CLSA Wire

2017 State Policy Agenda

CLSA’s seasoned state government relations team is engaged on behalf of the life sciences sector in multiple ways through strategic collaborations and direct lobbying in Sacramento to advance innovation, investment and job creation for California’s treasured life sciences ecosystem. Our 2017 policy priorities include:

Mandatory Price Reporting or Advance Notice Legislation

In 2017, we expect health insurers to continue their unrelenting campaign to convince policymakers that the price of therapies is the primary cost driver of health insurance premium increases. In the insurers’ continuing public relations campaign seeking legislation to require myriad drug-specific cost information from manufacturers, they focused on price increases for specific drugs, selected companies’ profit margins, and certain payers’ statements on specialty drug costs, among many other things – often attempting to attribute the examples of bad actors to the entire industry. Indeed, high profile examples of price increases in the media have helped the insurers and others build their false narrative that drug and biotech companies need to be further regulated at the state level to discourage or prevent such price increases.

We expect several state legislative efforts attacking California’s biopharmaceutical industry in 2017, though state policymakers will also be mindful of preserving major California healthcare reforms in the face of threats at the national level.

In 2017, CLSA will:

  • Make it a top organizational priority to defeat any legislation inhibiting the ability of California’s life sciences industry to innovate or otherwise continue to bring life-saving treatments and cures to patients.
  • Maintain a continuous campaign to educate the public and policymakers about the clinical and economic value provided to patients and the healthcare system by the therapies created by California’s life sciences industry.
  • Continue to exert policy leadership in California on issues impacting innovation and access to or coverage of our members’ products.

Extended Producer Responsibility

The California Legislature continues to propose and enact exceptionally aggressive environmental management laws. These laws, however well-intentioned, may significantly hinder the state’s ability to attract and retain businesses engaged in biomedical research and innovation. During this debate, CLSA has developed a strong reputation for credibility rooted in evidence-based positions that rest on solid scientific research.

We anticipate this year will be no different. We expect to see continued efforts to pass “extended producer responsibility” (EPR) laws at the local level, which seek to impose the cost of mandatory take- back and other product stewardship programs solely upon drug, device, and diagnostics manufacturers. Several localities have already passed these programs.  However, this year, we are particularly optimistic that a compromise statewide EPR bill may advance. We continue to seek preemption of all local programs that continue to emerge throughout the state, as well as existing programs to the extent possible.

In 2017, CLSA will:

  • Continue to coordinate with other industry associations and the Legislature to work toward a responsible statewide solution on household hazardous waste disposal and EPR.
  • If needed, re-engage independent scientific expert(s) to provide CLSA with the necessary technical expertise on the subject area.
  • Continue to convene the CLSA EPR Task Force to provide reliable expertise on scientific issues and to credibly educate policymakers on the practical implications of overreaching environmental requirements.
  • Continue to provide legislators with a clear understanding of our highly-regulated industry’s commitment to practices that are environmentally sound, safe, and convenient for consumers.

State Budget and Adequate Funding for Access to Healthcare, Education, Research and Workforce Development

CLSA continues to oppose tax and budget issues that hinder biomedical innovation and to support tax policies that encourage the growth of the life sciences industry in the state.

Similarly important to encouraging the growth of life sciences in California, the state’s higher education community remains an important component of CLSA’s advocacy. We strongly support adequate funding for the University of California and the California State University systems, which provide the highly-trained workforce on which our companies rely.

Earlier this year, the Governor released his proposed $179.5 billion state spending plan. Budget negotiations between the Governor and the Legislature will continue through much of 2017. The budget negotiations will include funding proposals for numerous public programs that provide access to care for Californians, including Medi-Cal, while maintaining caution as to what may come of the Affordable Care Act and how changes to the program might affect California.

In 2017, CLSA will:

  • Advocate for protecting patient access to biomedical therapies in the state budget, while working to foster a tax environment that promotes biomedical research and innovation, including protection of the state’s research and development tax credit and opposing increased taxation and fees on the California biopharmaceutical and device industries.
  • Continue to work with the Governor’s team to advocate for continued funding to implement and bolster precision and personalized medicine efforts.
  • Oppose efforts to impose new or higher corporate income, commercial property, or other taxes and fees on our members.
  • Advocate for protecting higher education funding in order to educate our workforce and partner with the industry on research to maintain a thriving biomedical industry in California.
  • Advocate for bolstering K-14 STEM education programs.
  • Effectively communicate the role that the industry plays in providing well-paying jobs to students with math and science degrees.
  • Look for opportunities to build goodwill and strategic relationships with key California stakeholders through activity around these education and workforce issues.

Other Issues

Fail First/Step Therapy

If “step therapy” or “fail first” legislation is reintroduced this year, CLSA will support efforts to limit this type of utilization management imposed by health plans.

Access to Innovation

Similar to the last several years, as public-payer and publicly subsidized programs become increasingly important, CLSA must remain vigilant in two primary areas—backdoor “price control” efforts and policies that impede access to treatments developed by California’s life sciences industry.

A host of issues, however, span both public and commercial health insurance markets. Some of the concerns about access to care and price controls include:

  • Copay issues: CLSA will continue its efforts to ensure copays are reasonable and clearly communicated to ensure patients can make appropriate coverage choices.
  • Continuity of care: CLSA will explore ways to ensure patients can maintain continuity of care as they move between coverage, such as from Covered California to Medi-Cal or vice versa.
  • Specialty drug issues: CLSA will support ensuring meaningful access to specialty drugs and orphan drugs in public programs.
  • Flawed use of “evidence based medicine” (EBM): CLSA will continue to oppose efforts to use technology assessment panels, health evidence review panels, biased “value-based purchasing,” and other flawed EBM models which elevate costs over value or otherwise deny access to appropriate therapies.
  • Physician/Specialist network adequacy: CLSA will support efforts to ensure Medi-Cal patients may access care at California’s non-profit and research institutions. CLSA will also voice support for residency programs and other programs designed to increase the supply of primary care and specialist physicians. Additionally, CLSA will support improvements in assessing the adequacy of provider networks, particularly specialist networks, and in ensuring the accuracy of provider directories.
  • Formulary disclosure issues: CLSA will continue to look for opportunities to ensure health plans clearly and conveniently communicate formularies to enrollees and potential enrollees.

In 2017 CLSA will:

  • Advocate for healthcare reforms that facilitate patients’ access to proper testing, therapies, and treatments.
  • CLSA will oppose efforts to impose backdoor price controls, excessive copays, restrict continuity of care, require excessive prior authorizations, or otherwise restrict access to appropriate patient care.