Biosimilars, Long-Term Care Ombudsman Bills Pass, Head to Governor's Desk

by David Gorn

RELATED TOPICS:

The state Assembly and Senate yesterday passed dozens of bills, including a proposal to regulate the dispensing of biosimilar medications and another to give more penalty authority to the office of the state's long-term care ombudsman.

SB 609 by Sen. Lois Wolk (D-Davis) continues Wolk's efforts to beef up the ombudsman's office for handling long-term care complaints. Wolk authored a successful bill last year, which gave the long-term care ombudsman more of an advocacy role and called for creation of an annual report. This year's bill increases penalties for any providers of long-term care who interfere with investigations by the ombudsman's office.

The bill to regulate biosimilar medications -- which are a lower-cost version of medications called biologics -- was a more complicated and controversial piece of legislation.

One of the points of contention in SB 598 by Sen. Jerry Hill (D-San Mateo) is that it's too early to regulate the dispensing of a drug that's not yet on the U.S. market and still awaits FDA approval. This bill would allow pharmacists to dispense less-expensive biosimilars when physicians prescribe biologic medications. Pharmacists also would be required to notify prescribing physicians within five days of making the change.

The powerful CalPERS board, which oversees the state employees' pension fund, recently came out against SB 598, and opponents have said they'll target the governor directly, to urge a veto of the bill.

The legislative session ends Sept. 13. The governor has 30 days from that date to sign or veto legislation.

Other bills that made the cut yesterday:

• SB 158 by Sen. Lou Correa (D-Santa Ana) would create a pilot demonstration project at the state's regional centers, designed to improve access to autism services.

• SB 672 by Sen. Mark Leno (D-San Francisco) would redefine CalFresh eligibility requirements, simplifying verification of dependent care expense deductions.

• SB 534 by Sen. Ed Hernandez (D-West Covina) would change some requirements around some types of health facilities. The bill gives state regulators the authority to enforce federal standards for chronic dialysis clinics, surgical clinics and rehabilitation clinics, until the state Department of Public Health sets its own standards.

stephanie hueg
SB598 CalPERS opposes this bill for one significant reason, it contains the notification to the Dr. from the pharmacist that a substitution was made. Who should know more that their Pt. has received a drug that he/she did not order. What of the complications that may arise. No one will have the change information except the pharmacist who is not required to put this into a Pt. record.

to share your thoughts on this article.