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New Law Alert
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The California Legislature recently enacted a number of new laws affecting physicians, non-physician clinicians, health care plans, and patients. Effective January 1, 2004 (unless noted otherwise): nurse practitioners may furnish or order Schedule II controlled substances; physicians providing prenatal care are required to obtain a blood specimen to test for the Rh blood type, Hepatitis B skin antigen and HIV, unless the pregnant patient does not consent to testing; patients undergoing infertility treatments must be allowed to determine the disposition of embryos remaining after treatment is completed; psychologists may authorize the early release of persons under 72-hour holds or other involuntary psychiatric holds, if specified criteria has been met; medical assistants cannot perform clinical laboratory tests; pharmacists may furnish emergency contraceptive drug therapy; authorization forms for the release of medical information must be in 14-point type; by January 1,2005, physicians who prescribe Schedule II controlled substances will be asked to use “security printer" forms instead of the Department of Justice's triplicate forms; and language translation services and information must be provided by health service providers and health insurers. Nurse practitioners authorized to furnish or order Schedule II controlled substancesBusiness & Professions Code §2836.1 has been amended to allow nurse practitioners (NP) to furnish or order Schedule II through Schedule V controlled substances as defined by the California Uniform Controlled Substances Act. The drugs are limited to those agreed upon by the NP, supervising physician or surgeon, and as specified in the NP’s pre-approved standardized procedure or protocol. When furnishing Schedule II or III controlled substances, patient-specific protocols and procedures must be approved by the supervising physician or surgeon. Schedule II controlled substances require the standardized procedure to include the diagnosis of the illness, injury, or condition for which a Schedule II drug may be ordered or furnished. A copy of the nurse practitioner’s standardized procedure regarding controlled substances must be given to a requesting pharmacist if there is uncertainty about the NP furnishing the order. Nurse practitioners who furnish or order Schedule II drugs, must complete as part of their continuing education requirements, a course which includes discussion of Schedule II controlled substances. The continuing education course must adhere to standards developed by the Board of Registered Nursing. A reminder to MIEC policyholders: Physician or surgeon supervision of nurse practitioners does not require the physician’s physical presence; however, the physician and NP must collaborate and approve the NP's standardized procedure, and the physician must be telephonically available to the nurse practitioner when patients are examined. No physician or surgeon can supervise more than four nurse practitioners at one time. [Business & Professions Code §2836.1 (d) and (e)] HIV blood test for pregnant womenAs early as possible during a pregnant woman’s prenatal care, the physician, surgeon or other person providing prenatal care, or attending the patient at the time of delivery, is obligated under Health and Safety Code §125080 to attempt to obtain a blood specimen. The sample must be submitted for testing to determine rhesus (Rh) blood type, the presence of the Hepatitis B surface antigen, and HIV. Test results must be reported to the ordering physician and to the patient. A positive Hepatitis B and/or HIV test must be reported to the local health officer “with the information required and within the time frame” established by the California Code of Regulations, Title 17 Public Health starting at §2500. [Health & Safety Code §125085] Prior to obtaining a blood specimen, the treating physician must inform the pregnant woman: (1) of his/her intent to test for HIV; (2) of the routine nature of the test; (3) of the purpose of the test; (4) of the risks and benefits of the test; (5) of the risk of perinatal HIV transmission; (6) that approved treatments are known to decrease the risk of perinatal HIV transmission; and (7) that the woman has the right to accept or refuse the test. Consent for the HIV testing must be documented on a form developed by the Department of Health Services (DHS) and the Office of AIDS or on a form “substantially equivalent in content.” The patient must sign the form and a copy of the completed form must be kept in the patient’s medical chart. The DHS form provides sufficient documentation, and no laboratory or health care provider may require any additional written consent or written form as a condition for HIV testing. Once the test results have been received, the ordering health care provider must ensure that the pregnant patient receives information and counseling to explain the results and the implications to the mother’s and infant’s health, and the importance of receiving follow-up care. If the test resu1ts are positive, and whenever possible, the physician should refer the patient to a provider, provider group, or institution that specializes in prenatal care for HIV positive women. [Health & Safety Code §125090 and §125107 (d)] A reminder to MIEC policyholders: If a pregnant patient refuses to have the blood specimen tested for HIV, the treating physician should clearly document her refusal in the prenatal record. If the DHS consent form provides a space to note the patient's refusal, the physician may use the form to document refusal. Of note, by December 31, 2004, the DHS, Office of AIDS and other “stakeholders” must develop culturally-sensitive consent forms in English, Spanish, and other languages to be used when physicians obtain consent from Medi-Cal patients for the above-mentioned blood test. The form must include information about available referral and consultation resources for prenatal HIV treatment. [Health & Safety Code §125092] Fertility treatment and the disposition of human embryosInfertility patients must be allowed to make an informed, voluntary choice related to the disposition of any human embryos that remain following fertility treatment. A physician, surgeon, or other health care provider delivering infertility treatments must give their patients timely, relevant, and appropriate information to make an informed decision regarding remaining embryos generated during the treatment. The physician providing the treatment must give “the male and female partner, or the individual without a partner” a form that delineates advanced written directives as to the disposition of the embryos. The form must indicate the time limit on storage of the embryos and provide the following minimum disposition options in the event of the death of one or both partners, divorce or separation, decision to abandon, or failure to pay storage fees. Minimum disposition requirements include: (1) availability to the living partner; (2) availability to the male and female partner in the case of divorce or separation; (3) donation to research; (4) thawed with no further action; (5) donations to others; or (6) other disposition that is clearly stated. Should a patient consider donating the remaining embryos to research, the health care provider is obligated to provide a statement conveying how the embryos will be used, including derivation uses for human pluripotent stem cell research and human transplant research. Furthermore, the statement must address proper de-identification of the embryos and also indicate: (1) that donors will not receive subsequent information related to the testing of the embryos; (2) that derived cells or cell lines may be kept for years; (3) that the donor will receive no financial benefit related to any future commercial development; as human pluripotent stem cell research is not intended to directly benefit the donor; (4) that donated embryos will not be transferred to a woman’s uterus, nor will they survive the human pluripotent stem cell derivation process; (5) and that the embryos will be handled respectfully and in a manner customary for human tissue research. The patient’s consent must be in writing. Failure to provide patients with this information or to obtain written consent constitutes unprofessional conduct. [Health & Safety Code §125315] 5150 Hold and authorization for the patient's early releaseSeveral sections of California's Welfare & Institutions Code have been amended to allow psychologists to recommend, participate in a collaborative decision, and subsequently authorize an early release of patients in the following circumstances: involuntary 72-hour holds; involuntary commitments; certification for imminently suicidal persons; and certification of intensive treatment. These changes in the laws “shall not be construed to revise or to expand the scope of practice of psychologists.” [Welfare & Institutions Codes amended §§5152, 5257, 5264, and 5270.35] “[I]n those situations in which both a psychiatrist and psychologist have personally evaluated or examined a person who is placed under a 72-hour hold and there is a collaborative treatment relationship . . . either the psychiatrist or psychologist may authorize the release of the person from the hold, but only after they have consulted with one another.” If the two health care providers disagree about the early release, the hold must be maintained unless the facility’s medical director overrules the decision of either the opposing psychiatrist or psychologist. Both practitioners must document their findings, concerns, or objections in the medical record. [Welfare & Institutions Code §5152(a); See also §§5257, 5264, and 5270.35 applying similar language to psychiatrist and psychologist collaboration requirements.] If any other “professional person who is authorized to release the person” believes the patient can be released early but the treating psychiatrist objects, the case must be referred to the medical director. “If the matter is referred, the person shall be released before 72-hours have elapsed only if the psychiatrist making the final decision believes, as a result of the psychiatrist’s personal observations, that the person no longer requires evaluation or treatment.” [Welfare & Institutions Code §5152( a)] A person involuntarily detained at a mental health facility, and for whom post-discharge medication is prescribed, must be given written and oral information about the possible and probable side effects of the drug. A person designated by the mental health facility must provide the patient with the following information: (1) for what mental illness or behavior the patient is receiving medication; (2) the likelihood of improving or not improving without the medication; (3) reasonable alternative treatments available; and (4) the name, type, frequency, amount, instructions related to taking the medication, and the probable length of time the patient will need to take the drug. The designated individual must document in the patient’s medical chart that the information was provided to the patient. The State Department of Mental Health will develop and publicize written materials related to the effects of medications for use by county mental health staff or employees or administration to disseminate to county mental health programs. [Welfare & Institutions Code §5152(c)] Medical assistants and clinical laboratory testsBusiness and Professions Code §2069 has been amended to clarify that medical assistants may not perform clinical laboratory tests or examinations unless specifically authorized by the definitions found in California’s clinical laboratory laws commencing at §1206.5 of the Business & Professions Code. Clinical laboratory tests or examination “means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within the biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.” [Business and Professions Code §1206 (a)(4)] Furthermore, Business and Professions Code §2069 has been amended to clarify that the statute shall not be construed as an authorization for nurse practitioners, nurse-midwives or physician assistants to act as a laboratory director. Emergency contraceptionA pharmacist may furnish emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber, or by both the Pharmacy Board and Medical Board of California in consultation with the American College of Obstetricians and Gynecologists (ACOG), the California Pharmacists Association and other appropriate organizations. The pharmacist must have completed a training program on emergency contraception that includes at least one hour of continuing education on the subject. The pharmacist cannot require the person requesting emergency contraception drug therapy to provide individually identifiable medical information except as allowed by California’s Code of Regulation, Title 16 at §1707.1 for the purpose of maintaining a patient’s medication record. [Business & Professions Code §4052 (a)(8)] Recipients of emergency contraception must be given a standardized fact sheet, developed by the above-mentioned entities or by another nationally recognized medical organization. The fact sheet must include: indications for use of the drug; how to appropriately use the drug; the need for medical follow-up; and other pertinent information. [Business & Professions Code §4052 (b)] The amended code sections outline what fees a pharmacist providing emergency contraception drug therapy may charge patients. In particular, a pharmacist may not directly charge a patient a separate consultation fee, but the pharmacist may charge an administration fee not to exceed ten dollars ($10.00). [Business & Professions Code §§682 and 4052] Triplicate prescription form eliminatedThe California Legislature has eliminated the required triplicate form for prescribing Schedule II controlled substances in an effort to “increase patient access to appropriate pain medication and prevent the diversion of controlled substances for illicit use,” and to simplify prescription forms. Under the new law, effective January 1, 2005, a health care provider may prescribe any drug or device, including Schedule II controlled substances, using the official forms produced by “security printers,” defined as persons approved by the Board of Pharmacy to produce controlled substance prescription forms. The new prescription forms must contain: (1) a latent repetitive “void” pattern printed across its front (in the event the prescription is scanned or photocopied, the word “void” will appear on the form); (2) a watermark on the back of the form which reads, “California Security Prescription;” (3) a chemical void protection; (4) a feature printed in thermo-chromic ink; (5) an area of opaque writing that disappears if the prescription is lightened; (6) a description of the form’s security features; (7) six quantity check boxes; (8) a statement that the form is void if it contains more than one prescription per blank space; and (9) the prescriber’s name, category of licensure, license number, and federal controlled substance registration number. [Health & Safety Code §11162.1] Between July 1, 2004, and January 1, 2005, physicians can use either the Department of Justice’s triplicate forms or the new "security printer" forms to prescribe Schedule II controlled substances. The prescriber must sign in ink and the prescription should contain the date, the patient's name and address, the drug name, quantity, strength and instructions, and the provider’s address, category of professional licensure, and federal controlled substance registration number. The original and duplicate of the prescription must be delivered to the pharmacist filling the Schedule II medication, who will retain the duplicate copy, properly endorse the original and send it to the Department of Justice at the end of the month during which the prescription was filled. A pharmacist filling the prescription may correct errors on the medication request if they notify the prescribing physician, the healthcare provider approves the correction, and a corrected prescription is mailed to the pharmacist within seven (7) days of the prescription being dispensed. [Health & Safety Code §11164] Prescriptions for Schedule III, IV, or V controlled substances have similar requirements. However, they may be dispensed upon an oral request or electronically transmitted prescription, so long as a hard copy is subsequently produced.
[Health & Safety Code §11164] If a physician dispenses Schedule II controlled substances from their office, the practitioner must document: (1) the patient's name, address, gender and date of birth; (2) the prescriber’s category of licensure, federal controlled substance registration number, etc.; (3) the pharmacy prescription number, license number, federal controlled substance registration number, etc.; (4) the National Drug Code of the medication dispensed; (5) the quantity dispensed; (6) the ICD-9 code, if available; and (7) the date the medication was dispensed. The prescriber is required to send this information to the Department of Justice in hard copy or electronic form every month. Starting January 1, 2005, physicians must document and transmit similar information to the Department of Justice when they dispense Schedule III controlled substances. [Health & Safety Code §11190] Furthermore, as of July 1, 2004, prescriptions for Schedule II medications dispensed to terminally ill patients must meet the following requirements; (1) the prescription must be made using the Department of Justice triplicate form signed in ink by the prescribing physician or new security printer forms described in §11162.1, and (2) the provider must certify the patient is terminally ill by using the words “11159.2 Exemption” on the prescription form. If the physician fails to include the “exemption” language, a pharmacist may fill the prescription request only if the pharmacist has personal knowledge of the patient's terminal illness, and subsequently returns the prescription to the physician within 72-hours for correction. [Health & Safety Code §11159.2] For purposes of Health & Safety Code §11159.2 “terminally ill” is defined as follows: (1) reasonable medical judgment of the prescribing physician that the patient suffers from an incurable and irreversible illness; (2) if the illness takes its normal course, the patient will succumb to it within one year; and (3) prescribing the Schedule II controlled substance is for pain or symptom management rather than to cure the illness. Authorization form: release of medical informationAuthorization forms for release of medical information, genetic testing results disclosure authorizations, and employer authorizations for the disclosure of medical information must be printed in typeface no smaller than 14-point type, an increase from the previously accepted 8-point type. [Civil Code §§56.11, 56.17, and 56.21] Language translation for health care service plan enrollees with limited English language proficiencyBy January 1, 2006, the Department of Managed Health Care and the California Insurance Commissioner must adopt regulations and standards for language translation materials and language assistance to health care service plan enrollees and health insurance consumers which are provided by health insurance and health care service plan providers. Every health care service plan, specialized health care service plan, or health insurer must first assess the linguistic needs of the enrollee population, excluding Medi-Cal enrollees, in order to determine the translation and interpretation needs for medical services provided or which require assistance in obtaining covered benefits. The new regulations will include requirements for the translation of all vital documents produced by insurers and health care service plans. Vital documents are defined as: applications; consent forms; letters that contain eligibility and participation criteria notices pertaining to denial, reduction, modification or termination of services and benefits, or the right to file a grievance or appeal; and notices to advise limited English proficient enrollees of free language services. Translated languages will be specifically assessed by patient population criteria. However, explanation of benefits, or similar claims processing information, do not require translation, unless the document specifically requests the enrollee to respond to the plan. Contracts between health care providers and health care service plans must comply with the standards developed under these sections of the Health & Safety Code and Insurance Code. Furthermore, providers must cooperate with the language plan and provide any information necessary to assess compliance. [Health & Safety Code §1367.04 and Insurance Code §10133.8] MIEC’s legal consultant for this newsletter was William A. Miller, Esq., of Hassard Bonnington LLP, San Francisco, California.
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