BILL ANALYSIS Ó
AB 1668
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CONCURRENCE IN SENATE AMENDMENTS
AB
1668 (Calderon)
As Amended August 15, 2016
Majority vote
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|ASSEMBLY: |77-2 | (May 31, |SENATE: |38-0 |(August 18, |
| | |2016) | | |2016) |
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Original Committee Reference: HEALTH
SUMMARY: Authorizes the manufacturer of an investigational
drug, biological product, or device (investigational drug) that
is not yet approved by the United States Food and Drug
Administration (FDA) to make the investigational drug available
to a patient with a serious or immediately life-threatening
disease, when that patient has considered all other treatment
options currently approved by the FDA, has been unable to
participate in a relevant clinical trial, and for whom the
investigational drug has been recommended by the patient's
primary physician and a consulting physician. Specifies other
criteria and requirements for the use of investigational drugs.
The Senate amendments clarify that a health benefit plan, except
to the extent the plan provided coverage, is not liable for any
outstanding debt related to the treatment or lack of insurance
for the treatment.
AB 1668
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FISCAL EFFECT: According to the Senate Appropriations
Committee:
1)One-time costs of $20,000 and ongoing costs of $10,000 per
year to review plan filings by the Department of Insurance
(Insurance Fund).
2)One-time costs of $380,000 in 2015-16 to respond to requests
for information about prior independent medical review
decisions and ongoing costs of $210,000 per year to respond to
consumer complaints and requests for independent medical
review for access to investigational drugs by the Department
of Managed Health Care (Managed Care Fund).
3)Uncertain impact on state-funded California Public Employees'
Retirement System health care coverage (General Fund and
special funds). (See previous fiscal analysis)
COMMENTS: According to the author, this bill removes barriers
to accessing potentially life-saving drugs for terminally-ill
patients and doctors who believe an investigational drug could
be their last hope for survival. The author further states that
those patients that have exhausted all other treatment options,
and are not eligible for clinical trials, often seek access to
investigational new drugs but face a variety of hurdles. These
patients may seek compassionate use exemptions from the FDA, but
the process is cumbersome and approval comes too late for many.
The author explains this bill removes barriers for patients who
need to immediately obtain investigational treatments, while
also protecting physicians, hospitals, and manufacturers from
retribution.
Analysis Prepared by:
Rosielyn Pulmano / HEALTH / (916) 319-2097 FN:
00047360003206
AB 1668
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