NEW LAWS FOR 2002

By Catherine Hanson, J.D., CMA’s vice president for legal affairs.

Despite the 2001 energy crisis, the California Legislature last year still managed to pass a number of laws affecting the practice of medicine. The two of concern to most physicians relate to the Medical Board of California’s oversight of medical quality: One expands Section 805 reporting obligations and penalties, and the other requires physicians to obtain 12 CME hours in pain management and the appropriate care and treatment of terminally ill and dying patients. Depending on physicians’ specialties, however, other new laws may have significant bearing on how they run their practices and approach quality-of-care issues. All new laws discussed here took effect Jan. 1, 2002, unless otherwise noted.

MEDICAL BOARD OF CALIFORNIA

Expansion of Section 805 Reporting Obligations and Penalties
Section 805 of California’s Business & Professions Code has long required specified peer-review bodies to file prescribed reports with the appropriate licensing entity when a peer-review action relates to denial, rejection, termination, or revocation of medical staff privileges, membership, or employment based on any medical disciplinary cause or reason. Section 805 reports must also be filed when, based on any medical disciplinary cause or reason, privileges, membership, or employment are summarily suspended for more than 15 days or are restricted for a total of 30 days or more within any 12-month period–whether the suspension or restriction is determined by the peer review group or is self-imposed by the physician in question. Peer-review bodies must also file 805 reports on physicians who, after receiving notice of impending investigations indicating a medical or disciplinary cause or reason, resign or take leaves of absence from membership, staff privileges, or employment.

Additional 805 reporting obligations—805 reports are now required when a physician withdraws or abandons an application or request for renewal of staff privileges or membership in response to a notice of an impending investigation or impending denial or rejection for a medical disciplinary cause or action.

Increased penalties—The penalties for failing to make a required 805 report have been increased tenfold. For willful failures, MBC may levy a fine as high as $100,000, and if the person responsible for filing the report was a physician, the penalty potentially includes prosecution for unprofessional conduct. The law states that “voluntary and intentional violation of a known legal duty” constitutes willful failure. For nonwillful failures, the maximum fine is now $50,000. The fine must be proportional to the severity of the failure to report based on written findings on whether the failure caused patient harm or a risk to patient safety, whether the person who had the duty to report exercised due diligence or knew or should have known that the report would not be filed, or whether there had been a prior failure to file an 805 report. The fine may also be reduced if the matter involves a small or rural hospital as defined in Section 124840 of the Health & Safety Code. (Business & Professions Code §805)

Health plans may not automatically exclude physicians who have 805 reports on file—Health plans and health insurers are now prohibited from automatically excluding or deselecting physicians or other health care professionals who are the subject of an 805 report. Any action a health plan takes against a physician as a result of licensure probation must be reported to the Medical Board pursuant to Section 805 if the action is detrimental enough to meet the 805 reporting threshold and thus also triggers fair hearing rights for the physician under Business & Profession Code §809 et seq. (Business & Professions Code §805(m) and §805(f))

Comprehensive study of the peer-review process and Section 805 by IMQ—The Legislature has directed MBC to contract with the Institute for Medical Quality (IMQ) to conduct a comprehensive study of the peer-review process to evaluate “the continuing validity” of Sections 805 and 809-809.8 and “their relevance to the conduct of peer review in California,” and to issue a report no later than Nov. 1, 2002.

Among other things, the study is intended to determine the frequency of peer review and whether 805 requirements are being met, and to assess the cost of peer review to physicians and health facilities and the time required for completion of peer-review proceedings. The study must also describe the difficulties encountered by physicians and health facilities personnel who participate in peer review or who assemble peer-review panels.

IMQ, a CMA subsidiary long respected for quality-of-care surveillance, is prohibited from exercising authority over any entity’s peer-review process, but the law states that peer-review bodies, health facilities, clinics, and health plans must “cooperate with the Institute and provide data, information, and case files as requested in the time frame specified by the Institute.” (Business & Professions Code §805.2)

Other Medical Board– Related Laws
Mandatory CME for pain management—The Legislature has mandated that California physicians complete 12 hours of continuing medical education in pain management and the treatment of terminally ill and dying patients by Dec. 31, 2006. Physicians licensed on or after Jan. 1, 2002, must complete this requirement within four years of obtaining their initial license or by their second renewal date, whichever occurs first. Exempt from this CME requirement are pathologists, radiologists, and other categories of physicians MBC excuses because they do not engage in direct patient care, do not provide patient consultations, or do not reside in California. (Business & Professions Code §2241.6)

The Legislature intended that this law serve to broaden and update all physicians’ knowledge of appropriate care and treatment of patients suffering pain. In passing the law, the Legislature expressly stated, “For the past 20 years, medical journals have reported that physicians consistently fail to manage their patient’s pain appropriately. These studies also consistently report that the single most important cause of this problem is lack of physician knowledge and awareness regarding appropriate pain-management treatments.”

Interrogatories and MBC enforcement—State agencies may now “promulgate interrogatories pertinent or material to any inquiry, investigation, hearing, proceeding, or action.” CMA legal counsel strongly recommends that physicians do not respond to such requests from the Medical Board without expert legal assistance. (Government Code §§11181 and 11187)

Statute of limitations and MBC enforcement—The current statute of limitations for MBC prosecutions—three years from MBC discovery or seven years from occurrence—is now subject to the following exceptions, in addition to those for license fraud and intentional concealment:
• The seven-year limit extends to 10 years for cases involving alleged sexual misconduct.
• The limitations period does not begin to run during any period that an ongoing criminal investigation makes material evidence “unavailable to the board,” or, when the alleged act or omission involves a minor, until the minor turns 18. (Business & Professions Code §2230.5)

PATIENT'S RIGHTS

Hospital Discharges
Additions to written discharge policies—Hospitals now must have written discharge policies that include the following elements:
• Appropriate arrangements for post-hospital care must be made prior to discharge for patients “who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning.” This must include counseling of the patient and family members or individuals the hospital determines will be involved in providing the patient with post-hospital care.
• The patient, or the representative of the patient recognized by the law, must be informed, orally or in writing, of the continuing health care requirements following discharge, and each medication dispensed at the time of discharge.
• A transfer summary must be given to the patient or the patient’s representative and must accompany a patient being transferred to a skilled nursing facility, intermediate care facility, or distinct part-skilled nursing or intermediate care service unit of the hospital. The transfer summary must be signed by the physician who has authorized the transfer and must include essential information about the patient’s diagnosis, hospital course, pain treatment and management, medications, treatments, dietary requirements, rehabilitation potential, known allergies, and treatment plan. (Health & Safety Code §1262.5)

Written patients’ rights materials—In addition to other patients’ rights materials, hospitals must provide each patient on admission, or as soon as reasonably practical, written information on patients’ rights to: be informed of continuing health care requirements following discharge; authorize that a friend or family member be informed of the patient’s continuing health care requirements following discharge; participate actively in decisions regarding medical care, including the right to refuse treatment to the extent permitted by law; and appropriate pain assessment and treatment. A hospital must begin to fulfill this obligation once it has exhausted its current inventory of written patient-rights materials. (Health & Safety Code §1262.6)

Skilled Nursing Facilities
Admissions to skilled nursing facilities—New laws specify that skilled nursing facilities may admit patients only on a physician’s order, and only if the facility is able to provide necessary care for the patient. The skilled nursing facility administrator or designee must screen patients for admission to ensure the facility can provide the necessary care. Screening must include a preadmission personal interview (or, if not feasible, a telephone interview) with, as appropriate, the patient’s physician, patient, patient’s next of kin or sponsor, or representative of the facility from which the patient is being transferred. (Health & Safety Code §1262.7) No health plan or long-term care insurer may by contract prohibit or restrict any health facility’s compliance with these requirements. (Health & Safety Code §1262.7 and §1367.5; Insurance Codes §§10117.5, 10233.25)

OUTCOMES REPORTING

Public Reports of Medical Outcomes Data

For some time, the California Office of Statewide Health Planning and Development (OSHPD) has published hospital-specific risk-adjusted outcomes reports for various procedures and conditions. (For detailed information about these reports, see http://www.oshpd.state.ca.us.) The Legislature has now directed OSHPD to publish risk-adjusted outcomes reports—by hospital and by surgeon name—for surgical procedures.

The California Legislature and many health care experts around the country believe that improved collection and dissemination of medical outcomes data by hospital and, for surgical procedures or conditions, by surgeon will provide information needed to conduct quality-improvement efforts, improve decision-making by purchasers of health care and consumers, better inform decisions about resource allocation and regulation, and ultimately save money.

Outcomes of coronary artery bypass graft surgeries—The first of these new reports, to be issued July 1, 2005, will compare, by hospitals and by cardiac surgeons, outcomes of coronary artery bypass graft surgeries performed in California. OSHPD is entitled to only the “minimum data necessary,” and is directed to obtain that data from hospitals. Hospitals are directed to “make a reasonable effort to obtain the data from the physician’s office,” only when that is necessary. Disclosures must be risk-adjusted to ensure that physicians who treat older and sicker patients are not rated unfairly. OSHPD’s risk-adjustment model must be approved by a nine-member clinical panel consisting of three specialty society representatives, three CMA representatives, and three consumer representatives. (Health & Safety Code §128745 and §128748)

Surgeons’ right to review—This new law allows each each surgeon named in the report 30 days to review the preliminary report and, in the case of a dispute, to submit a statement contesting the report and explaining why the outcomes do not accurately reflect the quality of care provided by the physician. The law states that in response to a physician’s objection no flawed physician-specific data may be released until corrected, and no report based on a flawed risk-adjustment model may be released. If OSHPD disagrees with a physician’s objections, it must forward the disputed matter, while ensuring the physician’s anonymity, to the clinical panel for a final determination. (Health & Safety Code §128750)

Evaluation of reports’ impact—OSHPD must evaluate the impact of these outcome reports on mortality rates and any other quality measures OSHPD deems appropriate. (Health & Safety Code §128747)

MEDICAL RECORDS

Patients’ Access to Their Medical Records
Physicians have long been required to provide patients copies of their medical records subject to payment of a state-specified fee (generally 25 cents per page).

Free copy entitlement—Now patients, former patients, or their representatives are entitled to one free copy of the portion of the patient’s record relevant to appealing an eligibility denial for Medi-Cal, Social Security disability insurance, or Supplemental Security Income/State Supplementary Program for the Aged, Blind and Disabled (SSI/SSP) benefits. “Relevant” means the records regarding services provided from the time the patient applied for benefits until the denial of benefits.

The physician’s office must transmit the records within 30 days of receiving both a written request and proof (presumably a copy of the public-benefit program’s denial) that the records are needed to support the appeal. Physicians do not have to comply with this requirement when the patient is represented by a private attorney (one not employed by a nonprofit legal services entity) who is paying the costs of the appeal. Physicians may bill the patient for the copies if the patient’s appeal is successful. (Please see the sample request form on page 28.)(Health & Safety Code §123110)

Internet posting of lab results—A health care professional who has requested that a laboratory test be performed must, upon receipt of a written or oral request from the patient who had the test, provide the patient with the test results in plain language conveyed in the manner the health care professional deems most appropriate. The test results also must be recorded in the patient’s medical record and be reported to the patient within a reasonable time after they are received at the offices of the ordering practitioner.

Now physicians may comply with their obligation to provide clinical laboratory test results to patients by providing them in electronic form if: the patient consents (this requires written authorization), the physician reviews the results before they are delivered to the patient, the results are delivered to the patient within a reasonable period of time, access to the results is restricted by use of a secure personal identification number and otherwise meets all federal and state standards governing privacy and security of electronic medical records, the patient is advised of any charges that may be assessed to the patient or insurer for the privilege of receiving the results electronically, the patient is advised that he or she may call the physician for a more detailed explanation of the results, the results are not used for any commercial purpose without the patient’s written authorization, and patients are not required to pay anything if they refuse to receive the results electronically.

The following test results may not be transmitted to patients electronically: HIV antibody test; presence of antigens indicating hepatitis; drug abuse; and results related to routinely processed tissues, including skin biopsies, Pap smears, products of conception, and bone-marrow aspirations for morphological evaluation. Patients or physicians may revoke their consent to electronic transmission of test results at any time and without penalty, except to the extent action has already been taken in reliance on that consent. (Health & Safety Code §123148)

MANAGED CARE

Accurate provider lists required—Effective July 1, 2002, health plans must provide upon request a list of the contracting providers within the enrollee or prospective enrollee’s general geographic area, indicating which providers are not accepting new patients. The list must specify primary care providers, medical groups, IPAs, hospitals, and all other available contracting physicians, psychologists, acupuncturists, optometrists, podiatrists, chiropractors, licensed clinical social workers, marriage-and-family therapists, and nurse midwives.

The list must state that it is subject to change without notice; include a toll-free telephone number where enrollees can obtain current information, including whether or not a specific provider is accepting new patients; be provided in print or, with the enrollee’s permission, on the health plan’s Web site; and be updated at least quarterly (an insert or addendum to a printed provider directory suffices).

Health plans must also on request make the following information on their contracting health care professionals available in writing or through their toll-free telephone number: professional degree, board certification, and any recognized subspecialty qualification a specialist may have.

A health plan may delegate the obligations imposed by this law to its contracting intermediaries or specialized health care service plans, but if it does so, it must ensure that these requirements are met. (Health & Safety Code §1367.26)

Continuity of mental health care—Health care service plans (usually HMOs) and health insurers have long had an obligation to file a written policy with the Department of Managed Health Care (DMHC) or Department of Insurance (DOI) describing how they will facilitate continuity of care for new group-plan enrollees who were receiving services for an acute condition from a nonparticipating physician.

Effective July 1, 2002, health plans that provide employer-sponsored group coverage for specialized health care, including professional mental health services, must also file with the DMHC or DOI a written policy describing how these plans will facilitate continuity of care for new enrollees who have been receiving services for an acute, serious, or chronic mental health condition from a nonparticipating mental health provider when the enrollee’s employer has changed health plans.

This policy must allow the new enrollee a reasonable transition period to continue his or her course of treatment with that nonparticipating provider prior to transfer to another mental health provider and must include the provision of timely, appropriate, and medically necessary services. The policy may take into account the severity of the enrollee’s condition and the amount of time reasonably necessary to effect a safe transfer on a case-by-case basis.

Health plans are not required to accept the affected patients’ nonparticipating mental health professionals onto their panels, but they may require such participation as a condition of allowing them to continue to provide care to the patients.

With respect to either acute medical conditions or acute, serious, or chronic mental health conditions, the written policy must describe how requests to continue services with an existing physician are reviewed by the plan. The policy must ensure that reasonable consideration is given to the potential clinical effect that a change of physician would have on the enrollee’s treatment. Notice of the policy and information regarding how enrollees may request a review under the policy must be provided to all new enrollees, except those who were offered an out-of-network option, or who had the option to continue with their previous health plan or physician and voluntarily chose to change plans.

A plan may require any nonparticipating physician whose services are continued to agree in writing to meet the same contractual terms imposed on participating physicians, including location within the plan’s service area and reimbursement rates and methodologies. A plan is not liable for actions resulting solely from the negligence or malpractice of the existing physician.

This law does not apply to health plan contracts that include out-of-network coverage under which the enrollee is able to obtain services from the enrollee’s existing provider. (Please see page 32 for a sample letter physicians can use to request maintenance of a physician-patient relationship under this law.) (Health & Safety Code §1373.95; Insurance Code §10133.55)

CONSENT

Liability for disposition of remains—An agent acting under a power of attorney for health care is not liable for the disposition of a patient’s remains unless the agent specifically agrees to pay the costs or makes decisions that incur costs exceeding the resources available in the decedent’s estate or “other appropriate fund.” (Health & Safety Code §7100)

Orally designated surrogates—A patient’s oral designation of a surrogate is effective only for the shorter of the course of treatment or illness, the stay in the health care institution when the designation is made, or 60 days. The expiration of an oral designation does not affect the role the designee may have in making health care decisions under any other law or standards of practice.

The orally designated surrogate takes precedence over a power-of-attorney-for-health-care agent while the designation is effective, but the oral designation does not revoke the designation of the agent unless the patient communicates the intention to revoke that designation. (Probate Code §4711)

Contacting surrogates for incapacitated emergency patients—A new law requires that within 24 hours of an unconscious or noncommunicative patient’s arrival in an emergency department, acute care hospitals must make reasonable efforts to contact the patient’s “agent, surrogate, or family member or the person the hospital reasonably believes has the authority to make health care decisions.” The “reasonable effort” requirement is met by examining the patient’s personal effects, available medical records, and reports by emergency medical technicians or police for information about such agents, and contacting or attempting to contact any such agent.

The hospital must document in the patient’s medical record all efforts made to contact an agent or surrogate. Application of this section is suspended during any period in which the hospital implements its disaster and mass casualty program or its fire and internal disaster program. (Probate Code §4716)

Parity for domestic partner—Domestic partners now have the same authority as spouses to make health care decisions for each other if one of them becomes incapacitated. (Probate Code §4716)

Domestic partners are defined as “two adults who have chosen to share one another’s lives in an intimate and committed relationship of mutual caring,” who have both filed a “Declaration of Domestic Partnership” with the Secretary of State, and who otherwise meet the requirements of Family Code §297.

CMA legal counsel believes physicians should be able to rely on their patients’ representation of domestic partnership, at least in the absence of any reason to doubt its veracity. Physicians should document in the medical record the fact that this representation was made. Or, physicians may wish to work with their institutions to develop the appropriate documents for completion by patients and potential surrogates claiming domestic partner status.

GYNECOLOGICAL CANCER INFORMATION

For several years, the physician primarily responsible for performing a patient’s annual gynecological examination has been responsible for providing that patient with standardized information, written in lay language, about symptoms and appropriate methods for diagnosing gynecological cancers. DHS publishes an acceptable brochure, which is available in Spanish or English, and copies can be obtained from the Office of Women’s Health by fax (916/653-3535), phone (916/653-3330), or Web site (http://www.dhs.ca.gov/director/owh).

Citations and fines—The law now states that a physician who violates this requirement may be cited and fined by the MBC on the second and subsequent violations. (Business & Professions Code §2249)

ABUSE REPORTING

Child-abuse reporting—Effective July 31, 2001, physicians are authorized, but are not required, to report known or reasonably suspected instances in which mental suffering has been inflicted on a child, or a child’s emotional well-being is endangered in any other way, when physicians learn of this suffering outside their professional capacity or scope of employment. (Penal Code §11166.05)

CMA legal counsel advises that because there may be disagreement as to what constitutes “neglect” versus endangerment of a child’s well-being, when learning of such suffering in their professional capacity, physicians are best advised to report endangerment of a child’s well-being pursuant to their mandatory-reporting obligations.

Enhanced forensic evaluation of domestic violence or elder abuse—The California Legislature has found that “adequate protection of victims of domestic violence and of elder and dependent-adult abuse has been hampered by lack of consistent and comprehensive medical examinations. Enhancing examination procedures, documentation, and evidence collection will improve investigation and prosecution efforts.” Based on these findings, the Office of Criminal Justice must establish, by Jan. 1, 2003, medical forensic forms, instructions, and an examination protocol for victims of domestic violence and elder and dependent-adult abuse and neglect, using the sexual-assault form and guidelines as a model. These forms are to be accessible on the Internet.

This new law requires that the Department of Justice work with CMA and other stakeholders to develop these forms and to determine whether it would be appropriate and forensically sound to develop separate or joint forms for medical findings relating to the different types of abuse. (Penal Code §11161.2)

PHYSICIAN OVERTIME

Physicians whose primary duties require licensure and who are paid at least $55 per hour (to be adjusted annually each October 1—to be effective the following January 1—by the percentage increase in the California Consumer Price Index for urban wage earners and clerical workers) do not have to be paid for overtime per Labor Code §510. This exemption does not apply to interns or residents or physicians covered by valid collective-bargaining agreements. (Labor Code §515.6)

WORKERS’ COMP

Workers’ compensation review companies—Employers or workers’ compensation insurers that contract with bill-review companies must now make available to such companies the bills and all documentation submitted by the health care provider. If a review company needs more information, it must contact the claims administrator or insurer to obtain it. Review companies are prohibited from altering the procedure codes billed or from recommending reduction of the bill before they have received the documentation. If the review company recommends a reduction, it must give the health care provider a specific explanation for the reduction or alteration of the procedure code, identifying the specific billing or documentation deficiency leading the company to conclude that its recommended payment “more accurately represents the service performed.”

This section does not apply when the review company reduces the bill to the amount specified in the Official Medical Fee Schedule (OMFS) (see below), preferred provider contract, or other negotiated rate for the codes billed, unless the health care provider has billed more for “extraordinary services.” The Workers’ Compensation Appeals Board (WCAB) has jurisdiction over disputes arising out of this section. (Labor Code §4603.2)

Workers’ compensation fee schedule—Health care providers and health facilities may now contract with employers’ workers’ comp carriers or “contracting agents” to provide services at rates that differ from, and even exceed, the OMFS. (Labor Code §5307.11)

ALLIED HEALTH PROFESSIONALS
Nurse midwives and controlled substances—Certified nurse midwives with DEA certificates are now allowed to order or furnish controlled substances under the following circumstances:

• The midwives practice in those settings in and conditions under which the law has previously authorized them to furnish prescription drugs. Those settings now include licensed birth centers.
• The furnishing or ordering of Schedule II or III drugs follows a patient-specific protocol approved by the treating or supervising physician. Schedule II drugs may only be furnished or ordered in a licensed acute care hospital.

A copy of the section of certified midwives’ standardized procedure relating to controlled substances must be provided on request to any licensed pharmacist who is uncertain about the midwife’s authority. (Business & Professions Code §2746.51)

Supervision of medical assistants—In community or free clinics only, certified nurse practitioners (CNP), certified nurse midwives (CNM), and physician assistants (PA) may now supervise the work of the medical assistants when the physician is not physically present. Such supervision may take place only on a clinic’s supervising physician’s written authorization delegating medical assistant supervision to the CNP, CNM, or PA. These written instructions may authorize medical assistants to perform tasks when the supervising physician is not on site, as long as the following apply:

• The CNP or CNM is working under standardized procedures as defined by §2725 of the Business & Professions Code or protocol.
• The physician assistant is providing services authorized by Business & Professions Code §3502, and is approved to do so by the supervising physician. (Business & Professions Code §2069)

Psychotherapist definition expanded—The application of the psychotherapist-patient privilege has been expanded to cover all communications between patients and people who are, or who the patient reasonably believes to be, psychotherapists. Effective Oct. 2, 2001, advance-practice RNs who are certified as clinical nurse specialists and who participate in expert clinical practice in the specialty of psychiatric/mental health nursing are “psychotherapists” for the purpose of the privilege. (Evidence Code §1010)

Pharmacists
Skin punctures for routine assessments—To clarify previous ambiguities under the law, Business & Professions Code §§1206.5 and 4052.1 now provide that when performing routine patient-assessment procedures, pharmacists may perform skin punctures together with simple “waived” clinical laboratory tests (see http://www.hcfa.gov/medicaid/clia/cliahome.htm for the current list) as long as they do so under the overall operation and administration of a clinical laboratory director.

Emergency contraception—A new law allows a pharmacist to initiate dispensing of emergency contraception (the morning-after pill) provided a physician or other “authorized prescriber acting within his or her scope of practice” develops with the pharmacist standardized procedures or protocols for the initiation of an emergency contraception prescription, and the pharmacist has completed a training program on emergency contraception. The pharmacist must give each recipient of emergency contraception drugs a standardized fact sheet covering the indications for use of the drug, how to use it, the need for medical follow-up, and other appropriate information. (Business & Professions Code §4052)

Therapeutic substitution—Effective Jan. 1, 2002, a pharmacist may “select a different form of medication with the same active chemical ingredients of equivalent strength and duration of therapy as the prescribed drug product,” provided both of the following conditions are met: The change will improve the patient’s ability to comply with the prescribed drug therapy; and the prescriber has not stated, “Do not substitute,” either orally or in handwriting or in a personally initialed check box on the prescription form.

The pharmacist who substitutes a drug under this law assumes “the same responsibility for selecting the dispensed product as would be incurred in filling a prescription for a drug product using the prescribed form of medication.” On the other hand, a prescriber incurs no liability for a pharmacist’s substitution pursuant to this law. (Business & Professions Code §4052.5)

Therapeutic initiation or adjustment in hospitals and other settings—In another scope-of-practice expansion, a pharmacist who is acting as part of the care provided by a licensed health care facility, licensed home-care health agency, or licensed clinic in which there is physician oversight, or a health care professional who contracts with a health plan with regard to a plan enrollee, or a physician, may “initiate” or “adjust” a patient’s drug regimen provided all of three conditions are met.

First, the patient’s physician or other prescriber has issued a specific written order or authorization allowing the pharmacist to do so for the specific patient.

Second, the pharmacist is following policies, procedures, or protocols developed by physicians, pharmacists, and nurses requiring that: a) the pharmacist function as part of a multidisciplinary group including physicians and nurses; b) both the pharmacist and the patient’s prescriber have access to the patient’s medical records, and c) the patient has first been seen by a physician for the condition.

With respect to cases involving licensed health care facilities (generally hospitals and other institutional facilities defined in Health & Safety Code §1250), the policies, procedures, or protocols must additionally have been approved by the facility administrator, and the pharmacist must have received appropriate training as specified in those policies and procedures.

For home health care agencies, clinics, health plans, or physicians, the pharmacist must have either successfully completed clinical residency training or demonstrated clinical experience in direct patient care. Moreover, a pharmacist who initiates a drug regimen must, within 24 hours, notify the patient’s prescriber or enter the appropriate information in an electronic patient record system shared by the physician. With respect to home health care agencies only, such pharmacist-generated medication changes, adjustments, or modifications may occur only where there is a written, patient-specific protocol approved by the treating or supervising physician, and the pharmacist must notify the treating or supervising physician of any such actions in writing within 24 hours.

Third, the pharmacist’s access to prescription, patient-profile, and other relevant medical interactions is secure from unauthorized access and use. (Business & Professions Code §§4051 and 4052) cp

CMA resources for more information on these and other laws affecting medical practice:

• 2001 California Physician’s Legal Handbook.To order CPLH, see the ad on page 24.
• CMA ON-CALL, the24-hour information-on-demand service. Available free to members on the Internet at www.cmanet.org/logon. Also available by fax by calling 800/592-4CMA ($1 per page for members, $2 per page for nonmembers; index is free).
• If you have further questions, contact CMA’s legal division (legalinfo@calmed.org or 415/882-5144).