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Posted by: C. Brandi Hannagan

Last month, Assembly Member Chris Rogers introduced Assembly Bill 1460 to prohibit prescription drug manufacturers from engaging in discriminatory practices against 340B participating providers and their contract pharmacies. More specifically, when a 340B covered entity uses a specified pharmacy, including a contract pharmacy, to dispense a 340B drug to a covered entity’s eligible patient, prescription drug manufacturers are prohibited from engaging in discriminatory practices that impose additional conditions, prohibit, restrict, deny, or interfere with the covered entity’s purchase or delivery of 340B drugs. With this bill, California joins other states aiming to use state legislation to fill gaps in the federal 340B statute, which does not prohibit drug manufacturers from employing such restrictions. Coauthored by Assembly Member Rhodesia Ransom, AB 1460 would add section 127472 to the Health and Safety Code.

This week, CSHA would like to acknowledge platinum sponsor, Jones Day.  

Jones Day is a global law firm with more than 2,500 lawyers in 40 offices across five continents. The Firm is distinguished by: a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.

CSHA extends its gratitude to Jones Day for its generous partnership and support of the Annual Meeting and Spring Seminar.

CSHA is committed to creating a culture that recognizes the value of individuals with diverse backgrounds, talents, experiences, and perspectives at all levels of the organization. For the first time, CSHA is conducting a voluntary and anonymous member demographic survey to understand the composition of CSHA membership and leadership. CSHA will aggregate the data and share a compilation of overall percentage by category with the entire CSHA membership (e.g., years in practice, practice area, sexuality, gender, race/ethnicity/ancestry, disability, and veteran status).  CSHA leadership will review the data to understand the diversity within the organization and measure progress on creating an inclusive environment for all members.  CSHA will not receive any identifying information along with the survey responses and therefore will not be able to tie any particular response to a specific member.  Participation is purely voluntary, but sharing this information will provide important and meaningful data regarding the diversity of CSHA’s membership. Members can indicate that they prefer not to answer any or all of the questions.  Members can also simply ignore the survey.

To complete the survey, click here. Please only complete the survey once.

The data collected through this survey will be stored securely using Google Forms, which is part of Google Workspace. Google Workspace leverages Google Cloud Platform (GCP) infrastructure, ensuring high levels of data protection and privacy.  Key security features include:

  • Encryption: All data is encrypted both in transit and at rest, providing a robust layer of security against unauthorized access.
  • Regular Security Audits: Google conducts regular security audits and adheres to stringent compliance standards.
  • Redundancy and Reliability: Data is stored across multiple secure data centers, ensuring redundancy and reliability.

For more information about Google’s privacy policy, click here.  CSHA is committed to safeguarding your information and ensuring that your data is handled with the utmost care and confidentiality.  CSHA will never sell or share member information to any third-party. 

CSHA is pleased to provide information on the following actions by the Trump administration that potentially impact health care in California.  Given how rapidly events are changing at the federal level, readers are cautioned to double check the current status of any information in this feature.

CSHA is pleased to provide information on the following recent actions by the Trump administration that potentially impact health care in California.  Given how rapidly events are changing at the federal level, readers are cautioned to double check the current status of any information in this feature.   

Federal Executive Actions Impacting Health Care In California

HHS Disclaimer on Advisory Opinions (February 26, 2025). On February 26, HHS Office of General Counsel added a disclaimer to two HHS Advisory Opinions stating that they “represented the view of OGC during a prior Administration…They do not represent the views of the current Administration.” The two Biden-era advisory opinions are 24-02 Advisory Opinion saying that a state cannot exclude a provider for allegations that it violated Comstock when acting in reliance to the OLC memo and 24-10 Advisory Opinion stating that HHS lacks the authority to approve work requirements for Medicaid enrollment. The HHS disclaimer that these opinions no longer represent the current Administration’s views will not have immediate impacts on California as California is unlikely to exclude providers based on the misapplication of the Comstock Act or ask HHS to impose work requirements in the Medi-Cal program.

HHS Rescinds Richardson Waiver (February 28, 2025). HHS posted a notice rescinding the policy on Public Participation in rulemaking to eliminate notice and public comment related to any HHS decisions related to “agency management or personnel or to public property, loans, grants, benefits, or contracts.” The Waiver has been in place since 1971 and imposes notice-and-comment periods beyond what is required by The Administrative Procedure Act. You can find press coverage here and here. While there is no immediate impact to care in California, this has broad implications for the rule-making process that governs the Medicaid program, including conditions of participation or how federal grant programs are administered.

 

CSHA is committed to creating a culture that recognizes the value of individuals with diverse backgrounds, talents, experiences, and perspectives at all levels of the organization. For the first time, CSHA is conducting a voluntary and anonymous member demographic survey to understand the composition of CSHA membership and leadership. CSHA will aggregate the data and share a compilation of overall percentage by category with the entire CSHA membership (e.g., years in practice, practice area, sexuality, gender, race/ethnicity/ancestry, disability, and veteran status).  CSHA leadership will review the data to understand the diversity within the organization and measure progress on creating an inclusive environment for all members.  CSHA will not receive any identifying information along with the survey responses and therefore will not be able to tie any particular response to a specific member.  Participation is purely voluntary, but sharing this information will provide important and meaningful data regarding the diversity of CSHA’s membership. Members can indicate that they prefer not to answer any or all of the questions.  Members can also simply ignore the survey. 

To complete the survey, click here. Please only complete the survey once.

The data collected through this survey will be stored securely using Google Forms, which is part of Google Workspace. Google Workspace leverages Google Cloud Platform (GCP) infrastructure, ensuring high levels of data protection and privacy.  Key security features include:

  • Encryption: All data is encrypted both in transit and at rest, providing a robust layer of security against unauthorized access.
  • Regular Security Audits: Google conducts regular security audits and adheres to stringent compliance standards.
  • Redundancy and Reliability: Data is stored across multiple secure data centers, ensuring redundancy and reliability.

For more information about Google’s privacy policy, click here.  CSHA is committed to safeguarding your information and ensuring that your data is handled with the utmost care and confidentiality.  CSHA will never sell or share member information to any third-party. 

This week, CSHA would like to acknowledge platinum sponsor Skadden, Arps, Slate, Meagher & Flom LLP.

Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates delivers the highest quality advice and novel solutions to legal challenges, enabling clients to achieve their business goals. The firm is known for the innovative and creative thinking it relies on to handle the most complex transactions, litigation/controversy issues, and regulatory matters, as well as the open, collaborative relationships it builds with clients, including corporations; financial and governmental entities; small, entrepreneurial companies; and cultural, educational and charitable institutions. Skadden’s attorneys, who reflect a broad array of backgrounds and perspectives, collaborate seamlessly across the firm’s 21 offices in the world’s major financial centers.

For further information, visit: https://www.linkedin.com/company/skadden-arps-slate-meagher-flom-llp-affiliates/

CSHA extends its gratitude to Skadden for its generous partnership and support of the Annual Meeting and Spring Seminar.

Recently, Assembly Health Committee Chairwoman Mia Bonta (CA-AD 18) introduced legislation that would remove the cap on participants and require California’s Department of Health Care Services (DHCS) to study the Home and Community-Based Alternatives (HCBA) waiver rates and fiscal impacts. (See AB 315, introduced on January 23, 2025.)

Under this proposal, DHCS has until March 1, 2026, to provide a report to the Legislature on the fiscal and rate impacts of a full-scale expansion of the HCBA program and what it would mean. Bonta’s bill is aimed at determining the cost of removing the cap and offering all Californians on Medi-Cal the opportunity to remain at home in the face of significant medical needs.

California’s HCBA waiver allows Californians with significant medical needs to receive care in their homes or in the community, without the need to move into an institutional setting such as a nursing home or long-term care. Currently, the HCBA waiver is capped at 5,000 participants. Bonta’s bill would remove the cap and build on the existing program by requiring that all eligible Californians be allowed to participate.

The bill calls on DHCS to provide a rate analysis because the rates have not increased since 2007 and the pool of qualified providers is continuing to shrink, jeopardizing the ability to provide this home-based care. More to come in this space.

Recently, Assembly Health Committee Chairwoman Mia Bonta (CA-AD 18) introduced legislation that would prohibit cost-sharing for Californians under age 21. (See AB 298, introduced on January 23, 2025.) AB 298 prohibits health plans from imposing a “deductible, coinsurance, copayment, or other cost-sharing requirement for in-network health care services provided to an enrollee under 21 years of age” for policies issued or renewed after January 1, 2026.

Under AB 298, “in-network” care means covered services: (1) by a contracting provider, (2) at a contracting health facility – even if the provider is not contracted, (3) in an emergency department, and (4) noncontracted care provided due to timely access requirements pursuant to Health & Safety Code section 1367.03. The bill claims it does not expand or impact scope of coverage for out-of-network emergency services, save for emergency care provided to an enrollee under age 21.

The rules are different, though, for high deductible plans coupled with health savings accounts. For those plans, health insurance policies would be prohibited from imposing (1) a deductible, coinsurance, copayment or other cost-sharing for preventive care services for insureds under age 21; and (2) coinsurance, a copayment, or other cost-sharing for in-network care provided to an insured under age 21, once the deductible is met.

Presumably, the policy behind this legislation is to increase health care usage by younger Californians and to encourage use by reducing financial barriers for families. According to Assemblymember Bonta’s press release (no Fact Sheet has yet been published), families facing uncertain medical care for children are less likely to seek timely care for financial reasons. Citing a recent publication in JAMA Pediatrics, Financial barriers to care among low-income children with asthma: health care reform implications, Bonta’s bill would increase timely usage and mitigation of adverse health outcomes in children.

And it also makes sense that increased use as a child may lead to a “habit” of using and relying on health care as California’s children become adults. More to come in this space.

AI in health and healthcare is a growing market and most large insurers and providers have enthusiastically jumped on board. However, as a recent rash of media about the limits of AI has illuminated, uses of AI in healthcare may soon come crashing down on providers and insurers. As with all AI, healthcare AI relies on existing content to learn. But what happens when that content was AI-generated to begin with? And it was wrong? Healthcare is necessarily individualized – one small difference between patients can mean all the difference in diagnosis and treatment. Will an AI doc be able to see those differences and know to ask for them? And what happens when it doesn’t?

A recent Watching by Katie Howells (Beyer) highlighted concerns regarding AI in healthcare from California’s Attorney General. (See The Weekly.) But the amount, types, and uses of AI in healthcare continue to advance rapidly and exponentially. Every day, new apps reach the market and insurers and doctors are using them at alarming rates without necessary safeguards in place. AI has the promise of advancing individualized medical care… until it doesn’t.

Assemblymember Maggy Krell (CA-AD 6) is at the forefront of this issue. On January 24, 2025, Assemblymember Krell introduced AB 316, legislation that could prevent healthcare insurers and providers from using AI technology as a defense in civil proceedings. If enacted, this bill means that a defendant cannot blame AI technology for causing harm where the defendant either “developed or used” the AI. We should expect increasing attempts by California legislators to adapt to AI and a changing healthcare landscape. Stay tuned for more developments in this space.*

*Written without the help or interference of AI.


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