Bill Text: CA AB1306 | 2015-2016 | Regular Session | Amended
Bill Title: Healing arts: certified nurse-midwives: scope of practice.
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Engrossed - Dead) 2016-08-31 - Assembly refused to concur in Senate amendments. (Ayes 31. Noes 21. Page 6600.) [AB1306 Detail]
Download: California-2015-AB1306-Amended.html
BILL NUMBER: AB 1306 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 30, 2016
AMENDED IN SENATE JUNE 20, 2016
AMENDED IN SENATE JULY 1, 2015
AMENDED IN ASSEMBLY MAY 28, 2015
INTRODUCED BY Assembly Member Burke
(Coauthor: Assembly Member Mark Stone)
FEBRUARY 27, 2015
An act to amend Sections 510, 650.01, 650.02, 2725.1,
2746.2, 2746.5, 2746.51, 2746.52, 4061, 4076, and 4170 of, and to add
Section 2746.6 to, the Business and Professions Code, relating to
healing arts.
LEGISLATIVE COUNSEL'S DIGEST
AB 1306, as amended, Burke. Healing arts: certified
nurse-midwives: scope of practice.
(1) Existing law, the Nursing Practice Act, provides for the
licensure and regulation of the practice of nursing by the Board of
Registered Nursing and authorizes the board to issue a certificate to
practice nurse-midwifery to a person who meets educational standards
established by the board or the equivalent of those educational
standards. The act makes the violation of any of its provisions a
misdemeanor punishable upon conviction by imprisonment in the county
jail for not less than 10 days nor more than one year, or by a fine
of not less than $20 nor more than $1,000, or by both that fine and
imprisonment.
This bill would additionally require an applicant for a
certificate to practice nurse-midwifery to provide evidence of
current advanced level national certification by a certifying body
that meets standards established and approved by the board. The bill
would also require the board to create and appoint a Nurse-Midwifery
Advisory Committee consisting of certified nurse-midwives in good
standing with experience in hospital settings, alternative birth
settings, and home settings, a nurse-midwife educator, as specified,
2 qualified physicians, and a consumer of midwifery care.
This The bill would require the committee to
consist of a majority of certified nurse-midwives and would require
the committee to make recommendations to the board on all matters
related to nurse-midwifery practice, education, disciplinary actions,
standards of care, and other matters specified by the board, and
would require the committee to meet regularly, but at least twice a
year. This bill would prohibit corporations and other
artificial legal entities from having professional rights,
privileges, or powers under the act, except as specified. The bill
would authorize specified entities to employ a certified
nurse-midwife and charge for professional services rendered by that
certified nurse-midwife, as provided.
(2) The act authorizes a certified nurse-midwife, under the
supervision of a licensed physician and surgeon, to attend cases of
normal childbirth and to provide prenatal, intrapartum, and
postpartum care, including family-planning care, for the mother, and
immediate care for the newborn, and provides that the practice of
nurse-midwifery constitutes the furthering or undertaking by a
certified person, under the supervision of a licensed physician and
surgeon who has current practice or training in obstetrics, to assist
a woman in childbirth so long as progress meets criteria accepted as
normal.
This bill would delete those provisions and would instead
authorize a certified nurse-midwife to manage a full range of
gynecological and obstetric care services for women from adolescence
beyond menopause, as provided. The bill would authorize a certified
nurse-midwife to practice under that gynecological and obstetric
care services authorization without supervision of a
physician and surgeon in certain settings,
including, but not limited to, a home setting, as specified.
This The bill would prohibit entities described in
those specified settings from interfering with, controlling, or
otherwise directing the professional judgment of such a certified
nurse-midwife, as specified. The bill would declare that the
practice of nurse-midwifery within a health care system provides for
consultation, collaboration, or referral as indicated by the health
status of the client and the resources of the medical personnel
available in the setting of care, and would provide that the practice
of nurse-midwifery emphasizes informed consent, preventive care, and
early detection and referral of complications to a physician and
surgeon.
(3) The act authorizes a certified nurse-midwife to furnish and
order drugs or devices incidentally to the provision of family
planning services, routine health care or perinatal care, and care
rendered consistently with the certified nurse-midwife's educational
preparation in specified facilities and clinics, and only in
accordance with standardized procedures and protocols, as specified.
This bill would delete the requirement that drugs or devices are
furnished or ordered in accordance with standardized procedures and
protocols. The bill would authorize a certified nurse-midwife to
furnish and order drugs or devices in connection with care rendered
in a home, and would authorize a certified nurse-midwife to directly
procure supplies and devices, to order, obtain, and administer drugs
and diagnostic tests, to order laboratory and diagnostic testing, and
to receive reports that are necessary to his or her practice as a
certified nurse-midwife and that are consistent with nurse-midwifery
education preparation.
(4) The act also authorizes a certified nurse-midwife to perform
and repair episiotomies and to repair first-degree and 2nd-degree
lacerations of the perineum in a licensed acute care hospital and a
licensed alternate birth center, if certain requirements are met,
including, but not limited to, that episiotomies are performed
pursuant to protocols developed and approved by the supervising
physician and surgeon.
This bill would also authorize a certified nurse-midwife to
perform and repair episiotomies and to repair first-degree and
2nd-degree lacerations of the perineum in a home, and would delete
all requirements that those procedures be performed pursuant to
protocols developed and approved by the supervising physician and
surgeon. The bill would require a certified nurse-midwife to provide
emergency care to a patient during times when a physician and surgeon
is unavailable.
This bill would provide that a consultative relationship between
a certified nurse-midwife and a physician and surgeon by it
self itself is not a basis for finding the
physician and surgeon liable for any acts or omissions on the part of
the certified nurse-midwife. The bill would also update
cross-references as needed.
(5) Because the act makes a violation of any of its provisions a
misdemeanor, this bill would expand the scope of an existing crime
and therefore this bill would impose a state-mandated local program.
(6) Existing law provides prescribed protection against
retaliation for health care practitioners who advocate for
appropriate health care for their patients. Existing law defines
"health care practitioner" for those purposes to mean a person who
engages in acts that are the subject of licensure or regulation under
specific law or initiative act and who is either a licentiate, as
defined, a party to a contract with a payer whose decision, policy,
or practice is subject to such advocacy, or an individual designated
in a contract with a payer whose decision, policy, or practice is
subject to such advocacy, where the individual is granted the right
to appeal denials of payment or authorization for treatment under the
contract.
This bill would expand that protection against retaliation to
certified nurse-midwives.
(6)
(7) Existing law prohibits a licensee, as defined, from
referring a person for laboratory, diagnostic, nuclear medicine,
radiation oncology, physical therapy, physical rehabilitation,
psychometric testing, home infusion therapy, or diagnostic imaging
goods or services if the licensee or his or her immediate family has
a financial interest with the person or entity that receives the
referral, and makes a violation of that prohibition punishable as a
misdemeanor. Under existing law, the Medical Board of California is
required to review the facts and circumstances of any conviction for
violating the prohibition, and to take appropriate disciplinary
action if the licensee has committed unprofessional conduct. Existing
law provides that, among other exceptions, this prohibition does not
apply to a licensee who refers a person to a health facility if
specified conditions are met.
This bill would include a certified nurse-midwife under the
definition of a licensee, which would expand the scope of an existing
crime and therefore impose a state-mandated local program. The bill
would require the Board of Registered Nursing to review the facts and
circumstances of any conviction of a certified nurse-midwife for
violating that prohibition, and would require the board to take
appropriate disciplinary action if the certified nurse-midwife has
committed unprofessional conduct. The bill would additionally
authorize a licensee to refer a person to a licensed alternative
birth center, as defined, or a nationally accredited alternative
birth center.
(7)
(8) The California Constitution requires the state to
reimburse local agencies and school districts for certain costs
mandated by the state. Statutory provisions establish procedures for
making that reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 510 of the Business
and Professions Code is amended to read:
510. (a) The purpose of this section is to provide protection
against retaliation for health care practitioners who advocate for
appropriate health care for their patients pursuant to Wickline v.
State of California 192 Cal. App. 3d 1630.
(b) It is the public policy of the State of California that a
health care practitioner be encouraged to advocate for appropriate
health care for his or her patients. For purposes of this section,
"to advocate for appropriate health care" means to appeal a payer's
decision to deny payment for a service pursuant to the reasonable
grievance or appeal procedure established by a medical group,
independent practice association, preferred provider organization,
foundation, hospital medical staff and governing body, or payer, or
to protest a decision, policy, or practice that the health care
practitioner, consistent with that degree of learning and skill
ordinarily possessed by reputable health care practitioners with the
same license or certification and practicing according to the
applicable legal standard of care, reasonably believes impairs the
health care practitioner's ability to provide appropriate health care
to his or her patients.
(c) The application and rendering by any individual, partnership,
corporation, or other organization of a decision to terminate an
employment or other contractual relationship with or otherwise
penalize a health care practitioner principally for advocating for
appropriate health care consistent with that degree of learning and
skill ordinarily possessed by reputable health care practitioners
with the same license or certification and practicing according to
the applicable legal standard of care violates the public policy of
this state.
(d) This section shall not be construed to prohibit a payer from
making a determination not to pay for a particular medical treatment
or service, or the services of a type of health care practitioner, or
to prohibit a medical group, independent practice association,
preferred provider organization, foundation, hospital medical staff,
hospital governing body acting pursuant to Section 809.05, or payer
from enforcing reasonable peer review or utilization review protocols
or determining whether a health care practitioner has complied with
those protocols.
(e) (1) Except as provided in paragraph (2), appropriate health
care in a hospital licensed pursuant to Section 1250 of the Health
and Safety Code shall be defined by the appropriate hospital
committee and approved by the hospital medical staff and the
governing body, consistent with that degree of learning and skill
ordinarily possessed by reputable health care practitioners with the
same license or certification and practicing according to the
applicable legal standard of care.
(2) To the extent the issue is under the jurisdiction of the
medical staff and its committees, appropriate health care in a
hospital licensed pursuant to Section 1250 of the Health and Safety
Code shall be defined by the hospital medical staff and approved by
the governing body, consistent with that degree of learning and skill
ordinarily possessed by reputable health care practitioners with the
same license or certification and practicing according to the
applicable legal standard of care.
(f) Nothing in this section shall be construed to prohibit the
governing body of a hospital from taking disciplinary actions against
a health care practitioner as authorized by Sections 809.05, 809.4,
and 809.5.
(g) Nothing in this section shall be construed to prohibit the
appropriate licensing authority from taking disciplinary actions
against a health care practitioner.
(h) For purposes of this section, "health care practitioner" means
either a person who is described in subdivision (f) of
Section 900 and who is either (1) a licentiate as defined in Section
805, or (2) a party to a contract with a payer whose decision,
policy, or practice is subject to the advocacy described in
subdivision (b), or (3) an individual designated in a contract with a
payer whose decision, policy, or practice is subject to the advocacy
described in subdivision (b), where the individual is granted the
right to appeal denials of payment or authorization for treatment
under the contract. contract, or a person who
is described in Section 2746.2.
(i) Nothing in this section shall be construed to revise or expand
the scope of practice of any health care practitioner, or to revise
or expand the types of health care practitioners who are authorized
to obtain medical staff privileges or to submit claims for
reimbursement to payers.
(j) The protections afforded health care practitioners by this
section shall be in addition to the protections available under any
other law of this state.
SECTION 1. SEC. 2. Section 650.01 of
the Business and Professions Code is amended to read:
650.01. (a) Notwithstanding Section 650, or any other law, it is
unlawful for a licensee to refer a person for laboratory, diagnostic
nuclear medicine, radiation oncology, physical therapy, physical
rehabilitation, psychometric testing, home infusion therapy, or
diagnostic imaging goods or services if the licensee or his or her
immediate family has a financial interest with the person or in the
entity that receives the referral.
(b) For purposes of this section and Section 650.02, the following
shall apply:
(1) "Diagnostic imaging" includes, but is not limited to, all
X-ray, computed axial tomography, magnetic resonance imaging nuclear
medicine, positron emission tomography, mammography, and ultrasound
goods and services.
(2) A "financial interest" includes, but is not limited to, any
type of ownership interest, debt, loan, lease, compensation,
remuneration, discount, rebate, refund, dividend, distribution,
subsidy, or other form of direct or indirect payment, whether in
money or otherwise, between a licensee and a person or entity to whom
the licensee refers a person for a good or service specified in
subdivision (a). A financial interest also exists if there is an
indirect financial relationship between a licensee and the referral
recipient including, but not limited to, an arrangement whereby a
licensee has an ownership interest in an entity that leases property
to the referral recipient. Any financial interest transferred by a
licensee to any person or entity or otherwise established in any
person or entity for the purpose of avoiding the prohibition of this
section shall be deemed a financial interest of the licensee. For
purposes of this paragraph, "direct or indirect payment" shall not
include a royalty or consulting fee received by a physician and
surgeon who has completed a recognized residency training program in
orthopedics from a manufacturer or distributor as a result of his or
her research and development of medical devices and techniques for
that manufacturer or distributor. For purposes of this paragraph,
"consulting fees" means those fees paid by the manufacturer or
distributor to a physician and surgeon who has completed a recognized
residency training program in orthopedics only for his or her
ongoing services in making refinements to his or her medical devices
or techniques marketed or distributed by the manufacturer or
distributor, if the manufacturer or distributor does not own or
control the facility to which the physician is referring the patient.
A "financial interest" shall not include the receipt of capitation
payments or other fixed amounts that are prepaid in exchange for a
promise of a licensee to provide specified health care services to
specified beneficiaries. A "financial interest" shall not include the
receipt of remuneration by a medical director of a hospice, as
defined in Section 1746 of the Health and Safety Code, for specified
services if the arrangement is set out in writing, and specifies all
services to be provided by the medical director, the term of the
arrangement is for at least one year, and the compensation to be paid
over the term of the arrangement is set in advance, does not exceed
fair market value, and is not determined in a manner that takes into
account the volume or value of any referrals or other business
generated between parties.
(3) For the purposes of this section, "immediate family" includes
the spouse and children of the licensee, the parents of the licensee,
and the spouses of the children of the licensee.
(4) "Licensee" means a physician as defined in Section 3209.3 of
the Labor Code, and a certified nurse-midwife as defined in Article
2.5 (commencing with Section 2746) of Chapter 6 of Division 2 of the
Business and Professions Code.
(5) "Licensee's office" means either of the following:
(A) An office of a licensee in solo practice.
(B) An office in which services or goods are personally provided
by the licensee or by employees in that office, or personally by
independent contractors in that office, in accordance with other
provisions of law. Employees and independent contractors shall be
licensed or certified when licensure or certification is required by
law.
(6) "Office of a group practice" means an office or offices in
which two or more licensees are legally organized as a partnership,
professional corporation, or not-for-profit corporation, licensed
pursuant to subdivision (a) of Section 1204 of the Health and Safety
Code, for which all of the following apply:
(A) Each licensee who is a member of the group provides
substantially the full range of services that the licensee routinely
provides, including medical care, consultation, diagnosis, or
treatment through the joint use of shared office space, facilities,
equipment, and personnel.
(B) Substantially all of the services of the licensees who are
members of the group are provided through the group and are billed in
the name of the group and amounts so received are treated as
receipts of the group, except in the case of a multispecialty clinic,
as defined in subdivision ( l ) of Section 1206 of the
Health and Safety Code, physician services are billed in the name of
the multispecialty clinic and amounts so received are treated as
receipts of the multispecialty clinic.
(C) The overhead expenses of, and the income from, the practice
are distributed in accordance with methods previously determined by
members of the group.
(c) It is unlawful for a licensee to enter into an arrangement or
scheme, such as a cross-referral arrangement, that the licensee
knows, or should know, has a principal purpose of ensuring referrals
by the licensee to a particular entity that, if the licensee directly
made referrals to that entity, would be in violation of this
section.
(d) No claim for payment shall be presented by an entity to any
individual, third party payer, or other entity for a good or service
furnished pursuant to a referral prohibited under this section.
(e) No insurer, self-insurer, or other payer shall pay a charge or
lien for any good or service resulting from a referral in violation
of this section.
(f) A licensee who refers a person to, or seeks consultation from,
an organization in which the licensee has a financial interest,
other than as prohibited by subdivision (a), shall disclose the
financial interest to the patient, or the parent or legal guardian of
the patient, in writing, at the time of the referral or request for
consultation.
(1) If a referral, billing, or other solicitation is between one
or more licensees who contract with a multispecialty clinic pursuant
to subdivision ( l ) of Section 1206 of the Health and
Safety Code or who conduct their practice as members of the same
professional corporation or partnership, and the services are
rendered on the same physical premises, or under the same
professional corporation or partnership name, the requirements of
this subdivision may be met by posting a conspicuous disclosure
statement at the registration area or by providing a patient with a
written disclosure statement.
(2) If a licensee is under contract with the Department of
Corrections or the California Youth Authority, and the patient is an
inmate or parolee of either respective department, the requirements
of this subdivision shall be satisfied by disclosing financial
interests to either the Department of Corrections or the California
Youth Authority.
(g) A violation of subdivision (a) shall be a misdemeanor. In the
case of a licensee who is a physician, the Medical Board of
California shall review the facts and circumstances of any conviction
pursuant to subdivision (a) and take appropriate disciplinary action
if the licensee has committed unprofessional conduct. In the case of
a licensee who is a certified nurse-midwife, the Board of Registered
Nursing shall review the facts and circumstances of any conviction
pursuant to subdivision (a) and take appropriate disciplinary action
if the licensee has committed unprofessional conduct. Violations of
this section may also be subject to civil penalties of up to five
thousand dollars ($5,000) for each offense, which may be enforced by
the Insurance Commissioner, Attorney General, or a district attorney.
A violation of subdivision (c), (d), or (e) is a public offense and
is punishable upon conviction by a fine not exceeding fifteen
thousand dollars ($15,000) for each violation and appropriate
disciplinary action, including revocation of professional licensure,
by the Medical Board of California, the Board of Registered Nursing,
or other appropriate governmental agency.
(h) This section shall not apply to referrals for services that
are described in and covered by Sections 139.3 and 139.31 of the
Labor Code.
(i) This section shall become operative on January 1, 1995.
SEC. 2. SEC. 3. Section 650.02 of the
Business and Professions Code is amended to read:
650.02. The prohibition of Section 650.01 shall not apply to or
restrict any of the following:
(a) A licensee may refer a patient for a good or service otherwise
prohibited by subdivision (a) of Section 650.01 if the licensee's
regular practice is located where there is no alternative provider of
the service within either 25 miles or 40 minutes traveling time, via
the shortest route on a paved road. If an alternative provider
commences furnishing the good or service for which a patient was
referred pursuant to this subdivision, the licensee shall cease
referrals under this subdivision within six months of the time at
which the licensee knew or should have known that the alternative
provider is furnishing the good or service. A licensee who refers to
or seeks consultation from an organization in which the licensee has
a financial interest under this subdivision shall disclose this
interest to the patient or the patient's parents or legal guardian in
writing at the time of referral.
(b) A licensee, when the licensee or his or her immediate family
has one or more of the following arrangements with another licensee,
a person, or an entity, is not prohibited from referring a patient to
the licensee, person, or entity because of the arrangement:
(1) A loan between a licensee and the recipient of the referral,
if the loan has commercially reasonable terms, bears interest at the
prime rate or a higher rate that does not constitute usury, is
adequately secured, and the loan terms are not affected by either
party's referral of any person or the volume of services provided by
either party.
(2) A lease of space or equipment between a licensee and the
recipient of the referral, if the lease is written, has commercially
reasonable terms, has a fixed periodic rent payment, has a term of
one year or more, and the lease payments are not affected by either
party's referral of any person or the volume of services provided by
either party.
(3) Ownership of corporate investment securities, including
shares, bonds, or other debt instruments that may be purchased on
terms generally available to the public and that are traded on a
licensed securities exchange or NASDAQ, do not base profit
distributions or other transfers of value on the licensee's referral
of persons to the corporation, do not have a separate class or
accounting for any persons or for any licensees who may refer persons
to the corporation, and are in a corporation that had, at the end of
the corporation's most recent fiscal year, or on average during the
previous three fiscal years, stockholder equity exceeding
seventy-five million dollars ($75,000,000).
(4) Ownership of shares in a regulated investment company as
defined in Section 851(a) of the federal Internal Revenue Code, if
the company had, at the end of the company's most recent fiscal year,
or on average during the previous three fiscal years, total assets
exceeding seventy-five million dollars ($75,000,000).
(5) A one-time sale or transfer of a practice or property or other
financial interest between a licensee and the recipient of the
referral if the sale or transfer is for commercially reasonable terms
and the consideration is not affected by either party's referral of
any person or the volume of services provided by either party.
(6) A personal services arrangement between a licensee or an
immediate family member of the licensee and the recipient of the
referral if the arrangement meets all of the following requirements:
(A) It is set out in writing and is signed by the parties.
(B) It specifies all of the services to be provided by the
licensee or an immediate family member of the licensee.
(C) The aggregate services contracted for do not exceed those that
are reasonable and necessary for the legitimate business purposes of
the arrangement.
(D) A person who is referred by a licensee or an immediate family
member of the licensee is informed in writing of the personal
services arrangement that includes information on where a person may
go to file a complaint against the licensee or the immediate family
member of the licensee.
(E) The term of the arrangement is for at least one year.
(F) The compensation to be paid over the term of the arrangement
is set in advance, does not exceed fair market value, and is not
determined in a manner that takes into account the volume or value of
any referrals or other business generated between the parties.
(G) The services to be performed under the arrangement do not
involve the counseling or promotion of a business arrangement or
other activity that violates any state or federal law.
(c) (1) A licensee may refer a person to a health facility, as
defined in Section 1250 of the Health and Safety Code, a licensed
alternative birth center, as defined in paragraph (4) of subdivision
(b) of Section 1204 of the Health and Safety Code, or to any
facility, or nationally accredited alternative birth center, owned or
leased by a health facility, if the recipient of the referral does
not compensate the licensee for the patient referral, and any
equipment lease arrangement between the licensee and the referral
recipient complies with the requirements of paragraph (2) of
subdivision (b).
(2) Nothing shall preclude this subdivision from applying to a
licensee solely because the licensee has an ownership or leasehold
interest in an entire health facility or an entity that owns or
leases an entire health facility.
(3) A licensee may refer a person to a health facility for any
service classified as an emergency under subdivision (a) or (b) of
Section 1317.1 of the Health and Safety Code.
(4) A licensee may refer a person to any organization that owns or
leases a health facility licensed pursuant to subdivision (a), (b),
or (f) of Section 1250 of the Health and Safety Code if the licensee
is not compensated for the patient referral, the licensee does not
receive any payment from the recipient of the referral that is based
or determined on the number or value of any patient referrals, and
any equipment lease arrangement between the licensee and the referral
recipient complies with the requirements of paragraph (2) of
subdivision (b). For purposes of this paragraph, the ownership may be
through stock or membership, and may be represented by a parent
holding company that solely owns or controls both the health facility
organization and the affiliated organization.
(d) A licensee may refer a person to a nonprofit corporation that
provides physician services pursuant to subdivision ( l )
of Section 1206 of the Health and Safety Code if the nonprofit
corporation is controlled through membership by one or more health
facilities or health facility systems and the amount of compensation
or other transfer of funds from the health facility or nonprofit
corporation to the licensee is fixed annually, except for adjustments
caused by physicians joining or leaving the groups during the year,
and is not based on the number of persons utilizing goods or services
specified in Section 650.01.
(e) A licensee compensated or employed by a university may refer a
person for a physician service, to any facility owned or operated by
the university, or to another licensee employed by the university,
provided that the facility or university does not compensate the
referring licensee for the patient referral. In the case of a
facility that is totally or partially owned by an entity other than
the university, but that is staffed by university physicians, those
physicians may not refer patients to the facility if the facility
compensates the referring physicians for those referrals.
(f) The prohibition of Section 650.01 shall not apply to any
service for a specific patient that is performed within, or goods
that are supplied by, a licensee's office, or the office of a group
practice. Further, the provisions of Section 650.01 shall not alter,
limit, or expand a licensee's ability to deliver, or to direct or
supervise the delivery of, in-office goods or services according to
the laws, rules, and regulations governing his or her scope of
practice.
(g) The prohibition of Section 650.01 shall not apply to cardiac
rehabilitation services provided by a licensee or by a suitably
trained individual under the direct or general supervision of a
licensee, if the services are provided to patients meeting the
criteria for Medicare reimbursement for the services.
(h) The prohibition of Section 650.01 shall not apply if a
licensee is in the office of a group practice and refers a person for
services or goods specified in Section 650.01 to a multispecialty
clinic, as defined in subdivision ( l ) of Section 1206 of
the Health and Safety Code.
(i) The prohibition of Section 650.01 shall not apply to health
care services provided to an enrollee of a health care service plan
licensed pursuant to the Knox-Keene Health Care Service Plan Act of
1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the
Health and Safety Code).
(j) The prohibition of Section 650.01 shall not apply to a request
by a pathologist for clinical diagnostic laboratory tests and
pathological examination services, a request by a radiologist for
diagnostic radiology services, or a request by a radiation oncologist
for radiation therapy if those services are furnished by, or under
the supervision of, the pathologist, radiologist, or radiation
oncologist pursuant to a consultation requested by another physician.
(k) This section shall not apply to referrals for services that
are described in and covered by Sections 139.3 and 139.31 of the
Labor Code.
( l ) This section shall become operative on January 1,
1995.
SEC. 3. SEC. 4. Section 2725.1 of
the Business and Professions Code is amended to read:
2725.1. (a) Notwithstanding any other law, a registered nurse may
dispense drugs or devices upon an order by a licensed physician and
surgeon or an order by a certified nurse-midwife, nurse practitioner,
or physician assistant issued pursuant to Section 2746.51, 2836.1,
or 3502.1, respectively, if the registered nurse is functioning
within a licensed primary care clinic as defined in subdivision (a)
of Section 1204 of, or within a clinic as defined in subdivision (b),
(c), (h), or (j) of Section 1206 of, the Health and Safety Code.
(b) No clinic shall employ a registered nurse to perform
dispensing duties exclusively. No registered nurse shall dispense
drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the
retailing of drugs or poisons. No registered nurse shall compound
drugs. Dispensing of drugs by a registered nurse, except a certified
nurse-midwife who functions pursuant to Section 2746.51 or a nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1, or protocol, shall not include
substances included in the California Uniform Controlled Substances
Act (Division 10 (commencing with Section 11000) of the Health and
Safety Code). Nothing in this section shall exempt a clinic from the
provisions of Article 13 (commencing with Section 4180) of Chapter 9.
(c) This section shall not be construed to limit any other
authority granted to a certified nurse-midwife pursuant to Article
2.5 (commencing with Section 2746), to a nurse practitioner pursuant
to Article 8 (commencing with Section 2834), or to a physician
assistant pursuant to Chapter 7.7 (commencing with Section 3500).
(d) This section shall not be construed to affect the sites or
types of health care facilities at which drugs or devices are
authorized to be dispensed pursuant to Chapter 9 (commencing with
Section 4000).
SEC. 4. SEC. 5. Section 2746.2 of
the Business and Professions Code is amended to read:
2746.2. (a) Each applicant shall show by evidence satisfactory to
the board that he or she has met the educational standards
established by the board or has at least the equivalent thereof,
including evidence of current advanced level national certification
by a certifying body that meets standards established and approved by
the board.
(b) The board shall create and appoint a Nurse-Midwifery Advisory
Committee consisting of certified nurse-midwives in good standing
with experience in hospital settings, alternative birth center
settings, and home settings, a nurse-midwife educator who has
demonstrated familiarity with educational standards in the delivery
of maternal-child health care, a consumer of midwifery care, and at
least two qualified physicians, including an obstetrician that has
experience working with nurse-midwives. The committee membership
shall consist of a majority of certified nurse-midwives and shall
make recommendations to the board on all matters related to
nurse-midwifery practice, education, and other matters as specified
by the board. The committee shall meet regularly, but at least twice
a year.
(c) Corporations
and other artificial legal entities shall have no professional
rights, privileges, or powers. However, the Board of Registered
Nursing may in its discretion, after such investigation and review of
such documentary evidence as it may require, and under regulations
adopted by it, grant approval of the employment of licensees on a
salary basis by licensed charitable institutions, foundations, or
clinics, if no charge for professional services rendered patients is
made by any such institution, foundation, or clinic.
(d) Notwithstanding subdivision (c), the following entities may
employ a certified nurse-midwife and charge for professional services
rendered by a certified nurse-midwife; however, the entity shall not
interfere with, control, or otherwise direct the professional
judgment of a certified nurse-midwife:
(1) A clinic operated under subdivision (h) or (p) of Section 1206
of the Health and Safety Code.
(2) A hospital owned and operated by a health care district
pursuant to Division 23 (commencing with Section 32000) of the Health
and Safety Code.
(3) A clinic operated primarily for the purpose of medical
education or nursing education by a public or private nonprofit
university medical school, which is approved by the Medical Board or
the Osteopathic Medical Board of California, provided the certified
nurse-midwife holds an academic appointment on the faculty of the
university, including, but not limited to, the University of
California medical schools and hospitals.
(4) A licensed alternative birth center, as defined in paragraph
(4) of subdivision (b) of Section 1204 of the Health and Safety Code,
or a nationally accredited alternative birth center owned or
operated by a nursing corporation, as defined in Section 2775 of the
Business and Professions Code.
(5) A health facility described in Section 1250 of the Health and
Safety Code if the certified-nurse midwife is practicing under the
supervision of a physician and surgeon.
(6) A clinic operated under subdivision (a) of Section 1204 of the
Health and Safety code.
(e) As used in this section, supervision shall not be construed to
require the physical presence of a supervising physician and
surgeon. A facility described in paragraphs (1) to (4), inclusive, of
subdivision (d) that employs a certified-nurse midwife shall not
require supervision by a physician and surgeon of the certified-nurse
midwife.
SEC. 5. SEC. 6. Section 2746.5 of
the Business and Professions Code is amended to read:
2746.5. (a) The certificate to practice nurse-midwifery
authorizes the holder to manage a full range of primary gynecological
and obstetric care services for women from adolescence to beyond
menopause, consistent with the Core Competencies for Basic Midwifery
practice promulgated by the American College of Nurse-Midwives, or
its successor national professional organization, as approved by the
board. These services include, but are not limited to, primary health
care, gynecologic and family planning services, preconception care,
care during pregnancy, childbirth, and the postpartum period,
immediate care of the newborn, and treatment of male partners for
sexually transmitted infections, utilizing consultation,
collaboration, or referral to appropriate levels of health care
services, as indicated.
(b) A certified nurse-midwife may practice under this section
without supervision of a physician and surgeon in the
following settings:
(1) A licensed clinic as described in Chapter 1 (commencing with
Section 1200) of Division 2 of the Health and Safety Code.
(2) A facility as described in Chapter 2 (commencing with Section
1250) of Division 2 of the Health and Safety Code.
(3) A facility as described in Chapter 2.5 (commencing with
Section 1440) of Division 2 of the Health and Safety Code.
(4) A medical group practice, including a professional medical
corporation, a medical partnership, a medical foundation exempt from
licensure pursuant to Section 1206 of the Health and Safety Code, or
another lawfully organized group of physicians that delivers,
furnishes, or otherwise arranges for or provides health care
services.
(5) A licensed alternative birth center, as described in Section
1204 of the Health and Safety Code, or nationally accredited birth
center.
(6) A nursing corporation, as defined in Section 2775 of the
Business and Professions Code.
(7) A home setting.
(A) Except as provided in subparagraph (B), a certified
nurse-midwife shall only attend during normal, low-risk pregnancy and
childbirth in the home setting when all of the following conditions
apply:
(i) There is the absence of all of the following:
(I) Any preexisting maternal disease or condition creating risks
beyond that of a normal, low-risk pregnancy or birth, as defined in
the American College of Nurse-Midwives' standard-setting documents
and any future changes to those documents.
(II) Disease arising from or during the pregnancy creating risks
beyond that of a normal, low-risk pregnancy or birth, as defined in
the American College of Nurse-Midwives' standard-setting documents
and any future changes to those documents.
(III) Prior caesarean delivery.
(ii) There is a singleton fetus.
(iii) There is cephalic presentation at the onset of labor.
(iv) The gestational age of the fetus is greater than 370/7 weeks
and less than 420/7 completed weeks of pregnancy at the onset of
labor.
(v) Labor is spontaneous or induced in an outpatient setting.
(B) If a potential certified nurse-midwife client meets the
conditions specified in subclauses (I) and (II) of clause (i) and
clauses (ii) to (v), inclusive, of subparagraph (A), but fails to
meet the condition specified in subclause (III) of clause (i) of
subparagraph (A), and the woman still desires to be a client of the
certified nurse-midwife, the certified nurse-midwife shall provide
the woman with a referral for an examination by a physician and
surgeon trained in obstetrics and gynecology. A certified
nurse-midwife may assist the woman in pregnancy and childbirth only
if an examination by a physician and surgeon trained in obstetrics
and gynecology is obtained and, based upon review of the client's
medical file, the certified nurse-midwife determines that the risk
factors presented by the woman's condition do not increase the woman'
s risk beyond that of a normal, low-risk pregnancy and birth. The
certified nurse-midwife may continue care of the client during a
reasonable interval between the referral and the initial appointment
with the physician and surgeon.
(c) An entity described in subdivision (b) shall not interfere
with, control, or otherwise direct the professional judgment of a
certified nurse-midwife functioning pursuant to this section in a
manner prohibited by Section 510 or any other law.
(c)
(d) As used in this chapter, the practice of
nurse-midwifery within a health care system provides for
consultation, collaboration, or referral as indicated by the health
status of the patient and the resources and medical personnel
available in the setting of care. The practice of nurse-midwifery
care emphasizes informed consent, preventive care, and early
detection and referral of complications to physicians and surgeons.
While practicing in a hospital setting, the certified nurse-midwife
shall collaboratively care for women with more complex health needs.
(d)
(e) A certified nurse-midwife practicing under
subdivision (a) shall be subject to all credentialing and quality
standards held by the facility in which he or she practices. The peer
review body shall include nurse-midwives as part of the peer review
body that reviews nurse-midwives. The peer review body of that
facility shall impose standards that ensure quality and patient
safety in their facility. The standards shall be approved by the
relevant governing body unless found by a court to be arbitrary and
capricious.
(e)
(f) The practice of nurse-midwifery does not include
the assisting of childbirth by any forcible or mechanical means or
the performance of a version.
(f)
(g) A certified nurse-midwife is not authorized to
practice medicine and surgery by the provisions of this chapter.
(g)
(h) Any regulations promulgated by a state department
that affect the scope of practice of a certified nurse-midwife shall
be developed in consultation with the board and the Nurse-Midwifery
Advisory Committee.
SEC. 6. SEC. 7. Section 2746.51 of
the Business and Professions Code is amended to read:
2746.51. (a) Neither this chapter nor any other law shall be
construed to prohibit a certified nurse-midwife from furnishing or
ordering drugs or devices, including controlled substances classified
in Schedule II, III, IV, or V under the California Uniform
Controlled Substances Act (Division 10 (commencing with Section
11000) of the Health and Safety Code), when the drugs or devices are
furnished or ordered related to the provision of any of the
following:
(1) Family planning services, as defined in Section 14503 of the
Welfare and Institutions Code.
(2) Routine health care or perinatal care, as defined in
subdivision (d) of Section 123485 of the Health and Safety Code.
(3) Care rendered, consistent with the certified nurse-midwife's
educational preparation or for which clinical competency has been
established and maintained, to persons within a facility specified in
subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the
Health and Safety Code, a clinic as specified in Section 1204 of the
Health and Safety Code, a general acute care hospital as defined in
subdivision (a) of Section 1250 of the Health and Safety Code, a
licensed birth center as defined in Section 1204.3 of the Health and
Safety Code, or a special hospital specified as a maternity hospital
in subdivision (f) of Section 1250 of the Health and Safety Code.
(4) Care rendered in a home pursuant to subdivision (a) of Section
2746.5.
(b) (1) The furnishing or ordering of drugs or devices by a
certified nurse-midwife is conditional on the issuance by the board
of a number to the applicant who has successfully completed the
requirements of paragraph (2). The number shall be included on all
transmittals of orders for drugs or devices by the certified
nurse-midwife. The board shall maintain a list of the certified
nurse-midwives that it has certified pursuant to this paragraph and
the number it has issued to each one. The board shall make the list
available to the California State Board of Pharmacy upon its request.
Every certified nurse-midwife who is authorized pursuant to this
section to furnish or issue a drug order for a controlled substance
shall register with the United States Drug Enforcement
Administration.
(2) The board has certified in accordance with paragraph (1) that
the certified nurse-midwife has satisfactorily completed a course in
pharmacology covering the drugs or devices to be furnished or ordered
under this section. The board shall establish the requirements for
satisfactory completion of this paragraph.
(3) Certified nurse-midwives who are certified by the board and
hold an active furnishing number, who are currently authorized to
furnish Schedule II controlled substances, and who are registered
with the United States Drug Enforcement Administration shall provide
documentation of continuing education specific to the use of Schedule
II controlled substances in settings other than a hospital based on
standards developed by the board.
(c) Drugs or devices furnished or ordered by a certified
nurse-midwife may include Schedule II controlled substances under the
California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety Code) when
the drugs and devices are furnished or ordered in accordance with
requirements referenced in paragraphs (1) to (3), inclusive, of
subdivision (b). In a nonhospital setting, a Schedule II controlled
substance shall be furnished by a certified nurse-midwife only during
labor and delivery and only after a consultation with a physician
and surgeon.
(d) Furnishing of drugs or devices by a certified nurse-midwife
means the act of making a pharmaceutical agent or agents available to
the patient.
(e) "Drug order" or "order" for purposes of this section means an
order for medication or for a drug or device that is dispensed to or
for an ultimate user, issued by a certified nurse-midwife as an
individual practitioner, within the meaning of Section 1306.03 of
Title 21 of the Code of Federal Regulations. Notwithstanding any
other law, (1) a drug order issued pursuant to this section shall be
treated in the same manner as a prescription of a physician; (2) all
references to "prescription" in this code and the Health and Safety
Code shall include drug orders issued by certified nurse-midwives;
and (3) the signature of a certified nurse-midwife on a drug order
issued in accordance with this section shall be deemed to be the
signature of a prescriber for purposes of this code and the Health
and Safety Code.
(f) A certified nurse-midwife is authorized to directly procure
supplies and devices, to order, obtain, and administer drugs and
diagnostic tests, to order laboratory and diagnostic testing, and to
receive reports that are necessary to his or her practice as a
certified nurse-midwife and consistent with nurse-midwifery education
preparation.
SEC. 7. SEC. 8. Section 2746.52 of
the Business and Professions Code is amended to read:
2746.52. (a) Notwithstanding Section 2746.5, the certificate to
practice nurse-midwifery authorizes the holder to perform and repair
episiotomies, and to repair first-degree and second-degree
lacerations of the perineum, in a licensed acute care hospital, as
defined in subdivision (a) of Section 1250 of the Health and Safety
Code, in a licensed alternate birth center, as defined in paragraph
(4) of subdivision (b) of Section 1204 of the Health and Safety Code,
or a nationally accredited birth center, and in a home pursuant to
paragraph (7) of subdivision (b) of Section 2746.5.
(b) The certified nurse-midwife performing and repairing
first-degree and second-degree lacerations of the perineum shall do
both of the following:
(1) Ensure that all complications are referred to a physician and
surgeon immediately.
(2) Ensure immediate care of patients who are in need of care
beyond the scope of practice of the certified nurse-midwife, or
provide emergency care for times when a physician and surgeon is not
available.
SEC. 8. SEC. 9. Section 2746.6 is
added to the Business and Professions Code, to read:
2746.6. A consultative relationship between a certified
nurse-midwife and a physician and surgeon shall not, by itself,
provide the basis for finding a physician and surgeon liable for any
act or omission of the certified nurse-midwife.
SEC. 9. SEC. 10. Section 4061 of the
Business and Professions Code is amended to read:
4061. (a) A manufacturer's sales representative shall not
distribute any dangerous drug or dangerous device as a complimentary
sample without the written request of a physician, dentist,
podiatrist, optometrist, veterinarian, or naturopathic doctor
pursuant to Section 3640.7. However, a certified nurse-midwife who
functions pursuant to Section 2746.51, a nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1, or protocol, a physician assistant who functions pursuant to
a protocol described in Section 3502.1, or a naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, may sign for the request and receipt of
complimentary samples of a dangerous drug or dangerous device that
has been identified in the standardized procedure, protocol, or
practice agreement. Standardized procedures, protocols, and practice
agreements shall include specific approval by a physician. A review
process, consistent with the requirements of Section 2725, 3502.1, or
3640.5, of the complimentary samples requested and received by a
nurse practitioner, certified nurse-midwife, physician assistant, or
naturopathic doctor, shall be defined within the standardized
procedure, protocol, or practice agreement.
(b) Each written request shall contain the names and addresses of
the supplier and the requester, the name and quantity of the specific
dangerous drug desired, the name of the certified nurse-midwife,
nurse practitioner, physician assistant, or naturopathic doctor, if
applicable, receiving the samples pursuant to this section, the date
of receipt, and the name and quantity of the dangerous drugs or
dangerous devices provided. These records shall be preserved by the
supplier with the records required by Section 4059.
(c) Nothing in this section is intended to expand the scope of
practice of a certified nurse-midwife, nurse practitioner, physician
assistant, or naturopathic doctor.
SEC. 10. Section 4076 of the Business and
Professions Code is amended to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife who
functions pursuant to Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders
otherwise, either the manufacturer's trade name of the drug or the
generic name and the name of the manufacturer. Commonly used
abbreviations may be used. Preparations containing two or more active
ingredients may be identified by the manufacturer's trade name or
the commonly used name or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to Section 2746.51,
the nurse practitioner who functions pursuant to a standardized
procedure described in Section 2836.1 or protocol, the physician
assistant who functions pursuant to Section 3502.1, the naturopathic
doctor who functions pursuant to a standardized procedure or protocol
described in Section 3640.5, or the pharmacist who functions
pursuant to a policy, procedure, or protocol pursuant to Section
4052.1, 4052.2, or 4052.6.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication system contains the aforementioned
information or the information is otherwise readily available at the
time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to Section 2746.51, the nurse
practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or
4052.6.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
SEC. 11. Section 4076 of the Business
and Professions Code is amended to read:
4076. (a) A pharmacist shall not dispense any prescription except
in a container that meets the requirements of state and federal law
and is correctly labeled with all of the following:
(1) Except when the prescriber or the certified nurse-midwife who
functions pursuant to a standardized procedure or protocol
described in Section 2746.51, the nurse practitioner who
functions pursuant to a standardized procedure described in Section
2836.1 or protocol, the physician assistant who functions pursuant to
Section 3502.1, the naturopathic doctor who functions pursuant to a
standardized procedure or protocol described in Section 3640.5, or
the pharmacist who functions pursuant to a policy, procedure, or
protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders
otherwise, either the manufacturer's trade name of the drug or the
generic name and the name of the manufacturer. Commonly used
abbreviations may be used. Preparations containing two or more active
ingredients may be identified by the manufacturer's trade name or
the commonly used name or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the
certified nurse-midwife who functions pursuant to a
standardized procedure or protocol described in Section
2746.51, the nurse practitioner who functions pursuant to a
standardized procedure described in Section 2836.1 or protocol, the
physician assistant who functions pursuant to Section 3502.1, the
naturopathic doctor who functions pursuant to a standardized
procedure or protocol described in Section 3640.5, or the pharmacist
who functions pursuant to a policy, procedure, or protocol pursuant
to Section 4052.1, 4052.2, or 4052.6.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number
or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug
dispensed.
(10) The condition or purpose for which the drug was prescribed if
the condition or purpose is indicated on the prescription.
(11) (A) Commencing January 1, 2006, the physical description of
the dispensed medication, including its color, shape, and any
identification code that appears on the tablets or capsules, except
as follows:
(i) Prescriptions dispensed by a veterinarian.
(ii) An exemption from the requirements of this paragraph shall be
granted to a new drug for the first 120 days that the drug is on the
market and for the 90 days during which the national reference file
has no description on file.
(iii) Dispensed medications for which no physical description
exists in any commercially available database.
(B) This paragraph applies to outpatient pharmacies only.
(C) The information required by this paragraph may be printed on
an auxiliary label that is affixed to the prescription container.
(D) This paragraph shall not become operative if the board, prior
to January 1, 2006, adopts regulations that mandate the same labeling
requirements set forth in this paragraph.
(b) If a pharmacist dispenses a prescribed drug by means of a unit
dose medication system, as defined by administrative regulation, for
a patient in a skilled nursing, intermediate care, or other health
care facility, the requirements of this section will be satisfied if
the unit dose medication
system contains the aforementioned information or the information is
otherwise readily available at the time of drug administration.
(c) If a pharmacist dispenses a dangerous drug or device in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include on individual unit dose
containers for a specific patient, the name of the certified
nurse-midwife who functions pursuant to a standardized
procedure or protocol described in Section 2746.51, the
nurse practitioner who functions pursuant to a standardized procedure
described in Section 2836.1 or protocol, the physician assistant who
functions pursuant to Section 3502.1, the naturopathic doctor who
functions pursuant to a standardized procedure or protocol described
in Section 3640.5, or the pharmacist who functions pursuant to a
policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or
4052.6.
(d) If a pharmacist dispenses a prescription drug for use in a
facility licensed pursuant to Section 1250 of the Health and Safety
Code, it is not necessary to include the information required in
paragraph (11) of subdivision (a) when the prescription drug is
administered to a patient by a person licensed under the Medical
Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing
Practice Act (Chapter 6 (commencing with Section 2700)), or the
Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section
2840)), who is acting within his or her scope of practice.
(e) A pharmacist shall use professional judgment to provide a
patient with directions for use that enhance the patient's
understanding of those directions, consistent with the prescriber's
instructions.
SEC. 11. SEC. 12. Section 4170 of the
Business and Professions Code is amended to read:
4170. (a) A prescriber shall not dispense drugs or dangerous
devices to patients in his or her office or place of practice unless
all of the following conditions are met:
(1) The dangerous drugs or dangerous devices are dispensed to the
prescriber's own patient, and the drugs or dangerous devices are not
furnished by a nurse or physician attendant.
(2) The dangerous drugs or dangerous devices are necessary in the
treatment of the condition for which the prescriber is attending the
patient.
(3) The prescriber does not keep a pharmacy, open shop, or
drugstore, advertised or otherwise, for the retailing of dangerous
drugs, dangerous devices, or poisons.
(4) The prescriber fulfills all of the labeling requirements
imposed upon pharmacists by Section 4076, all of the recordkeeping
requirements of this chapter, and all of the packaging requirements
of good pharmaceutical practice, including the use of childproof
containers.
(5) The prescriber does not use a dispensing device unless he or
she personally owns the device and the contents of the device, and
personally dispenses the dangerous drugs or dangerous devices to the
patient packaged, labeled, and recorded in accordance with paragraph
(4).
(6) The prescriber, prior to dispensing, offers to give a written
prescription to the patient that the patient may elect to have filled
by the prescriber or by any pharmacy.
(7) The prescriber provides the patient with written disclosure
that the patient has a choice between obtaining the prescription from
the dispensing prescriber or obtaining the prescription at a
pharmacy of the patient's choice.
(8) A certified nurse-midwife who functions pursuant to Section
2746.51, a nurse practitioner who functions pursuant to a
standardized procedure described in Section 2836.1, or protocol, a
physician assistant who functions pursuant to Section 3502.1, or a
naturopathic doctor who functions pursuant to Section 3640.5, may
hand to a patient of the supervising physician and surgeon, if
applicable, a properly labeled prescription drug prepackaged by a
physician and surgeon, a manufacturer as defined in this chapter, or
a pharmacist.
(b) The Medical Board of California, the State Board of Optometry,
the Bureau of Naturopathic Medicine, the Dental Board of California,
the Osteopathic Medical Board of California, the Board of Registered
Nursing, the Veterinary Medical Board, and the Physician Assistant
Committee shall have authority with the California State Board of
Pharmacy to ensure compliance with this section, and those boards are
specifically charged with the enforcement of this chapter with
respect to their respective licensees.
(c) "Prescriber," as used in this section, means a person, who
holds a physician's and surgeon's certificate, a license to practice
optometry, a license to practice naturopathic medicine, a license to
practice dentistry, a license to practice veterinary medicine, or a
certificate to practice podiatry, and who is duly registered by the
Medical Board of California, the State Board of Optometry, the Bureau
of Naturopathic Medicine, the Dental Board of California, the
Veterinary Medical Board, or the Board of Osteopathic Examiners of
this state.
SEC. 12. SEC. 13. No reimbursement
is required by this act pursuant to Section 6 of Article XIII B of
the California Constitution because the only costs that may be
incurred by a local agency or school district will be incurred
because this act creates a new crime or infraction, eliminates a
crime or infraction, or changes the penalty for a crime or
infraction, within the meaning of Section 17556 of the Government
Code, or changes the definition of a crime within the meaning of
Section 6 of Article XIII B of the California Constitution.
