin and related drugs, but Maryland’s top law enforcement official has pledged that his reaction to the problem will not deter appropriate prescribing and use of the drugs.
Meeting with a group of pain experts at MedChi recently, Attorney General J. Joseph Curran, Jr. said he wants to be sure that law enforcement responses to prescription drug abuse do not adversely affect legitimate use of pain medications. However, he said that pressure is building to allow enforcement response to Medicaid fraud and other crimes related to Oxycontin abuse, particularly in light of intense media attention to the issue.
Physicians also can deter abuse by limiting the patient’s ability to “play” the system by getting prescriptions from multiple physicians and multiple pharmacies. Pain experts require patients to deal with only one physician-prescriber and only one pharmacy. Patients are also informed that any infraction of the rules will result in dismissal from the physician’s care.
MINNESOTA
COMPLEMENTARY AND ALTERNATIVE HEALTH CARE
From Update, a publication of the Minnesota Board of Medical Practice
The Complementary and Alternative Health Care Providers Act, passed by the Minnesota Legislature during its 2000 session, became effective July 1, 2001.
This law, Minnesota Statues Chapter 146A, allows a broad scope of complementary and alternative modalities to be accessed by patients in Minnesota. The providers are not credentialed or regulated by the state. They do not have to meet any education or training standards. There is no definition of the scope of practice for any of the individual modalities.
The law does the following:
provides a definition of complementary and alternative care;
requires all providers to give each client a clients’ bill of rights;
defines prohibited acts, including unlicensed practice of medicine;
provides that if a complementary and alternative care provider is already licensed or registered by a health care licensing board, the provider remains under the jurisdiction of that board;
authorizes the Minnesota Department of Health to investigate allegations of misconduct by providers;
authorizes the Minnesota Department of Health to restrict a provider’s right to practice in order to protect the public.
NORTH CAROLINA
SELLING GOODS WITHIN A MEDICAL PRACTICE
From Forum, a publication of the North Carolina Medical Board
The North Carolina Medical Board in 2001 issued a new position statement on the sale of goods from physician offices. In it, the Board tells physicians they are not at liberty to engage in any form of commerce within their offices. Physicians are expected to sell their services, but when can physicians also sell goods as part of their practices? The position statement concerns both non-health related and health related goods, with different guidance for each.
NON-HEALTH RELATED GOODS
The Board holds that physicians “should not sell any non-health related goods from their offices or other treatment settings.” The position statement gives no examples, which would require an almost endless list of possibilities, but suffice to say that physicians should not sell telephone cards, household products, or other consumer items from their practices.
The Board does allow for the “Girl Scout cookie” exception. Physicians may sell Girl Scout cookies or any item that is low cost and for the benefit of charitable or community organizations, provided that physicians and/or their staffs receive no share of the proceeds, conduct sales only occasionally, and do not pressure patients into buying.
HEALTH-RELATED GOODS
The position statement permits the sale of “practice-related items,” including “ointments, creams, and lotions by dermatologists; splints and appliances by orthopedists; eyeglasses by ophthalmologists, etc.” Physicians may sell these “only after the patient has been told if those items, or generically similar items, can be obtained locally from another source.” The phrase “generically similar items” and the word “locally” are not further defined. Physicians are encouraged not to be exclusive distributors or to personally brand items.
This portion of the Position Statement differs from the AMA’s analogous Current Opinion, 8.063. The AMA speaks discouragingly of such sales as “present[ing] a financial conflict of interest, risk[ing] placing undue pressure on the patient, and threaten[ing] to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own.” The AMA would require that physicians:
sell only products with scientifically valid claims of benefit as judged by “peer-reviewed literature and other unbiased scientific sources”;
sell only products serving an “immediate and pressing need of patients,” such as selling crutches to a patient with broken leg;
sell at cost or give away all items not meeting the above criteria;
disclose their financial arrangements regarding such sales;
disclose the availability of products, or their equivalents, elsewhere; and
not engage in exclusive distributorships.
CONCLUSION
Physicians are expected to sell their services. Physicians are permitted to sell prescription drugs. Physicians who sell other things should carefully consider the Board’s new position statement. Physicians who come to look on their patients as potential customers for the sale of these other things can expect trouble from the Board.
TEXAS
PROFILES MANDATORY
From Medical Board Report, a publication of the Texas State Board of Medical Examiners
Texas Physician Profiles, enacted by the Legislature in 1999, became mandatory September 1. Beginning with annual registration applications mailed in September with an expiration date of November 30, 2001, physicians must have provided all profile information as specified by the legislation and TSBME rule. Profile information was collected on a voluntary basis during the past year as a pilot project.
At least 12 other states have passed physician profile legislation with content similar to the Texas profile. Legislation passed by the Texas legislature this spring created profile requirements for other professions, including attorneys, chiropractors, podiatrists, optometrists, physician therapists, occupational therapists, dentists, psychologists, and pharmacists.
Many Texas physicians have already provided all of their profile data during the voluntary pilot period. The first profiles became available to the public in September as required by the legislation.
Much of the information in the profile was already available to the public through license verifications. Profiles provide additional information about education and training along with new information about patient series, such as Medicaid acceptance, accessibility for persons with disabilities, hospital privileges, and any language translation services offered. The legislation also requires that physicians provide a description of any criminal charges and discipline taken by another state licensing board. Profile reports must also include any disciplinary actions taken by TSBME and the results of any investigations the Board conducted as a result of malpractice claims.
Some physicians expressed concerns about publication of their mailing address in the profile. In response, the Board has proposed rules to exclude the mailing address from the profile report. However, it will continue to be public information and will be reported in license verifications as it has been previously.
The law requires the board to collect and update the profile data at the time of annual registration of physician permits. Therefore, the size of the annual registration application has increased to 4 pages. The annual registration application will now display any profile information previously submitted by the physician in the pilot year as well as any Board restrictions or actions taken.
A NEW ANNUAL REGISTRATION PROCESS
The implementation of profiles has meant changes to the annual registration process. Physicians and others handling annual registration applications should pay close attention to the application and instructions to avoid delays in receiving a permit. Always allow at least 5 working days for processing of the application and fee.
Following are some changes that should be noted:
Data entry is being preformed by an outsource vendor and the completed application, along with payment, must be sent in the return envelope provided. Sending a completed application and fee directly to TSBME offices will delay the registration process since the application must be rerouted to the vendor for processing.
Do not separate the payment coupon from the rest of the application. Both parts must be mailed intact along with payment in the same return envelope to avoid delays.
Annual registration applications will be “pre-populated” with some profile information. A majority of physicians provided at least some of the profile data during this year’s pilot project. This information will be printed on your application. Other information already held by TSBME, such as disciplinary actions, will also be displayed so physicians can see what is being reported in their profile. You will need to complete all sections of the form that are not pre-populated as well as review the pre-populated data and make corrections as necessary to any information you previously submitted.
