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AB-1387 Home medical device retail facility business: licensing: inspections.(2017-2018)

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Date Published: 04/18/2017 09:00 PM
AB1387:v98#DOCUMENT

Amended  IN  Assembly  April 18, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 1387


Introduced by Assembly Member Arambula

February 17, 2017


An act to amend amend, repeal, and add Section 111656.1 of the Health and Safety Code, relating to public health.


LEGISLATIVE COUNSEL'S DIGEST


AB 1387, as amended, Arambula. Home medical device retail facility business: licensing: inspections.
The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.
This bill would modify modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

The people of the State of California do enact as follows:


SECTION 1.

 Section 111656.1 of the Health and Safety Code is amended to read:

111656.1.
 (a) (1) After January 1, 2002, prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. Nothing in this section shall prohibit the department from inspecting any medical device retail facility prior to January 1, 2002.
(2) The (A) After the initial inspection pursuant to paragraph (1), the department shall inspect a licensee that is accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, only upon a complaint made to the department regarding the licensee. The
(B) A licensee shall only be deemed to be accredited and subject to inspection pursuant to subparagraph (A) if all of the following conditions exist:
(i) The licensee is accredited by the accrediting organization at least every three years.
(ii) The licensee is subject to unannounced onsite midcycle surveys by the accrediting organization to validate ongoing compliance.
(iii) Within 30 days following an inspection by the accrediting organization, the accrediting organization notifies the department regarding the status of the licensee’s accreditation.
(iv) If the licensee is less than fully accredited, the accrediting organization notifies the department of the reasons for the lack of full accreditation and any corrective action plan recommended to the licensee.
(C) The department shall inspect a licensee that ceased to be accredited in compliance with subparagraph (B) pursuant to paragraph (3).
(3) The department shall inspect a licensee that is not accredited by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services, or its successor entity, at least annually.
(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).
(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(d) Commencing July 1, 2003, the department shall by July 30 of each year, publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(e) Commencing January 1, 2003, the department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
(g) This section shall remain in effect only until January 1, 2023, and as of that date is repealed.

SEC. 2.

 Section 111656.1 is added to the Health and Safety Code, to read:

111656.1.
 (a) Prior to issuing a license required by Section 111656, the department shall inspect each place of business to determine ownership, adequacy of facilities, and personnel qualifications. The department shall inspect each licensee at least annually thereafter.
(b) The annual license fee for a home medical device retail facility shall be eight hundred fifty dollars ($850) until adjusted pursuant to subdivision (c).
(c) The annual license fee required by Sections 111656 and 111630 shall be adjusted annually, commencing July 1, 2003, by the department so that license fee revenues cover the estimated licensing program costs. Adjusted fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(d) The department shall by July 30 of each year publish the amount of fees to be charged as adjusted pursuant to this section. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(e) The department shall, on or before January 10 of each year, provide the Legislature with a report recommending fee rates. The report shall describe the estimated licensing program costs for the next fiscal year to carry out the licensing, regulating, inspecting, and other duties and responsibilities of the department in carrying out the provisions of this article. The department shall describe the projected license fee amount so that license fee revenues cover the estimated licensing program costs. Projected fee amounts shall take into account the resources required for inspections and other activities to support licensing during the previous year and shall take into account projected workload and changes in department overhead costs during the upcoming year.
(f) The Drug and Device Safety Fund is hereby created as a special fund in the State Treasury. All moneys collected by the department under this section and Sections 111656.7, 111656.8, 111656.12, and 111630, and fines and penalties collected by the department in the enforcement of this article, shall be deposited in the fund for use by the department upon appropriation by the Legislature for the purposes of providing funds necessary to carry out and implement the provisions of this article relating to drugs and devices.
(g) This section shall become operative on January 1, 2023.