BILL NUMBER: SB 289 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 19, 2012
AMENDED IN SENATE JANUARY 4, 2012
AMENDED IN SENATE MARCH 24, 2011
INTRODUCED BY Senator Hernandez
FEBRUARY 14, 2011
An act to amend Section 14105.28 Sections
1206, 1222.5, and 2069 of the Welfare and Institutions
Business and Professions Code, relating to
Medi-Cal healing arts .
LEGISLATIVE COUNSEL'S DIGEST
SB 289, as amended, Hernandez. Medi-Cal: inpatient
hospital reimbursement methodology. Clinical
laboratory techniques: training and instruction.
Existing law provides for the licensure and regulation of clinical
laboratories and various clinical laboratory health care
professionals by the State Department of Health Care Services.
Existing law authorizes the department to approve schools seeking to
provide instruction in clinical laboratory techniques, as specified.
This bill would authorize the department to approve specified
institutions seeking to provide instruction in clinical laboratory
techniques, as specified, including, among others, a California
licensed clinical laboratory and an accredited college or university
in the United States. The bill would provide that a college or
university holding a specified accreditation shall not be required to
obtain separate approval for clinical training sites, as defined, if
certain requirements are met.
The bill would also make technical, nonsubstantive changes to
these provisions.
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 Program provisions.
Existing law requires the department, subject to federal approval,
to develop and implement a Medi-Cal payment methodology based on
diagnosis-related groups that reflects the costs and staffing levels
associated with quality of care for patients in all general acute
care hospitals, as specified. Existing law requires the department to
submit status reports to the Legislature on the implementation of
these provisions, and requires the methodology to be implemented on
July 1, 2012, or on the date that the Director of Health Care
Services executes a specified declaration, whichever is later.
This bill would require the department to include prescribed
information in the status reports submitted to the Legislature, and
would make other technical, nonsubstantive changes to these
provisions.
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 1206 of the Business
and Professions Code is amended to read:
1206. (a) For the purposes of this chapter the following
definitions are applicable:
(1) "Analyte" means the substance or constituent being measured
including, but not limited to, glucose, sodium, or theophyline, or
any substance or property whose presence or absence, concentration,
activity, intensity, or other characteristics are to be determined.
(1)
(2) "Biological specimen" means any material that is
derived from the human body.
(2)
(3) "Blood electrolyte analysis" means the measurement
of electrolytes in a blood specimen by means of ion selective
electrodes on instruments specifically designed and manufactured for
blood gas and acid-base analysis.
(3)
(4) "Blood gas analysis" means a clinical laboratory
test or examination that deals with the uptake, transport, and
metabolism of oxygen and carbon dioxide in the human body.
(4)
(5) "Clinical laboratory test or examination" means the
detection, identification, measurement, evaluation, correlation,
monitoring, and reporting of any particular analyte, entity, or
substance within a biological specimen for the purpose of obtaining
scientific data which may be used as an aid to ascertain the
presence, progress, and source of a disease or physiological
condition in a human being, or used as an aid in the prevention,
prognosis, monitoring, or treatment of a physiological or
pathological condition in a human being, or for the performance of
nondiagnostic tests for assessing the health of an individual.
(5)
(6) "Clinical laboratory science" means any of the
sciences or scientific disciplines used to perform a clinical
laboratory test or examination.
(6)
(7) "Clinical laboratory practice" means the
application of clinical laboratory sciences or the use of any means
that applies the clinical laboratory sciences within or outside of a
licensed or registered clinical laboratory. Clinical laboratory
practice includes consultation, advisory, and other activities
inherent to the profession.
(7)
(8) "Clinical laboratory" means any place used, or any
establishment or institution organized or operated, for the
performance of clinical laboratory tests or examinations or the
practical application of the clinical laboratory sciences. That
application may include any means that applies the clinical
laboratory sciences.
(9) "Clinical training site" means any place, establishment, or
institution used by a department-approved program for the training of
clinical laboratory scientists or limited clinical laboratory
scientists to conduct training or instruction of licensed trainees or
phlebotomy students in clinical laboratory practice, techniques,
theory, or other training required pursuant to this chapter.
(8)
(10) "Direct and constant supervision" means personal
observation and critical evaluation of the activity of unlicensed
laboratory personnel by a physician and surgeon, or by a person
licensed under this chapter other than a trainee, during the entire
time that the unlicensed laboratory personnel are engaged in the
duties specified in Section 1269.
(11) "Direct and responsible supervision" means both of the
following:
(A) Personal observation and critical evaluation of the activity
of a trainee by a physician and surgeon, or by a person licensed
under this chapter other than a trainee, during the entire time that
the trainee is performing clinical laboratory tests or examinations.
(B) Personal review by the physician and surgeon or the licensed
person of all results of clinical laboratory testing or examination
performed by the trainee for accuracy, reliability, and validity
before the results are reported from the laboratory.
(12) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(9)
(13) "Location" means either a street and city address,
or a site or place within a street and city address, where any of
the clinical laboratory sciences or scientific disciplines are
practiced or applied, or where any clinical laboratory tests or
examinations are performed.
(10)
(14) "Physician office laboratory" means a clinical
laboratory that is licensed or registered under Section 1265, and
that is either: (A) a clinical laboratory that is owned and operated
by a partnership or professional corporation that performs clinical
laboratory tests or examinations only for patients of five or fewer
physicians and surgeons or podiatrists who are shareholders,
partners, or employees of the partnership or professional corporation
that owns and operates the clinical laboratory; or (B) a clinical
laboratory that is owned and operated by an individual licensed
physician and surgeon or a podiatrist, and that performs clinical
laboratory tests or examinations only for patients of the physician
and surgeon or podiatrist who owns and operates the clinical
laboratory.
(15) "Point-of-care laboratory testing device" means a portable
laboratory testing instrument to which the following applies:
(A) It is used within the proximity of the patient for whom the
test or examination is being conducted.
(B) It is used in accordance with the patient test management
system, the quality control program, and the comprehensive quality
assurance program established and maintained by the laboratory
pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C) It meets the following criteria:
(i) Performs clinical laboratory tests or examinations classified
as waived or of moderate complexity under the federal Clinical
Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec.
263a).
(ii) Performs clinical laboratory tests or examinations on
biological specimens that require no preparation after collection.
(iii) Provides clinical laboratory tests or examination results
without calculation or discretionary intervention by the testing
personnel.
(iv) Performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration or
maintenance, except resetting pursuant to the manufacturer's
instructions or basic cleaning.
(11)
(16) "Public health laboratory" means a laboratory that
is operated by a city or county in conformity with Article 5
(commencing with Section 101150) of Chapter 2 of Part 3 of Division
101 of the Health and Safety Code and the regulations adopted
thereunder.
(17) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(12)
(18) "Specialty" means histocompatibility,
microbiology, diagnostic immunology, chemistry, hematology,
immunohematology, pathology, genetics, or other specialty specified
by regulation adopted by the department.
(13)
(19) "Subspecialty" for purposes of microbiology, means
bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases,
or other subspecialty specified by regulation adopted by the
department; for purposes of diagnostic immunology, means syphilis
serology, general immunology, or other subspecialty specified by
regulation adopted by the department; for purposes of chemistry,
means routine chemistry, clinical microscopy, endocrinology,
toxicology, or other subspecialty specified by regulation adopted by
the department; for purposes of immunohematology, means ABO/Rh Type
and Group, antibody detection for transfusion, antibody detection
nontransfusion, antibody identification, compatibility, or other
subspecialty specified by regulation adopted by the department; for
pathology, means tissue pathology, oral pathology, diagnostic
cytology, or other subspecialty specified by regulation adopted by
the department; for purposes of genetics, means molecular biology
related to the diagnosis of human genetic abnormalities,
cytogenetics, or other subspecialty specified by regulation adopted
by the department.
(14) "Direct and responsible supervision" means both of the
following:
(A) Personal observation and critical evaluation of the activity
of a trainee by a physician and surgeon, or by a person licensed
under this chapter other than a trainee, during the entire time that
the trainee is performing clinical laboratory tests or examinations.
(B) Personal review by the physician and surgeon or the licensed
person of all results of clinical laboratory testing or examination
performed by the trainee for accuracy, reliability, and validity
before the results are reported from the laboratory.
(15) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(16) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(17) "Point-of-care laboratory testing device" means a portable
laboratory testing instrument to which the following applies:
(A) It is used within the proximity of the patient for whom the
test or examination is being conducted.
(B) It is used in accordance with the patient test management
system, the quality control program, and the comprehensive quality
assurance program established and maintained by the laboratory
pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C) It meets the following criteria:
(i) Performs clinical laboratory tests or examinations classified
as waived or of moderate complexity under CLIA.
(ii) Performs clinical laboratory tests or examinations on
biological specimens that require no preparation after collection.
(iii) Provides clinical laboratory tests or examination results
without calculation or discretionary intervention by the testing
personnel.
(iv) Performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration or
maintenance, except resetting pursuant to the manufacturer's
instructions or basic cleaning.
(18) "Analyte" means the substance or constituent being measured
including, but not limited to, glucose, sodium, or theophyline, or
any substance or property whose presence or absence, concentration,
activity, intensity, or other characteristics are to be determined.
(b) Nothing in this chapter shall restrict, limit, or prevent any
person licensed to provide health care services under the laws of
this state, including, but not limited to, licensed physicians and
surgeons and registered nurses, from practicing the profession or
occupation for which he or she is licensed.
(c) Nothing in this chapter shall authorize any person to perform
or order health care services, or utilize the results of the clinical
laboratory test or examination, unless the person is otherwise
authorized to provide that care or utilize the results. The inclusion
of a person in Section 1206.5 for purposes of performing a clinical
laboratory test or examination shall not be interpreted to authorize
a person, who is not otherwise authorized, to perform venipuncture,
arterial puncture, or skin puncture.
SEC. 2. Section 1222.5 of the Business
and Professions Code is amended to read:
1222.5. (a) The department may approve
schools any of the following seeking to
provide instruction in clinical laboratory technic which in the
judgment of the department will provide instruction adequate to
prepare individuals to meet the requirements for licensure or
performance of duties under this chapter and regulations of the
department. The department shall establish by regulation the
ratio of licensed clinical laboratory scientists to licensed
trainees on the staff of the laboratory approved as a school and the
minimum requirements for training in any specialty or in the entire
field of clinical laboratory science or practice. Application for
approval shall be made on forms provided by the department.
department:
(1) A California licensed clinical laboratory.
(2) An accredited college or university in the United States of
America.
(3) A United States military medical laboratory specialist program
of at least 52 weeks duration.
(4) A laboratory owned and operated by the United States
government.
(b) A college or university holding valid accreditation by the
National Accrediting Agency for Clinical Laboratory Sciences that
meets the requirements of subdivision (a) shall not be required to
obtain separate approval for a clinical training site, provided that
the clinical training site has obtained certification under the
federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42
U.S.C. Sec. 263a).
(c) The department shall establish by regulation the ratio of
licensed clinical laboratory scientists to licensed trainees on the
staff of the clinical training site and the minimum requirements for
training in any specialty or in the entire field of clinical
laboratory science or practice. Application for approval shall be
made on forms provided by the department.
SEC. 3. Section 2069 of the Business
and Professions Code is amended to read:
2069. (a) (1) Notwithstanding any other provision of law, a
medical assistant may administer medication only by intradermal,
subcutaneous, or intramuscular injections and perform skin tests and
additional technical supportive services upon the specific
authorization and supervision of a licensed physician and surgeon or
a licensed podiatrist. A medical assistant may also perform all these
tasks and services in a clinic licensed pursuant to subdivision (a)
of Section 1204 of the Health and Safety Code upon the specific
authorization of a physician assistant, a nurse practitioner, or a
nurse-midwife.
(2) The supervising physician and surgeon at a clinic described in
paragraph (1) may, at his or her discretion, in consultation with
the nurse practitioner, nurse-midwife, or physician assistant provide
written instructions to be followed by a medical assistant in the
performance of tasks or supportive services. These written
instructions may provide that the supervisory function for the
medical assistant for these tasks or supportive services may be
delegated to the nurse practitioner, nurse-midwife, or physician
assistant within the standardized procedures or protocol, and that
tasks may be performed when the supervising physician and surgeon is
not onsite, so long as the following apply:
(A) The nurse practitioner or nurse-midwife is functioning
pursuant to standardized procedures, as defined by Section 2725, or
protocol. The standardized procedures or protocol shall be developed
and approved by the supervising physician and surgeon, the nurse
practitioner or nurse-midwife, and the facility administrator or his
or her designee.
(B) The physician assistant is functioning pursuant to regulated
services defined in Section 3502 and is approved to do so by the
supervising physician or surgeon.
(b) As used in this section and Sections 2070 and 2071, the
following definitions shall apply:
(1) "Medical assistant" means a person who may be unlicensed, who
performs basic administrative, clerical, and technical supportive
services in compliance with this section and Section 2070 for a
licensed physician and surgeon or a licensed podiatrist, or group
thereof, for a medical or podiatry corporation, for a physician
assistant, a nurse practitioner, or a nurse-midwife as provided in
subdivision (a), or for a health care service plan, who is at least
18 years of age, and who has had at least the minimum amount of hours
of appropriate training pursuant to standards established by the
Division of Licensing. The medical assistant shall be issued a
certificate by the training institution or instructor indicating
satisfactory completion of the required training. A copy of the
certificate shall be retained as a record by each employer of the
medical assistant.
(2) "Specific authorization" means a specific written order
prepared by the supervising physician and surgeon or the supervising
podiatrist, or the physician assistant, the nurse practitioner, or
the nurse-midwife as provided in subdivision (a), authorizing the
procedures to be performed on a patient, which shall be placed in the
patient's medical record, or a standing order prepared by the
supervising physician and surgeon or the supervising podiatrist, or
the physician assistant, the nurse practitioner, or the nurse-midwife
as provided in subdivision (a), authorizing the procedures to be
performed, the duration of which shall be consistent with accepted
medical practice. A notation of the standing order shall be placed on
the patient's medical record.
(3) "Supervision" means the supervision of procedures authorized
by this section by the following practitioners, within the scope of
their respective practices, who shall be physically present in the
treatment facility during the performance of those procedures:
(A) A licensed physician and surgeon.
(B) A licensed podiatrist.
(C) A physician assistant, nurse practitioner, or nurse-midwife as
provided in subdivision (a).
(4) "Technical supportive services" means simple routine medical
tasks and procedures that may be safely performed by a medical
assistant who has limited training and who functions under the
supervision of a licensed physician and surgeon or a licensed
podiatrist, or a physician assistant, a nurse practitioner, or a
nurse-midwife as provided in subdivision (a).
(c) Nothing in this section shall be construed as authorizing the
licensure of medical assistants. Nothing in this section shall be
construed as authorizing the administration of local anesthetic
agents by a medical assistant. Nothing in this section shall be
construed as authorizing the division to adopt any regulations that
violate the prohibitions on diagnosis or treatment in Section 2052.
(d) Notwithstanding any other provision of law, a medical
assistant may not be employed for inpatient care in a licensed
general acute care hospital as defined in subdivision (a) of Section
1250 of the Health and Safety Code.
(e) Nothing in this section shall be construed as authorizing a
medical assistant to perform any clinical laboratory test or
examination for which he or she is not authorized by Chapter 3
(commencing with Section 1206.5). Nothing in this section shall be
construed as authorizing a nurse practitioner, nurse-midwife, or
physician assistant to be a laboratory director of a clinical
laboratory, as those terms are defined in paragraph (7)
(8) of subdivision (a) of Section 1206 and
subdivision (a) of Section 1209.
SECTION 1. Section 14105.28 of the Welfare and
Institutions Code is amended to read:
14105.28. (a) It is the intent of the Legislature to design a new
Medi-Cal inpatient hospital reimbursement methodology based on
diagnosis-related groups that more effectively ensures all of the
following:
(1) Encouragement of access by setting higher payments for
patients with more serious conditions.
(2) Rewards for efficiency by allowing hospitals to retain savings
from decreased length of stays and decreased costs per day.
(3) Improvement of transparency and understanding by defining the
"product" of a hospital in a way that is understandable to both
clinical and financial managers.
(4) Improvement of fairness so that different hospitals receive
similar payment for similar care and payments to hospitals are
adjusted for significant cost factors that are outside the hospital's
control.
(5) Encouragement of administrative efficiency and minimizing
administrative burdens on hospitals and the Medi-Cal program.
(6) That payments depend on data that has high consistency and
credibility.
(7) Simplification of the process for determining and making
payments to the hospitals.
(8) Facilitation of improvement of quality and outcomes.
(9) Facilitation of implementation of state and federal provisions
related to hospital acquired conditions.
(10) Support of provider compliance with all applicable state and
federal requirements.
(b) (1) (A) (i) The department shall develop and implement a
payment methodology based on diagnosis-related groups, subject to
federal approval, that reflects the costs and staffing levels
associated with quality of care for patients in all general acute
care hospitals in state and out of state, including Medicare critical
access hospitals, but excluding public hospitals, psychiatric
hospitals, and rehabilitation hospitals, which include alcohol and
drug rehabilitation hospitals.
(ii) The payment methodology developed pursuant to this section
shall be implemented on July 1, 2012, or on the date upon which the
director executes a declaration certifying that all necessary federal
approvals have been obtained and the methodology is sufficient for
formal implementation, whichever is later.
(B) The diagnosis-related group-based payments shall apply to all
claims, except claims for psychiatric inpatient days, rehabilitation
inpatient days, managed care inpatient days, and swing bed stays for
long-term care services, provided, however, that psychiatric and
rehabilitation inpatient days shall be excluded regardless of whether
the stay was in a distinct-part unit. The department may exclude or
include other claims and services as may be determined during the
development of the payment methodology.
(C) Implementation of the new payment methodology shall be
coordinated with the development and implementation of the
replacement Medicaid Management Information System pursuant to the
contract entered into pursuant to Section 14104.3, effective on May
3, 2010.
(2) The department shall evaluate alternative diagnosis-related
group algorithms for the new Medi-Cal reimbursement system for the
hospitals to which paragraph (1) applies. The evaluation shall
include, but not be limited to, consideration of all of the following
factors:
(A) The basis for determining diagnosis-related group base price,
and whether different base prices should be used taking into account
factors such as geographic location, hospital size, teaching status,
the local hospital wage area index, and any other variables that may
be relevant.
(B) Classification of patients based on appropriate acuity
classification systems.
(C) Hospital case mix factors.
(D) Geographic or regional differences in the cost of operating
facilities and providing care.
(E) Payment models based on diagnosis-related groups used in other
states.
(F) Frequency of group updates for the diagnosis-related groups.
(G) The extent to which the particular grouping algorithm for the
diagnosis-related groups accommodates the International
Classification of Diseases, 10th Revision (ICD-10), diagnosis and
procedure codes, and applicable requirements of the federal Health
Insurance Portability and Accountability Act of 1996 (HIPAA; Public
Law 104-191).
(H) The basis for calculating relative weights for the various
diagnosis-related groups.
(I) Whether policy adjusters should be used, for which care
categories they should be used, and the frequency of updates to the
policy adjusters.
(J) The extent to which the payment system is budget neutral and
can be expected to result in state budget savings in future years.
(K) Other factors that may be relevant to determining payments,
including, but not limited to, add-on payments, outlier payments,
capital payments, payments for medical education, payments in the
case of early transfers of patients, and payments based on
performance and quality of care.
(c) The department shall submit to the Legislature status reports
on the implementation of this section on April 1, 2011, April 1,
2012, April 1, 2013, and April 1, 2014. The status reports submitted
pursuant to this subdivision shall include a list of the claims and
services excluded pursuant to subparagraph (B) of paragraph (1) of
subdivision (b).
(d) The alternatives for a new system described in paragraph (2)
of subdivision (b) shall be developed in consultation with recognized
experts with experience in hospital reimbursement, economists, the
federal Centers for Medicare and Medicaid Services, and other
interested parties.
(e) In implementing this section, the department may contract, as
necessary, on a bid or nonbid basis, for professional consulting
services from nationally recognized higher education and research
institutions, or other qualified individuals and entities not
associated with a particular hospital or hospital group, with
demonstrated expertise in hospital reimbursement systems. The rate
setting system described in subdivision (b) shall be developed with
all possible expediency. This subdivision establishes an accelerated
process for issuing contracts
pursuant to this section and contracts entered into
pursuant to this subdivision shall be exempt from the requirements of
Chapter 1 (commencing with Section 10100) and Chapter 2 (commencing
with Section 10290) of Part 2 of Division 2 of the Public Contract
Code.
(f) (1) The department may adopt emergency regulations to
implement the provisions of this section in accordance with
rulemaking provisions of the Administrative Procedure Act (Chapter
3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title
2 of the Government Code). The initial adoption of emergency
regulations and one readoption of the initial regulations shall be
deemed to be an emergency and necessary for the immediate
preservation of the public peace, health and safety, or general
welfare. Initial emergency regulations and the one readoption of
those regulations shall be exempt from review by the Office of
Administrative Law. The initial emergency regulations and the one
readoption of those regulations authorized by this section shall be
submitted to the Office of Administrative Law for filing with the
Secretary of State and publication in the California Code of
Regulations.
(2) As an alternative to paragraph (1), and notwithstanding the
rulemaking provisions of Chapter 3.5 (commencing with Section 11340)
of Part 1 of Division 3 of Title 2 of the Government Code, or any
other provision of law, the department may implement and administer
this section by means of provider bulletins, all-county letters,
manuals, or other similar instructions, without taking regulatory
action. The department shall notify the fiscal and appropriate policy
committees of the Legislature of its intent to issue a provider
bulletin, all-county letter, manual, or other similar instruction, at
least five days prior to issuance. In addition, the department shall
provide a copy of any provider bulletin, all-county letter, manual,
or other similar instruction issued under this paragraph to the
fiscal and appropriate policy committees of the Legislature.