As Introduced

128th General Assembly
Regular Session
2009-2010
S. B. No. 309


Senator Miller, R. 


A BILL
To amend section 3702.31 and to enact sections 1
3701.94 and 3701.941 of the Revised Code to 2
prohibit clinical laboratory services providers 3
from inducing physicians to refer patients in 4
exchange for remuneration and from placing 5
laboratory personnel in physician offices.6


BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

       Section 1. That section 3702.31 be amended and sections 7
3701.94 and 3701.941 of the Revised Code be enacted to read as 8
follows:9

       Sec. 3701.94.  (A) As used in this section and section 10
3701.941 of the Revised Code:11

       (1) "Clinical laboratory services" means the microbiological, 12
serological, chemical, hematological, biophysical, cytological, or 13
pathological examination of materials derived from the human body 14
for purposes of obtaining information for the diagnosis, 15
prevention, treatment, or screening of any disease or impairment 16
or for the assessment of health. "Clinical laboratory services" 17
also means the collection or preparation of specimens for testing.18

       (2) "Clinical laboratory services provider" means any person, 19
or any employee, employer, agent, representative, or other 20
fiduciary of such person, who provides clinical laboratory 21
services.22

       (3) "Group practice" has the same meaning as in section 23
4731.65 of the Revised Code.24

       (4) "Hospital" has the same meaning as in section 3727.01 of 25
the Revised Code.26

       (5) "Physician" means an individual authorized under Chapter 27
4731. of the Revised Code to practice medicine and surgery, 28
osteopathic medicine and surgery, or podiatric medicine and 29
surgery.30

       (B) No clinical laboratory services provider shall, directly 31
or indirectly, offer, give, pay, or deliver, or agree to offer, 32
give, pay, or deliver, any remuneration, in cash or in kind, 33
including any kickback, bribe, or rebate, to any physician or 34
group practice to induce the physician or group practice to do 35
either of the following:36

       (1) Refer patients to the clinical laboratory services 37
provider;38

       (2) Enter into an arrangement whereby the clinical 39
laboratory services provider and the physician or group practice 40
agree to split fees.41

       (C)(1) Subject to division (C)(2) of this section, no 42
clinical laboratory services provider shall give to a physician or 43
group practice, supply the physician or group practice with, or 44
place in the physician's or group practice's office any 45
individual, including an employee, agent, representative, or 46
other fiduciary of the clinical laboratory services provider, 47
whether paid or unpaid, for the purpose of having that individual 48
perform clinical laboratory services for the physician or group 49
practice. 50

       (2) Nothing in division (C)(1) of this section prohibits a 51
clinical laboratory services provider from entering into a 52
laboratory management services contract with a hospital, including 53
a contract that requires the clinical laboratory services 54
provider to place employees or agents who perform functions 55
directly related to the provision of clinical laboratory services 56
at the hospital, as long as the contract specifies that the 57
hospital will pay fair market value for the laboratory management 58
services rendered.59

       Sec. 3701.941.  If the director of health determines that a 60
clinical laboratory services provider has violated division (B) or 61
(C) of section 3701.94 of the Revised Code, the director shall 62
impose a civil penalty of not less than one thousand dollars and 63
not more than ten thousand dollars for each day that the clinical 64
laboratory violates either prohibition. 65

       Sec. 3702.31.  (A) The quality monitoring and inspection fund 66
is hereby created in the state treasury. The director of health 67
shall use the fund to administer and enforce this section and 68
sections 3702.11 to 3702.20, 3702.30, 3702.301, and 3702.32, and 69
3701.94 of the Revised Code and rules adopted pursuant to those 70
sections. The director shall deposit in the fund any moneys71
collected pursuant to this section or section 3702.32 or 3701.94172
of the Revised Code. All investment earnings of the fund shall be 73
credited to the fund.74

       (B) The director of health shall adopt rules pursuant to75
Chapter 119. of the Revised Code establishing fees for both of the76
following:77

       (1) Initial and renewal license applications submitted under78
section 3702.30 of the Revised Code. The fees established under79
division (B)(1) of this section shall not exceed the actual and80
necessary costs of performing the activities described in division81
(A) of this section.82

       (2) Inspections conducted under section 3702.15 or 3702.30 of 83
the Revised Code. The fees established under division (B)(2) of 84
this section shall not exceed the actual and necessary costs85
incurred during an inspection, including any indirect costs86
incurred by the department for staff, salary, or other87
administrative costs. The director of health shall provide to88
each health care facility or provider inspected pursuant to89
section 3702.15 or 3702.30 of the Revised Code a written statement90
of the fee. The statement shall itemize and total the costs91
incurred. Within fifteen days after receiving a statement from92
the director, the facility or provider shall forward the total93
amount of the fee to the director.94

       (3) The fees described in divisions (B)(1) and (2) of this95
section shall meet both of the following requirements:96

       (a) For each service described in section 3702.11 of the97
Revised Code, the fee shall not exceed one thousand seven hundred98
fifty dollars annually, except that the total fees charged to a99
health care provider under this section shall not exceed five100
thousand dollars annually.101

       (b) The fee shall exclude any costs reimbursable by the102
United States centers for medicare and medicaid services as part 103
of the certification process for the medicare program established 104
under Title XVIII of the "Social Security Act," 79 Stat. 286 105
(1935), 42 U.S.C.A. 1395, as amended, and the medicaid program 106
established under Title XIX of the "Social Security Act," 79 Stat. 107
286 (1965), 42 U.S.C. 1396.108

       (4) The director shall not establish a fee for any service109
for which a licensure or inspection fee is paid by the health care110
provider to a state agency for the same or similar licensure or111
inspection.112

       Section 2.  That existing section 3702.31 of the Revised 113
Code is hereby repealed.114