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Laws Of The State Of California

Cancer & Biopsy

CALIFORNIA CODES
HEALTH AND SAFETY CODE
SECTION 109250-109295

109250.  The effective diagnosis, care, treatment or cure of persons
suffering from cancer is of paramount public importance.  Vital
statistics indicate that approximately 16 percent of the total deaths
in the United States annually result from one or another of the
forms of cancer.  It is established that accurate and early diagnosis
of many forms of cancer, followed by prompt application of methods
of treatment that are scientifically proven, either materially
reduces the likelihood of death from cancer or may materially prolong
the useful life of individuals suffering therefrom.


   Despite intensive campaigns of public education, there is a lack
of adequate and accurate information among the public with respect to
presently proven methods for the diagnosis, treatment, and cure of
cancer.  Various persons in this state have represented and continue
to represent themselves as possessing medicines, methods, techniques,
skills, or devices for the effective diagnosis, treatment, or cure
of cancer, whose representations are misleading to the public, with
the result that large numbers of the public, relying on the
representations, needlessly die of cancer, and substantial amounts of
the savings of individuals and families relying on the
representations are needlessly wasted.


   It is, therefore, in the public interest that the public be
afforded full and accurate knowledge as to the facilities and methods
for the diagnosis, treatment, and cure of cancer available in this
state and that to that end there be provided means for testing and
investigating the value or lack thereof of alleged cancer remedies,
devices, drugs, or compounds, and informing the public of the facts
found, and protecting the public from misrepresentation in these
matters.


   The importance of continuing scientific research to determine the
cause or cure of cancer is recognized, and the department shall
administer this article and Article 2 (commencing with Section
109300) with due regard for the importance of bona fide scientific
research and the clinical testing in hospitals, clinics, or similar
institutions of new drugs or compounds.

109255.  There is in the department a Cancer Advisory Council
composed of nine physicians and surgeons licensed to practice
medicine in, and residing in, this state, three persons who are not
physicians and surgeons, two persons representing nonprofit cancer
research institutes recognized by the National Cancer Institute, and
the director of the department, who shall be an ex officio member.
The members of the council shall be appointed by the Governor to
serve for terms of four years.  The Governor, in appointing the first
members, shall appoint at least one member from the faculty of each
of the schools teaching medicine and surgery and located in this
state that are approved by the Medical Board of California.  The
Governor shall endeavor to maintain one member from the faculty of
each school in making subsequent appointments.

109260.  The members of the council, other than the director of the
department, shall receive no compensation for their services, but
shall be allowed their actual necessary traveling expenses incurred
in the discharge of their duties.
   Except as provided in Section 109390 the council is not required
to conduct meetings open to the public in accordance with Article 9
(commencing with Section 11120) of Chapter 1 of Part 1 of Division 3
of Title 2 of the Government Code.

109265.  The council shall annually elect one of its members to
serve as chairman.  The council shall meet at least twice each year,
and as often in addition as necessary, for the purpose of carrying
out its duties.

109270.  The department shall:
   (a) Prescribe reasonable regulations with respect to the
administration of this article and Article 2 (commencing with Section
109300).
   (b) Investigate violations of this article and Article 2
(commencing with Section 109300), and report the violations to the
appropriate enforcement authority.
   (c) Secure the investigation and testing of the content, method of
preparation, efficacy, or use of drugs, medicines, compounds, or
devices proposed to be used, or used, by any individual, person,
firm, association, or other entity in the state for the diagnosis,
treatment, or cure of cancer, prescribe reasonable regulations with
respect to the investigation and testing, and make findings of fact
and recommendations upon completion of any such investigation and
testing.
   (d) Adopt a regulation prohibiting the prescription,
administration, sale or other distribution of any drug, substance, or
device found to be harmful or of no value in the diagnosis,
prevention or treatment of cancer.
   (e) Hold hearings in respect of those matters involving compliance
with this article and Article 2 (commencing with Section 109300) and
subpoena witnesses and documents.  Any or all hearings may be held
before the Cancer Advisory Council.  Any administrative action to be
taken by the department as a result of the hearings shall be taken
only after receipt of the recommendations of the council.  Prior to
issuance of a cease and desist order under Section 109345, a hearing
shall be held.  The person furnishing a sample under Section 109295
shall be given due notice of the hearing and an opportunity to be
heard.
   (f) Contract with independent scientific consultants for
specialized services and advice.
   In the exercise of the powers granted by this section, the
department shall consult with the Cancer Advisory Council.

109275.  (a) Physicians and surgeons shall inform patients being
treated for any form of breast cancer of the alternative efficacious
methods of treatment by providing the patient with the written
summary described in subdivision (c).
   (b) The failure of a physician and surgeon to inform a patient, by
means of a standardized written summary developed by the department
on the recommendation of the Cancer Advisory Council in accordance
with subdivision (c), in layman's language and in a language
understood by the patient, of alternative efficacious methods of
treatment that may be medically viable, including surgical,
radiological, or chemotherapeutic treatments or combinations thereof,
when the patient is being treated for any form of breast cancer,
constitutes unprofessional conduct within the meaning of Chapter 5
(commencing with Section 2000) of Division 2 of the Business and
Professions Code.
   (c) (1) A standardized written summary in layman's language and in
a language understood by the patient shall be developed by the
department with the recommendations of the Cancer Advisory Council,
and shall be printed and made available by the Medical Board of
California to physicians and surgeons, for the purposes of informing
the patient of the advantages, disadvantages, risks and descriptions
of the procedures with regard to medically viable and efficacious
alternative methods of treatment for breast cancer as required by
subdivision (a).
   (2) Commencing no later than January 1, 1995, and every three
years thereafter, the department shall review the written summary and
shall revise the written summary if the department determines that
new or revised information should be included in the written summary.

   (3) At the next revision of the standardized written summary
required by this section, the department shall incorporate all of the
following additional information:
   (A) Information regarding methods of treatment for breast cancer
that are in the investigational or clinical trial stage and are
recognized for treatment by the Physician's Data Query of the
National Cancer Institute.
   (B) Available reference numbers, including, but not limited to,
the "800" telephone numbers for the National Cancer Institute and the
American Cancer Society, in order for breast cancer patients to
obtain the most recent information.
   (C) A discussion of breast reconstruction surgery, including, but
not limited to, problems, benefits, and alternatives.
   (D) Statistics on the incidence of breast cancer.
   (d) Prior to performance of a biopsy, the physician and surgeon
shall note on the patient's chart that he or she has given the
patient the written summary required by this section.
   (e) The Medical Board of California shall establish a distribution
system for the breast cancer treatment alternatives written summary
that is linked to the process of biennial renewal of physician and
surgeon licenses.

109277.  (a) Every person or entity who owns or operates a health
facility or a clinic, or who is licensed as a physician and surgeon
and rents or owns the premises where his or her practice is located,
shall cause a sign or notice to be posted where a physician and
surgeon performs breast cancer screening or biopsy as an outpatient
service, or in a reasonably proximate area to where breast cancer
screening or biopsy is performed.  A sign or notice posted at the
patient registration area of the health facility, clinic, or
physician and surgeon's office shall constitute compliance with this
section.
   (b) The sign or notice shall read as follows:

      "BE INFORMED"

   "If you are a patient being treated for any form of breast cancer,
or prior to performance of a biopsy for breast cancer, your
physician and surgeon is required to provide you a written summary of
alternative efficacious methods of treatment, pursuant to Section
109275 of the California Health and Safety Code."   "The information
about methods of treatment was developed by the State Department of
Health Services to inform patients of the advantages, disadvantages,
risks, and descriptions of procedures."
   (c) The sign shall be not less than eight and one-half inches by
11 inches and shall be conspicuously displayed so as to be readable.
The words "BE INFORMED" shall not be less than one-half inch in
height and shall be centered on a single line with no other text.
The message on the sign shall appear in English, Spanish, and
Chinese.

109278.  (a) The medical care provider primarily responsible for
providing to a patient an annual gynecological examination shall
provide to that patient during the annual examination a standardized
summary in layperson's language and in a language understood by the
patient containing a description of the symptoms and appropriate
methods of diagnoses for gynecological cancers.  Use of existing
publications developed by nationally recognized cancer organizations
is not precluded by this section.
   (b) For the purposes of this section, "medical care provider"
means a health care professional licensed pursuant to Division 2
(commencing with Section 500) of the Business and Professions Code or
pursuant to an initiative act referred to in that division providing
medical care within his or her lawful scope of practice.

109280.  A standardized written summary in layman's language and in
a language understood by patients shall be developed by the
department on the recommendation of the Cancer Advisory Council and
printed and made available by the Medical Board of California to
physicians and surgeons, concerning the advantages, disadvantages,
risks, and descriptions, of procedures with regard to medically
viable and efficacious alternative methods of treatment of prostate
cancer.  Physicians and surgeons are urged to make the summary
available to patients when appropriate.

109282.  (a) Every person or entity who owns or operates a health
facility or a clinic, or who is licensed as a physician and surgeon
and rents or owns the premises where his or her practice is located,
shall cause a sign or notice to be posted where prostate cancer
screening or treatment is performed by any physician and surgeon, or
in a reasonably proximate area to where prostate cancer screening or
treatment is performed.  A sign or notice posted at the patient
registration area of the health facility, clinic, or physician and
surgeon's office shall constitute compliance with this section.
   (b) The sign or notice shall read as follows:

      "BE INFORMED"
      "If you are a patient being treated for any form of prostate
cancer, or prior to performance of a biopsy for prostate cancer, your
physician and surgeon is urged to provide you a written summary of
alternative efficacious methods of treatment, pursuant to Section
109280 of the California Health and Safety Code."
   "The information about methods of treatment was developed by the
State Department of Health Services to inform patients of the
advantages, disadvantages, risks, and descriptions of procedures."

   (c) The sign shall be not less than eight and one-half inches by
11 inches and shall be conspicuously displayed so as to be readable.
The words "BE INFORMED" shall not be less than one-half inch in
height and shall be centered on a single line with no other text.
The message on the sign shall appear in English, Spanish, and
Chinese.

109285.  For the purposes of this article and Article 2 (commencing
with Section 109300) "cancer" means all malignant neoplasms
regardless of the tissue of origin, including malignant lymphoma,
Hodgkins disease, and leukemia.

109290.  No person may undertake to treat or alleviate cancer by use
of drugs, surgery, or radiation unless the person holds a license
issued under a law of this state expressly authorizing the diagnosis
and treatment of disease by use of drugs, surgery, or radiation.

109295.  On written request by the department, delivered personally
or by mail, any individual, person, firm, association, or other
entity engaged, or representing himself, or itself, as engaged, in
the diagnosis, treatment, alleviation, or cure of cancer shall
furnish the department with the sample as the department may deem
necessary for adequate testing of any drug, medicine, compound, or
device used or prescribed by the individual, person, firm,
association, or other entity in the diagnosis, treatment,
alleviation, or cure of cancer, and shall specify the formula of any
drug or compound and name all ingredients by their common or usual
names, and shall, upon like request by the department, furnish
further necessary information as it may request as to the composition
and method of preparation of and the use that any drug, compound, or
device is being put by the individual, person, firm, association, or
other entity.  This section shall apply to any individual, person,
firm, association, or other entity that renders health care or
services to individuals who have or believe they have cancer.  This
section also applies to any individual, person, firm, association, or
other entity that by implication causes individuals to believe they
have cancer.
   The failure to either provide the sample, disclose the formula, or
name the ingredients as required by this section shall be
conclusively presumed that the drug, medicine, compound or device
that is the subject of the department's request has no value in the
diagnosis, treatment, alleviation, or cure of cancer.

 

CALIFORNIA CODES HEALTH AND SAFETY CODE SECTION 103875-103885 103875. (a) The department shall conduct a program of epidemiological assessments of the incidence of cancer. The program shall encompass all areas of the state for which cancer incidence data are available. The program shall include the monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment generally. (b) The program shall be under the direction of the director, who may enter into contracts as are necessary for the conduct of the program and may accept, on behalf of the state, grants of public or private funds for the program. The director shall analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies. (c) It is the intent of the Legislature that an appropriation be included in each Budget Act in an amount sufficient to provide for the annual cost of the program. 103885. (a) The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based tumor registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature. (b) The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide, on a timely basis, cancer incidence data as designated by the state department to the department. The department may contract with an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association, representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. (c) The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative. (d) (1) Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the department's authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the state department or the authorized representative for its cost to access and report the information. (2) Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall report each cancer case to the department or the authorized representative of the department except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnosis or treatment of that instance of cancer. (e) Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 11/2 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department. (f) All physicians and surgeon, hospitals, outpatient clinics, nursing homes and all other facilities, individuals or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund. (g) All information reported pursuant to this section shall be confidential as provided in Section 100330, except that the department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect. The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states' cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes set forth in this subdivision if those out-of-state registries, agencies, officers, or researchers agree in writing to maintain the confidentiality of the information, and in the case of researchers, if they have obtained the approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations. (h) For the purpose of this section, "cancer" means all malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkins disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin. (i) Nothing in this section shall preempt the authority of facilities or individuals, providing diagnostic or treatment services to patients with cancer, to maintain their own facility-based tumor registries. (j) It is the intent of the Legislature that the department, in establishing a system pursuant to this section, maximize the use of available federal funds.

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