Amended in Senate April 8, 2013

Senate Bill No. 117

Introduced by Senator begin delete Rubio end delete begin insert Hueso end insert

January 17, 2013

An act to amend begin delete Sections 116275, 116475, and 116590 end delete begin insert Section 2234.1 end insert of, and to begin delete add end delete begin insert repeal end insert Section begin delete 116276 to, end delete begin insert 2257 of, the Business and Professions Code, end insert begin insert 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, end insert the Health and Safety Code, relating to begin delete drinking water. end delete begin insert health care. end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 117, as amended, begin delete Rubio end delete   begin insert Hueso end insert . begin delete Drinking water: State Water Resources Control Board. end delete begin insert Integrative cancer treatment. end insert

begin insert

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.

end insert begin insert

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 applicable licensing board. 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.

end insert begin delete

Existing law, the California Safe Drinking Water Act, provides for the operation of public water systems, and imposes on the State Department of Public Health various responsibilities and duties. Existing law requires the department to conduct research, studies, and demonstration projects relating to the provision of a dependable, safe supply of drinking water, to adopt regulations to implement the California Safe Drinking Water Act, and to enforce provisions of the federal Safe Drinking Water Act.

end delete begin delete

This bill would transfer the various duties and responsibilities imposed on the department by the California Safe Drinking Water Act to the State Water Resources Control Board and make conforming changes.

end delete

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 2234.1 of the end insert begin insert Business and Professions
Code end insert begin insert is amended to read: end insert

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.

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 2257 of the end insert begin insert Business and Professions Code end insert begin insert is
repealed. end insert

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

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 109270 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin insert

begin insert SEC. 4. end insert   

end insert

begin insert Section 109285 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin insert

begin insert SEC. 5. end insert   

end insert

begin insert Section 109295 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin insert

begin insert SEC. 6. end insert   

end insert

begin insert Section 109300 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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.

begin insert

begin insert SEC. 7. end insert   

end insert

begin insert Section 109350 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

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 .

begin insert

begin insert SEC. 8. end insert   

end insert

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

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.

begin insert

begin insert SEC. 9. end insert   

end insert

begin insert Article 2.5 (commencing with Section 109400) is added
to Chapter 4 of Part 4 of Division 104 of the end insert begin insert Health and Safety
Code end insert begin insert , to read: end insert

begin insert

 

Article begin insert 2.5. end insert   Integrative Cancer Treatment

 

begin insert 109400. end insert   

For purposes of this article:

(a) “Integrative cancer treatment” means the use of a
combination of evidence-based substances or therapies 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.

begin insert 109401. end insert   

(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).

begin insert 109402. end insert   

(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, in whole or in part, the conventional treatment
for treating cancer in California.

(2) The conventional treatment for treating cancer in California
consists of radiation, chemotherapy, and surgery.

(3) All or part of 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.

begin insert 109403. end insert   

For purposes of paragraph (2) of subdivision (a) of
Section 109401, a treatment meets the evidence-based medical
standard for integrative cancer treatment if one of the following
requirements is met:

(a) The treatment is recognized by the Physician’s Data Query
of the National Cancer Institute.

(b) The treatment has been published in at least three
peer-reviewed scientific medical journals.

(c) The treatment has been reported in at least three
peer-reviewed articles published in complementary and alternative
medicine journals to have the potential of reducing the size of a
cancer, slowing the progression of a cancer, or improving the
quality of life of a patient with cancer.

begin insert 109404. end insert   

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 reverses, 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.

begin insert 109405. end insert   

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.

begin insert 109406. end insert   

The failure of a physician and surgeon to comply with
this article constitutes unprofessional conduct and cause for
discipline by his or her licensing board. That person shall not be
subject to Section 109335 or 109370.

end insert

All matter omitted in this version of the bill appears in the bill as introduced in the Senate, January 17, 2013. (JR11)