Bill Text: CA AB1278 | 2013-2014 | Regular Session | Introduced
Bill Title: Integrative cancer treatment.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2014-02-03 - From committee: Filed with the Chief Clerk pursuant to Joint Rule 56. [AB1278 Detail]
Download: California-2013-AB1278-Introduced.html
BILL NUMBER: AB 1278 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Hueso
FEBRUARY 22, 2013
An act to amend Section 2234.1 of, and to repeal Section 2257 of,
the Business and Professions Code, and to amend Sections 109270,
109285, 109295, 109300, 109350, and 109375 of, and to add Article 2.5
(commencing with Section 109400) to Chapter 4 of Part 4 of Division
104 of, the Health and Safety Code, relating to health care.
LEGISLATIVE COUNSEL'S DIGEST
AB 1278, as introduced, Hueso. Integrative cancer treatment.
Existing law prohibits the sale, prescription, or administration
of a drug, medicine, compound, or device to be used in the diagnosis,
treatment, alleviation, or cure of cancer unless it has been
approved by the federal Food and Drug Administration or by the State
Department of Public Health, as specified, and makes a violation of
that provision a misdemeanor. The Medical Practice Act provides for
the licensure and regulation of physicians and surgeons by the
Medical Board of California and requires the board to take action
against a licensee who is charged with unprofessional conduct. The
act immunizes a physician and surgeon from discipline for providing
advice or treatment that constitutes alternative or complementary
medicine if the treatment or advice meets certain requirements. The
Osteopathic Act provides for the licensure and regulation of
osteopathic physicians and surgeons by the Osteopathic Medical Board
of California and requires the board to enforce the Medical Practice
Act with respect to its licensees.
This bill would prohibit a physician and surgeon, including an
osteopathic physician and surgeon, from recommending, prescribing, or
providing integrative cancer treatment, as defined, to cancer
patients unless certain requirements are met. The bill would specify
that a failure of a physician and surgeon to comply with these
requirements constitutes unprofessional conduct and cause for
discipline by the individual's licensing entity. The bill would
require the State Department of Public Health to investigate
violations of these provisions and to hold hearings with respect to
compliance with these provisions. The bill would make conforming
changes to other related provisions.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 2234.1 of the Business and Professions Code is
amended to read:
2234.1. (a) A physician and surgeon shall not be subject to
discipline pursuant to subdivision (b), (c), or (d) of Section 2234
solely on the basis that the treatment or advice he or she rendered
to a patient is alternative or complementary medicine, including the
treatment of persistent Lyme Disease, if that treatment or advice
meets all one of the following
requirements , as applicable :
(1) The treatment or advice is for a condition other than cancer
and meets all of the following requirements:
(1)
(A) It is provided after informed consent and a
good-faith prior examination of the patient, and medical indication
exists for the treatment or advice, or it is provided for health or
well-being.
(2)
(B) It is provided after the physician and surgeon has
given the patient information concerning conventional treatment and
describing the education, experience, and credentials of the
physician and surgeon related to the alternative or complementary
medicine that he or she practices.
(3)
(C) In the case of alternative or complementary
medicine, it does not cause a delay in, or discourage traditional
diagnosis of, a condition of the patient.
(4)
(D) It does not cause death or serious bodily injury to
the patient.
(2) The treatment or advice is for cancer and is given in
compliance with Article 2.5 (commencing with Section 109400) of
Chapter 4 of Part 4 of Division 104 of the Health and Safety Code.
(b) For purposes of this section, "alternative or complementary
medicine," means those health care methods of diagnosis, treatment,
or healing that are not generally used but that provide a reasonable
potential for therapeutic gain in a patient's medical condition that
is not outweighed by the risk of the health care method.
(c) Since the National Institute of Medicine has reported that it
can take up to 17 years for a new best practice to reach the average
physician and surgeon, it is prudent to give attention to new
developments not only in general medical care but in the actual
treatment of specific diseases, particularly those that are not yet
broadly recognized in California.
SEC. 2. Section 2257 of the Business and Professions Code is
repealed.
2257. The violation of Section 109275 of the Health and Safety
Code, relating to informed consent for the treatment of breast
cancer, constitutes unprofessional conduct.
SEC. 3. Section 109270 of the Health and Safety Code is amended to
read:
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
Article 2.5 (commencing with Section 109400), 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 , except as
authorized under Article 2.5 (commencing with Section 109400)
.
(e) Hold hearings in with respect
of to those matters involving
compliance with this article and ,
Article 2 (commencing with Section 109300) , and Article 2.5
(commencing with Section 109400), 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 or manufacturer contact information
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.
SEC. 4. Section 109285 of the Health and Safety Code is amended to
read:
109285. For the purposes of this article and
, Article 2 (commencing with Section 109300) , and
Article 2.5 (commencing with Section 109400), "cancer" means
all malignant neoplasms regardless of the tissue of origin, including
malignant lymphoma, Hodgkins disease, and leukemia.
SEC. 5. Section 109295 of the Health and Safety Code is amended to
read:
109295. (a) On written request by the
department, delivered personally or by mail, any individual, person,
firm, association, or other entity engaged, or representing himself,
herself, or itself, as engaged, in the diagnosis,
treatment, alleviation, or cure of cancer shall furnish
do all of the following:
(1) 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 cancer. The individual, person, firm,
association, or other entity may alternatively furnish the department
with the contact information of the manufacturer of the drug,
medicine, compound, or device.
(2) Specify the formula of any
drug or compound and name all ingredients by their common or usual
names, and shall, upon like names.
(3) Upon request by
of the department, furnish further necessary
information as it the department 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
(b) 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
(c) Upon the failure to
either provide the sample or the manufacturer's
contact information , disclose the formula, or name the
ingredients as required by this section , it 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.
SEC. 6. Section 109300 of the Health and Safety Code is amended to
read:
109300. The sale, offering for sale, holding for sale,
delivering, giving away, prescribing , or administering of
any drug, medicine, compound, or device to be used in the diagnosis,
treatment, alleviation, or cure of cancer is unlawful and prohibited
unless (1) an one of the following applies:
(a) An application with respect
thereto has been approved under Section 505 of the federal Food, Drug
, and Cosmetic Act , or (2) there
.
(b) The use is consistent with Article 2.5 (commencing with
Section 109400).
(c) There has been approved an
application filed with the board setting forth all of the
following :
(a)
(1) Full reports of investigations that have been made
to show whether or not the drug, medicine, compound, or device is
safe for the use, and whether the drug, medicine, compound, or device
is effective in the use;
(b)
(2) A full list of the articles used as components of
the drug, medicine, compound, or device;
(c)
(3) A full statement of the composition of the drug,
medicine, compound, or device;
(d)
(4) A full description of the methods used in, and the
facilities and controls used for, the manufacture, processing, and
packing of the drug, medicine, or compound or in the case of a
device, a full statement of its composition, properties, and
construction and the principle or principles of its operation;
(e)
(5) Such samples of the drug, medicine, compound, or
device and of the articles used as components of the drug, medicine,
compound, or device as the board may require; and
(f)
(6) Specimens of the labeling and advertising proposed
to be used for the drug, medicine, compound, or device.
SEC. 7. Section 109350 of the Health and Safety Code is amended to
read:
109350. The department may direct that any
an individual, person, firm, association, or other entity
shall cease and desist any further prescribing, recommending, or use
of any drug, medicine, compound, or device for which no application
has been approved under this article and Article 1 (commencing with
Section 109250) unless its use is exempt under Section 109325 or
109330 or authorized under Article 2.5 (commencing with Section
109400) .
SEC. 8. Section 109375 of the Health and Safety Code is amended to
read:
109375. The director shall investigate possible violations of
this article and , Article 1
(commencing with Section 109250) , and Article 2.5 (commencing
with Section 109400), and report violations to the appropriate
enforcement authority.
SEC. 9. Article 2.5 (commencing with Section 109400) is added to
Chapter 4 of Part 4 of Division 104 of the Health and Safety Code, to
read:
Article 2.5. Integrative Cancer Treatment
109400. For purposes of this article:
(a) "Integrative cancer treatment" means the use of evidence-based
substances or therapies that are not the standard of care for cancer
treatment, for the purpose of reducing the size of a cancer, slowing
the progression of a cancer, or improving the quality of life of a
patient with cancer, by a physician and surgeon practicing within his
or her scope of practice.
(b) "Physician and surgeon" means a physician and surgeon licensed
pursuant to Section 2050 of the Business and Professions Code or an
osteopathic physician and surgeon licensed pursuant to the
Osteopathic Act.
(c) An individual "prescribes" a treatment when he or she orders
the treatment or a course of treatment.
(d) An individual "provides" a treatment when he or she actually
renders, administers, furnishes, or dispenses the treatment to the
patient.
109401. (a) Notwithstanding any other provision of law, a
physician and surgeon shall not recommend or prescribe integrative
cancer treatment for cancer patients unless the following
requirements are met, as applicable:
(1) The treatment is recommended or prescribed after informed
consent is given, as provided in Section 109402.
(2) The treatment recommended or prescribed meets the
evidence-based medical standard provided in Section 109403.
(3) The physician and surgeon prescribing the treatment complies
with the patient reevaluation requirements set forth in Section
109404 after the treatment begins.
(4) The physician and surgeon prescribing the treatment complies
with all of the standards of care set forth in Section 109405.
(b) A physician and surgeon shall not provide integrative cancer
treatment for cancer patients unless the treatment is prescribed by a
physician and surgeon in compliance with subdivision (a).
109402. (a) For purposes of paragraph (1) of subdivision (a) of
Section 109401, informed consent has been given if the patient signs
a form stating either of the following:
(1) The name and telephone number of the physician and surgeon
from whom the patient is receiving conventional cancer care and
whether the patient has been informed of the type of cancer from
which the patient suffers and his or her prognosis using conventional
treatment options.
(2) That the patient has declined to be under the care of an
oncologist or other physician and surgeon providing conventional
cancer care.
(b) The form described in subdivision (a) shall include all of the
following information:
(1) The type of care the patient will be receiving or that is
being recommended is not the standard of care for treating cancer in
California.
(2) The standard of care for treating cancer in California
consists of radiation, chemotherapy, and surgery.
(3) The treatment that the physician and surgeon will be
prescribing or recommending is not approved by the federal Food and
Drug Administration for the treatment of cancer.
(4) The care that the patient will be receiving or that is being
recommended is not mutually exclusive of the patient receiving
conventional cancer treatment.
(5) The following written statements:
THE STATE DEPARTMENT OF PUBLIC HEALTH AND THE PHYSICIAN
PRESCRIBING YOUR INTEGRATIVE CANCER CARE RECOGNIZE THE IMPORTANCE OF
USING CONVENTIONAL CANCER TREATMENTS, INCLUDING RADIATION,
CHEMOTHERAPY, AND SURGERY. IT IS HIGHLY RECOMMENDED THAT YOU SEE AN
ONCOLOGIST OR ANOTHER PHYSICIAN TO PROVIDE YOU WITH CONVENTIONAL
CANCER CARE.
ANY AND ALL MEDICAL TREATMENTS INVOLVE SOME DEGREE OF RISK OF
INJURY UP TO AND INCLUDING DEATH.
109403. For purposes of paragraph (2) of subdivision (a) of
Section 109401, a treatment meets the evidence-based medical standard
for integrative cancer treatment if all of the following
requirements are met:
(a) In the opinion of the physician and surgeon recommending or
prescribing the treatment, the treatment has the potential to reduce
the size of a cancer, slow the progression of a cancer, or improve
the quality of life of a patient with cancer, based on reasonable
evidence from peer-reviewed scientific medical journals.
(b) In the opinion of the physician and surgeon recommending or
prescribing the treatment, the expected benefits of the treatment
substantially outweigh the expected harm from the treatment, as
derived from peer-reviewed scientific or medical journals.
(c) The treatment, when properly provided, does not cause death or
bodily injury to the patient.
109404. For purposes of paragraph (3) of subdivision (a) of
Section 109401, a physician and surgeon prescribing integrative
cancer treatment complies with the patient reevaluation requirements
if all of the following conditions are satisfied:
(a) The patient is informed regarding the measurable results
achieved within the timeframe established pursuant to paragraph (2)
of subdivision (a) of Section 109405 and at regular and appropriate
intervals during the treatment plan.
(b) The physician and surgeon reevaluates treatment when progress
stalls or reverse,s in the opinion of the physician and surgeon or
the patient, or as evidenced by objective evaluations.
(c) The patient is informed about and agrees to any proposed
change or changes in treatment, including, but not limited to, the
risks and benefits of the proposed change or changes, the costs
associated with the proposed change or changes, and the timeframe
within which the proposed change or changes will be reevaluated.
109405. For purposes of paragraph (4) of subdivision (a) of
Section 109401, a physician and surgeon complies with all of the
standards of care in prescribing integrative cancer treatment under
this article if all of the following requirements are met:
(a) The physician and surgeon provides the patient with all of the
following when prescribing the treatment:
(1) Information regarding the treatment prescribed, including its
usefulness in treating cancer.
(2) A timeframe and plan for reevaluating the treatment using
standard and conventional means in order to assess treatment
efficacy.
(3) A cost estimate for the prescribed treatment.
(b) The physician and surgeon ensures that relevant, generally
accepted tests are administered to confirm the effectiveness and
progress of the treatment.
(c) The physician and surgeon, prior to prescribing or changing
the treatment, makes a good faith effort to obtain from the patient
all relevant charts, records, and laboratory results relating to the
patient's conventional cancer care.
(d) At the request of the patient, the physician and surgeon makes
a good faith effort to coordinate the care of the patient with the
physician and surgeon providing conventional cancer care to the
patient.
(e) At the request of the patient, the physician and surgeon
provides a synopsis of any treatment rendered pursuant to this
article to the physician and surgeon providing conventional cancer
care to the patient, including subjective and objective assessments
of the patient's state of health and response to that treatment.
109406. The failure of a physician and surgeon to comply with
this article constitutes unprofessional conduct and cause for
discipline by that individual's licensing entity. That person shall
not be subject to Section 109335 or 109370.
