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(i) “Patient” means a person needing a blood clotting product
for home use.
(j) (1) “Provider of blood clotting products for home use” means
all the following pharmacies, except as described in Section
125286.35, that dispense blood clotting factors for home use:
(A) Hospital pharmacies.
(B) Health system pharmacies.
(C) Pharmacies affiliated with hemophilia treatment centers.
(D) Specialty home care pharmacies.
(E) Retail pharmacies.
(2) The providers described in this subdivision shall include a
health care service plan and all its affiliated providers if the
health care service plan exclusively contracts with a single
medical group in a specified geographic area to provide
professional services to its enrollees.
125286.25. Requirements for Providers of Blood Clotting
Products for Home Use
Each provider of blood clotting products for home use shall
meet all of the following requirements:
(a) Have sufficient knowledge and understanding of bleeding
disorders to accurately follow the instructions of the prescribing
physician and ensure high-quality service for the patient and the
medical and psychosocial management thereof, including, but
not limited to, home therapy.
(b) Have access to a provider with sufficient clinical experience
providing services to persons with bleeding disorders that
enables the provider to know when patients have an appropriate
supply of clotting factor on hand and about proper storage and
refrigeration of clotting factors.
(c) Maintain 24-hour on-call service seven days a week for every
day of the year, adequately screen telephone calls for
emergencies, acknowledge all telephone calls within one hour or
less, and have access to knowledgeable pharmacy staffing on call
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24 hours a day, to initiate emergency requests for clotting
factors.
(d) Have the ability to obtain all brands of blood clotting
products approved by the federal Food and Drug Administration
in multiple assay ranges (low, medium, and high, as applicable)
and vial sizes, including products manufactured from human
plasma and those manufactured with recombinant biotechnology
techniques, provided manufacturer supply exists and payer
authorization is obtained.
(e) Supply all necessary ancillary infusion equipment and
supplies with each prescription, as needed.
(f) Store and ship, or otherwise deliver, all blood clotting
products in conformity with all state and federally mandated
standards, including, but not limited to, the standards set forth in
the product’s approved package insert (PI).
(g) Upon receiving approved authorization for a nonemergency
prescription, provided manufacturer supply exists, ship the
prescribed blood clotting products and ancillary infusion
equipment and supplies to the patient within two business days
or less for established and new patients.
(h) Upon receiving approved authorization to dispense a
prescription for an emergency situation, provided manufacturer
supply exists, deliver prescribed blood products, ancillary infusion
equipment and supplies, and medications to the patient within
12 hours for patients living within 100 miles of a major
metropolitan airport, and within one day for patients living more
than 100 miles from a major metropolitan airport.
(i) Provide patients who have ordered their products with a
designated contact telephone number for reporting problems
with a delivery and respond to these calls within a reasonable
time period.
(j) Provide patients with notification of Class 1 and Class 2 recalls
and withdrawals of blood clotting products and ancillary infusion
equipment within 24 hours of the provider of blood clotting
products for home use receiving notification and participate in
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the National Patient Notification System for blood clotting
product recalls.
(k) Provide language interpretive services over the telephone or
in person, as needed by the patient.
(l) Have a detailed plan for meeting the requirements of this
article in the event of a natural or manmade disaster or other
disruption of normal business operations.
(m) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and retain
copies of the patient’s prescriptions.
(n) Comply with the privacy and confidentiality requirements of
the federal Health Insurance Portability and Accountability Act of
1996 (HIPAA).
125286.30. Administration and Enforcement
The California State Board of Pharmacy shall administer and
enforce this article.
125286.35. Exemptions
Nothing in this article shall apply to either hospital pharmacies
or health system pharmacies that dispense blood clotting
products due only to emergency, urgent care, or inpatient
encounters, or if an inpatient is discharged with a supply of blood
clotting products for home use.
DIVISION 114. Prescription Drug Discount Prohibition
132000. Prescription Drug Discount Prohibition - Food and
Drug Administration’s “Approved Drug Products with
Therapeutic Equivalence Evaluations”
(a) Except as provided in Section 132004, a person who
manufactures a prescription drug shall not offer in the state a
discount, repayment, product voucher, or other reduction in an
individual’s out-of-pocket expenses associated with his or her
health insurance, health care service plan, or other health
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coverage, including, but not limited to, a copayment,
coinsurance, or deductible, for a prescription drug if a lower cost
generic drug is covered under the individual’s health insurance,
health care service plan, or other health coverage on a lower
cost-sharing tier that is designated to be therapeutically
equivalent as indicated by the United States Food and Drug
Administration’s “Approved Drug Products with Therapeutic
Equivalence Evaluations.”
(b) The prohibition in subdivision (a) shall not apply to a
branded prescription drug, until the time that the first drug
designated in the United States Food and Drug Administration’s
“Approved Drug Products with Therapeutic Equivalence
Evaluations” as therapeutically equivalent to that branded
prescription drug has been nationally available for three calendar
months.
132002. Prescription Drug Discount Prohibition - Active
Ingredients Regulated by Food and Drug Administration,
Available at Lower Cost and Otherwise Not Contraindicated
Except as provided in Section 132004, a person who
manufactures a prescription drug shall not offer in the state a
discount, repayment, product voucher, or other reduction in the
individual’s out-of-pocket expenses associated with his or her
health insurance, health care service plan, or other health
coverage, including, but not limited to, a copayment,
coinsurance, or deductible, for a prescription drug if the active
ingredients of the drug are contained in products regulated by
the federal Food and Drug Administration, are available without
prescription at a lower cost, and are not otherwise
contraindicated for treatment of the condition for which the
prescription drug is approved.
132004. Prescription Drug Discount Prohibition - Exceptions
The prohibitions in Sections 132000 and 132002 shall not apply
to any of the following:
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(a) A discount, repayment, product voucher, or other payment
to a patient or another person on the patient’s behalf for a
prescription drug required under a United States Food and Drug
Administration Risk Evaluation and Mitigation Strategy for the
purpose of monitoring or facilitating the use of that prescription
drug in a manner consistent with the approved labeling of the
prescription drug.
(b) A single-tablet drug regimen for treatment or prevention of
human immunodeficiency virus (HIV) or acquired immune
deficiency syndrome (AIDS) that is as effective as a multitablet
regimen, unless, consistent with clinical guidelines and peer-
reviewed scientific and medical literature, the multitablet
regimen is clinically equally effective or more effective and is
more likely to result in adherence to the drug regimen.
(c) The individual has completed any applicable step therapy or
prior authorization requirements for the branded prescription
drug as mandated by the individual’s health insurer, health care
service plan, or other health coverage.
(d) A discount, repayment, product voucher, or other reduction
in an individual’s out-of-pocket expenses is not associated with
his or her health insurance, health care service plan, or other
health coverage.
(e) Rebates received by a state agency.
132006. Prescription Drug Discount Prohibition - Exception if
Product is Free for Patient and Insurer, Health Care Service Plan
or Other Health Coverage
This division does not prohibit an entity, including an entity that
manufactures prescription drugs or a patient assistance program
that is solely funded by one or more manufacturers, from
offering a pharmaceutical product free of any cost, if the product
is free of cost to both the patient and his or her health insurer,
health care service plan, or other health coverage.
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132008. Pharmacist’s Ability to Substitute Prescription Drug;
Assistance by Independent Charity Patient Assistance Program;
Assistance by Pharmaceutical Manufacturer
(a) This division shall not be deemed to affect a pharmacist’s
ability to substitute a prescription drug pursuant to Section 4073
of the Business and Professions Code.
(b) (1) This division shall not prohibit or limit assistance to a
patient provided by an independent charity patient assistance
program.
(2) For purposes of this section, “independent charity patient
assistance program” means a program that meets all of the
following requirements:
(A) The program does not allow a pharmaceutical manufacturer
or an affiliate of the manufacturer, including, but not limited to,
an employee, agent, officer, shareholder, contractor, wholesaler,
distributor, or pharmacy benefits manager, to exert any direct or
indirect influence or control over the charity or subsidy program.
(B) Assistance is awarded in a truly independent manner that
severs any link between a pharmaceutical manufacturer’s
funding and the beneficiary.
(C) Assistance is awarded without regard to the pharmaceutical
manufacturer’s interest and without regard to the beneficiary’s
choice of product, provider, practitioner, supplier, health
insurance, health care service plan, or other health coverage.
(D) Assistance is awarded based upon a reasonable, verifiable,
and uniform measure of financial need that is applied in a
consistent manner.
(E) The pharmaceutical manufacturer does not solicit or receive
data from the program that would facilitate the manufacturer in
correlating the amount or frequency of its donations with the
number of subsidized prescriptions for its products.
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DIVISION 116. SURPLUS MEDICATION COLLECTION
AND DISTRIBUTION
CHAPTER 2. HEALTH FACILITIES
150200. Legislative Intent to Establish Voluntary Drug
Repository and Distribution Program
It is the intent of the Legislature in enacting this division to
authorize the establishment of a voluntary drug repository and
distribution program for the purpose of distributing surplus
medications to persons in need of financial assistance to ensure
access to necessary pharmaceutical therapies. It is also the intent
of the Legislature that the health and safety of Californians are
protected and promoted through this program, while reducing
unnecessary waste at licensed health and care facilities, by
allowing those facilities to donate unused and unexpired
medications that were never in the hands of a patient or resident
and for which no credit or refund to the patient or resident could
be received.
150201. Definitions
(a) “Donor organization” means an entity described in
subdivision (a) of Section 150202.
(b) “Eligible entity” means all of the following:
(1) A licensed pharmacy, as defined in subdivision (a) of Section
4037 of the Business and Professions Code, that is county owned
or that contracts with the county pursuant to this division and is
not on probation with the California State Board of Pharmacy.
(2) A licensed pharmacy, as defined in subdivision (a) of Section
4037 of the Business and Professions Code, that is owned and
operated by a primary care clinic, as defined in Section 1204, that
is licensed by the State Department of Public Health and is not on
probation with the California State Board of Pharmacy.
(3) A primary care clinic, as defined in Section 1204, that is
licensed by the State Department of Public Health and licensed to
726
administer and dispense drugs pursuant to subparagraph (A) of
paragraph (1) of subdivision (a) of Section 4180 of the Business
and Professions Code and is not on probation with the California
State Board of Pharmacy.
(c) “Medication” or “medications” means a dangerous drug, as
defined in Section 4022 of the Business and Professions Code.
(d) “Participating entity” means an eligible entity that has
received written or electronic documentation from the county
health department pursuant to paragraph (3) of subdivision (a) of
Section 150204 and that operates a repository and distribution
program pursuant to this division.
150202. Authorized Donations of Unused Medications
(a) Notwithstanding any other law, a donor organization is
defined, for purposes of this division, to refer to one of the
following health and care facilities that may donate centrally
stored unused medications under a program established
pursuant to this division:
(1) A licensed general acute care hospital, as defined in Section
1250.
(2) A licensed acute psychiatric hospital, as defined in Section
1250.
(3) A licensed skilled nursing facility, as defined in Section 1250,
including a skilled nursing facility designated as an institution for
mental disease.
(4) A licensed intermediate care facility, as defined in Section
1250.
(5) A licensed intermediate care facility/developmentally
disabled-habilitative facility, as defined in Section 1250.
(6) A licensed intermediate care facility/developmentally
disabled-nursing facility, as defined in Section 1250.
(7) A licensed correctional treatment center, as defined in
Section 1250.
(8) A licensed psychiatric health facility, as defined in Section
1250.2.
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(9) A licensed chemical dependency recovery hospital, as
defined in Section 1250.3.
(10) A licensed residential care facility for the elderly, as defined
in Section 1569.2, with 16 or more residents.
(11) An approved mental health rehabilitation center, as
described in Section 5675 of the Welfare and Institutions Code.
(b) Medication donated by health and care facilities pursuant to
subdivision (a) shall meet the requirements of subdivisions (c)
and (d) of Section 150204 and shall be unexpired medication that
would have otherwise been destroyed by the facility or another
appropriate entity.
(c) Medication eligible for donation by the health and care
facilities pursuant to subdivision (a) shall be directly delivered
from the dispensing pharmacy, wholesaler or manufacturer, to
the health or care facility and subsequently centrally stored.
Centrally stored medication that originated from a patient or
resident is not eligible for donation under this division.
150202.5. Authorized Donations of Unused Medications;
Manufacturer Medications
Notwithstanding any other law, a pharmacy, licensed in
California and not on probation with the California State Board of
Pharmacy, whose primary or sole type of pharmacy practice type
is limited to a skilled nursing facility, home health care, board and
care, or mail order, may donate unused, unexpired medication
that meets the requirements of subdivisions (c) and (d) of Section
150204, under a program established pursuant to this division
and that meets either of the following requirements:
(a) The medication was received directly from a manufacturer or
wholesaler.
(b) The medication was returned from a health facility to the
issuing pharmacy, in a manner consistent with state and federal
law.
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150203. Drug Wholesalers or Manufacturers May Donate
Unused Medications
Notwithstanding any other provision of law, a wholesaler
licensed pursuant to Article 11 (commencing with Section 4160)
of Chapter 9 of Division 2 of the Business and Professions Code
and a drug manufacturer that is legally authorized under federal
law to manufacture and sell pharmaceutical drugs may donate
unused medications under the voluntary drug repository and
distribution program established by a county pursuant to this
division.
150204. County May Establish Repository and Distribution
Program for Dispensing Donated Drugs
(a) (1) A county may establish, by an action of the county board
of supervisors or by an action of the public health officer of the
county, as directed by the county board of supervisors, a
repository and distribution program for purposes of this division.
The county shall advise the California State Board of Pharmacy
within 30 days from the date it establishes a repository and
distribution program.
(2) Only an eligible entity, pursuant to Section 150201, may
participate in this program to dispense medication donated to
the drug repository and distribution program.
(3) An eligible entity that seeks to participate in the program
shall inform the county health department and the California
State Board of Pharmacy in writing of its intent to participate in
the program. An eligible entity may not participate in the
program until it has received written or electronic
documentation from the county health department confirming
that the department has received its notice of intent.
(4) (A) A participating entity shall disclose to the county health
department on a quarterly basis the name and location of the
source of all donated medication it receives.
(B) A participating primary care clinic, as described in Section
150201, shall disclose to the county health department the name
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of the licensed physician who shall be accountable to the
California State Board of Pharmacy for the clinic’s program
operations pursuant to this division. This physician shall be the
professional director, as defined in subdivision (c) of Section 4182
of the Business and Professions Code.
(C) The county board of supervisors or public health officer of
the county shall, upon request, make available to the California
State Board of Pharmacy the information in this division.
(5) The county board of supervisors, the public health officer of
the county, and the California State Board of Pharmacy may
prohibit an eligible or participating entity from participating in
the program if the entity does not comply with the provisions of
the program, pursuant to this division. If the county board of
supervisors, the public health officer of the county, or the
California State Board of Pharmacy prohibits an eligible or
participating entity from participating in the program, it shall
provide written notice to the prohibited entity within 15 days of
making this determination. The county board of supervisors, the
public health officer of the county, and the California State Board
of Pharmacy shall ensure that this notice also is provided to one
another.
(b) A county that elects to establish a repository and distribution
program pursuant to this division shall establish written
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
participating entity.
(5) Ensuring the privacy of individuals for whom the medication
was originally prescribed.
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(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 the United States Pharmacopoeia (USP) 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 health or care facility, as described in
Section 150202, shall have been under the control of a staff
member of the health or care facility who is licensed in California
as a health care professional or has completed, at a minimum,
the training requirements specified in Section 1569.69.
(d) (1) Only medication that is donated in unopened, tamper-
evident packaging or modified unit dose containers that meet
USP standards 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, and
once identified, shall be quarantined immediately and handled
and disposed of in accordance with the Medical Waste
Management Act (Part 14 (commencing with Section 117600) of
Division 104).
(2) (A) A medication that is the subject of a United States Food
and Drug Administration managed risk evaluation and mitigation
strategy pursuant to Section 355-1 of Title 21 of the United
States Code shall not be donated if this inventory transfer is
prohibited by that strategy, or if the inventory transfer requires
prior authorization from the manufacturer of the medication.
(B) A medication that is the subject of a United States Food and
Drug Administration managed risk evaluation and mitigation
strategy pursuant to Section 355-1 of Title 21 of the United
731
States Code, the donation of which is not prohibited pursuant to
subparagraph (A), shall be managed and dispensed according to
the requirements of that strategy.
(e) A pharmacist or physician at a participating entity 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 or physician 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 the following ways:
(1) Dispensed to an eligible patient.
(2) Destroyed.
(3) Returned to a reverse distributor or licensed waste hauler.
(4) (A) Transferred to another participating entity within the
county to be dispensed to eligible patients pursuant to this
division. Notwithstanding this paragraph, a participating county-
owned pharmacy may transfer eligible donated medication to a
participating county-owned pharmacy within another adjacent
county that has adopted a program pursuant to this division, if
the pharmacies transferring the medication have a written
agreement between the entities that outlines protocols and
procedures for safe and appropriate drug transfer that are
consistent with this division.
(B) Medication donated under this division shall not be
transferred by any participating entity more than once, and after
it has been transferred, shall be dispensed to an eligible patient,
destroyed, or returned to a reverse distributor or licensed waste
hauler.
(C) Medication transferred pursuant to this paragraph shall be
transferred with documentation that identifies the drug name,
strength, and quantity of the medication, and the donation
facility from where the medication originated shall be identified
732
on medication packaging or in accompanying documentation.
The document shall include a statement that the medication may
not be transferred to another participating entity and must be
handled pursuant to subparagraph (B). A copy of this document
shall be kept by the participating entity transferring the
medication and the participating entity receiving the medication.
(h) Medication that is donated to the repository and distribution
program that does not meet the requirements of this division
shall not be distributed or transferred under this program and
shall be either destroyed or returned to a reverse distributor.
Donated medication that does not meet the requirements of this
division shall not be sold, dispensed, or otherwise transferred to
any other entity.
(i) (1) Except as provided in paragraph (2), 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.
(2) A pharmacy that exists solely to operate the repository and
distribution program may repackage a reasonable quantity of
donated medicine in anticipation of dispensing the medicine to
its patient population. The pharmacy shall have repackaging
policies and procedures in place for identifying and recalling
medications. Medication that is repackaged shall be labeled with
the earliest expiration date.
(j) Medication donated to the repository and distribution
program shall be segregated from the participating entity’s other
drug stock by physical means, for purposes including, but not
limited to, inventory, accounting, and inspection.
(k) A participating entity shall keep complete records of the
acquisition and disposition of medication donated to, and
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transferred, dispensed, and destroyed under, the repository and
distribution program. These records shall be kept separate from
the participating entity’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.
(l) 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 Service Act (42 U.S.C. Sec. 262),
an intravenously injected drug, or an infused drug, shall include
specific procedures to ensure that these medications are
packaged, transported, stored, and dispensed at appropriate
temperatures and in accordance with USP standards and the
Pharmacy Law.
(n) Notwithstanding any other provision of law, a participating
entity 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.
150205. Liability
(a) The following persons and entities shall not be subject to
criminal or civil liability for injury caused when donating,
accepting, or dispensing prescription drugs in compliance with
this division:
(1) A prescription drug manufacturer, wholesaler, governmental
entity, or participating entity.
(2) A pharmacist or physician who accepts or dispenses
prescription drugs.
(3) A licensed health or care facility, as described in Section
150202, or a pharmacy, as described in Section 150202.5.
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(b) A surplus medication collection and distribution
intermediary, as described in Section 150208, shall not be subject
to criminal or civil liability for injury caused when facilitating the
donation of medications to or transfer of medications in
compliance with this division.
150206. No Immunity for Noncompliance or Negligence
The immunities provided in Section 150205 shall not apply in
cases of noncompliance with this division, bad faith, or gross
negligence.
150207. Disciplinary Actions
Nothing in this division shall affect disciplinary actions taken by
licensing and regulatory agencies.
150208. Surplus Medication Collection and Distribution
Intermediary; Requirements
(a) A surplus medication collection and distribution intermediary
that is licensed pursuant to Section 4169.5 of the Business and
Professions Code, established for the purpose of facilitating the
donation of medications to or transfer of medications between
participating entities under a program established pursuant to
this division is authorized to operate under this section.
(b) A surplus medication collection and distribution
intermediary shall comply with the following:
(1) It shall not take possession, custody, or control of dangerous
drugs and devices.
(2) It shall ensure that notification is provided to participating
entities that a package has been shipped when the surplus
medication collection and distribution intermediary has
knowledge of the shipment and provided logistical support to
facilitate a shipment directly from a donor organization, as
defined in subdivision (a) of Section 150202, to a participating
entity.
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(3) It shall not select, or direct a donor organization, as defined
in subdivision (a) of Section 150202, to select, a specific
participating entity to receive surplus medications.
(c) A surplus medication collection and distribution intermediary
is authorized to do the following:
(1) Charge membership, administrative, or overhead fees
sufficient to cover the reasonable costs of the support and
services provided.
(2) Contract directly with a county to facilitate the donation of
medications to or transfer of medications between participating
entities and provide general support in a county’s
implementation of a program established pursuant to this
division.
(d) No participating entities shall receive donated medication
directly from the surplus medication collection and distribution
intermediary.
DIVISION 117. CANCER MEDICATION RECYCLING ACT
150400. Name of Act
This division shall be known, and may be cited, as the Cancer
Medication Recycling Act.
150401. Definitions
For purposes of this division, the following definitions apply:
(a) “Donor” means an individual who donates unused
prescription drugs to a participating practitioner for the purpose
of redistribution to established patients of that practitioner.
(b) “Ineligible drugs” means drugs that are not able to be
accepted for redistribution as part of the program established
pursuant to this division. “Ineligible drugs” include all controlled
substances, including all opioids, all compounded medications,
injectable medications, drugs that have an approved United
States Food and Drug Administration Risk Evaluation and
736
Mitigation Strategy (REMS) requirement, and all growth factor
medications.
(c) “Participating practitioner” means a person who is licensed to
practice medicine by the Medical Board of California and is board
certified in medical oncology or hematology and is registered
with a surplus medication collection and distribution
intermediary.
(d) “Recipient” means an individual who voluntarily receives
donated prescription medications.
(e) “Surplus medication collection and distribution intermediary”
means an entity licensed pursuant to Section 4169.5 of the
Business and Professions Code as a surplus medication collection
and distribution intermediary, as described in Section 150208.
(f) “Unused cancer medication” or “medication” means a
medication or drug, including a “dangerous drug” as defined in
Section 4022 of the Business and Professions Code or a “drug” as
defined in Section 4025 of the Business and Professions Code,
that is prescribed as part of a cancer treatment plan and is in its
original container or packaging.
150402. An unused cancer medication that is not an ineligible
drug as defined in subdivision (b) of Section 150401 may be
donated to a participating practitioner, and a participating
practitioner may accept and redistribute the donated
prescription drugs.
150403. Requirements for Participating Practitioner
(a) A participating practitioner shall comply with all of the
following:
(1) Be registered with a surplus medication collection and
distribution intermediary in order to participate in the program
established pursuant to this division and Article 11.7
(commencing with Section 4169.7) of Chapter 9 of Division 2 of
the Business and Professions Code.
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(2) Only accept donated medications originally prescribed for
use by established patients of that participating practitioner or
practice.
(3) Distribute a medication only if it will not expire before the
proper use by the recipient based on the participating
practitioner’s directions for use.
(4) Refuse a medication that has previously been redistributed.
(5) Store all donated medications separately from all other
medication stock.
(6) Store all donated medications in compliance with the
manufacturer’s storage requirements per the drug monograph.
(7) Remove or redact all confidential patient information,
personal information, and any other information through which
the prior patient could be identified from donated medications.
(8) Require all donors to read and sign the donor form approved
by the surplus medication collection and distribution
intermediary.
(9) Keep all donor forms and recipient forms in the records for
at least three years.
(10) Examine the donated drug to determine that it has not
been adulterated or misbranded and certify that the medication
has been stored in compliance with the requirements of the
product.
(11) Require all recipients of a donated medication to read and
sign the recipient form approved by the surplus medication
collection and distribution intermediary.
(12) Dispose of any donated medications that were collected
but not redistributed in accordance with all local, state, and
federal requirements for the disposal of medications.
(13) Monitor all United States Food and Drug Administration
(FDA) or manufacturer recalls, market withdrawals, and safety
alerts and communicate with recipients if medications they
received may be impacted by the FDA action.
738
(14) Inspect all donated medications to determine that the
drugs are unaltered, safe, and suitable for redistribution and
meet all of the following conditions:
(A) Tamper-resistant packaging is unopened and intact or, in the
case of unit dose packaging, the tamper-resistant dose packaging
is intact for each dose donated.
(B) Tablets or capsules have a uniformity of color, shape, imprint
or markings, texture, and odor.
(C) Liquids have a uniformity of color, thickness, particulates,
transparency, and odor.
(D) The date of donation is less than six months from the date of
the initial prescription or prescription refill.
(15) Establish policies and procedures for the administration of
the cancer medication recycling program, including, but not
limited to, criteria for determining medication distribution to
patients. Provide the surplus medication collection and
distribution intermediary with updated sections of their policy
and procedures manual that indicate how the practitioner will
accept, reuse, and keep records of donated medications, if
requested.
(b) A donor is not subject to a penalty pursuant to the Sherman
Food, Drug, and Cosmetic Law, as set forth in Part 5
(commencing with Section 109875) of Division 104, for an injury
caused when donating, accepting, or dispensing medication in
compliance with this division, unless an injury arising from the
donated medication is caused by the gross negligence,
recklessness, or intentional conduct of the donor, or in cases of
noncompliance with this division.
(c) A participating practitioner that receives and redistributes a
donated medication is not subject to a penalty pursuant to the
Sherman Food, Drug, and Cosmetic Law, as set forth in Part 5
(commencing with Section 109875) of Division 104, resulting
from the condition of the donated medication unless an injury
arising from the donated medication is caused by the gross
negligence, recklessness, or intentional conduct of the
739
participating practitioner, in cases of noncompliance with this
division, or in cases of malpractice unrelated to the quality of the
medication.
(d) The following persons and entities are not subject to criminal
or civil liability for an injury caused when participating in the
program established pursuant to this division, including, but not
limited to, donating, accepting, or dispensing prescription drugs
in compliance with this division:
(1) A prescription drug manufacturer, wholesaler, or
participating entity.
(2) A participating practitioner who accepts or dispenses
prescription drugs.
(3) A donor, as defined in Section 150401.
(4) A surplus medication collection and distribution
intermediary.
(e) The immunities provided in subdivision (d) do not apply in
cases of noncompliance with this division, gross negligence,
recklessness, intentional conduct, or in cases of malpractice
unrelated to the quality of the medication.
(f) This division shall not affect disciplinary actions taken by
licensing and regulatory agencies.
150404. Division Repeal Date
This division shall remain in effect only until January 1, 2027, and
as of that date is repealed.
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CALIFORNIA CIVIL CODE
Division 1. Persons
PART 2.6. CONFIDENTIALITY OF MEDICAL
INFORMATION
CHAPTER 1. DEFINITIONS
Section
56.
Citation
56.05.
Definitions
56.06.
Application to Businesses
56.07.
Corporation or Entity to Provide Patient with Copy
of Medical Information, Profile or Summary
Maintained
CHAPTER 2. DISCLOSURE OF MEDICAL INFORMATION
BY PROVIDERS
Section
56.1007.
Authorized Disclosure of Medical Information
56.10.
Prohibition of Unauthorized Disclosure of Medical
Information
56.101.
Protection of Electronic Medical Information
Integrity; Record Changes Made to Electronic
Medical Record
56.102.
Disclosure of Medical Information to
Pharmaceutical Company not Required;
Exceptions
56.104.
Standards for Disclosing Information Related to
Outpatient Psychotherapy
56.105.
Disclosure of Records in Malpractice Suits
741
56.11.
Standards for Authorizing Medical Information
Disclosure
56.12.
Requirement to Furnish Information
56.13.
Prohibition of Further Disclosure
56.14.
Limitations on Use of Disclosed Information
56.15.
Patient’s Right to Cancel or Modify Disclosure
Authorization
56.16.
Information Providers May Disclose Without
Authorization
CHAPTER 6. RELATIONSHIP TO EXISTING LAW
Section
56.30
Exceptions to the Act
56.31
Disclosure of Patient Information Related to HIV
Prohibited without Authorization
CHAPTER 7. VIOLATIONS
Section
56.35.
Limitation on Damage Awards and Attorney Fee
Awards
56.36.
Penalties
56.37.
Requiring Patient to Authorize Disclosure of
Information as a Condition for Service is
Prohibited
742
CONFIDENTIALITY OF MEDICAL INFORMATION
56. Citation/Confidentiality of Medical Information Act
This part may be cited as the Confidentiality of Medical
Information Act.
56.05. Definitions
For purposes of this part:
(a) “Authorization” means permission granted in accordance
with Section 56.11 or 56.21 for the disclosure of medical
information.
(b) “Authorized recipient” means any person who is authorized
to receive medical information pursuant to Section 56.10 or
56.20.
(c) “Confidential communications request” means a request by a
subscriber or enrollee that health care service plan
communications containing medical information be
communicated to him or her at a specific mail or email address or
specific telephone number, as designated by the subscriber or
enrollee.
(d) “Contractor” means any person or entity that is a medical
group, independent practice association, pharmaceutical benefits
manager, or a medical service organization and is not a health
care service plan or provider of health care. “Contractor” does
not include insurance institutions as defined in subdivision (k) of
Section 791.02 of the Insurance Code or pharmaceutical benefits
managers 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).
(e) “Endanger” means that the subscriber or enrollee fears that
disclosure of his or her medical information could subject the
subscriber or enrollee to harassment or abuse.
(f) “Enrollee” has the same meaning as that term is defined in
Section 1345 of the Health and Safety Code.
743
(g) “Health care service plan” means any entity regulated
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).
(h) “Licensed health care professional” means any person
licensed or certified pursuant to Division 2 (commencing with
Section 500) of the Business and Professions Code, the
Osteopathic Initiative Act or the Chiropractic Initiative Act, or
Division 2.5 (commencing with Section 1797) of the Health and
Safety Code.
(i) “Marketing” means to make a communication about a
product or service that encourages recipients of the
communication to purchase or use the product or service.
“Marketing” does not include any of the following:
(1) Communications made orally or in writing for which the
communicator does not receive direct or indirect remuneration,
including, but not limited to, gifts, fees, payments, subsidies, or
other economic benefits, from a third party for making the
communication.
(2) Communications made to current enrollees solely for the
purpose of describing a provider’s participation in an existing
health care provider network or health plan network of a Knox-
Keene licensed health plan to which the enrollees already
subscribe; communications made to current enrollees solely for
the purpose of describing if, and the extent to which, a product
or service, or payment for a product or service, is provided by a
provider, contractor, or plan or included in a plan of benefits of a
Knox-Keene licensed health plan to which the enrollees already
subscribe; or communications made to plan enrollees describing
the availability of more cost-effective pharmaceuticals.
(3) Communications that are tailored to the circumstances of a
particular individual to educate or advise the individual about
treatment options, and otherwise maintain the individual’s
adherence to a prescribed course of medical treatment, as
provided in Section 1399.901 of the Health and Safety Code, for a
744
chronic and seriously debilitating or life-threatening condition as
defined in subdivisions (d) and (e) of Section 1367.21 of the
Health and Safety Code, if the health care provider, contractor, or
health plan receives direct or indirect remuneration, including,
but not limited to, gifts, fees, payments, subsidies, or other
economic benefits, from a third party for making the
communication, if all of the following apply:
(A) The individual receiving the communication is notified in the
communication in typeface no smaller than 14-point type of the
fact that the provider, contractor, or health plan has been
remunerated and the source of the remuneration.
(B) The individual is provided the opportunity to opt out of
receiving future remunerated communications.
(C) The communication contains instructions in typeface no
smaller than 14-point type describing how the individual can opt
out of receiving further communications by calling a toll-free
number of the health care provider, contractor, or health plan
making the remunerated communications. No further
communication may be made to an individual who has opted out
after 30 calendar days from the date the individual makes the opt
out request.
(j) “Medical information” means any individually identifiable
information, in electronic or physical form, in possession of or
derived from a provider of health care, health care service plan,
pharmaceutical company, or contractor regarding a patient’s
medical history, mental or physical condition, or treatment.
“Individually identifiable” means that the medical information
includes or contains any element of personal identifying
information sufficient to allow identification of the individual,
such as the patient’s name, address, electronic mail address,
telephone number, or social security number, or other
information that, alone or in combination with other publicly
available information, reveals the individual’s identity.
745
(k) “Patient” means any natural person, whether or not still
living, who received health care services from a provider of
health care and to whom medical information pertains.
(l) “Pharmaceutical company” means any company or business,
or an agent or representative thereof, that manufactures, sells,
or distributes pharmaceuticals, medications, or prescription
drugs. “Pharmaceutical company” does not include a
pharmaceutical benefits manager, as included in subdivision (c),
or a provider of health care.
(m) “Provider of health care” means any person licensed or
certified pursuant to Division 2 (commencing with Section 500) of
the Business and Professions Code; any person licensed pursuant
to the Osteopathic Initiative Act or the Chiropractic Initiative Act;
any person certified pursuant to Division 2.5 (commencing with
Section 1797) of the Health and Safety Code; any clinic, health
dispensary, or health facility licensed pursuant to Division 2
(commencing with Section 1200) of the Health and Safety Code.
“Provider of health care” does not include insurance institutions
as defined in subdivision (k) of Section 791.02 of the Insurance
Code.
(n) “Sensitive services” means all health care services described
in Sections 6924, 6925, 6926, 6927, 6928, and 6929 of the Family
Code, and Sections 121020 and 124260 of the Health and Safety
Code, obtained by a patient at or above the minimum age
specified for consenting to the service specified in the section.
(o) “Subscriber” has the same meaning as that term is defined in
Section 1345 of the Health and Safety Code.
56.06. Application to Businesses
(a) Any business organized for the purpose of maintaining
medical information, as defined in subdivision (g) of Section
56.05, in order to make the information available to an individual
or to a provider of health care at the request of the individual or
a provider of health care, for purposes of allowing the individual
to manage his or her information, or for the diagnosis and
746
treatment of the individual, shall be deemed to be a provider of
health care subject to the requirements of this part. However,
nothing in this section shall be construed to make a business
specified in this subdivision a provider of health care for purposes
of any law other than this part, including laws that specifically
incorporate by reference the definitions of this part.
(b) Any business that offers software or hardware to consumers,
including a mobile application or other related device that is
designed to maintain medical information, as defined in
subdivision (j) of Section 56.05, in order to make the information
available to an individual or a provider of health care at the
request of the individual or a provider of health care, for
purposes of allowing the individual to manage his or her
information, or for the diagnosis, treatment, or management of a
medical condition of the individual, shall be deemed to be a
provider of health care subject to the requirements of this part.
However, nothing in this section shall be construed to make a
business specified in this subdivision a provider of health care for
purposes of any law other than this part, including laws that
specifically incorporate by reference the definitions of this part.
(c) Any business described in subdivision (a) or (b) shall maintain
the same standards of confidentiality required of a provider of
health care with respect to medical information disclosed to the
business.
(d) Any business described in subdivision (a) or (b) shall be
subject to the penalties for improper use and disclosure of
medical information prescribed in this part.
(e) Any business described in this section is subject to the
penalties for improper use and disclosure of medical information
prescribed in this part.
56.07. Corporation or Entity to Provide Patient with Copy of
Medical Information, Profile or Summary Maintained
(a) Except as provided in subdivision (c), upon the patient's
written request, any corporation described in Section 56.06, or
747
any other entity that compiles or maintains medical information
for any reason, shall provide the patient, at no charge, with a
copy of any medical profile, summary, or information maintained
by the corporation or entity with respect to the patient.
(b) A request by a patient pursuant to this section shall not be
deemed to be an authorization by the patient for the release or
disclosure of any information to any person or entity other than
the patient.
(c) This section shall not apply to any patient records that are
subject to inspection by the patient pursuant to Section 123110
of the Health and Safety Code and shall not be deemed to limit
the right of a health care provider to charge a fee for the
preparation of a summary of patient records as provided in
Section 123130 of the Health and Safety Code. This section shall
not apply to a health care service plan licensed pursuant to
Chapter 2.2 (commencing with Section 1340) of Division 2 of the
Health and Safety Code or a disability insurer licensed pursuant
to the Insurance Code. This section shall not apply to medical
information compiled or maintained by a fire and casualty insurer
or its retained counsel in the regular course of investigating or
litigating a claim under a policy of insurance that it has written.
For the purposes of this section, a fire and casualty insurer is an
insurer writing policies that may be sold by a fire and casualty
licensee pursuant to Section 1625 of the Insurance Code.
CHAPTER 2. DISCLOSURE OF MEDICAL INFORMATION
BY PROVIDERS
56.10. Prohibition of Unauthorized Disclosure of Medical
Information
(a) A provider of health care, health care service plan, or
contractor shall not disclose medical information regarding a
patient of the provider of health care or an enrollee or subscriber
of a health care service plan without first obtaining an
authorization, except as provided in subdivision (b) or (c).
748
(b) A provider of health care, a health care service plan, or a
contractor shall disclose medical information if the disclosure is
compelled by any of the following:
(1) By a court pursuant to an order of that court.
(2) By a board, commission, or administrative agency for
purposes of adjudication pursuant to its lawful authority.
(3) By a party to a proceeding before a court or administrative
agency pursuant to a subpoena, subpoena duces tecum, notice
to appear served pursuant to Section 1987 of the Code of Civil
Procedure, or any provision authorizing discovery in a proceeding
before a court or administrative agency.
(4) By a board, commission, or administrative agency pursuant
to an investigative subpoena issued under Article 2 (commencing
with Section 11180) of Chapter 2 of Part 1 of Division 3 of Title 2
of the Government Code.
(5) By an arbitrator or arbitration panel, when arbitration is
lawfully requested by either party, pursuant to a subpoena duces
tecum issued under Section 1282.6 of the Code of Civil
Procedure, or another provision authorizing discovery in a
proceeding before an arbitrator or arbitration panel.
(6) By a search warrant lawfully issued to a governmental law
enforcement agency.
(7) By the patient or the patient’s representative pursuant to
Chapter 1 (commencing with Section 123100) of Part 1 of
Division 106 of the Health and Safety Code.
(8) By a medical examiner, forensic pathologist, or coroner,
when requested in the course of an investigation by a medical
examiner, forensic pathologist, or coroner’s office for the
purpose of identifying the decedent or locating next of kin, or
when investigating deaths that may involve public health
concerns, organ or tissue donation, child abuse, elder abuse,
suicides, poisonings, accidents, sudden infant deaths, suspicious
deaths, unknown deaths, or criminal deaths, or upon notification
of, or investigation of, imminent deaths that may involve organ
or tissue donation pursuant to Section 7151.15 of the Health and
749
Safety Code, or when otherwise authorized by the decedent’s
representative. Medical information requested by a medical
examiner, forensic pathologist, or coroner under this paragraph
shall be limited to information regarding the patient who is the
decedent and who is the subject of the investigation or who is
the prospective donor and shall be disclosed to a medical
examiner, forensic pathologist, or coroner without delay upon
request. A medical examiner, forensic pathologist, or coroner
shall not disclose the information contained in the medical
record obtained pursuant to this paragraph to a third party
without a court order or authorization pursuant to paragraph (4)
of subdivision (c) of Section 56.11.
(9) When otherwise specifically required by law.
(c) A provider of health care or a health care service plan may
disclose medical information as follows:
(1) The information may be disclosed to providers of health
care, health care service plans, contractors, or other health care
professionals or facilities for purposes of diagnosis or treatment
of the patient. This includes, in an emergency situation, the
communication of patient information by radio transmission or
other means between emergency medical personnel at the scene
of an emergency, or in an emergency medical transport vehicle,
and emergency medical personnel at a health facility licensed
pursuant to Chapter 2 (commencing with Section 1250) of
Division 2 of the Health and Safety Code.
(2) The information may be disclosed to an insurer, employer,
health care service plan, hospital service plan, employee benefit
plan, governmental authority, contractor, or other person or
entity responsible for paying for health care services rendered to
the patient, to the extent necessary to allow responsibility for
payment to be determined and payment to be made. If (A) the
patient is, by reason of a comatose or other disabling medical
condition, unable to consent to the disclosure of medical
information and (B) no other arrangements have been made to
pay for the health care services being rendered to the patient,
750
the information may be disclosed to a governmental authority to
the extent necessary to determine the patient’s eligibility for, and
to obtain, payment under a governmental program for health
care services provided to the patient. The information may also
be disclosed to another provider of health care or health care
service plan as necessary to assist the other provider or health
care service plan in obtaining payment for health care services
rendered by that provider of health care or health care service
plan to the patient.
(3) The information may be disclosed to a person or entity that
provides billing, claims management, medical data processing, or
other administrative services for providers of health care or
health care service plans or for any of the persons or entities
specified in paragraph (2). However, information so disclosed
shall not be further disclosed by the recipient in a way that would
violate this part.
(4) The information may be disclosed to organized committees
and agents of professional societies or of medical staffs of
licensed hospitals, licensed health care service plans, professional
standards review organizations, independent medical review
organizations and their selected reviewers, utilization and quality
control peer review organizations as established by Congress in
Public Law 97-248 in 1982, contractors, or persons or
organizations insuring, responsible for, or defending professional
liability that a provider may incur, if the committees, agents,
health care service plans, organizations, reviewers, contractors,
or persons are engaged in reviewing the competence or
qualifications of health care professionals or in reviewing health
care services with respect to medical necessity, level of care,
quality of care, or justification of charges.
(5) The information in the possession of a provider of health
care or a health care service plan may be reviewed by a private or
public body responsible for licensing or accrediting the provider
of health care or a health care service plan. However, no patient-
identifying medical information may be removed from the
751
premises except as expressly permitted or required elsewhere by
law, nor shall that information be further disclosed by the
recipient in a way that would violate this part.
(6) The information may be disclosed to a medical examiner,
forensic pathologist, or county coroner in the course of an
investigation by a medical examiner, forensic pathologist, or
coroner’s office when requested for all purposes not included in
paragraph (8) of subdivision (b). A medical examiner, forensic
pathologist, or coroner shall not disclose the information
contained in the medical record obtained pursuant to this
paragraph to a third party without a court order or authorization
pursuant to paragraph (4) of subdivision (c) of Section 56.11.
(7) The information may be disclosed to public agencies, clinical
investigators, including investigators conducting epidemiologic
studies, health care research organizations, and accredited public
or private nonprofit educational or health care institutions for
bona fide research purposes. However, no information so
disclosed shall be further disclosed by the recipient in a way that
would disclose the identity of a patient or violate this part.
(8) A provider of health care or health care service plan that has
created medical information as a result of employment-related
health care services to an employee conducted at the specific
prior written request and expense of the employer may disclose
to the employee’s employer that part of the information that:
(A) Is relevant in a lawsuit, arbitration, grievance, or other claim
or challenge to which the employer and the employee are parties
and in which the patient has placed in issue his or her medical
history, mental or physical condition, or treatment, provided that
information may only be used or disclosed in connection with
that proceeding.
(B) Describes functional limitations of the patient that may
entitle the patient to leave from work for medical reasons or limit
the patient’s fitness to perform his or her present employment,
provided that no statement of medical cause is included in the
information disclosed.
752
(9) Unless the provider of health care or a health care service
plan is notified in writing of an agreement by the sponsor,
insurer, or administrator to the contrary, the information may be
disclosed to a sponsor, insurer, or administrator of a group or
individual insured or uninsured plan or policy that the patient
seeks coverage by or benefits from, if the information was
created by the provider of health care or health care service plan
as the result of services conducted at the specific prior written
request and expense of the sponsor, insurer, or administrator for
the purpose of evaluating the application for coverage or
benefits.
(10) The information may be disclosed to a health care service
plan by providers of health care that contract with the health
care service plan and may be transferred among providers of
health care that contract with the health care service plan, for
the purpose of administering the health care service plan.
Medical information shall not otherwise be disclosed by a health
care service plan except in accordance with this part.
(11) This part does not prevent the disclosure by a provider of
health care or a health care service plan to an insurance
institution, agent, or support organization, subject to Article 6.6
(commencing with Section 791) of Chapter 1 of Part 2 of Division
1 of the Insurance Code, of medical information if the insurance
institution, agent, or support organization has complied with all
of the requirements for obtaining the information pursuant to
Article 6.6 (commencing with Section 791) of Chapter 1 of Part 2
of Division 1 of the Insurance Code.
(12) The information relevant to the patient’s condition, care,
and treatment provided may be disclosed to a probate court
investigator in the course of an investigation required or
authorized in a conservatorship proceeding under the
Guardianship-Conservatorship Law as defined in Section 1400 of
the Probate Code, or to a probate court investigator, probation
officer, or domestic relations investigator engaged in determining
753
the need for an initial guardianship or continuation of an existing
guardianship.
(13) The information may be disclosed to an organ procurement
organization or a tissue bank processing the tissue of a decedent
for transplantation into the body of another person, but only
with respect to the donating decedent, for the purpose of aiding
the transplant. For the purpose of this paragraph, “tissue bank”
and “tissue” have the same meanings as defined in Section 1635
of the Health and Safety Code.
(14) The information may be disclosed when the disclosure is
otherwise specifically authorized by law, including, but not
limited to, the voluntary reporting, either directly or indirectly, to
the federal Food and Drug Administration of adverse events
related to drug products or medical device problems, or to
disclosures made pursuant to subdivisions (b) and (c) of Section
11167 of the Penal Code by a person making a report pursuant to
Sections 11165.9 and 11166 of the Penal Code, provided that
those disclosures concern a report made by that person.
(15) Basic information, including the patient’s name, city of
residence, age, sex, and general condition, may be disclosed to a
state-recognized or federally recognized disaster relief
organization for the purpose of responding to disaster welfare
inquiries.
(16) The information may be disclosed to a third party for
purposes of encoding, encrypting, or otherwise anonymizing
data. However, no information so disclosed shall be further
disclosed by the recipient in a way that would violate this part,
including the unauthorized manipulation of coded or encrypted
medical information that reveals individually identifiable medical
information.
(17) For purposes of disease management programs and
services as defined in Section 1399.901 of the Health and Safety
Code, information may be disclosed as follows: (A) to an entity
contracting with a health care service plan or the health care
service plan’s contractors to monitor or administer care of
754
enrollees for a covered benefit, if the disease management
services and care are authorized by a treating physician, or (B) to
a disease management organization, as defined in Section
1399.900 of the Health and Safety Code, that complies fully with
the physician authorization requirements of Section 1399.902 of
the Health and Safety Code, if the health care service plan or its
contractor provides or has provided a description of the disease
management services to a treating physician or to the health care
service plan’s or contractor’s network of physicians. This
paragraph does not require physician authorization for the care
or treatment of the adherents of a well-recognized church or
religious denomination who depend solely upon prayer or
spiritual means for healing in the practice of the religion of that
church or denomination.
(18) The information may be disclosed, as permitted by state
and federal law or regulation, to a local health department for
the purpose of preventing or controlling disease, injury, or
disability, including, but not limited to, the reporting of disease,
injury, vital events, including, but not limited to, birth or death,
and the conduct of public health surveillance, public health
investigations, and public health interventions, as authorized or
required by state or federal law or regulation.
(19) The information may be disclosed, consistent with
applicable law and standards of ethical conduct, by a
psychotherapist, as defined in Section 1010 of the Evidence
Code, if the psychotherapist, in good faith, believes the
disclosure is necessary to prevent or lessen a serious and
imminent threat to the health or safety of a reasonably
foreseeable victim or victims, and the disclosure is made to a
person or persons reasonably able to prevent or lessen the
threat, including the target of the threat.
(20) The information may be disclosed as described in Section
56.103.
(21) (A) The information may be disclosed to an employee
welfare benefit plan, as defined under Section 3(1) of the
755
Employee Retirement Income Security Act of 1974 (29 U.S.C. Sec.
1002(1)), which is formed under Section 302(c)(5) of the Taft-
Hartley Act (29 U.S.C. Sec. 186(c)(5)), to the extent that the
employee welfare benefit plan provides medical care, and may
also be disclosed to an entity contracting with the employee
welfare benefit plan for billing, claims management, medical data
processing, or other administrative services related to the
provision of medical care to persons enrolled in the employee
welfare benefit plan for health care coverage, if all of the
following conditions are met:
(i) The disclosure is for the purpose of determining eligibility,
coordinating benefits, or allowing the employee welfare benefit
plan or the contracting entity to advocate on the behalf of a
patient or enrollee with a provider, a health care service plan, or
a state or federal regulatory agency.
(ii) The request for the information is accompanied by a written
authorization for the release of the information submitted in a
manner consistent with subdivision (a) and Section 56.11.
(iii) The disclosure is authorized by and made in a manner
consistent with the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191).
(iv) Any information disclosed is not further used or disclosed by
the recipient in any way that would directly or indirectly violate
this part or the restrictions imposed by Part 164 of Title 45 of the
Code of Federal Regulations, including the manipulation of the
information in any way that might reveal individually identifiable
medical information.
(B) For purposes of this paragraph, Section 1374.8 of the Health
and Safety Code shall not apply.
(22) Information may be disclosed pursuant to subdivision (a) of
Section 15633.5 of the Welfare and Institutions Code by a person
required to make a report pursuant to Section 15630 of the
Welfare and Institutions Code, provided that the disclosure under
subdivision (a) of Section 15633.5 concerns a report made by that
person. Covered entities, as they are defined in Section 160.103
756
of Title 45 of the Code of Federal Regulations, shall comply with
the requirements of the Health Insurance Portability and
Accountability Act (HIPAA) privacy rule pursuant to subsection (c)
of Section 164.512 of Title 45 of the Code of Federal Regulations
if the disclosure is not for the purpose of public health
surveillance, investigation, intervention, or reporting an injury or
death.
(d) Except to the extent expressly authorized by a patient,
enrollee, or subscriber, or as provided by subdivisions (b) and (c),
a provider of health care, health care service plan, contractor, or
corporation and its subsidiaries and affiliates shall not
intentionally share, sell, use for marketing, or otherwise use
medical information for a purpose not necessary to provide
health care services to the patient.
(e) Except to the extent expressly authorized by a patient or
enrollee or subscriber or as provided by subdivisions (b) and (c), a
contractor or corporation and its subsidiaries and affiliates shall
not further disclose medical information regarding a patient of
the provider of health care or an enrollee or subscriber of a
health care service plan or insurer or self-insured employer
received under this section to a person or entity that is not
engaged in providing direct health care services to the patient or
his or her provider of health care or health care service plan or
insurer or self-insured employer.
(f) For purposes of this section, a reference to a “medical
examiner, forensic pathologist, or coroner” means a coroner or
deputy coroner as described in subdivision (c) of Section 830.35
of the Penal Code, or a licensed physician who currently performs
official autopsies on behalf of a county coroner’s office or a
medical examiner’s office, whether as a government employee or
under contract to that office.
757
56.1007. Authorized Disclosure of Medical Information
(a) A provider of health care, health care service plan, or
contractor may, in accordance with subdivision (c) or (d), disclose
to a family member, other relative, domestic partner, or a close
personal friend of the patient, or any other person identified by
the patient, the medical information directly relevant to that
person's involvement with the patient's care or payment related
to the patient's health care.
(b) A provider of health care, health care service plan, or
contractor may use or disclose medical information to notify, or
assist in the notification of, including identifying or locating, a
family member, a personal representative of the patient, a
domestic partner, or another person responsible for the care of
the patient of the patient's location, general condition, or death.
Any use or disclosure of medical information for those
notification purposes shall be in accordance with the provisions
of subdivision (c), (d), or (e), as applicable.
(c) (1) Except as provided in paragraph (2), if the patient is
present for, or otherwise available prior to, a use or disclosure
permitted by subdivision (a) or (b) and has the capacity to make
health care decisions, the provider of health care, health care
service plan, or contractor may use or disclose the medical
information if it does any of the following:
(A) Obtains the patient's agreement.
(B) Provides the patient with the opportunity to object to the
disclosure, and the patient does not express an objection.
(C) Reasonably infers from the circumstances, based on the
exercise of professional judgment, that the patient does not
object to the disclosure.
(2) A provider of health care who is a psychotherapist, as
defined in Section 1010 of the Evidence Code, may use or
disclose medical information pursuant to this subdivision only if
the psychotherapist complies with subparagraph (A) or (B) of
paragraph (1).
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(d) If the patient is not present, or the opportunity to agree or
object to the use or disclosure cannot practicably be provided
because of the patient's incapacity or an emergency
circumstance, the provider of health care, health care service
plan, or contractor may, in the exercise of professional judgment,
determine whether the disclosure is in the best interests of the
patient and, if so, disclose only the medical information that is
directly relevant to the person's involvement with the patient's
health care. A provider of health care, health care service plan, or
contractor may use professional judgment and its experience
with common practice to make reasonable inferences of the
patient's best interest in allowing a person to act on behalf of the
patient to pick up filled prescriptions, medical supplies, X-rays, or
other similar forms of medical information.
(e) A provider of health care, health care service plan, or
contractor may use or disclose medical information to a public or
private entity authorized by law or by its charter to assist in
disaster relief efforts, for the purpose of coordinating with those
entities the uses or disclosures permitted by subdivision (b). The
requirements in subdivisions (c) and (d) apply to those uses and
disclosures to the extent that the provider of health care, health
care service plan, or contractor, in the exercise of professional
judgment, determines that the requirements do not interfere
with the ability to respond to the emergency circumstances.
(f) Nothing in this section shall be construed to interfere with or
limit the access authority of Protection and Advocacy, Inc., the
Office of Patients' Rights, or any county patients' rights advocates
to access medical information pursuant to any state or federal
law.
56.101. Protection of Electronic Medical Information Integrity;
Record Changes Made to Electronic Medical Record
(a) Every provider of health care, health care service plan,
pharmaceutical company, or contractor who creates, maintains,
preserves, stores, abandons, destroys, or disposes of medical
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