Bill Text: CA AB830 | 2009-2010 | Regular Session | Chaptered
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-Chaptered.html
BILL NUMBER: AB 830 CHAPTERED
BILL TEXT
CHAPTER 479
FILED WITH SECRETARY OF STATE OCTOBER 11, 2009
APPROVED BY GOVERNOR OCTOBER 11, 2009
PASSED THE SENATE AUGUST 31, 2009
PASSED THE ASSEMBLY SEPTEMBER 2, 2009
AMENDED IN SENATE AUGUST 25, 2009
AMENDED IN SENATE AUGUST 17, 2009
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 1367.21 and 1370.4 of the Health and
Safety Code, to amend Sections 10123.195 and 10145.3 of the 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, Cook. Drugs and devices.
Existing law references various drug compendiums and compendia,
including the United States Pharmacopoeia, for purposes of the
Knox-Keene Health Care Service Plan Act of 1975, disability
insurance, and for Medi-Cal.
This bill would revise these references to include references to a
specified compendia, if recognized by the federal Centers for
Medicare and Medicaid Services, as specified, or with respect to
Medi-Cal, a compendia that is listed in a specified federal Medicaid
provision of the federal Social Security Act.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
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 any of the following:
(A) The American Hospital Formulary Service's Drug Information.
(B) One of the following compendia, if recognized by the federal
Centers for Medicare and Medicaid Services as part of an anticancer
chemotherapeutic regimen:
(i) The Elsevier Gold Standard's Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) 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. 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) Either of the following reference compendia:
(A) The American Hospital Formulary Service's Drug Information.
(B) The American Dental Association Accepted Dental Therapeutics.
(5) Any of the following reference compendia, if recognized by the
federal Centers for Medicare and Medicaid Services as part of an
anticancer chemotherapeutic regimen:
(A) The Elsevier Gold Standard's Clinical Pharmacology.
(B) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(C) The Thomson Micromedex DrugDex.
(6) 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.
(7) 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. 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 any of the following:
(A) The American Hospital Formulary Service's Drug Information.
(B) One of the following compendia, if recognized by the federal
Centers for Medicare and Medicaid Services as part of an anticancer
chemotherapeutic regimen:
(i) The Elsevier Gold Standard's Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) 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. 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) Either of the following reference compendia:
(A) The American Hospital Formulary Service's Drug Information.
(B) The American Dental Association Accepted Dental Therapeutics.
(5) Any of the following reference compendia, if recognized by the
federal Centers for Medicare and Medicaid Services as part of an
anticancer chemotherapeutic regimen:
(A) The Elsevier Gold Standard's Clinical Pharmacology.
(B) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(C) The Thomson Micromedex DrugDex.
(6) 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.
(7) 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. 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) 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:
(A) Any vaccine to protect against human immunodeficiency virus
(HIV) infection.
(B) 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.
(C) 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 a compendia listed in Section 1927 of the federal
Social Security Act (42 U.S.C. Sec. 1396r-8).
(D) 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. 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 a compendia listed in Section 1927 of the federal
Social Security Act (42 U.S.C. Sec. 1396r-8).
