The CSP has been actively involved in several bills this year:
AB 1328 (Irwin) would expand the current ability of pharmacists to perform certain types of clinical lab testing to include all lab tests classified as waived. Current law allows pharmacists to perform limited types of testing for therapeutic drug monitoring when done in collaboration with the patient’s physician. The Society of Health System Pharmacists sponsored AB 1328, which would have initially allowed them to be directors of a lab doing only waived testing, and allowed them to order, perform and interpret waived tests. They argue that with the pandemic, the ability of pharmacists to provide testing would have been helpful and that they can be an important source for patients to access limited testing who may not have access to a physician.
The CSP has indicated our position of Oppose Unless Amended to request that the categories of tests be limited or be condition based. Though waived tests are classified in that manner since they are relatively easy to perform and have a lower risk of error, there are implications for the patient in the results of those tests and whether they are appropriately ordered or necessary. AB 1328 was amended to exclude waived tests in several categories (listed below) as we continue to seek additional limitations.
A licensed pharmacist shall not perform clinical laboratory tests or examinations classified as waived under CLIA that are utilized for purposes of the following:
- Surgery.
- Diagnosis or treatment of heart failure.
- Female fertility.
- Ovulation prediction.
The bill was also amended at our request to require pharmacists to provide notice of positive test results to the patient’s physician, or, if the patient does not have one, a list of physicians that they could contact for follow-up care. AB 1328 is on the Assembly Floor and we will continue efforts to exclude additional types of waived tests from this expanded authority.
SB 535 (Limon) would eliminate the ability of any insurer or health plan to require prior authorization for cancer biomarker tests. The bill is sponsored by a broad-based coalition of patient advocacy groups who are concerned with the impact of any delays related to prior authorization requirements on the ability to utilize this testing for an individualized patient treatment plan. It is not a mandate for coverage but is still opposed by the health plans. SB 535 passed the Senate Health Committee and is awaiting action in the Senate Appropriations Committee.
AB 1400 (Kalra) is the expansive health care for all legislation that would provide health care coverage for all Californians with a wide array of covered services including long term care. The costs for such a bill are staggering; and a prior version of the bill died in the Assembly in the last session. AB 1400 is now a 2-year bill, meaning there will be no hearing or movement this year. The issue has broad support among the Democrats, but funding and many specifics have yet to be resolved.
AB 1132 (Wood) was a reintroduction of a bill from last year that would have given the Attorney General expanded authority to review mergers and acquisitions of hospitals, physician groups, and clinical labs among other provider types. Existing law requires such a review for non-profit mergers, but this would greatly extend that authority. It would require notice of the merger, demonstration that it would not adversely impact competition for health care services, and not diminish patient access to care, reduced outcomes, etc. The prior bill did not pass the Legislature and AB 1132 would have given review authority to the Department of Managed Health Care. The bill was amended in April to remove these provisions and now deals solely with Medi-Cal managed care contracting.
UHC Designated Diagnostic Provider Lab Program
We have previously provided information on the requirements for a lab to enroll with UHC and indicate the specific procedures that they will provider and perform. We are informed that another delay has been announced to 1/1/2022 instead of the previous July 2021 enrollment deadline. We are also informed that UHC must submit and receive approval for these changes in California through the DMHC.
