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<ns0:Id>20250AB__184399INT</ns0:Id>
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<ns0:Action>
<ns0:ActionText>INTRODUCED</ns0:ActionText>
<ns0:ActionDate>2026-02-11</ns0:ActionDate>
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<ns0:SessionYear>2025</ns0:SessionYear>
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<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Assembly Member Elhawary</ns0:AuthorText>
<ns0:Authors>
<ns0:Legislator>
<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Elhawary</ns0:Name>
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<ns0:Title> An act to add Sections 1342.76 and 121027 to the Health and Safety Code, and to add Section 10123.1936 to the Insurance Code, relating to public health. </ns0:Title>
<ns0:RelatingClause>public health</ns0:RelatingClause>
<ns0:GeneralSubject>
<ns0:Subject>Communicable diseases: hepatitis B and C.</ns0:Subject>
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<html:p>Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. </html:p>
<html:p>This bill would prohibit a health care service plan and health insurer from subjecting direct-acting antiviral drugs that are medically necessary for the treatment of hepatitis C to prior authorization. The bill would specify that these provisions do not require a health care service plan or health insurer to cover all therapeutically equivalent versions without prior authorization. The bill would prohibit a health care service plan and health insurer from imposing prior authorization requirements, as specified, and would
require a health care service plan and health insurer’s clinical criteria for hepatitis C treatment to align with current guidelines and the standard of care consistent with the standards of the American Liver Foundation and Infectious Diseases Society of America. Because a violation of these provisions by a health care service plan would be a crime, this bill would impose a state-mandated local program.</html:p>
<html:p>Existing law requires public health records related to human immunodeficiency virus or acquired immunodeficiency syndrome, containing personally identifying information, that were developed or acquired by a state or local public health agency, or an agent of that agency, to be confidential and not disclosed, except as otherwise provided by law for public health purposes or pursuant to a written authorization by the person who is the subject of the record or by their guardian or conservator. Existing law additionally authorizes disclosure when the confidential
information is necessary for the coordination of, linkage to, or reengagement in care for a person. Existing law makes disclosure of confidential public health records punishable by various civil penalties or as a misdemeanor, as specified. </html:p>
<html:p>This bill would make public health records relating to hepatitis B and hepatitis C, containing personally identifying information, that were developed or acquired by a local health agency, or an agent of that agency, to be confidential and not disclosed, except as otherwise provided by law or with the written consent of the person who is the subject of the record or by their legal representative. The bill would authorize a local health officer to disclose any information when necessary to facilitate clinical management, treatment coordination, and prevent the spread of disease or occurrence of additional cases. The bill would apply existing civil and criminal penalties to unauthorized disclosures of confidential public health
records covered by these provisions. By expanding the scope of an existing crime, this bill would impose a state-mandated local program.</html:p>
<html:p>Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest.</html:p>
<html:p>This bill would make legislative findings to that effect.</html:p>
<html:p>The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.</html:p>
<html:p>This bill would provide that no reimbursement is required by this act for a specified reason.</html:p>
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<ns0:VoteRequired>MAJORITY</ns0:VoteRequired>
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<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
<ns0:BillSection id="id_1250F6FA-90A9-49AD-85D2-9A806150CEBB">
<ns0:Num>SECTION 1.</ns0:Num>
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Section 1342.76 is added to the
<ns0:DocName>Health and Safety Code</ns0:DocName>
, to read:
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<ns0:LawSection id="id_955A0594-5690-43F2-ABC4-387DA419106F">
<ns0:Num>1342.76.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
A health care service plan shall not subject direct-acting antiviral drugs that are medically necessary for the treatment of hepatitis C, including, but not limited to, sofosbuvir/velpatasvir, sofosbuvir/ledipasvir, glecaprevir/pibrentasvir, or elbasvir/grazoprevir, to prior authorization, except as provided in paragraph (2).
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
If the United States Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the treatment of hepatitis C, this section does not require a health care service plan to cover all of the therapeutically equivalent versions without prior authorization, if at least one therapeutically equivalent version is covered without prior
authorization.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
A health care service plan’s clinical criteria for hepatitis C treatment and prior authorization shall align with the current guidelines and the standard of care consistent with the standards of the American Liver Foundation and Infectious Diseases Society of America, and shall not impose prior authorization requirements, including, but not limited to, all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
A liver biopsy.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Genotype testing.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Sobriety requirements.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Fibrosis staging thresholds.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Elastography or FibroScan documentation.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
Ultrasound
documentation.
</html:p>
<html:p>
(7)
<html:span class="EnSpace"/>
A specialist referral or evaluation.
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<ns0:Num>SEC. 2.</ns0:Num>
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Section 121027 is added to the
<ns0:DocName>Health and Safety Code</ns0:DocName>
, to read:
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<ns0:Num>121027.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
Public health records relating to hepatitis B and hepatitis C containing personally identifying information that were developed or acquired by local health agencies or their agents shall be confidential and shall not be disclosed except as otherwise provided by law or with the written consent of the individual who is the subject of the record or by the legal representative of the individual.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
A local health officer may, for the purposes of case investigation and linkage to, or reengagement in care for, the person with hepatitis B or hepatitis C, may request and disclose without written consent of the individual any information, including personally identifying information, in hepatitis B and hepatitis C public health records from the
person’s health care provider or health care facilities as may be necessary to facilitate clinical management, treatment coordination, and the prevention of the spread of disease or occurrence of additional cases.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
A local health officer, for the purposes of facilitating appropriate hepatitis B and hepatitis C medical care and treatment, may further disclose the information to the person positive for hepatitis B or hepatitis C who is the subject of the record, or the health care provider who provides the person’s hepatitis care, for the purpose of proactively offering and coordinating care and treatment services. Any personally identifying information received pursuant to this subdivision by a health care provider or health care facility shall be confidential and shall not be further disclosed except as required by law or with the written consent of the individual.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
Any
disclosures authorized by subdivision (a), (b), or (c) shall include only the information necessary for the purpose of that disclosure and shall be made only upon the agreement that the information will be kept confidential as described in subdivision (a). Any unauthorized further disclosure shall be subject to the penalties described in subdivision (e).
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
A person who negligently discloses the content of a confidential public health record to a third party, except pursuant to a written authorization, as described in subdivision (a), or as otherwise authorized by law, shall be subject to a civil penalty in an amount not to exceed five thousand dollars ($5,000), plus court costs, as determined by the court. The penalty and costs shall be paid to the person whose record was disclosed.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
A person who willfully or maliciously discloses the content of any
confidential public health record to a third party, except pursuant to a written authorization, or as otherwise authorized by law, shall be subject to a civil penalty in an amount not less than five thousand dollars ($5,000) and not more than twenty-five thousand dollars ($25,000), plus court costs, as determined by the court. The penalty and costs shall be paid to the person whose confidential public health record was disclosed.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
A person who willfully, maliciously, or negligently discloses the content of a confidential public health record to a third party, except pursuant to a written authorization, or as otherwise authorized by law, that results in economic, bodily, or psychological harm to the person whose confidential public health record was disclosed, is guilty of a misdemeanor, punishable by imprisonment in a county jail for a period not to exceed one year, or a fine not to exceed twenty-five thousand dollars ($25,000), or both,
plus court costs, as determined by the court. The penalty and costs shall be paid to the person whose confidential public health record was disclosed.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
A person who commits an act described in paragraph (1), (2), or (3) is liable to the person whose confidential public health record was disclosed for all actual damages for economic, bodily, or psychological harm that is a proximate result of the act.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Each violation of this section is a separate and actionable offense.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
This section does not limit or expand the right of an injured person whose confidential public health record was disclosed to recover damages under any other applicable law.
</html:p>
<html:p>
(7)
<html:span class="EnSpace"/>
For the purposes of this section, a confidential public health record means the same as defined in
subdivision (c) of Section 121035.
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<ns0:Num>SEC. 3.</ns0:Num>
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Section 10123.1936 is added to the
<ns0:DocName>Insurance Code</ns0:DocName>
, to read:
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<ns0:LawSection id="id_F79C4E63-7211-4655-9599-65A5144C32DC">
<ns0:Num>10123.1936.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
A health insurer shall not subject direct-acting antiviral drugs that are medically necessary for the treatment of hepatitis C, including, but not limited to, sofosbuvir/velpatasvir, sofosbuvir/ledipasvir, glecaprevir/pibrentasvir, or elbasvir/grazoprevir, to prior authorization, except as provided in paragraph (2).
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
If the United States Food and Drug Administration has approved one or more therapeutic equivalents of a drug, device, or product for the treatment of hepatitis C, this section does not require a health insurer to cover all of the therapeutically equivalent versions without prior authorization, if at least one therapeutically equivalent version is covered without prior authorization.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
A health insurer’s clinical criteria for hepatitis C treatment and prior authorization shall align with the current guidelines and the standard of care consistent with the standards of the American Liver Foundation and Infectious Diseases Society of America, and shall not impose prior authorization requirements, including, but not limited to, all of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
A liver biopsy.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Genotype testing.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Sobriety requirements.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Fibrosis staging thresholds.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Elastography or FibroScan documentation.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
Ultrasound documentation.
</html:p>
<html:p>
(7)
<html:span class="EnSpace"/>
A specialist referral or evaluation.
</html:p>
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<ns0:Num>SEC. 4.</ns0:Num>
<ns0:Content>
<html:p>The Legislature finds and declares that Section 2 of this act, which adds Section 121027 to the Health and Safety Code, imposes a limitation on the public’s right of access to the meetings of public bodies or the writings of public officials and agencies within the meaning of Section 3 of Article I of the California Constitution. Pursuant to that constitutional provision, the Legislature makes the following findings to demonstrate the interest protected by this limitation and the need for protecting that interest:</html:p>
<html:p>In order to protect confidential and personal medical information, it is necessary that the public health records relating to hepatitis B and hepatitis C, as described in this act, remain confidential.</html:p>
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<ns0:Num>SEC. 5.</ns0:Num>
<ns0:Content>
<html:p>
No reimbursement is required by this act pursuant to Section 6 of Article XIII
<html:span class="ThinSpace"/>
B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII
<html:span class="ThinSpace"/>
B of the California Constitution.
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