Bill Text: CA AB830 | 2009-2010 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Drugs and devices.
Spectrum: Bipartisan Bill
Status: (Passed) 2009-10-11 - Chaptered by Secretary of State - Chapter 479, Statutes of 2009. [AB830 Detail]
Download: California-2009-AB830-Amended.html
Bill Title: Drugs and devices.
Spectrum: Bipartisan Bill
Status: (Passed) 2009-10-11 - Chaptered by Secretary of State - Chapter 479, Statutes of 2009. [AB830 Detail]
Download: California-2009-AB830-Amended.html
BILL NUMBER: AB 830 AMENDED
BILL TEXT
AMENDED IN SENATE JULY 6, 2009
AMENDED IN ASSEMBLY APRIL 23, 2009
AMENDED IN ASSEMBLY APRIL 1, 2009
INTRODUCED BY Assembly Member Cook
(Principal coauthor: Assembly Member Krekorian)
FEBRUARY 26, 2009
An act to amend Sections 13, 4025, 4053, and 4342 of the
Business and Professions Code, to amend Sections 1367.21, 1370.4,
11014, 109920, 109985, 111225, 111235, 111656.4, and 150204 of the
Health An act to amend Sections 1367.21 and 1370.4 of
the Health and Safety Code, to amend Sections 10123.195 and
10145.3 of the Insurance Code, to amend Section 383 of the
Penal Code, to amend Section 47121 of the Public Resources Code, and
to amend Sections Insurance Code, and to amend
Sections 14105.43 and 14133.2 of the Welfare and Institutions
Code, relating to drugs and devices.
LEGISLATIVE COUNSEL'S DIGEST
AB 830, as amended, Cook. Drugs and devices.
Existing law references various drug compendiums and compendia,
including the United States Pharmacopoeia, in various
licensure, health care, and social services provisions
for purposes of the Knox-Keene Health Care Service Plan Act of 1975,
disability insurance, and for Medi- Cal .
This bill would replace these references with a
compendium approved by the federal Centers for Medicare and Medicaid
Services references to a specified compendia
, as approved by the federal Centers for Medicare and
Medicaid Services .
Existing law makes it a crime to knowingly sell, or keep or offer
for sale, or otherwise dispose of any drug or medicine, knowing that
it is adulterated. A drug is deemed to be adulterated based upon the
standard of strength, quality, or purity in the United States
Pharmacopoeia.
This bill would replace the above drug compendium's with a
compendium approved by the federal Centers for Medicare and Medicaid
Services. By changing the definition of a crime, this bill would
impose a state-mandated local program.
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 no .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 13 of the Business and
Professions Code is amended to read:
13. The term "materia medica" as used in this code or in any
initiative act referred to in this code, means those substances
listed in a compendium or supplement thereof approved by the federal
Centers for Medicare and Medicaid Services, except substances covered
by subdivision (a) of Section 4052 and Section 4057.
SEC. 2. Section 4025 of the Business and
Professions Code is amended to read:
4025. "Drug" means any of the following:
(a) Articles recognized in a compendium or supplement thereof
approved by the federal Centers for Medicare and Medicaid Services.
(b) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals.
(c) Articles (other than food) intended to affect the structure or
any function of the body of humans or other animals.
(d) Articles intended for use as a component of any article
specified in subdivision (a), (b), or (c).
SEC. 3. Section 4053 of the Business and
Professions Code is amended to read:
4053. (a) Notwithstanding Section 4051, the board may issue a
license as a designated representative to provide sufficient and
qualified supervision in a wholesaler or veterinary food-animal drug
retailer. The designated representative shall protect the public
health and safety in the handling, storage, and shipment of dangerous
drugs and dangerous devices in the wholesaler or veterinary
food-animal drug retailer.
(b) An individual may apply for a designated representative
license. In order to obtain and maintain that license, the individual
shall meet all of the following requirements:
(1) He or she shall be a high school graduate or possess a general
education development equivalent.
(2) He or she shall have a minimum of one year of paid work
experience, in the past three years, related to the distribution or
dispensing of dangerous drugs or dangerous devices or meet all of the
prerequisites to take the examination required for licensure as a
pharmacist by the board.
(3) He or she shall complete a training program approved by the
board that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California law and federal law
relating to the distribution of dangerous drugs and dangerous
devices.
(B) Knowledge and understanding of California law and federal law
relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the standards relating to the
safe storage and handling of drugs in a compendium approved by the
federal Centers for Medicare and Medicaid Services.
(E) Knowledge and understanding of prescription terminology,
abbreviations, dosages and format.
(4) The board may, by regulation, require training programs to
include additional material.
(5) The board may not issue a license as a designated
representative until the applicant provides proof of completion of
the required training to the board.
(c) The veterinary food-animal drug retailer or wholesaler shall
not operate without a pharmacist or a designated representative on
its premises.
(d) Only a pharmacist or a designated representative shall prepare
and affix the label to veterinary food-animal drugs.
(e) Section 4051 shall not apply to any laboratory licensed under
Section 351 of Title III of the Public Health Service Act (Public Law
78-410).
SEC. 4. Section 4342 of the Business and
Professions Code is amended to read:
4342. (a) The board may institute any action or actions as may be
provided by law and that, in its discretion, are necessary, to
prevent the sale of pharmaceutical preparations and drugs that do not
conform to the standard and tests as to quality and strength,
provided in the latest edition of a compendium approved by the
federal Centers for Medicare and Medicaid Services or that violate
any provision of the Sherman Food, Drug and Cosmetic Law (Part 5
(commencing with Section 109875) of Division 104 of the Health and
Safety Code).
(b) Any knowing or willful violation of any regulation adopted
pursuant to Section 4006 shall be subject to punishment in the same
manner as is provided in Sections 4336 and 4321.
SEC. 5. SECTION 1. Section 1367.21
of the Health and Safety Code is amended to read:
1367.21. (a) No health care service plan contract which covers
prescription drug benefits shall be issued, amended, delivered, or
renewed in this state if the plan limits or excludes coverage for a
drug on the basis that the drug is prescribed for a use that is
different from the use for which that drug has been approved for
marketing by the federal Food and Drug Administration (FDA), provided
that all of the following conditions have been met:
(1) The drug is approved by the FDA.
(2) (A) The drug is prescribed by a participating licensed health
care professional for the treatment of a life-threatening condition;
or
(B) The drug is prescribed by a participating licensed health care
professional for the treatment of a chronic and seriously
debilitating condition, the drug is medically necessary to treat that
condition, and the drug is on the plan formulary. If the drug is not
on the plan formulary, the participating subscriber's request shall
be considered pursuant to the process required by Section 1367.24.
(3) The drug has been recognized for treatment of that condition
by either of the following:
(A) A compendium
approved by the federal Centers for Medicare and Medicaid Services.
by one of the following compendia, as approved by the
federal Centers for Medicare and Medicaid Services:
(A) The American Hospital Formulary Service's Drug Information.
(B) The Elsevier Gold Standard's Clinical Pharmacology.
(C) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(D) The Thomson Micromedex DrugDex.
(B)
(E) Two articles from major peer reviewed medical
journals that present data supporting the proposed off-label use or
uses as generally safe and effective unless there is clear and
convincing contradictory evidence presented in a major peer reviewed
medical journal.
(b) It shall be the responsibility of the participating prescriber
to submit to the plan documentation supporting compliance with the
requirements of subdivision (a), if requested by the plan.
(c) Any coverage required by this section shall also include
medically necessary services associated with the administration of a
drug, subject to the conditions of the contract.
(d) For purposes of this section, "life-threatening" means either
or both of the following:
(1) Diseases or conditions where the likelihood of death is high
unless the course of the disease is interrupted.
(2) Diseases or conditions with potentially fatal outcomes, where
the end point of clinical intervention is survival.
(e) For purposes of this section, "chronic and seriously
debilitating" means diseases or conditions that require ongoing
treatment to maintain remission or prevent deterioration and cause
significant long-term morbidity.
(f) The provision of drugs and services when required by this
section shall not, in itself, give rise to liability on the part of
the plan.
(g) Nothing in this section shall be construed to prohibit the use
of a formulary, copayment, technology assessment panel, or similar
mechanism as a means for appropriately controlling the utilization of
a drug that is prescribed for a use that is different from the use
for which that drug has been approved for marketing by the FDA.
(h) If a plan denies coverage pursuant to this section on the
basis that its use is experimental or investigational, that decision
is subject to review under Section 1370.4.
(i) Health care service plan contracts for the delivery of
Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act
(Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of
the Welfare and Institutions Code) are exempt from the requirements
of this section.
SEC. 6. SEC. 2. Section 1370.4 of
the Health and Safety Code is amended to read:
1370.4. (a) Every health care service plan shall provide an
external, independent review process to examine the plan's coverage
decisions regarding experimental or investigational therapies for
individual enrollees who meet all of the following criteria:
(1) (A) The enrollee has a life-threatening or seriously
debilitating condition.
(B) For purposes of this section, "life-threatening" means either
or both of the following:
(i) Diseases or conditions where the likelihood of death is high
unless the course of the disease is interrupted.
(ii) Diseases or conditions with potentially fatal outcomes, where
the end point of clinical intervention is survival.
(C) For purposes of this section, "seriously debilitating" means
diseases or conditions that cause major irreversible morbidity.
(2) The enrollee's physician certifies that the enrollee has a
condition, as defined in paragraph (1), for which standard therapies
have not been effective in improving the condition of the enrollee,
for which standard therapies would not be medically appropriate for
the enrollee, or for which there is no more beneficial standard
therapy covered by the plan than the therapy proposed pursuant to
paragraph (3).
(3) Either (A) the enrollee's physician, who is under contract
with or employed by the plan, has recommended a drug, device,
procedure , or other therapy that the physician certifies
in writing is likely to be more beneficial to the enrollee than any
available standard therapies, or (B) the enrollee, or the enrollee's
physician who is a licensed, board-certified or board-eligible
physician qualified to practice in the area of practice appropriate
to treat the enrollee's condition, has requested a therapy that,
based on two documents from the medical and scientific evidence, as
defined in subdivision (d), is likely to be more beneficial for the
enrollee than any available standard therapy. The physician
certification pursuant to this subdivision shall include a statement
of the evidence relied upon by the physician in certifying his or her
recommendation. Nothing in this subdivision shall be construed to
require the plan to pay for the services of a nonparticipating
physician provided pursuant to this subdivision, that are not
otherwise covered pursuant to the plan contact.
(4) The enrollee has been denied coverage by the plan for a drug,
device, procedure, or other therapy recommended or requested pursuant
to paragraph (3).
(5) The specific drug, device, procedure, or other therapy
recommended pursuant to paragraph (3) would be a covered service,
except for the plan's determination that the therapy is experimental
or investigational.
(b) The plan's decision to delay, deny, or modify experimental or
investigational therapies shall be subject to the independent medical
review process under Article 5.55 (commencing with Section 1374.30)
except that, in lieu of the information specified in subdivision (b)
of Section 1374.33, an independent medical reviewer shall base his or
her determination on relevant medical and scientific evidence,
including, but not limited to, the medical and scientific evidence
defined in subdivision (d).
(c) The independent medical review process shall also meet the
following criteria:
(1) The plan shall notify eligible enrollees in writing of the
opportunity to request the external independent review within five
business days of the decision to deny coverage.
(2) If the enrollee's physician determines that the proposed
therapy would be significantly less effective if not promptly
initiated, the analyses and recommendations of the experts on the
panel shall be rendered within seven days of the request for
expedited review. At the request of the expert, the deadline shall be
extended by up to three days for a delay in providing the documents
required. The timeframes specified in this paragraph shall be in
addition to any otherwise applicable timeframes contained in
subdivision (c) of Section 1374.33.
(3) Each expert's analysis and recommendation shall be in written
form and state the reasons the requested therapy is or is not likely
to be more beneficial for the enrollee than any available standard
therapy, and the reasons that the expert recommends that the therapy
should or should not be provided by the plan, citing the enrollee's
specific medical condition, the relevant documents provided, and the
relevant medical and scientific evidence, including, but not limited
to, the medical and scientific evidence as defined in subdivision
(d), to support the expert's recommendation.
(4) Coverage for the services required under this section shall be
provided subject to the terms and conditions generally applicable to
other benefits under the plan contract.
(d) For the purposes of subdivision (b), "medical and scientific
evidence" means the following sources:
(1) Peer-reviewed scientific studies published in or accepted for
publication by medical journals that meet nationally recognized
requirements for scientific manuscripts and that submit most of their
published articles for review by experts who are not part of the
editorial staff.
(2) Peer-reviewed literature, biomedical compendia, and other
medical literature that meet the criteria of the National Institutes
of Health's National Library of Medicine for indexing in Index
Medicus, Excerpta Medicus (EMBASE), Medline, and MEDLARS database
of Health Services Technology Assessment Research (HSTAR).
(3) Medical journals recognized by the Secretary of Health and
Human Services, under Section 1861(t)(2) of the Social Security Act.
(4) A compendium approved by the federal Centers for Medicare and
Medicaid Services.
(4) The following standard reference compendia, as approved by the
federal Centers for Medicare and Medicaid Services: the American
Hospital Formulary Service's Drug Information, the American Dental
Association Accepted Dental Therapeutics, the Elsevier Gold Standard'
s Clinical Pharmacology, the National Comprehensive Cancer Network
Drug and Biologics Compendium, and the Thomson Micromedex DrugDex.
(5) Findings, studies, or research conducted by or under the
auspices of federal government agencies and nationally recognized
federal research institutes, including the Federal Agency for Health
Care Policy and Research, National Institutes of Health, National
Cancer Institute, National Academy of Sciences, Health Care Financing
Administration, Congressional Office of Technology Assessment, and
any national board recognized by the National Institutes of Health
for the purpose of evaluating the medical value of health services.
(6) Peer-reviewed abstracts accepted for presentation at major
medical association meetings.
(e) The independent review process established by this section
shall be required on and after January 1, 2001.
SEC. 7. Section 11014 of the Health and Safety
Code is amended to read:
11014. "Drug" means (a) substances recognized as drugs in a
compendium approved by the federal Centers for Medicare and Medicaid
Services; (b) substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or animals;
(c) substances (other than food) intended to affect the structure or
any function of the body of man or animals; and (d) substances
intended for use as a component of any article specified in
subdivision (a), (b), or (c) of this section. It does not include
devices or their components, parts, or accessories.
SEC. 8. Section 109920 of the Health and Safety
Code is amended to read:
109920. "Device" means any instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory, that is
any of the following:
(a) Recognized in a compendium or supplement thereof approved by
the federal Centers for Medicare and Medicaid Services.
(b) Intended for use in the diagnosis of disease or other
condition, or in the cure, mitigation, treatment, or prevention of
disease in humans or any other animal.
(c) Intended to affect the structure or any function of the body
of humans or any other animal and that does not achieve any of its
principal intended purposes through chemical action within or on the
body of humans or other animals and that is not dependent upon being
metabolized for the achievement of any of its principal intended
purposes.
SEC. 9. Section 109985 of the Health and Safety
Code is amended to read:
109985. "Official compendium" means a compendium or supplement
thereof approved by the federal Centers for Medicare and Medicaid
Services.
SEC. 10. Section 111225 of the Health and
Safety Code is amended to read:
111225. As used in this chapter, with respect to a drug or drug
ingredient, "established name" means either of the following:
(a) The name designated pursuant to Section 508 of the federal act
(21 U.S.C. Sec. 358).
(b) If there is no designated name and the drug or ingredient is
an article recognized in a compendium approved by the federal Centers
for Medicare and Medicaid Services, then the official title in the
compendia is the established name.
If neither subdivision (a) or (b) of this section applies, the
common or usual name, if any, of the drug or of the ingredient is the
established name. When an article is recognized in a compendium
approved by the federal Centers for Medicare and Medicaid Services
and in the Homeopathic Pharmacopoeia under different official titles,
the official title used in the approved compendium shall apply
unless it is labeled and offered for sale as a homeopathic drug. If
it is labeled and offered for sale as a homeopathic drug, the
official title used in the Homeopathic Pharmacopoeia shall apply.
SEC. 11. Section 111235 of the Health and
Safety Code is amended to read:
111235. Whenever a drug is recognized in both a compendium
approved by the federal Centers for Medicare and Medicaid Services
and the Homeopathic Pharmacopoeia of the United States, it shall be
subject to the requirements of the approved compendium unless it is
labeled and offered for sale as a homeopathic drug. If it is labeled
and offered for sale as a homeopathic drug, it shall be subject to
the Homeopathic Pharmacopoeia of the United States and not to those
of the approved compendium.
SEC. 12. Section 111656.4 of the Health and
Safety Code is amended to read:
111656.4. Section 4051 of the Business and Professions Code shall
not prohibit a home medical device retail facility from selling or
dispensing prescription devices if the department finds that
sufficient qualified supervision is employed by the home medical
device retail facility to adequately safeguard and protect the public
health. Each person applying to the department for this exemption
shall meet the following requirements to obtain and maintain the
exemption:
(a) A licensed pharmacist or an exemptee who meets the
requirements set forth in paragraphs (1) to (5), inclusive, and whose
license of exemption is currently valid, shall be in charge of the
home medical device retail facility.
(1) He or she shall be a high school graduate or possess a general
education development equivalent.
(2) He or she shall have a minimum of one year of paid work
experience related to the distribution or dispensing of dangerous
drugs or dangerous devices.
(3) He or she shall complete a training program that addresses
each of the following subjects that are applicable to his or her
duties:
(A) Knowledge and understanding of state and federal laws relating
to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of state and federal laws relating
the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the standards relating to the
safe storage and handling of drugs in a compendium approved by the
federal Centers for Medicare and Medicaid Services.
(E) Knowledge and understanding relating to the safe storage and
handling of home medical devices.
(F) Knowledge and understanding of prescription terminology,
abbreviations, and format.
(4) The department may, by regulation, require training programs
that include additional material.
(5) The department shall not issue an exemptee a license until the
applicant provides proof of completion of the required training that
the department determines is adequate to fulfill these requirements.
(b) The licensed pharmacist or exemptee shall be on the premises
at all times that prescription devices are available for sale or
fitting unless the prescription devices are stored separately from
other merchandise and are under the exclusive control of the licensed
pharmacist or exemptee. A licensed pharmacist or an exemptee need
not be present in the warehouse facility of a home medical device
retail facility unless the department establishes that requirement by
regulation based upon the need to protect the public.
(c) The department may require an exemptee to complete a
designated number of hours of coursework in department-approved
courses of home health education in the disposition of any
disciplinary action taken against the exemptee.
(d) Each premises maintained by a home medical device retail
facility shall have a license issued by the department and shall have
a licensed pharmacist or exemptee on the premises if prescription
devices are furnished, sold, or dispensed.
(e) A home medical device retail facility may establish locked
storage (a lock box or locked area) for emergency or after working
hours furnishing of prescription devices. Locked storage may be
installed or placed in a service vehicle of the home medical device
retail facility for emergency or after hours service to patients
having prescriptions for prescription devices.
(f) The department may by regulation authorize a licensed
pharmacist or exemptee to direct an employee of the home medical
device retail facility who operates the service vehicle equipped with
locked storage described in subdivision (e) to deliver a
prescription device from the locked storage to patients having
prescriptions for prescription devices. These regulations shall
establish inventory requirements for the locked storage by a licensed
pharmacist or exemptee to take place shortly after a prescription
device has been delivered from the locked storage to a patient.
SEC. 13. Section 150204 of the Health and
Safety Code is amended to read:
150204. (a) A county may establish, by ordinance, a repository
and distribution program for purposes of this division. Only
pharmacies that are county-owned or that contract with the county
pursuant to this division may participate in this program to dispense
medication donated to the drug repository and distribution program.
(b) A county that elects to establish a repository and
distribution program pursuant to this division shall establish
procedures for, at a minimum, all of the following:
(1) Establishing eligibility for medically indigent patients who
may participate in the program.
(2) Ensuring that patients eligible for the program shall not be
charged for any medications provided under the program.
(3) Developing a formulary of medications appropriate for the
repository and distribution program.
(4) Ensuring proper safety and management of any medications
collected by and maintained under the authority of a county-owned or
county-contracted, licensed pharmacy.
(5) Ensuring the privacy of individuals for whom the medication
was originally prescribed.
(c) Any medication donated to the repository and distribution
program shall comply with the requirements specified in this
division. Medication donated to the repository and distribution
program shall meet all of the following criteria:
(1) The medication shall not be a controlled substance.
(2) The medication shall not have been adulterated, misbranded, or
stored under conditions contrary to standards set by a compendium
approved by the federal Centers for Medicare and Medicaid Services or
the product manufacturer.
(3) The medication shall not have been in the
possession of a patient or any individual member of the public, and
in the case of medications donated by a skilled nursing facility,
shall have been under the control of staff of the skilled nursing
facility.
(d) Only medication that is donated in unopened, tamper-evident
packaging or modified unit dose containers that meet standards in a
compendium approved by the federal Centers for Medicare and Medicaid
Services is eligible for donation to the repository and distribution
program, provided lot numbers and expiration dates are affixed.
Medication donated in opened containers shall not be dispensed by the
repository and distribution program.
(e) A pharmacist shall use his or her professional judgment in
determining whether donated medication meets the standards of this
division before accepting or dispensing any medication under the
repository and distribution program.
(f) A pharmacist shall adhere to standard pharmacy practices, as
required by state and federal law, when dispensing all medications.
(g) Medication that is donated to the repository and distribution
program shall be handled in any of the following ways:
(1) Dispensed to an eligible patient.
(2) Destroyed.
(3) Returned to a reverse distributor.
(h) Medication that is donated to the repository and distribution
program that does not meet the requirements of this division shall
not be distributed under this program and shall be either destroyed
or returned to a reverse distributor. This medication shall not be
sold, dispensed, or otherwise transferred to any other entity.
(i) Medication donated to the repository and distribution program
shall be maintained in the donated packaging units until dispensed to
an eligible patient under this program, who presents a valid
prescription. When dispensed to an eligible patient under this
program, the medication shall be in a new and properly labeled
container, specific to the eligible patient and ensuring the privacy
of the individuals for whom the medication was initially dispensed.
Expired medication shall not be dispensed.
(j) Medication donated to the repository and distribution program
shall be segregated from the pharmacy's other drug stock by physical
means, for purposes including, but not limited to, inventory,
accounting, and inspection.
(k) The pharmacy shall keep complete records of the acquisition
and disposition of medication donated to and dispensed under the
repository and distribution program. These records shall be kept
separate from the pharmacy's other acquisition and disposition
records and shall conform to the Pharmacy Law (Chapter 9 (commencing
with Section 4000) of Division 2 of the Business and Professions
Code), including being readily retrievable.
() Local and county protocols established pursuant to this
division shall conform to the Pharmacy Law regarding packaging,
transporting, storing, and dispensing all medications.
(m) County protocols established for packaging, transporting,
storing, and dispensing medications that require refrigeration,
including, but not limited to, any biological product as defined in
Section 351 of the Public Health and Service Act (42 U.S.C. Sec.
262), an intravenously injected drug, or an infused drug, include
specific procedures to ensure that these medications are packaged,
transported, stored, and dispensed at their appropriate temperatures
and in accordance with standards in a compendium approved by the
federal Centers for Medicare and Medicaid Services and the Pharmacy
Law.
(n) Notwithstanding any other provision of law, a participating
county-owned or county-contracted pharmacy shall follow the same
procedural drug pedigree requirements for donated drugs as it would
follow for drugs purchased from a wholesaler or directly from a drug
manufacturer.
SEC. 14. SEC. 3. Section 10123.195
of the Insurance Code is amended to read:
10123.195. (a) No group or individual disability insurance policy
issued, delivered, or renewed in this state or certificate of group
disability insurance issued, delivered, or renewed in this state
pursuant to a master group policy issued, delivered, or renewed in
another state that, as a provision of hospital, medical, or surgical
services, directly or indirectly covers prescription drugs shall
limit or exclude coverage for a drug on the basis that the drug is
prescribed for a use that is different from the use for which that
drug has been approved for marketing by the federal Food and Drug
Administration (FDA), provided that all of the following conditions
have been met:
(1) The drug is approved by the FDA.
(2) (A) The drug is prescribed by a contracting licensed health
care professional for the treatment of a life-threatening condition;
or
(B) The drug is prescribed by a contracting licensed health care
professional for the treatment of a chronic and seriously
debilitating condition, the drug is medically necessary to treat that
condition, and the drug is on the insurer's formulary, if any.
(3) The drug has been recognized for treatment of that condition
by either of the following:
(A) A compendium
approved by the federal Centers for Medicare and Medicaid Services.
by one of the following compendia, as approved by the
federal Centers for Medicare and Medicaid Services:
(A) The American Hospital Formulary Service's Drug Information.
(B) The Elsevier Gold Standard's Clinical Pharmacology.
(C) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(D) The Thomson Micromedex DrugDex.
(B)
(E) Two articles from major peer reviewed medical
journals that present data supporting the proposed off-label use or
uses as generally safe and effective unless there is clear and
convincing contradictory evidence presented in a major peer reviewed
medical journal.
(b) It shall be the responsibility of the contracting prescriber
to submit to the insurer documentation supporting compliance with the
requirements of subdivision (a), if requested by the insurer.
(c) Any coverage required by this section shall also include
medically necessary services associated with the administration of a
drug subject to the conditions of the contract.
(d) For purposes of this section, "life-threatening" means either
or both of the following:
(1) Diseases or conditions where the likelihood of death is high
unless the course of the disease is interrupted.
(2) Diseases or conditions with potentially fatal outcomes, where
the end point of clinical intervention is survival.
(e) For purposes of this section, "chronic and seriously
debilitating" means diseases or conditions that require ongoing
treatment to maintain remission or prevent deterioration and cause
significant long-term morbidity.
(f) The provision of drugs and services when required by this
section shall not, in itself, give rise to liability on the part of
the insurer.
(g) This section shall not apply to a policy of disability
insurance that covers hospital, medical, or surgical expenses which
is issued outside of California to an employer whose principal place
of business is located outside of California.
(h) Nothing in this section shall be construed to prohibit the use
of a formulary, copayment, technology assessment panel, or similar
mechanism as a means for appropriately controlling the utilization of
a drug that is prescribed for a use that is different from the use
for which that drug has been approved for marketing by the FDA.
(i) If an insurer denies coverage pursuant to this section on the
basis that its use is experimental or investigational, that decision
is subject to review under the Independent Medical Review System of
Article 3.5 (commencing with Section 10169).
(j) This section is not applicable to vision-only, dental-only,
Medicare or Champus supplement, disability income, long-term care,
accident-only, specified disease or hospital confinement indemnity
insurance.
SEC. 15. SEC. 4. Section 10145.3 of
the Insurance Code is amended to read:
10145.3. (a) Every disability insurer that covers hospital,
medical, or surgical benefits shall provide an external, independent
review process to examine the insurer's coverage decisions regarding
experimental or investigational therapies for individual insureds who
meet all of the following criteria:
(1) (A) The insured has a life-threatening or seriously
debilitating condition.
(B) For purposes of this section, "life-threatening" means either
or both of the following:
(i) Diseases or conditions where the likelihood of death is high
unless the course of the disease is interrupted.
(ii) Diseases or conditions with potentially fatal outcomes, where
the end point of clinical intervention is survival.
(C) For purposes of this section, "seriously debilitating" means
diseases or conditions that cause major irreversible morbidity.
(2) The insured's physician certifies that the insured has a
condition, as defined in paragraph (1), for which standard therapies
have not been effective in improving the condition of the insured,
for which standard therapies would not be medically appropriate for
the insured, or for which there is no more beneficial standard
therapy covered by the insurer than the therapy proposed pursuant to
paragraph (3).
(3) Either (A) the insured's contracting physician has recommended
a drug, device, procedure, or other therapy that the physician
certifies in writing is likely to be more beneficial to the insured
than any available standard therapies, or (B) the insured, or the
insured's physician who is a licensed, board-certified or
board-eligible physician qualified to practice in the area of
practice appropriate to treat the insured's condition, has requested
a therapy that, based on two documents from the medical and
scientific evidence, as defined in subdivision (d), is likely to be
more beneficial for the insured than any available standard therapy.
The physician certification pursuant to this subdivision shall
include a statement of the evidence relied upon by the physician in
certifying his or her recommendation. Nothing in this subdivision
shall be construed to require the insurer to pay for the services of
a noncontracting physician, provided pursuant to this subdivision,
that are not otherwise covered pursuant to the contract.
(4) The insured has been denied coverage by the insurer for a
drug, device, procedure, or other therapy recommended or requested
pursuant to paragraph (3), unless coverage for the specific therapy
has been excluded by the insurer's contract.
(5) The specific drug, device, procedure, or other therapy
recommended pursuant to paragraph (3) would be a covered service
except for the insurer's determination that the therapy is
experimental or under investigation.
(b) The insurer's decision to deny, delay, or modify experimental
or investigational therapies shall be subject to the independent
medical review process established under Article 3.5 (commencing with
Section 10169) of Chapter 1 of Part 2 of Division 2, except that in
lieu of the information specified in subdivision (b) of Section
10169.3, an independent medical reviewer shall base his or her
determination on relevant medical and scientific evidence, including,
but not limited to, the medical and scientific evidence defined in
subdivision (d).
(c) The independent medical review process shall also meet the
following criteria:
(1) The insurer shall notify eligible insureds in writing of the
opportunity to request the external independent review within five
business days of the decision to deny coverage.
(2) If the insured's physician determines that the proposed
therapy would be significantly less effective if not promptly
initiated, the analyses and recommendations of the experts on the
panel shall be rendered within seven days of the request for
expedited review. At the request of the expert, the deadline shall be
extended by up to three days for a delay in providing the documents
required. The timeframes specified in this paragraph shall be in
addition to any otherwise applicable timeframes contained in
subdivision (c) of Section 10169.3.
(3) Each expert's analysis and recommendation shall be in written
form and state the reasons the requested therapy is or is not likely
to be more beneficial for the insured than any available standard
therapy, and the reasons that the expert recommends that the therapy
should or should not be covered by the insurer, citing the insured's
specific medical condition, the relevant documents, and the relevant
medical and scientific evidence, including, but not limited to, the
medical and scientific evidence as defined in subdivision (d), to
support the expert's recommendation.
(4) Coverage for the services required under this section shall be
provided subject to the terms and conditions generally applicable to
other benefits under the contract.
(d) For the purposes of subdivision (b), "medical and scientific
evidence" means the following sources:
(1) Peer-reviewed scientific studies published in or accepted for
publication by medical journals that meet nationally recognized
requirements for scientific manuscripts and that submit most of their
published articles for review by experts who are not part of the
editorial staff.
(2) Peer-reviewed literature, biomedical compendia and other
medical literature that meet the criteria of the National Institutes
of Health's National Library of Medicine for indexing in Index
Medicus, Excerpta Medicus (EMBASE), Medline and MEDLARS database
of Health Services Technology Assessment Research (HSTAR).
(3) Medical journals recognized by the Secretary of Health and
Human Services, under Section 1861(t)(2) of the Social Security Act.
(4) A compendium approved by the federal Centers for Medicare and
Medicaid Services.
(4) The following standard reference compendia, as approved by the
federal Centers for Medicare and Medicaid Services: the American
Hospital Formulary Service's Drug Information, the American Dental
Association Accepted Dental Therapeutics, the Elsevier Gold Standard'
s Clinical Pharmacology, the National Comprehensive Cancer Network
Drug and Biologics Compendium, and the Thomson Micromedex DrugDex.
(5) Findings, studies, or research conducted by or under the
auspices of federal government agencies and nationally recognized
federal research institutes, including the Federal Agency for Health
Care Policy and Research, National Institutes of Health, National
Cancer Institute, National Academy of Sciences, Health Care Financing
Administration, Congressional Office of Technology Assessment, and
any national board recognized by the National Institutes of Health
for the purpose of evaluating the medical value of health services.
(6) Peer-reviewed abstracts accepted for presentation at major
medical association meetings.
(e) The independent review process established by this section
shall be required on and after January 1, 2001.
SEC. 16. Section 383 of the Penal Code is
amended to read:
383. Every person who knowingly sells, or keeps or offers for
sale, or otherwise disposes of any article of food, drink, drug, or
medicine, knowing that the same is adulterated or has become tainted,
decayed, spoiled, or otherwise unwholesome or unfit to be eaten or
drunk, with intent to permit the same to be eaten or drunk, is guilty
of a misdemeanor, and must be fined not exceeding one thousand
dollars ($1,000), or imprisoned in the county jail not exceeding six
months, or both, and may, in the discretion of the court, be adjudged
to pay, in addition, all the necessary expenses, not exceeding one
thousand dollars ($1,000), incurred in inspecting and analyzing these
articles. The term "drug," as used herein, includes all medicines
for internal or external use, antiseptics, disinfectants, and
cosmetics. The term "food," as used herein, includes all articles
used for food or drink by man, whether simple, mixed, or compound.
Any article is deemed to be adulterated within the meaning of this
section:
(a) In case of drugs: (1) if, when sold under or by a name
recognized in a compendium approved by the federal Centers of
Medicare and Medicaid Services, it differs materially from the
standard of strength, quality, or purity laid down therein; (2) if,
when sold under or by a name not recognized in a compendium approved
by the federal Centers of Medicare and Medicaid Services, but which
is found in some other pharmacopoeia or other standard work on
materia medica, it differs materially from the standard of strength,
quality, or purity laid down in such work; (3) if its strength,
quality, or purity falls below the professed standard under which it
is sold.
(b) In the case of food: (1) if any substance or substances have
been mixed with it, so as to lower or depreciate, or injuriously
affect its quality, strength, or purity; (2) if any inferior or
cheaper substance or substances have been substituted wholly or in
part for it; (3) if any valuable or necessary constituent or
ingredient has been wholly or in part abstracted from it; (4) if it
is an imitation of, or is sold under the name of, another article;
(5) if it consists wholly, or in part, of a diseased, decomposed,
putrid, infected, tainted, or rotten animal or vegetable substance or
article, whether manufactured or not; or in the case of milk, if it
is the produce of a diseased animal; (6) if it is colored, coated,
polished, or powdered, whereby damage or inferiority is concealed, or
if by any means it is made to appear better or of greater value than
it really is; (7) if it contains any added substance or ingredient
which is poisonous or injurious to health.
SEC. 17. Section 47121 of the Public Resources
Code is amended to read:
47121. For the purposes of this article, the following terms have
the following meanings, unless the context clearly requires
otherwise:
(a) "Consumer" means an individual purchaser or owner of a drug.
"Consumer" does not include a business, corporation, limited
partnership, or an entity involved in a wholesale transaction between
a distributor and retailer.
(b) "Drug" means any of the following:
(1) Articles recognized in a compendium or supplement thereof
approved by the federal Centers for Medicare and Medicaid Services.
(2) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals.
(3) Articles, excluding food, intended to affect the structure or
function of the body of humans or other animals.
(4) Articles intended for use as a component of an article
specified in paragraph (1), (2), or (3).
(c) "Participant" means any entity which the board deems
appropriate for implementing and evaluating a model program and which
chooses to participate, including, but not limited to, governmental
entities, pharmacies, veterinarians, clinics, and other medical
settings.
(d) "Sale" includes, but is not limited to, transactions conducted
through sales outlets, catalogs, or the Internet, or any other
similar electronic means, but does not include a sale that is a
wholesale transaction with a distributor or retailer.
SEC. 18. SEC. 5. Section 14105.43 of
the Welfare and Institutions Code is amended to read:
14105.43. (a) (1) Notwithstanding other provisions of this
chapter, any drug which is approved by the federal Food and Drug
Administration for use in the treatment of acquired immunodeficiency
syndrome (AIDS) or an AIDS-related condition shall be deemed to be
approved for addition to the Medi-Cal list of contract drugs only for
the purpose of treating AIDS or an AIDS-related condition, for the
period prior to the completion of the procedures established pursuant
to Section 14105.33.
(2) (A) In addition to any drug that is deemed to be approved
pursuant to paragraph (1), any drug that meets any of the following
criteria shall be a Medi-Cal benefit, subject to utilization
controls:
(i) Any vaccine to protect against human immunodeficiency virus
(HIV) infection.
(ii) Any antiviral agent, immune modulator, or other agent to be
administered to persons who have been infected with human
immunodeficiency virus to counteract the effects of that infection.
(iii) Any drug or biologic used to treat opportunistic infections
associated with acquired immune deficiency syndrome, that have been
found to be medically accepted indications and that has either been
approved by the federal Food and Drug Administration or
recognized for that use in either of the following:
(I) A compendium
approved by the federal Centers for Medicare and Medicaid Services.
recognized for that use in one of the following
compendia, as approved by the federal Centers for Medicare and
Medicaid Services:
(I) The American Hospital Formulary Service's Drug Information.
(II) The Elsevier Gold Standard's Clinical Pharmacology.
(III) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(IV) The Thomson Micromedex DrugDex.
(II)
(V) Two articles from peer reviewed medical journals
that present data supporting the proposed use or uses as generally
safe and effective.
(iv) Any drug or biologic used to treat the chemotherapy-induced
suppression of the human immune system resulting from the treatment
of acquired immune deficiency syndrome.
(3) The department shall add any drug deemed to be approved
pursuant to paragraph (1) to the Medi-Cal list of contract drugs or
allow the provision of the drug as a Medi-Cal benefit, subject to
utilization controls, pursuant to paragraph (2), only if the
manufacturer of the drug has executed a contract with the Centers for
Medicare and Medicaid Services which provides for rebates in
accordance with Section 1396r-8 of Title 42 of the United States
Code.
(b) Any drug deemed to be approved pursuant to paragraph (1) of
subdivision (a) shall be immediately added to the Medi-Cal list of
contract drugs, and shall be exempt from the contract requirements of
Section 14105.33.
(c) If it is determined pursuant to subdivision (c) of Section
14105.39 that a drug to which subdivision (a) applies should not be
placed on the Medi-Cal list of contract drugs, that drug shall no
longer be deemed to be approved for addition to the list of contract
drugs pursuant to subdivision (a).
SEC. 19. SEC. 6. Section 14133.2 of
the Welfare and Institutions Code is amended to read:
14133.2. (a) The director shall include in the Medi-Cal list of
contract drugs any drug approved for the treatment of cancer by the
federal Food and Drug Administration, so long as the manufacturer has
executed a contract with the Health Care Financing Administration
which provides for rebates in accordance with Section 1396r-8 of
Title 42 of the United States Code. These drugs shall be exempt from
the contract requirements of Section 14105.33.
(b) In addition to any drug added to the list of contract drugs
pursuant to subdivision (a), any drug that meets either of the
following criteria and for which the manufacturer has executed a
contract with the Health Care Financing Administration that provides
for rebates in accordance with Section 1396r-8 of Title 42 of the
United States Code, shall be a Medi-Cal benefit, subject to
utilization controls, unless the contract requirements of Section
14105.33 have been complied with:
(1) Any drug approved by the federal Food and Drug Administration
for treatment of opportunistic infections associated with cancer.
(2) Any drug or biologic used in an anticancer chemotherapeutic
regimen for a medically accepted indication, which has either been
approved by the federal Food and Drug Administration, or
recognized for that use in either of the following:
(A) A compendium
approved by the federal Centers for Medicare and Medicaid Services.
recognized for that use in one of the following
compendia, as approved by the federal Centers for Medicare and
Medicaid Services:
(A) The American Hospital Formulary Service's Drug Information.
(B) The Elsevier Gold Standard's Clinical Pharmacology.
(C) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(D) The Thomson Micromedex DrugDex.
(B)
(E) Two articles from peer reviewed medical journals
that present data supporting the proposed use or uses as generally
safe and effective.
SEC. 20. 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.
