California Legislature—2013–14 Regular Session

Assembly Bill No. 1278

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 begin delete all end delete begin insert one end insert of the following requirements begin insert , as applicable end insert :

begin insert

(1) The treatment or advice is for a condition other than cancer
and meets all of the following requirements:

end insert begin delete

(1)

end delete

begin insert (A) end insert  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.

begin delete

(2)

end delete

begin insert (B) end insert  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.

begin delete

(3)

end delete

begin insert (C) end insert  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.

begin delete

(4)

end delete

begin insert (D) end insert  It does not cause death or serious bodily injury to the patient.

begin insert

(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.

end insert

(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.

begin delete

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.

end delete

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 begin delete and end delete begin insert , end insert Article 2
(commencing with Section 109300), begin insert and Article 2.5 (commencing
with Section 109400), end insert 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 begin insert , end insert or treatment of cancer begin insert , except as authorized under
Article 2.5 (commencing with Section 109400) end insert .

(e) Hold hearings begin delete in end delete begin insert with end insert respect begin delete of end delete begin insert to end insert those matters involving
compliance with this article begin delete and end delete begin insert , end insert Article 2 (commencing with
Section 109300) begin insert , and Article 2.5 (commencing with Section
109400), end insert 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 begin insert or manufacturer contact information end insert
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 begin delete and end delete begin insert , end insert Article 2
(commencing with Section 109300) begin insert , and Article 2.5 (commencing
with Section 109400), end insert “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.  

begin insert (a) end insert begin insert   end insert On written request by the department, delivered
personally or by mail, any individual, person, firm, association,
or other entity engaged, or representing himself, begin insert herself, end insert or itself,
as engaged, in the diagnosis, treatment, alleviation, or cure of
cancer shall begin delete furnish end delete begin insert do all of the following: end insert

begin insert (1) end insert begin insert   end insert begin insert Furnish end insert 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 begin delete cancer, and shall specify end delete begin insert 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. end insert

begin insert (2) end insert begin insert   end insert begin insert Specify end insert the formula of any drug or compound and name all
ingredients by their common or usual begin delete names, and shall, upon like end delete
begin insert names. end insert

begin insert (3) end insert begin insert   end insert begin insert Upon end insert request begin delete by end delete begin insert of end insert the department, furnish further necessary
information as begin delete it end delete begin insert the department end insert 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. begin delete This end delete

begin insert (b) end insert begin insert   end insert begin insert This end insert 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.

begin delete

The

end delete

begin insert (c) end insert begin insert   end insert begin insert Upon the end insert failure to begin delete either end delete provide the sample begin insert or the
manufacturer’s contact information end insert , disclose the formula, or name
the ingredients as required by this section begin insert , it end insert 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 begin insert , end insert 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 begin delete (1)
an end delete begin insert one of the following applies: end insert

begin insert (a) end insert begin insert   end insert begin insert An end insert application with respect thereto has been approved under
Section 505 of the federal Food, Drug begin insert , end insert and Cosmetic Act begin delete , or (2)
there end delete begin insert . end insert

begin insert

(b) The use is consistent with Article 2.5 (commencing with
Section 109400).

end insert

begin insert (c) end insert begin insert   end insert begin insert There end insert has been approved an application filed with the board
setting forth begin insert all of the following end insert :

begin delete

(a)

end delete

begin insert (1) end insert  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;

begin delete

(b)

end delete

begin insert (2) end insert  A full list of the articles used as components of the drug,
medicine, compound, or device;

begin delete

(c)

end delete

begin insert (3) end insert  A full statement of the composition of the drug, medicine,
compound, or device;

begin delete

(d)

end delete

begin insert (4) end insert  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;

begin delete

(e)

end delete

begin insert (5) end insert  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

begin delete

(f)

end delete

begin insert (6) end insert  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 begin delete any end delete begin insert an end insert 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 begin insert or
authorized under Article 2.5 (commencing with Section 109400) end insert .

SEC. 8.  

Section 109375 of the Health and Safety Code is
amended to read:

109375.  

The director shall investigate possible violations of
this article begin delete and end delete begin insert , end insert Article 1 (commencing with Section 109250) begin insert , and
Article 2.5 (commencing with Section 109400), end insert 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.