Cal. Code Regs. tit. 22 § 51000.60

Current through Register 2024 Notice Reg. No. 50, December 13, 2024
Section 51000.60 - Established Place of Business Requirements
(a) The applicant or provider shall have an established place of business appropriate and adequate for the services billed or claimed to the Medi-Cal program as relevant to his or her scope of practice or type of business. This section does not apply to an applicant or provider who is subject to Section 51000.30(a)(1)(A) - (E).
(b) Failure to have an established place of business at the time of any inspection by the Department for enrollment, continued enrollment, enrollment at a new, additional or change in location, or enrollment pursuant to Section 51000.30(b) warrants denial of an application or shall make a provider subject to temporary suspension from the Medi-Cal program, which shall include temporary deactivation of the provider's number and each business address used by the provider to provide services, goods, supplies, or merchandise to Medi-Cal beneficiaries, effective 15 days from the date of notice to the provider.
(c) "Established place of business" means a business address of the provider or applicant that meets all of the following criteria:
(1) Is open and conducting business at the time the application is submitted for participation in the Medi-Cal program;
(2) Has the administrative and fiscal foundation to survive as a going concern. This criterion shall be shown by financial records such as a business plan, bank statements, loan documents, promissory notes, invoices, accounts receivable, business tax records, payroll records and contractual agreements;
(3) Has adequate inventory and staff to meet current and anticipated sales and service requirements for its business;
(4) Operates in compliance with Section 51000.30(e);
(5) Has Worker's Compensation insurance as required by state law;
(6) Obtains and maintains, for any individual licensed or certified pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, the Osteopathic Initiative Act, or the Chiropractic Initiative Act, Professional Liability insurance coverage in an amount not less than $100,000 per claim, with a minimum annual aggregate of not less than $300,000, from an authorized insurer pursuant to Section 700 of the Insurance Code;
(7) Has the necessary equipment, office supplies and facilities available to carry out its business, including storage and retrieval of all documentation as required by Section 51476;
(8) Has the necessary service agreements to process cash and credit card transactions if operating as a retail business, or has the necessary payment mechanisms to process patient billing claims if the applicant or provider is a physician/medical practice; and
(9) Unless the applicant is requesting enrollment or the provider is enrolled pursuant to Welfare and Institutions Code Section 14043.15(b)(2) the following criteria also apply;
(A) Is located in a building either owned by the applicant or provider, or the applicant or provider has obtained a signed lease agreement; or if the applicant or provider is a substance use disorder clinic located on space donated at no cost, the applicant or provider has obtained verification from the space owner that it is authorized to use the space to provide substance use disorder services.
(B) Has regular and permanently posted business hours, unless the applicant or provider is a substance use disorder clinic;
(C) Is identifiable as a medical/healthcare provider or business, by permanently attached signage that identifies the name of the provider or business as shown on the application, unless the applicant or provider is a substance use disorder clinic.
(D) Obtains and maintains Liability insurance coverage, that covers premises and operation, in an amount not less than $100,000 per claim, with a minimum annual aggregate of not less than $300,000, from an authorized insurer pursuant to Section 700 of the Insurance Code.
(d) If the applicant or provider intends to provide or currently provides durable medical equipment as defined in Section 51160, or is a medical device retailer as defined in Section 51251, or is a pharmacy as defined in Section 51106 and provides pharmaceutical services as defined in Section 51107, all criteria in subsection (a) through (c) above must be met, and the applicant or provider must additionally meet the following criteria:
(1) Provides service to the general public on a walk-in basis during regular business hours. A request for exemption from this requirement shall be stated on the application, appropriate for the services provided, and requires the approval of the Department;
(2) Has adequate inventory in stock either on the premises, or in a warehouse under the applicant's or provider's direct control, to meet current and anticipated sales volume.

Cal. Code Regs. Tit. 22, § 51000.60

1. New section filed 9-29-2004 as an emergency; operative 10-7-2004 (Register 2004, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-2005 or emergency language will be repealed by operation of law on the following day. Deemed emergency exempt from OAL pursuant to Welfare and Institutions Code section 14043.75.
2. New section refiled 1-27-2005 as an emergency; operative 2-5-2005 (Register 2005, No. 4). A Certificate of Compliance must be transmitted to OAL by 6-6-2005 or emergency language will be repealed by operation of law on the following day. Deemed emergency exempt from OAL review pursuant to Welfare and Institutions Code section 14043.75.
3. Amendment of section heading, section and NOTE refiled 6-2-2005 as an emergency; operative 6-7-2005 (Register 2005, No. 22). A Certificate of Compliance must be transmitted to OAL by 10-5-2005 or emergency language will be repealed by operation of law on the following day. Deemed emergency exempt from OAL review pursuant to Welfare and Institutions Code section 14043.75.
4. Certificate of Compliance as to 6-2-2005 order, including amendment of subsection (d)(1) and amendment of NOTE, transmitted to OAL 9-29-2005 and filed 11-10-2005 (Register 2005, No. 45).
5. Change without regulatory effect amending subsection (b) and amending NOTE filed 1-23-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 4).
6. Amendment of section heading and subsections (c)(9)(A)-(C) filed 8-17-2015 as a deemed emergency exempt from OAL review pursuant to Welfare and Institutions Code section 14043.75; operative 8-17-2015 (Register 2015, No. 34). A Certificate of Compliance must be transmitted to OAL by 2-16-2016 or emergency language will be repealed by operation of law on the following day.
7. Certificate of Compliance as to 8-17-2015 order transmitted to OAL 12-30-2015 and filed 2-11-2016 (Register 2016, No. 7).

Note: Authority cited: Section 20, Health and Safety Code; Sections 10725, 14043.37, 14043.4, 14043.75 and 14124.5, Welfare and Institutions Code; and Section 700, Insurance Code. Reference: Sections 14043, 14043.1, 14043.27, 14043.37, 14043.4, 14043.45, 14043.62 and 14043.7, Welfare and Institutions Code.

1. New section filed 9-29-2004 as an emergency; operative 10-7-2004 (Register 2004, No. 41). A Certificate of Compliance must be transmitted to OAL by 2-4-2005 or emergency language will be repealed by operation of law on the following day. Deemed emergency exempt from OAL pursuant to Welfare and Institutions Code section 14043.75.
2. New section refiled 1-27-2005 as an emergency; operative 2-5-2005 (Register 2005, No. 4). A Certificate of Compliance must be transmitted to OAL by 6-6-2005 or emergency language will be repealed by operation of law on the following day. Deemed emergency exempt from OAL review pursuant to Welfare and Institutions Code section 14043.75.
3. Amendment of section heading, section and Note refiled 6-2-2005 as an emergency; operative 6-7-2005 (Register 2005, No. 22). A Certificate of Compliance must be transmitted to OAL by 10-5-2005 or emergency language will be repealed by operation of law on the following day. Deemed emergency exempt from OAL review pursuant to Welfare and Institutions Code section 14043.75.
4. Certificate of Compliance as to 6-2-2005 order, including amendment of subsection (d)(1) and amendment of Note, transmitted to OAL 9-29-2005 and filed 11-10-2005 (Register 2005, No. 45).
5. Change without regulatory effect amending subsection (b) and amending Note filed 1-23-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 4).
6. Amendment of section heading and subsections (c)(9)(A)-(C) filed 8-17-2015 as a deemed emergency exempt from OAL review pursuant to Welfare and Institutions Code section 14043.75; operative 8-17-2015 (Register 2015, No. 34). A Certificate of Compliance must be transmitted to OAL by 2-16-2016 or emergency language will be repealed by operation of law on the following day.
7. Certificate of Compliance as to 8-17-2015 order transmitted to OAL 12-30-2015 and filed 2-11-2016 (Register 2016, No. 7).