State of California Health and Human Services Agency Department of Health Care Services JENNIFER KENT GAVIN NEWSOM D IRECTOR G OVERNOR Provider Enrollment Division MS 4704 P.O. Box 997412, Sacramento, CA 95899 - 7412 Phone: (916) 323 - 1945 Internet Address: www.dhcs.ca.gov/provgovpart/Pages/PED.aspx Dear Clinical Laboratory Provider Applicant: Thank you for your inquiry regarding participation in the Medi - Cal program. This letter addresses information about the enrollment application process for a specific provider type. PLEASE NOTE: Applicants and providers are required to submit their National Provider Identifier (NPI) with each Medi - Cal provider application package. Current Medi - Cal providers will be required to submi t both the NPI and any Medi - Cal provider numbers issued previously on any application forms submitted to the Department of Health Care Services (DHCS). Applicants are required to attach a copy of the CMS/National Plan and Provider Enumeration System (NPPE S) confirmation letter for each NPI listed in the application package. If providers are not eligible to receive an NPI, they should instead enter the word - Cal provider nu mber once the application is approved. Applicants and providers may be required to submit an application fee or proof of payment to or enrollment with Medicare or other state Medicaid programs. Effective January 1, 2013, DHCS requires certain applicants and providers to submit an application fee when requesting an enrollment action. The application fee collected is used to offset the cost of conducting the required screening as specified in Title 42 Code of Federal Regulations (CFR) , Section 455 Subpart E. Please reference the Medi - Cal - Cal Application Fee Requirements for Compliance with 42 Code of The moratorium on the enrollment of clinical laborator y providers expired October 3, 2015. This letter provides information for clinical laboratory applicants applying for enrollment in the Medi - Cal Fee - for - Service Program during the six - month period following th e expiration of the moratorium. State Medicai d Agencies are required to collect fingerprints and conduct criminal background checks from level. (42 CFR 247247 424.518, 455.434, and 455.450) Title 42, CFR, Section 455.450(e)(2) and Welfare a nd Institutions Code (W&I Code ), Section 14043.38(b)(4) specify that a provider that would have been prevented from applying for enrollment due to a moratorium that has been lifted in the past six months, be screened American LegalNet, Inc. www.FormsWorkFlow.com for all the required individuals have been submitted to an authorized State Identif ication Bureau (Bureau of Criminal Information and Analysis, Department of Justice [DOJ] in California). Providers and applicants must attach a copy of a prefilled DOJ Request for Live Scan Service (BCIA 8016) form for each required individual with their application, date stamped and show verification that all fees have been paid by either stamp from the public Live Scan operator or a receipt of payment. If you would have met one of the exemptions listed below, you do not need to be but you must submit a cover letter with your application advising which exemption you meet and include any necessary supporting documentation. 1. A clini c al laboratory owned and operated by a physician or physician group so long as the physician or ph y sician group only performs Provider - Performed Microscopy Procedures (PPMP) and/or waived clinical laboratory tests or examinations; 2. Current Medi - Cal enrolled c l inical laboratory providers that have at l east six actively enrolled lo c ation s, and seek to add a new bu s iness location, so long as the provider does not add new bu s iness activities, categories of serv i ce or billi n g codes other than those approved for enrollment at its exi s ting locations; this exemption is only applicable to clini c al laboratory providers who meet this c r iteria and all six lo c ations are continuously and actively enrolled and in good standing with Medi - Cal, from February 12, 2007, through t he date of application; 3. A clini c al laboratory that is owned and operated by a general acute care hospital or psychiatric hospital li c ensed pur s uant to Health and Safety Code (H&S Code) , Section 1250, et seq.; 4. A clini c al laboratory that is owned and operated by a clinic licen s ed pursuant to H&S Code , Section 1200, et seq.; 5. A public health labora t ory as defined in Bu si ness and Professions Cod e , Section 1206(a) and certified pursuant to H&S Code Section 101160; 6. The purchase of an existing clini c al labo r ato r y that is currently enrolled in the Medi - Cal program as a clini c al lab oratory, w hether it constitutes a change of ownership or not; unless it is being sold by a laboratory provider who has expanded their location(s) and/or services, under Exe m ption #13; 7. An out - of - state clinical laboratory requesting enrollment for the sol e purpose of providing services to a Medi - Cal beneficiary on an emergency basis, in accordance with the California Code of Regulations (CCR) , Title 22, Section 51006; 8. The change of location of an exi s ting clini c al laboratory that is currently enrolled in the Medi - Cal program as a clinical laboratory, so long as it neither constitutes a change of ownership nor involves the change or addition of specialty codes; 9. A clini c al laboratory that only seeks reimbursement for Medicare cost sharing amounts; 10. Currently enrolled clinical labora t ory providers that DHCS requir e s to submit an application for continued enroll m ent pursuant to CCR , Title 22, Section 51000.55; 11. A clini c al laboratory that performs a test or examination that is a Medi - Cal covered bene fit and the clinical l aboratory is the only Clinic a l Laboratory Improvement Amendments (CLIA) approved clinical laboratory in the United States to perform that te s t or examination; 12. Applicants whose sole business is, and continues to be throughout the e xistence of this moratorium, a clinical labora t ory performing only anatomic pathology ser v ices that has a l aboratory director cert if ied in anatomic pathology by the American Board of Pathology or the American Osteopathic Boa rd of Pathology; American LegalNet, Inc. www.FormsWorkFlow.com 13. A clini c al laboratory that is o w ned and operated by a professional medical corporation or partnership of profess i onal medical corporations, comprised of physicians that are certified by the American Board of Pathology or the American Osteopathic Board of Pathology in clini c al or anatomic pathology, who can provide eviden c e of a current contract to pro v ide pathology services at a licensed and Medi - Cal c ertified acute care hospital in California, that curren t ly is enrolled as a clinical laboratory provider and seeks to obtain a provider number for an additional location th a t will also p erform clinical labora t ory services, whether anatomic or clinical pa t hology ser v ices, and/or seeks to add new business activities, categories of service or billi n g co d es other than those approved at its initial e n rollment at its current business location. Exemption #13 only applies to those clinical lab providers who remain under the same common owner s hip and di r ectorship, as defined above, for all of their business l ocations, throughou t the period of this Moratorium; 14. A clini c al laboratory that performs a test or examination that is a Medi - Cal covered benefit and, as of the date of application denial or appro v al, no Medi - Cal provider offers a test or examination that fills the same functional role. Mult i ple ap p lica t ions from providers assert i ng this ex c eption will be granted or denied i n the order they were submitted; 15. A clini c al laborato r y, that is licen s ed by the California Department of Public Health (CDPH) as a clinic a l laboratory t hat will be providing s ervices exclusively to California Medi - Cal beneficiaries placed through the Interstate Compact Placement of Children program (IC P C) in an out - of - state residenti a l c a re facility approved by the California Department of