The Legislature wrapped up the first year of the two-year legislative session Friday night. The end of session saw a noticeable absence of controversial legislation in the healthcare area. With the recall election taking over the Governor was looking to avoid legislative issues that would either upset his allies or provide ammunition to his opponents looking to replace him. This led to a number of issues that were “tabled” under after the election. For the bills that did pass, the Governor has until October 10th to act on bills sent to him. Although the polls seem to suggest Newsom will not be recalled, even if he is recalled a new Governor will not be sworn in until the end of October or early November.

Looking at legislative issues we have been engaged on, the Chapter was very active in lobbying against AB 1278 (Nazarian). This bill was held in the Assembly Appropriations Committee which means it is dead for 2021 but is eligible to move in 2022.

 

You may recall this bill was introduced to do the following:

 

  • Require physicians to both verbally and in writing disclose to patients any renumeration received from a drug or device company prior to the intended use of a drug or device. Patient needs to sign written disclosure.
  • The written disclosure would include the following statement:
    • “If you would like further details on the information provided above you may discuss with Dr. ____ and/or visit openpaymentsdata.cms.gov, a federal tool used to search payments made by drug and device companies to physicians and teaching hospitals.”
  • Require physicians to post a notice in their office the website for the Open Payments Database along with a brief description of the database.

We engaged early with the author’s office to express our concerns with the bill. Drs. Daniele and Lepor, Lianna, and I met with the author, Assemblymember Nazarian, to walk through our concerns with the impact of bill. We have also been working closely with the California Medical Association (CMA) to have them oppose the bill. Together we lobbied against the bill, as a result of our efforts we have been able to obtain a number of amendments. The bill now does the following:

 

  • Require physicians to annually provide patients a written disclosure with the following information:
    • “The Open Payments database is a federal tool used to search payments made by drug and device companies to physicians and teaching hospitals. It can be found at https://openpaymentsdata.cms.gov.”
    • This disclosure would need to be signed by the patient and kept in the patient records.
  • Require physicians to post a notice in their office with the website address for the Open Payments Database and the following verbiage:
    • “For informational purposes only, a link to the federal Centers for Medicare and Medicaid Services (CMS) Open Payments web page is provided here. The federal Physician Payments Sunshine Act requires that detailed information about payment and other payments of value worth over ten dollars ($10) from manufacturers of drugs, medical devices, and biologics to physicians and teaching hospitals be made available to the public.”

Although some of the problematic provisions of the bill have been removed we remain Opposed to the bill and are seeking more changes as the bill is considered in 2022.

 

Additional Bills CA-ACC Is Advocating On

 

This bill would allow for certain cardiac procedures, already approved by CMS, to be done in ambulatory surgery centers (ASCs). CA-ACC leadership worked closely with the author and sponsor to ensure the appropriate patient protection measures were included in the bill. CA-ACC is in support of the bill. This bill was held in the Assembly Appropriations Committee and is no longer moving forward this year.

 

This bill would lower out-of-pocket costs for consumers by requiring certain medicines and benefits used to treat chronic disease be covered without subjecting patients to a deductible. CA-ACC is in support of this bill.   This bill was heard in the Assembly Health Committee but due to disagreements between the Chair of the Committee, Assemblymember Wood, the bill was held in Committee. The bill is eligible to be voted on next year.

 

This bill would authorize a licensed pharmacist to perform all clinical laboratory tests are classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) that can lawfully be used within the pharmacist’s practice.  The bill would also allow a pharmacist to perform health screenings under policies, procedures, or protocols. This bill is dead for 2021 but is eligible to move in 2022.

 

This bill would amend the step therapy and prior authorization processes including establishing standard exceptions for going through step therapy; require payers to provide an answer to prior authorization and step therapy requests within 72 hours or 24 hours in exigent situations; and require payers to have a physician in the same or similar specialty as the treating physician to review an appeal to a step therapy exception request denial.

 

Other Advocacy Topic

The chapter has been working on the development of the regulations related to AB 890 which is the legislation allowing nurse practitioners to practice without physician supervision.  Within the Board of Registered Nursing (BRN), The Nurse Practitioner Advisory Committee (NPAC) was established as required in AB 890 (Wood) to include seven members including two physicians. The NPAC includes a plastic surgeon in Beverley Hills and a family physician from the Central Valley. The advisory committee is charged with developing regulations to implement AB 890.

There have been multiple NPAC meetings walking through the legislation and taking public comments on what should be included in the regulations. Ramin Manshadi provided comments at the July meeting on behalf of the Chapter. The most recent meeting on August 31st was intended to have the NPAC provide recommendations on what should be included in the regulations. In a very disorganized meeting, it was unclear what the actual recommendations were from the NPAC to the BRN. I am still trying to get those from the BRN staff. The next step is for the BRN to develop draft regulations to then present to the BRN at the November meeting. Those draft regulations should be made public two weeks prior to the meeting. Once they are released, we will be able to review them and then be prepared to provide written comments prior to the BRN meeting in November.

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