(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 |
(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 |
(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 other | 46 |
fiduciary of the provider, whether paid or unpaid, for the purpose | 47 |
of having that individual perform clinical laboratory services for | 48 |
the physician or group practice. | 49 |
(2) Nothing in division (C)(1) of this section prohibits a | 50 |
clinical laboratory services provider from entering into a | 51 |
laboratory management services contract with a hospital, including | 52 |
a contract that requires the provider to place employees or agents | 53 |
who perform functions directly related to the provision of | 54 |
clinical laboratory services at the hospital, as long as the | 55 |
contract specifies that the hospital will pay fair market value | 56 |
for the laboratory management services rendered. | 57 |
Sec. 3702.31. (A) The quality monitoring and inspection fund | 64 |
is hereby created in the state treasury. The director of health | 65 |
shall use the fund to administer and enforce this section and | 66 |
sections 3702.11 to 3702.20, 3702.30, 3702.301, and 3702.32, and | 67 |
3701.94 of the Revised Code and rules adopted pursuant to those | 68 |
sections. The director shall deposit in the fund any moneys | 69 |
collected pursuant to this section or section 3702.32 or 3701.941 | 70 |
of the Revised Code. All investment earnings of the fund shall be | 71 |
credited to the fund. | 72 |
(2) Inspections conducted under section 3702.15 or 3702.30 of | 81 |
the Revised Code. The fees established under division (B)(2) of | 82 |
this section shall not exceed the actual and necessary costs | 83 |
incurred during an inspection, including any indirect costs | 84 |
incurred by the department for staff, salary, or other | 85 |
administrative costs. The director of health shall provide to each | 86 |
health care facility or provider inspected pursuant to section | 87 |
3702.15 or 3702.30 of the Revised Code a written statement of the | 88 |
fee. The statement shall itemize and total the costs incurred. | 89 |
Within fifteen days after receiving a statement from the director, | 90 |
the facility or provider shall forward the total amount of the fee | 91 |
to the director. | 92 |
(b) The fee shall exclude any costs reimbursable by the | 100 |
United States centers for medicare and medicaid services as part | 101 |
of the certification process for the medicare program established | 102 |
under Title XVIII of the "Social Security Act," 79 Stat. 286 | 103 |
(1935), 42 U.S.C.A. 1395, as amended, and the medicaid program | 104 |
established under Title XIX of the "Social Security Act," 79 Stat. | 105 |
286 (1965), 42 U.S.C. 1396. | 106 |