As Reported by the Senate Medicaid, Health and Human Services Committee

130th General Assembly
Regular Session
2013-2014
Sub. H. B. No. 366


Representative Sprague 

Cosponsors: Representatives Buchy, Hood, Phillips, Ruhl, Smith, Antonio, Barnes, Bishoff, Brown, Hagan, R., Schuring, Sears, Johnson, Adams, R., Amstutz, Anielski, Ashford, Baker, Beck, Blair, Blessing, Boose, Boyce, Budish, Burkley, Butler, Conditt, Damschroder, Derickson, DeVitis, Dovilla, Duffey, Fedor, Gerberry, Green, Hackett, Hagan, C., Hall, Hayes, Heard, Henne, Huffman, Landis, Letson, Lundy, Mallory, McClain, Milkovich, O'Brien, Perales, Pillich, Rogers, Rosenberger, Stebelton, Stinziano, Strahorn, Wachtmann, Williams, Winburn, Young Speaker Batchelder 

Senators Tavares, Brown 



A BILL
To amend sections 3712.03, 3712.04, and 3712.99 and 1
to enact section 3712.062 of the Revised Code to 2
require hospice care programs to establish 3
policies to prevent diversion of controlled 4
substances that contain opioids.5


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

       Section 1. That sections 3712.03, 3712.04, and 3712.99 be 6
amended and section 3712.062 of the Revised Code be enacted to 7
read as follows:8

       Sec. 3712.03.  (A) In accordance with Chapter 119. of the 9
Revised Code, the director of health shall adopt, and may amend 10
and rescind, rules:11

       (1) Providing for the licensing of persons or public agencies 12
providing hospice care programs within this state by the 13
department of health and for the suspension and revocation of 14
licenses;15

       (2) Establishing a license fee and license renewal fee for 16
hospice care programs, neither of which shall, except as provided 17
in division (B) of this section, exceed six hundred dollars. The 18
fees shall cover the three-year period during which an existing 19
license is valid as provided in division (B) of section 3712.04 of 20
the Revised Code.21

       (3) Establishing an inspection fee for hospice care programs 22
not to exceed, except as provided in division (B) of this section, 23
one thousand seven hundred fifty dollars;24

       (4) Establishing requirements for hospice care program 25
facilities and services;26

       (5) Establishing procedures a hospice care program must 27
follow while investigating a sign of suspected diversion of 28
controlled substances containing opioids pursuant to division 29
(B)(5) of section 3712.062 of the Revised Code;30

        (6) Establishing requirements for reporting to a local law 31
enforcement agency pursuant to division (B)(6) of section 3712.062 32
of the Revised Code the results of an investigation of suspected 33
diversion;34

       (7) Providing for a waiver of the requirement for the 35
provision of physical, occupational, or speech or language therapy 36
contained in division (A)(2) of section 3712.01 of the Revised 37
Code when the requirement would create a hardship because such 38
therapy is not readily available in the geographic area served by 39
the provider of a hospice care program;40

       (6)(8) Providing for the granting of licenses to provide 41
hospice care programs to persons and public agencies that are 42
accredited or certified to provide such programs by an entity 43
whose standards for accreditation or certification equal or exceed 44
those provided for licensure under this chapter and rules adopted 45
under it;46

       (7)(9) Establishing interpretive guidelines for each rule 47
adopted under this section.48

       (B) Subject to the approval of the controlling board, the 49
director may establish fees in excess of the maximum amounts 50
specified in this section, provided that the fees do not exceed 51
those amounts by greater than fifty per cent.52

       (C) The department of health shall:53

       (1) Grant, suspend, and revoke licenses for hospice care 54
programs in accordance with this chapter and rules adopted under 55
it;56

       (2) Make such inspections as are necessary to determine 57
whether hospice care program facilities and services meet the 58
requirements of this chapter and rules adopted under it; and59

       (3) Implement and enforce provisions of this chapter and 60
rules adopted under it as such provisions apply to hospice care 61
programs.62

       Sec. 3712.04.  (A) Every person or public agency that 63
proposes to provide a hospice care program shall apply to the 64
department of health for a license. Application shall be made on 65
forms prescribed and provided by the department, shall include 66
such information as the department requires, and shall be 67
accompanied by the license fee established by rules of the 68
director of health adopted under division (A) of section 3712.03 69
of the Revised Code.70

       The department shall grant a license to the applicant if the 71
applicant is in compliance with this chapter and rules adopted 72
under it.73

       (B) A license granted under this section shall be valid for 74
three years. Application for renewal of a license shall be made at 75
least ninety days before the expiration of the license in the same 76
manner as for an initial license, except that, if the program 77
provides hospice care and services in a hospice patient's home, 78
the application for renewal shall include written evidence 79
demonstrating that the applicant is in compliance with section 80
3712.062 of the Revised Code. The department shall renew the 81
license if the applicant meets the requirements of this chapter 82
and rules adopted under it.83

       (C) Subject to Chapter 119. of the Revised Code, the 84
department may suspend or revoke a license if the licensee made 85
any material misrepresentation in the application for the license 86
or no longer meets the requirements of this chapter or rules 87
adopted under it.88

       (D) A hospital, nursing home, home for the aged, county 89
medical care facility, or other health facility or agency that 90
provides a hospice care program shall be licensed to provide a 91
hospice care program under this section.92

       (E) A nursing home licensed under Chapter 3721. of the 93
Revised Code that does not hold itself out to be a hospice, does 94
not hold itself out as providing a hospice care program, does not 95
use the term hospice to describe or refer to its activities or 96
facilities, and that does not provide all of the services 97
enumerated in division (A) of section 3712.01 of the Revised Code 98
is not subject to the licensing provisions of this chapter.99

       Sec. 3712.062. (A) Each hospice care program licensed under 100
this chapter that provides hospice care and services in a hospice 101
patient's home shall establish a written policy establishing 102
procedures to be followed in preventing the diversion of 103
controlled substances containing opioids that are prescribed to 104
its hospice patients. The policy shall include procedures for the 105
disposal of any such drugs prescribed to a hospice patient as part 106
of the patient's interdisciplinary plan of care that are 107
relinquished to the program after the patient's death or that 108
otherwise are no longer needed by the patient. The policy shall 109
require that the disposal be documented by a program employee and 110
conducted in any of the following ways:111

        (1) Performed by a program employee and witnessed by the 112
patient or patient's family member; 113

       (2) Performed by the patient or patient's family member and 114
witnessed by a program employee;115

       (3) Performed by a program employee and witnessed by another 116
program employee.117

       (B) As part of a hospice patient's interdisciplinary plan of 118
care required by section 3712.06 of the Revised Code, each hospice 119
care program that provides hospice care and services in the 120
patient's home shall do all of the following:121

       (1) Before providing hospice care and services, distribute a 122
copy of the written policy established under division (A) of this 123
section to the patient and patient's family and discuss the 124
procedures included in the policy with the patient and patient's 125
family;126

       (2) Assess the patient, the patient's family, and the care 127
environment for any risk factors associated with diversion;128

       (3) Maintain records of controlled substances containing 129
opioids prescribed to the patient and included in the patient's 130
interdisciplinary plan of care, including accurate counts of the 131
numbers dispensed and used;132

       (4) Monitor the use and consumption of controlled substances 133
containing opioids prescribed to the patient and included in the 134
patient's interdisciplinary plan of care, including prescription 135
refills, for signs of diversion;136

       (5) Investigate any sign of suspected diversion in accordance 137
with rules adopted under division (A)(5) of section 3712.03 of the 138
Revised Code.139

       (6) Report the results of an investigation of suspected 140
diversion to the local law enforcement agency with jurisdiction 141
over the territory in which the hospice patient's home is located 142
in accordance with rules adopted under division (A)(6) of section 143
3712.03 of the Revised Code;144

       (7) Before providing hospice care and services, inform the 145
patient and the patient's family that the hospice care program 146
will dispose of any controlled substances containing opioids that 147
are no longer needed by the patient and were included in the 148
patient's interdisciplinary plan of care;149

       (8) After the patient's death or when no longer needed by the 150
patient, request, in writing, that the patient or patient's family 151
relinquish to the program for disposal any remaining controlled 152
substances containing opioids that were included in the patient's 153
interdisciplinary plan of care to the program;154

       (9) Report to the local law enforcement agency with 155
jurisdiction over the territory in which the hospice patient's 156
home is located the quantity and type of any remaining controlled 157
substances containing opioids that were included in the patient's 158
interdisciplinary plan of care and were not relinquished to the 159
program by the patient or patient's family.160

       (C) If a hospice care program complies with divisions (B)(8) 161
and (9) of this section, none of the following shall be liable in 162
damages to any person or government entity in a civil action for 163
injury, death, or loss to person or property that allegedly arises 164
from an action or omission relative to this section unless the 165
action or omission constitutes willful or wanton misconduct: the 166
program; a program employee, officer, or director; or a prescriber 167
of controlled substances containing opioids that were included in 168
the patient's interdisciplinary plan of care.169

       (D) No person who receives a written request under division 170
(B)(8) of this section shall fail to relinquish controlled 171
substances containing opioids that were included in a patient's 172
interdisciplinary plan of care.173

       (E) Following a report from a hospice program under division 174
(B)(9) of this section, the local law enforcement agency with 175
jurisdiction over the territory in which the hospice patient's 176
home is located shall investigate and dispose of the remaining 177
controlled substances containing opioids that were reported to the 178
agency pursuant to division (B)(9) of this section.179

       (F) After a review of the written evidence submitted under 180
division (B) of section 3712.04 of the Revised Code with an 181
application for license renewal, if the department determines that 182
the program is not in compliance with this section, the department 183
may suspend the program's license for not more than six months and 184
impose a fine not to exceed twenty thousand dollars.185

       (G) Not later than one year after the effective date of this 186
section, the director of health shall adopt rules in accordance 187
with Chapter 119. of the Revised Code establishing standards and 188
procedures for the submission and review of the written evidence 189
required by division (B) of section 3712.04 of the Revised Code 190
for renewal of a hospice care program license.191

       Sec. 3712.99. (A) Any person who violates division (A) of 192
section 3712.05 or division (A) of section 3712.051 of the Revised 193
Code is guilty of a misdemeanor of the second degree on a first 194
offense; on each subsequent offense the person is guilty of a 195
misdemeanor of the first degree.196

       (B) Any person who violates division (D) of section 3712.062 197
of the Revised Code is guilty of a minor misdemeanor.198

       Section 2. That existing sections 3712.03, 3712.04, and 199
3712.99 of the Revised Code are hereby repealed.200

       Section 3. Not later than one year after the effective date 201
of this act, each hospice care program that holds a license under 202
Chapter 3712. of the Revised Code on the act's effective date and 203
that provides hospice care and services in a hospice patient's 204
home shall submit to the Department of Health written evidence 205
demonstrating that the program is in compliance with section 206
3712.062 of the Revised Code, as enacted by this act. After a 207
review of the evidence submitted, if the Department determines 208
that the program is not in compliance with that section, the 209
Department may suspend the program's license for not more than six 210
months and impose a fine not to exceed twenty thousand dollars.211