Bill Text: CA SB447 | 2015-2016 | Regular Session | Amended


Bill Title: Medi-Cal: clinics: drugs, devices, and supplies.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Failed) 2016-11-30 - From Assembly without further action. [SB447 Detail]

Download: California-2015-SB447-Amended.html
BILL NUMBER: SB 447	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  AUGUST 1, 2016
	AMENDED IN ASSEMBLY  AUGUST 24, 2015
	AMENDED IN SENATE  JUNE 1, 2015
	AMENDED IN SENATE  APRIL 6, 2015

INTRODUCED BY   Senator Allen

                        FEBRUARY 25, 2015

   An act to  add Section 1222.1 to the Health and Safety
Code, and to amend Sections 14043.17 and 24005   amend
Section 14132.01  of the Welfare and Institutions Code, relating
to Medi-Cal.



	LEGISLATIVE COUNSEL'S DIGEST


   SB 447, as amended, Allen. Medi-Cal: clinics:  enrollment
applications.   drugs, devices, and supplies. 
   Existing law provides for the Medi-Cal program, which is
administered by the State Department of Health Care Services and
under which qualified low-income persons receive health care
benefits. The Medi-Cal program is, in part, governed and funded by
federal Medicaid provisions.
   The Medi-Cal program administers a program known as the Family
Planning, Access, Care, and Treatment (Family PACT) Program, to
provide comprehensive clinical family planning services to any person
who has a family income at or below 200% of the federal poverty
level and who is eligible to receive those services.  Existing
law specifies various requirements relating to reimbursement for the
provision of drugs and supplies under the Medi-Cal program and the
Family PACT Program that are   applicable to licensed
community clinics, free clinics, or intermittent clinics. Existing
law requires reimbursement for drugs and supplies covered under the
Medi-Cal program and the Family PACT Program and provided by these
clinics to be the lesser of the amount billed or the Medi-Cal
reimbursement rate and caps reimbursement at the net cost of the
drugs or products as provided by retail pharmacies under the Medi-Cal
program. Existing law sets the costs for drugs and supplies covered
under those programs at an aggregate amount equivalent to t 
 he sum of the actual acquisition cost of a drug or supply plus a
clinic dispensing fee not to exceed $12 per billing unit, as
specified. Existing law also sets the cost for a take-home drug that
is dispensed for use by the patient within a specific timeframe of 5
or fewer days from the date medically indicated at the actual
acquisition cost for that drug plus a clinic dispensing fee, not to
exceed $17 per prescription.  
    Existing law requires the State Department of Health Care
Services to approve the application of an affiliate clinic, as
defined, for enrollment into the Family PACT Program within 30 days
of receiving the application, as specified. Existing law also
requires the State Department of Public Health to implement a process
that allows an applicant for licensure as a primary care clinic, as
defined, to submit an application for review of the clinic's
qualifications for enrollment and certification in the Medi-Cal
program, and, among others, the Family PACT Program. Existing law
requires the State Department of Health Care Services, within 30 days
after receiving confirmation of certification for enrollment of an
affiliate clinic in the Medi-Cal program, to enroll the clinic in the
Medi-Cal program retroactive to the date of certification.

   This bill would eliminate the requirement that the State
Department of Health Care Services approve an application for
enrollment into the Family PACT Program, and would instead require a
primary care clinic or an affiliate clinic that is seeking to enroll
in the program to submit an application to the State Department of
Public Health. The bill would require a clinic not enrolled in the
Medi-Cal program to submit a consolidated application for enrollment
in both the Medi-Cal program and the Family PACT program, and would
require a clinic already enrolled in the Medi-Cal program to submit
an application for enrollment in the Family PACT Program. The bill
would require the State Department of Public Health to review that
application to certify the clinic for enrollment in those programs,
as applicable, and to notify the State Department of Health Care
Services of that certification within 15 days after it is granted.
The bill would require the State Department of Health Care Services
to enroll the clinic in those programs within 15 days after receiving
notification from the State Department of Public Health, as
specified. The bill would require the State Department of Public
Health to develop consolidated application forms, as specified.
 
   This bill would also require reimbursement for devices covered
under the Medi-Cal Program and the Family PACT Program. The bill
would revise the reimbursement formula described above and would
instead specify separate reimbursement formulas for contraceptive
drugs, devices, and supplies, and non-contraceptive drugs, devices,
and supplies. The bill would, for contraceptive drugs, devices, and
supplies, require a clinic to bill the Medi-Cal program and the
Family PACT Program at the Medi-Cal reimbursement rate. The bill
would, for non-contraceptive drugs, devices, and supplies, require a
clinic to bill the Medi-Cal program or the Family PACT Program at the
lesser of the clinic's usual charge made to the general public, or
its cost, defined as an aggregate amount equivalent to the sum of the
actual acquisition cost of the drug, device, or supply plus a clinic
dispensing fee. The bill would provide that the clinic dispensing
fee shall be determined by the department, as specified, or, if not
determined by the department, shall be the difference between the
actual acquisition cost and the Medi-Cal reimbursement rate. The bill
would require reimbursement for non-contraceptive drugs, devices,
and supplies to be the lesser of the amount billed, as described
above, or the Medi-Cal reimbursement rate, and would cap
reimbursement at the net cost of the drug, device, or supply when
provided by retail pharmacies under the Medi-Cal program. The bill
would require the department to seek federal approval of any state
plan amendments necessary to implement these provisions. The bill
would require the department, by July 1, 2018, to adopt regulations
to implement these provisions, as specified. Until those regulations
are adopted the bill would require the department to implement these
provisions by provider bulletins or similar instructions and provide
the Legislature with a semiannual status report, as specified. 

   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.


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

   SECTION 1.    Section 14132.01 of the  
Welfare and Institutions Code   is amended to r  
ead: 
   14132.01.  (a) Notwithstanding any other  provision of
 law, a community clinic or free clinic licensed pursuant to
subdivision (a) of Section 1204 of the Health and Safety Code or an
intermittent clinic operating pursuant to subdivision (h) of Section
1206 of the Health and Safety Code, that has a valid license pursuant
to Article 13 (commencing with Section 4180) of Chapter 9 of
Division 2 of the Business and Professions Code shall bill and be
reimbursed, as described in this section, for  drugs
  drugs, devices,  and supplies covered under the
Medi-Cal program and Family PACT  Waiver  Program.
   (b)    (1)  A clinic described
in subdivision (a) shall bill the Medi-Cal program and Family PACT
 Waiver  Program for  drugs  
contraceptive drugs, devices,  and supplies covered under those
programs at the  lesser of cost or the clinic's usual charge
made to the general public.   Medi-Cal reimbursement
rate.  
   (2) For purposes of this section, "cost" means an aggregate amount
equivalent to the sum of the actual acquisition cost of a drug or
supply plus a clinic dispensing fee not to exceed twelve dollars
($12) per billing unit as identified in either the Family PACT
Policies, Procedures, and Billing Instructions Manual, or the
Medi-Cal Inpatient/Outpatient Provider Manual governing outpatient
clinic billing for drugs and supplies, as applicable. For purposes of
this section, "cost" for a take-home drug that is dispensed for use
by the patient within a specific timeframe of five or less days from
the date medically indicated means actual acquisition cost for that
drug plus a clinic dispensing fee, not to exceed seventeen dollars
($17) per prescription. Reimbursement shall be at the lesser of the
amount billed or the Medi-Cal reimbursement rate, and shall not
exceed the net cost of these drugs or supplies when provided by
retail pharmacies under the Medi-Cal program.  
   (c) (1) A clinic described in subdivision (a) shall bill the
Medi-Cal program or the Family PACT Program for non-contraceptive
drugs, devices, and supplies covered under those programs at the
lesser of cost or the clinic's usual charge made to the general
public.  
   (2) For purposes of this subdivision only, "cost" means an
aggregate amount equivalent to the actual acquisition cost of a
non-contraceptive drug, device, or supply plus a clinic dispensing
fee as determined by the department and identified in either the
Medi-Cal Provider Manual or the Family PACT Policies, Procedures, and
Billing Instructions Manual. If the department does not identify a
clinic dispensing fee in either the Medi-Cal Provider Manual or the
Family PACT Policies, Procedures, and Billing Instructions Manual,
the clinic dispensing fee shall be the difference between the actual
acquisition cost and the Medi-Cal reimbursement rate.  
   (3) Reimbursement for non-contraceptive drugs, devices, and
supplies shall be the lesser of the amount billed or the Medi-Cal
reimbursement rate, and shall not exceed the net cost of the
non-contraceptive drugs, devices, and supplies when provided by
retail pharmacies under the Medi-Cal program.  
   (c) 
    (d)  A clinic described in subdivision (a) that
furnishes services free of charge, or at a nominal charge, as defined
in subsection (a) of Section 413.13 of Title 42 of the Code of
Federal Regulations, or that can demonstrate to the department, upon
request, that it serves primarily low-income patients, and its
customary practice is to charge patients on the basis of their
ability to pay, shall not be subject to reimbursement reductions
based on its usual charge to the general public. 
   (d) 
    (e)  Federally qualified health centers and rural health
clinics that are clinics as described in subdivision (a) may bill
and be reimbursed as described in this section, upon electing to be
reimbursed for pharmaceutical  goods and services 
 drugs, devices, and supplies delivered through their
dispensaries  on a fee-for-service basis, as permitted by
subdivision (k) of Section 14132.100. 
   (e) 
    (f)  A clinic that otherwise meets the qualifications
set forth in subdivision (a), that is eligible to, but that has
elected not to, utilize drugs purchased under the 340B Discount Drug
Program for its Medi-Cal patients, shall provide notification to the
Health Resources and Services Administration's Office of Pharmacy
Affairs that it is utilizing non-340B drugs for its Medi-Cal patients
in the manner and to the extent required by federal law. 
   (g) The department shall seek federal approval of any state plan
amendments necessary to implement this section.  
   (h) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by means of provider bulletins
or similar instructions until the time any necessary regulations are
adopted. Thereafter, by July 1, 2018, the department shall adopt
regulations in accordance with the requirements of Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2 of
the Government Code. Until those regulations have been adopted, the
department shall provide a status report to the Legislature on a
semiannual basis and pursuant to Section 9795 of the Government Code.
 
   (i) This section shall be implemented only if and to the extent
that federal financial participation is available and any necessary
federal approvals have been obtained.  
  SECTION 1.    Section 1222.1 is added to the
Health and Safety Code, to read:
   1222.1.  (a) (1) As part of the application for licensure either
as a primary care clinic, as described in subdivision (a) of Section
1204, or as an affiliate clinic, as described in Section 1218.1, the
department shall accept a consolidated application for enrollment in
both the Medi-Cal program and the Family PACT Program that is
submitted by a clinic pursuant to subparagraph (A) of paragraph (1)
of subdivision (t) of Section 24005 of the Welfare and Institutions
Code. The department shall review the clinic's qualifications for
enrollment in both the Medi-Cal program and the Family PACT Program,
and, if approved, shall transmit its certification for enrollment in
both programs to the State Department of Health Care Services within
15 calendar days of the date approval is granted.
   (2) The department shall accept an application for enrollment in
both the Medi-Cal program and the Family PACT Program, or for
enrollment in the Family PACT Program, from a licensed primary care
clinic, as described in subdivision (a) of Section 1204, or from a
licensed affiliate clinic, as described in Section 1218.1. The
department shall review the clinic's qualifications for enrollment in
the Medi-Cal program and the Family PACT Program, as applicable,
and, if approved, shall transmit its certification for enrollment in
those programs to the State Department of Health Care Services within
15 calendar days of the date approval is granted.
   (b) If a clinic submits an initial application for enrollment in
both the Medi-Cal program and the Family PACT Program pursuant to
paragraph (1) or (2) of subdivision (a), the department shall apply
the same certification date to its approval for enrollment in both
programs.
   (c) No later than June 30, 2016, the department shall develop a
consolidated Medi-Cal program and Family PACT Program initial
application form, and a Family PACT Program initial application form
for a clinic already enrolled in the Medi-Cal program, subject to all
of the following:
   (1) The department shall not require an applicant for enrollment
in the Family PACT Program to disclose any additional information
beyond what was required of a community clinic for enrollment in the
Family PACT Program as of December 31, 2014.
   (2) The department shall not require an applicant to attend a
provider orientation if the applicant is owned by a nonprofit
corporation that owns at least one other primary care clinic that has
held an active enrollment in the Family PACT Program for the
immediately preceding five years, and during that period has had no
demonstrated history of a repeated or uncorrected violation of this
chapter or any regulation adopted after the enactment of this chapter
that poses an immediate jeopardy to a patient, as that term is
defined in subdivision (f) of Section 1218.1.
   (d) Nothing in this section shall be construed to modify the
requirement that the department issue a license to an affiliate
clinic within 30 days of receipt of a completed application, as set
forth in subdivision (d) of Section 1218.1.
   (e) A subsequent change to information reported on the initial
application described in this section shall be reported to the
centralized application unit of the department within 35 calendar
days. The department shall review the clinic's changes, and, if
approved, shall transmit its approval to the State Department of
Health Care Services within 15 calendar days after approval is
granted. A provider that reports a change under this section other
than a change of ownership shall not be required to reenroll in
either the Medi-Cal program or the Family PACT Program. 

  SEC. 2.    Section 14043.17 of the Welfare and
Institutions Code is amended to read:
   14043.17.  (a) Notwithstanding any other law, within 15 calendar
days of receiving confirmation of certification for enrollment as a
Medi-Cal provider for a primary care clinic, as described in
subdivision (a) of Section 1204 of the Health and Safety Code, or an
affiliate primary care clinic that is licensed pursuant to Section
1218.1 of the Health and Safety Code, the department shall provide
written notice to the applicant informing the applicant that its
Medi-Cal enrollment is approved.
   (b) The department shall enroll the primary care clinic or the
affiliate clinic retroactive to the date of certification.
   (c) This section shall not be construed to limit the department's
authority pursuant to Section 14043.37, 14043.4, or 14043.7 to
conduct background checks, preenrollment inspections, or unannounced
visits.  
  SEC. 3.    Section 24005 of the Welfare and
Institutions Code is amended to read:
   24005.  (a) This section shall apply to the Family Planning,
Access, Care, and Treatment (Family PACT) Program identified in
subdivision (aa) of Section 14132 and this program.
   (b) Only licensed medical personnel with family planning skills,
knowledge, and competency may provide the full range of family
planning medical services covered in this program.
   (c) Medi-Cal enrolled providers, as determined by the department,
shall be eligible to provide family planning services under the
program when these services are within their scope of practice and
licensure. Those clinical providers electing to participate in the
program and approved by the department shall provide the full scope
of family planning education, counseling, and medical services
specified for the program, either directly or by referral, consistent
with standards of care issued by the department.
   (d) The department shall require providers to enter into clinical
agreements with the department to ensure compliance with standards
and requirements to maintain the fiscal integrity of the program.
Provider applicants, providers, and persons with an ownership or
control interest, as defined in federal Medicaid regulations, shall
be required to submit to the department their social security numbers
to the full extent allowed under federal law. All state and federal
statutes and regulations pertaining to the audit or examination of
Medi-Cal providers shall apply to this program.
   (e) Clinical provider agreements shall be signed by the provider
under penalty of perjury. The department may screen applicants at the
initial application and at any reapplication pursuant to
requirements developed by the department to determine provider
suitability for the program.
   (f) The department may complete a background check on clinical
provider applicants for the purpose of verifying the accuracy of
information provided to the department for purposes of enrolling in
the program and in order to prevent fraud and abuse. The background
check may include, but not be limited to, unannounced onsite
inspection prior to enrollment, review of business records, and data
searches. If discrepancies are found to exist during the
preenrollment period, the department may conduct additional
inspections prior to enrollment. Failure to remediate significant
discrepancies as prescribed by the director may result in denial of
the application for enrollment. Providers that do not provide
services consistent with the standards of care or that do not comply
with the department's rules related to the fiscal integrity of the
program may be disenrolled as a provider from the program at the sole
discretion of the department.
   (g) The department shall not enroll any applicant who, within the
previous 10 years:
   (1) Has been convicted of any felony or misdemeanor that involves
fraud or abuse in any government program, that relates to neglect or
abuse of a patient in connection with the delivery of a health care
item or service, or that is in connection with the interference with,
or obstruction of, any investigation into health care related fraud
or abuse.
   (2) Has been found liable for fraud or abuse in any civil
proceeding, or that has entered into a settlement in lieu of
conviction for fraud or abuse in any government program.
   (h) In addition, the department may deny enrollment to any
applicant that, at the time of application, is under investigation by
the department or any local, state, or federal government law
enforcement agency for fraud or abuse. The department shall not deny
enrollment to an otherwise qualified applicant whose felony or
misdemeanor charges did not result in a conviction solely on the
basis of the prior charges. If it is discovered that a provider is
under investigation by the department or any local, state, or federal
government law enforcement agency for fraud or abuse, that provider
shall be subject to immediate disenrollment from the program.
   (i) (1) The program shall disenroll as a program provider any
individual who, or any entity that, has a license, certificate, or
other approval to provide health care, which is revoked or suspended
by a federal, California, or other state's licensing, certification,
or other approval authority, has otherwise lost that license,
certificate, or approval, or has surrendered that license,
certificate, or approval while a disciplinary hearing on the license,
certificate, or approval was pending. The disenrollment shall be
effective on the date the license, certificate, or approval is
revoked, lost, or surrendered.
   (2) A provider shall be subject to disenrollment if the provider
submits claims for payment for the services, goods, supplies, or
merchandise provided, directly or indirectly, to a program
beneficiary, by an individual or entity that has been previously
suspended, excluded, or otherwise made ineligible to receive,
directly or indirectly, reimbursement from the program or from the
Medi-Cal program and the individual has previously been listed on
either the Suspended and Ineligible Provider List, which is published
by the department, to identify suspended and otherwise ineligible
providers or any list published by the federal Office of the
Inspector General regarding the suspension or exclusion of
individuals or entities from the federal Medicare and Medicaid
programs, to identify suspended, excluded, or otherwise ineligible
providers.
   (3) The department shall deactivate, immediately and without prior
notice, the provider numbers used by a provider to obtain
reimbursement from the program when warrants or documents mailed to a
provider's mailing address, its pay to address, or its service
address, if any, are returned by the United States Postal Service as
not deliverable or when a provider has not submitted a claim for
reimbursement from the program for one year. Prior to taking this
action, the department shall use due diligence in attempting to
contact the provider at its last known telephone number and to
ascertain if the return by the United States Postal Service is by
mistake and shall use due diligence in attempting to contact the
provider by telephone or in writing to ascertain whether the provider
wishes to continue to participate in the Medi-Cal program. If
deactivation pursuant to this section occurs, the provider shall meet
the requirements for reapplication as specified in regulation.
   (4) For purposes of this subdivision:
   (A) "Mailing address" means the address that the provider has
identified to the department in its application for enrollment as the
address at which it wishes to receive general program
correspondence.
   (B) "Pay to address" means the address that the provider has
identified to the department in its application for enrollment as the
address at which it wishes to receive warrants.
   (C) "Service address" means the address that the provider has
identified to the department in its application for enrollment as the
address at which the provider will provide services to program
beneficiaries.
   (j) Subject to Article 4 (commencing with Section 19130) of
Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code,
the department may enter into contracts to secure consultant services
or information technology including, but not limited to, software,
data, or analytical techniques or methodologies for the purpose of
fraud or abuse detection and prevention. Contracts under this section
shall be exempt from the Public Contract Code.
   (k) Except as provided in Section 1222.1 of the Health and Safety
Code, enrolled providers shall attend specific orientation approved
by the department in comprehensive family planning services. Enrolled
providers who insert IUDs or contraceptive implants shall have
received prior clinical training specific to these procedures.
   (  l  ) Upon receipt of reliable evidence that
would be admissible under the administrative adjudication provisions
of Chapter 5 (commencing with Section 11500) of Part 1 of Division 3
of Title 2 of the Government Code, of fraud or willful
misrepresentation by a provider under the program or commencement of
a suspension under Section 14123, the department may do any of the
following:
   (1) Collect any State-Only Family Planning program or Family
Planning, Access, Care, and Treatment Program overpayment identified
through an audit or examination, or any portion thereof from any
provider. Notwithstanding Section 100171 of the Health and Safety
Code, a provider may appeal the collection of overpayments under this
section pursuant to procedures established in Article 5.3
(commencing with Section 14170) of Chapter 7 of Part 3 of Division 9.
Overpayments collected under this section shall not be returned to
the provider during the pendency of any appeal and may be offset to
satisfy audit or appeal findings, if the findings are against the
provider. Overpayments shall be returned to a provider with interest
if findings are in favor of the provider.
   (2) Withhold payment for any goods or services, or any portion
thereof, from any State-Only Family Planning program or Family
Planning, Access, Care, and Treatment Program provider. The
department shall notify the provider within five days of any
withholding of payment under this section. The notice shall do all of
the following:
   (A) State that payments are being withheld in accordance with this
paragraph and that the withholding is for a temporary period and
will not continue after it is determined that the evidence of fraud
or willful misrepresentation is insufficient or when legal
proceedings relating to the alleged fraud or willful
misrepresentation are completed.
   (B) Cite the circumstances under which the withholding of the
payments will be terminated.
   (C) Specify, when appropriate, the type or types of claimed
payments being withheld.
   (D) Inform the provider of the right to submit written evidence
that is evidence that would be admissible under the administrative
adjudication provisions of Chapter 5 (commencing with Section 11500)
of Part 1 of Division 3 of Title 2 of the Government Code, for
consideration by the department.
   (3) Notwithstanding Section 100171 of the Health and Safety Code,
a provider may appeal a withholding of payment under this section
pursuant to Section 14043.65. Payments withheld under this section
shall not be returned to the provider during the pendency of any
appeal and may be offset to satisfy audit or appeal findings.
   (m) As used in this section:
   (1) "Abuse" means either of the following:
   (A) Practices that are inconsistent with sound fiscal or business
practices and result in unnecessary cost to the Medicaid program, the
Medicare program, the Medi-Cal program, including the Family
Planning, Access, Care, and Treatment Program, identified in
subdivision (aa) of Section 14132, another state's Medicaid program,
or the State-Only Family Planning program, or other health care
programs operated, or financed in whole or in part, by the federal
government or any state or local agency in this state or any other
state.
   (B) Practices that are inconsistent with sound medical practices
and result in reimbursement, by any of the programs referred to in
subparagraph (A) or other health care programs operated, or financed
in whole or in part, by the federal government or any state or local
agency in this state or any other state, for services that are
unnecessary or for substandard items or services that fail to meet
professionally recognized standards for health care.
   (2) "Fraud" means an intentional deception or misrepresentation
made by a person with the knowledge that the deception could result
in some unauthorized benefit to himself or herself or some other
person. It includes any act that constitutes fraud under applicable
federal or state law.
   (3) "Provider" means any individual, partnership, group,
association, corporation, institution, or entity, and the officers,
directors, owners, managing employees, or agents of any partnership,
group, association, corporation, institution, or entity, that
provides services, goods, supplies, or merchandise, directly or
indirectly, to a beneficiary and that has been enrolled in the
program.
   (4) "Convicted" means any of the following:
   (A) A judgment of conviction has been entered against an
individual or entity by a federal, state, or local court, regardless
of whether there is a post-trial motion or an appeal pending or the
judgment of conviction or other record relating to the criminal
conduct has been expunged or otherwise removed.
   (B) A federal, state, or local court has made a finding of guilt
against an individual or entity.
   (C) A federal, state, or local court has accepted a plea of guilty
or nolo contendere by an individual or entity.
   (D) An individual or entity has entered into participation in a
first offender, deferred adjudication, or other program or
arrangement where judgment of conviction has been withheld.
   (5) "Professionally recognized standards of health care" means
statewide or national standards of care, whether in writing or not,
that professional peers of the individual or entity whose provision
of care is an issue, recognize as applying to those peers practicing
or providing care within a state. When the United States Department
of Health and Human Services has declared a treatment modality not to
be safe and effective, practitioners that employ that treatment
modality shall be deemed not to meet professionally recognized
standards of health care. This definition shall not be construed to
mean that all other treatments meet professionally recognized
standards of care.
   (6) "Unnecessary or substandard items or services" means those
that are either of the following:
   (A) Substantially in excess of the provider's usual charges or
costs for the items or services.
   (B) Furnished, or caused to be furnished, to patients, whether or
not covered by Medicare, Medicaid, or any of the state health care
programs to which the definitions of applicant and provider apply,
and which are
substantially in excess of the patient's needs, or of a quality that
fails to meet professionally recognized standards of health care. The
department's determination that the items or services furnished were
excessive or of unacceptable quality shall be made on the basis of
information, including sanction reports, from the following sources:
   (i) The professional review organization for the area served by
the individual or entity.
   (ii) State or local licensing or certification authorities.
   (iii) Fiscal agents or contractors, or private insurance
companies.
   (iv) State or local professional societies.
   (v) Any other sources deemed appropriate by the department.
   (7) "Enrolled or enrollment in the program" means authorized under
any and all processes by the department or its agents or contractors
to receive, directly or indirectly, reimbursement for the provision
of services, goods, supplies, or merchandise to a program
beneficiary.
   (n) In lieu of, or in addition to, the imposition of any other
sanctions available, including the imposition of a civil penalty
under Sections 14123.2 or 14171.6, the program may impose on
providers any or all of the penalties pursuant to Section 14123.25,
in accordance with the provisions of that section. In addition,
program providers shall be subject to the penalties contained in
Section 14107.
   (o) (1) Notwithstanding any other provision of law, every primary
supplier of pharmaceuticals, medical equipment, or supplies shall
maintain accounting records to demonstrate the manufacture, assembly,
purchase, or acquisition and subsequent sale, of any
pharmaceuticals, medical equipment, or supplies, to providers.
Accounting records shall include, but not be limited to, inventory
records, general ledgers, financial statements, purchase and sales
journals, and invoices, prescription records, bills of lading, and
delivery records.
   (2) For purposes of this subdivision, the term "primary supplier"
means any manufacturer, principal labeler, assembler, wholesaler, or
retailer.
   (3) Accounting records maintained pursuant to paragraph (1) shall
be subject to audit or examination by the department or its agents.
The audit or examination may include, but is not limited to,
verification of what was claimed by the provider. These accounting
records shall be maintained for three years from the date of sale or
the date of service.
   (p) Each provider of health care services rendered to any program
beneficiary shall keep and maintain records of each service rendered,
the beneficiary to whom rendered, the date, and such additional
information as the department may by regulation require. Records
required to be kept and maintained pursuant to this subdivision shall
be retained by the provider for a period of three years from the
date the service was rendered.
   (q) A program provider applicant or a program provider shall
furnish information or copies of records and documentation requested
by the department. Failure to comply with the department's request
shall be grounds for denial of the application or automatic
disenrollment of the provider.
   (r) A program provider may assign signature authority for
transmission of claims to a billing agent subject to Sections 14040,
14040.1, and 14040.5.
   (s) Moneys payable or rights existing under this division shall be
subject to any claim, lien, or offset of the State of California,
and any claim of the United States of America made pursuant to
federal statute, but shall not otherwise be subject to enforcement of
a money judgment or other legal process, and no transfer or
assignment, at law or in equity, of any right of a provider of health
care to any payment shall be enforceable against the state, a fiscal
intermediary, or carrier.
   (t) (1) (A) Notwithstanding any other law, a primary care clinic,
as described in subdivision (a) of Section 1204 of the Health and
Safety Code, or an affiliate clinic, as described in Section 1218.1
of the Health and Safety Code, that is seeking to enroll as a
provider in both the Medi-Cal program and the Family PACT Program,
shall submit one consolidated application for enrollment in both the
Medi-Cal program and the Family PACT Program to the State Department
of Public Health, using the forms described in Section 1222.1 of the
Health and Safety Code. The effective date of enrollment for a clinic
enrolling in both programs at the same time shall be the date the
State Department of Public Health certifies the clinic for enrollment
in those programs.
   (B) A primary care clinic, as described in subdivision (a) of
Section 1204 of the Health and Safety Code, or an affiliate clinic,
as described in Section 1218.1 of the Health and Safety Code, that is
enrolled in the Medi-Cal program and that is seeking to enroll as a
provider in the Family PACT Program, shall submit an application for
enrollment in the Family PACT Program to the State Department of
Public Health using the forms described in Section 1222.1 of the
Health and Safety Code. The effective date of enrollment in the
Family PACT program for a clinic that was enrolled in the Medi-Cal
program at the time it applied to the Family PACT Program shall be
the date the State Department of Public Health certifies the clinic
for enrollment in the Family PACT Program.
   (2) Within 15 calendar days of receiving notification from the
State Department of Public Health that a clinic described in
subparagraph (A) or (B) of paragraph (1) is certified for enrollment,
the department shall enroll the clinic in the Family PACT Program.
   (3) A subsequent change to information reported on the initial
enrollment application described in this subdivision shall be
reported to the State Department of Public Health in a manner
determined by the State Department of Public Health within 35
calendar days. Within 15 calendar days of receiving notification from
the State Department of Public Health that a clinic's reported
changes are approved, the department shall update the clinic's
provider master file for the Medi-Cal program and the Family PACT
Program enrollments, as applicable. A provider described in this
subdivision that reports a change other than a change of ownership
shall not be required to reenroll in either the Medi-Cal program or
the Family PACT Program.
   (u) Providers, or the enrolling entity, shall make available to
all applicants and beneficiaries prior to, or concurrent with,
enrollment, information on the manner in which to apply for insurance
affordability programs, in a manner determined by the State
Department of Health Care Services. The information provided shall
include the manner in which applications can be submitted for
insurance affordability programs, information about the open
enrollment periods for the California Health Benefit Exchange, and
the continuous enrollment aspect of the Medi-Cal program.
                               
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