Communicable diseases: hepatitis C.

Removed the requirement that health care service plan and health insurer clinical criteria for hepatitis C treatment and prior authorization must align with current guidelines from the American Association for the Study of Liver Diseases, the Infectious Diseases Society of America, or other nonprofit professional associations specializing in hepatology or infectious disease.

Removed the prohibition on plans and insurers requesting seven specific items for prior authorization purposes: liver biopsy, genotype testing, proof of sobriety, fibrosis staging thresholds, elastography or liver stiffness documentation, ultrasound documentation, and specialist referral or evaluation.

Section numbers changed from 1342.77 to 1342.78 (Health and Safety Code) and from 10123.1936/10123.1937 to 10123.1937/10123.1938 (Insurance Code), indicating renumbering to avoid conflict with another bill.

Entire Section 121027 of the Health and Safety Code was deleted. This section would have made hepatitis B and C public health records confidential, authorized local health officers to disclose information for case investigation and care coordination, and imposed civil penalties (up to $5,000 for negligent disclosure, $5,000-$25,000 for willful or malicious disclosure) and misdemeanor criminal penalties (up to one year in jail or $25,000 fine) for unauthorized disclosures causing harm.

The constitutional findings section (former Section 4) demonstrating the need to limit public access to hepatitis B/C records was removed along with the confidentiality provisions it supported.

The therapeutic equivalents exception now requires that at least one 'pangenotypic and therapeutically equivalent version' be covered without prior authorization, rather than any 'therapeutically equivalent version.' This narrows when plans are excused from covering all equivalent drugs without prior auth.

The list of accepted clinical guideline sources was changed: the American Liver Foundation was removed, and a new option was added allowing alignment with 'generally accepted clinical practice guidelines of another nonprofit health care provider professional association or specialty society pertaining to clinical hepatology or infectious disease.'

The prohibition language shifted from plans 'shall not impose prior authorization requirements' to plans 'shall not request, for the purpose of determining prior authorization,' the following tests and information. The list of prohibited items (liver biopsy, genotype testing, sobriety requirements, fibrosis staging thresholds, elastography/FibroScan documentation, ultrasound documentation, specialist referral) remains substantively the same.

The bill's scope was narrowed from covering both hepatitis B and C to hepatitis C only, as reflected in the legislative counsel's digest changing from 'hepatitis B and C' to 'hepatitis C.'

A new exemption was added (subdivision (c) of Section 1342.77) stating the prior authorization restrictions do not apply to Medi-Cal managed care contracts with the State Department of Health Care Services entered into under specific Welfare and Institutions Code chapters.

Specific drug names (sofosbuvir/velpatasvir, sofosbuvir/ledipasvir, glecaprevir/pibrentasvir, elbasvir/grazoprevir) were removed from the statutory text, replacing them with the broader term 'direct-acting antiviral drugs that are medically necessary for the treatment of hepatitis C.'

Section numbering was reorganized: hepatitis C provisions moved from Sections 1342.76 and 10123.1936 to new Sections 1342.77 and 10123.1937, with the original section numbers left as empty placeholders likely reserved for separate hepatitis B legislation.

The prohibited prior authorization requests were refined: 'sobriety requirements' was changed to 'proof of sobriety,' and 'elastography or FibroScan documentation' was broadened to 'documentation of elastography or other measures of liver stiffness.'

Both Section 1342.76 (health care service plans) and Section 10123.1936 (health insurers) now require clinical criteria to align with the standards of the American Liver Foundation AND the Association for the Study of Liver Diseases AND the Infectious Diseases Society of America, rather than just the American Liver Foundation and Infectious Diseases Society of America.

The legislative digest was updated to note that existing law generally prohibits health care service plans or health insurers from subjecting antiretroviral drugs medically necessary for HIV/AIDS prevention to prior authorization or step therapy, providing additional context for the bill's hepatitis C provisions.

The short title in the act description contains a drafting error duplicating 'Section 1342.76' and section numbering in the operative text is inconsistent (SEC. 3 appears empty before SEC. 2 reappears for the Insurance Code provision).