BILL NUMBER: AB 2631	CHAPTERED  09/29/06

	CHAPTER  792
	FILED WITH SECRETARY OF STATE  SEPTEMBER 29, 2006
	APPROVED BY GOVERNOR  SEPTEMBER 29, 2006
	PASSED THE ASSEMBLY  AUGUST 28, 2006
	PASSED THE SENATE  AUGUST 23, 2006
	AMENDED IN SENATE  AUGUST 21, 2006
	AMENDED IN ASSEMBLY  MAY 25, 2006
	AMENDED IN ASSEMBLY  MAY 1, 2006
	AMENDED IN ASSEMBLY  MARCH 28, 2006

INTRODUCED BY   Assembly Member Laird

                        FEBRUARY 24, 2006

   An act to add Section 14105.75 to the Welfare and Institutions
Code, relating to Medi-Cal.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 2631, Laird  Medi-Cal: injectable drugs: utilization.
   Existing law provides for the Medi-Cal program, which is
administered by the State Department of Health Services and under
which qualified low-income persons receive health care benefits,
including prescription drug benefits.
   Existing law allows the department to impose utilization controls
on certain Medi-Cal benefits, including prescription drug benefits.
   Existing law allows the department to enter into contracts for
fiscal intermediary services in connection with processing the
payment of claims submitted by Medi-Cal providers.
   This bill would require the department, with respect to a drug
product in an injectable form that is not administered by the
patient, to develop and publish a medical benefit drug utilization
policy within 180 days of being notified by the manufacturer of
approval of the product by the federal Food and Drug Administration,
and publish the policy in the Medi-Cal provider bulletin immediately
following that 180-day period. The bill would provide that, if the
department is unable to complete and publish the policy within that
period, the department shall, until completion of the policy, allow
providers to use the utilization standards approved by the federal
Food and Drug Administration that are contained in the official
package circular or insert for the product when the department
reviews a provider's submission for utilization of the product. The
bill would require the department to allow the product to be billed
and reimbursed using a miscellaneous billing code until the permanent
code is assigned and published. The bill would require the
department to evaluate the necessity of utilization controls, and
publish all utilization controls in both the final drug utilization
policy and the Medi-Cal provider bulletin. It would further require
the department to ensure that the fiscal intermediary enters into the
Medi-Cal database the code assigned to the drug product within a
specified period.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 14105.75 is added to the Welfare and
Institutions Code, to read:
   14105.75.  (a) In order to ensure that drug products in an
injectable form that are not administered by the patient are
available to Medi-Cal beneficiaries pursuant to federal law, the
department shall do all of the following with respect to any such
drug product:
   (1) (A) Develop and publish a medical benefit drug utilization
policy within 180 days of being notified by the manufacturer of
approval of the product by the federal Food and Drug Administration.
The policy shall be published in the Medi-Cal provider bulletin that
immediately follows that 180-day period. The effective date of the
drug utilization policy shall be no later than the publication date
of the bulletin.
   (B) If the department is unable to complete and publish the policy
within the period specified in subparagraph (A), the department
shall, until completion of the utilization policy, allow providers to
use the utilization standards approved by the federal Food and Drug
Administration that are contained in the official package circular or
insert for the product when the department reviews a provider's
submission for utilization of the product. The department shall allow
the product to be billed and reimbursed using a miscellaneous
billing code until the permanent code is assigned and published
pursuant to paragraph (3).
   (2) Evaluate the necessity of utilization controls, and publish
all utilization controls in both the final drug utilization policy
and the Medi-Cal provider bulletin.
   (3) Ensure that the fiscal intermediary enters into the Medi-Cal
database the code assigned to the product within 60 days of the date
the code was assigned to the product.
   (b) Nothing in this section shall be construed to affect the
department's authority to require a provider to obtain prior
authorization for dispensing or administering an injectable drug.