Arnold & Associates
Legislative Advocacy
Phone: (916) 446-2646 ◊ Fax: (916) 446-6095 ◊ 1127 11th Street, Suite 820, Sacramento, CA95814
California Clinical Laboratory Association
LEGISLATIVE HIGHLIGHTS
2017 LEGISLATIVE YEAR
November 2, 2017
Kristi Foy
Michael Arnold
2017-2018 Regular Session
The 2017 legislative year has now ended. This was the first year of the 2017-2018biennial legislative session. During the rest of the fall, the Legislature will hold interim hearings on various topics. The State Legislature will return to Sacramento on Wednesday, January 3, 2018, to begin the second year of the two-year session.
Effective Dates of New Legislation
The bills that were passed this year by the Legislature and signed by the Governor will take effect on January 1, 2018 unless they include an urgency clause or contain a provision calling for some other effective date. Urgency measures take effect immediately upon chaptering by the Secretary of State. Bills are normally chaptered on the day following their signature by the Governor.
Two Year Bills
Since this was the first year of the biennial session, bills not passed to the Governor’s desk remain alive for consideration during next year. The rules provide that these measures must pass the house of origin by the end of January to remain alive for additional consideration. Thus, January will be a busy month.
Key Bills for 2017
AB 658 (Waldron) – Clinical Laboratory License Renewal Fees
This bill was sponsored by CCLA.The bill will temporarily suspend the annual renewal fee for clinical laboratory licenses until January 1, 2020. Every clinical laboratory operating in California must obtain a license from the Department of Public Health (DPH) and must pay an annual licensure fee to cover the cost of the licensure and regulation. In 2015, the State Auditor released a report finding that since 2008 the DPH has collected substantially more money in laboratory fees than it has spent. The State Auditor commented that “[When] fee revenue greatly exceeds costs, it is prudent for the State to achieve equilibrium in the most expeditious and administratively simple way possible.” AB 658 addresses this problem by suspending the fee for two years to allow DPH to spend down the surplus in the fund to an appropriate operating level. California labs will not have to pay for the laboratory license renewal for 2018 or 2019. The two-year suspension amounts to a savings of about $8.8 million for California laboratories. We are very happy to report that AB 658 was signed by the Governor as Chapter 345, Statutes of 2017.
AB 659 (Ridley-Thomas) – Medi-Cal Rates Data Reporting
CCLA also sponsored AB 659. This bill changes from annually to every three years the frequency by which clinical laboratories are required to submit data reports to the Department of Health Care Services (DHCS) for purposes of calculating a new Medi-Cal reimbursement rate. The current California annual requirement for the rate methodology calculations are time consuming and burdensome. In addition, DHCS has found it to be impossible to analyze the data and have the payment mechanism in place as required by July 1st of every year. This is due to the immense amount of data required to be submitted by clinical laboratories and the antiquated computer system being utilized at DHCS. This has led to incorrect payments under the new rates and multiple retroactive recoupments from laboratories. AB 659 will revise the current law by requiring the submission of data and the calculation of new rates once every three years, not annually. This is consistent with the federal reporting requirements by the Center for Medicare and Medicaid Services (CMS). The Clinical Laboratory Fee Schedule (CLFS) final rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System” (CMS-1621-F) was published in the Federal Register on June 23, 2016. The final CLFS rule implements section 216 of the Protecting Access to Medicare Act (PAMA) of 2014. Under the final rule, laboratories are required to report private payor rate and volume data and CMS calculates new Medicare CLFS rates (based on the weighted median private payor rates) every three years. AB 659 will make California reporting consistent with federal reporting. We are happy to report that AB 659 was passed by the Legislature and signed by the Governor as Chapter 346, Statutes of 2017.
AB 1316 (Quirk) – Public Health: Childhood Lead Poisoning: Prevention
This bill requires the California Department of Public Health (CDPH) to define "risk" in the regulations for the Childhood Lead Poisoning Prevention Program (CLPPP). Specifically, this bill requires CDPH to revise its regulations for the CLPPP to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure. It also requires CDPH to consider the most significant risk factors for childhood lead exposure, including, but not limited to, a child's time spent in a home, school, or building built before 1978, a child's proximity to a former lead or steel smelter or an industrial facility that historically emitted or currently emits lead, a child's proximity to a freeway or heavily travelled roadway, potential risk factors for lead exposure, and known sources of lead contamination. The bill also makes several technical and clarifying changes to the CLPPP statute and the mandate on health care service plans that offer preventive services for children. CDPH indicates that up to an additional 300,000 blood lead tests could be performed annually under this bill. AB 1316 was signed by the Governor as Chapter 507, Statutes of 2017
AB 1386 (Waldron ) - Genomic Cancer Testing Information
This bill requires the California Department of Health Care Services (DHCS), with recommendations from the Cancer Advisory Council, to include in its first revision of the standardized written summary made following the effective date of this bill, information relating to breast cancer susceptibility gene (BRCA) mutations, in order to increase genetic counseling and screening rates for individuals for whom BRCA test results can inform treatment decisions.
Women with newly diagnosed breast or ovarian cancer are at high risk for having a BRCA mutation, which increases the odds of cancer. These women often do not get genetic testing or even a chance to speak with a genetic counselor that would help them weigh the necessity of such a test. Test results could help guide treatment, as well as future efforts to prevent cancer by increasing patient knowledge of and access to breast and ovarian genetic testing in specified populations. This bill will require this testing information to be available to cancer patients. The bill was signed by the Governor as Chapter 693, Statutes of 2017.
SB 43 (Hill) - Antimicrobial-Resistant Infection: Reporting
This bill requires general acute care hospitals and clinical laboratories to submit annual antibiograms to the California Department of Public Health (CDPH) after July 1, 2019. Requires CDPH to, commencing January 2019, develop an appropriate format for the antibiogram report and to develop a method of estimation of the number of deaths caused by antimicrobial resistant infections. Requires CDPH to publish, commencing January 1, 2020, on an annual basis, information on incidences in hospital and deaths caused by antimicrobial organisms resistance to drugs. This bill was held by the Assembly Health Committee as a two-year bill.