As Introduced

128th General Assembly
Regular Session
2009-2010
H. B. No. 582


Representatives Burke, Bubp 


A BILL
To amend sections 4729.75, 4729.77, 4729.79, 4729.83, 1
4729.84, and 5111.172 and to enact sections 2
4729.791, 4729.821, 4729.831, 4731.055, 5111.179, 3
and 5111.1710 of the Revised Code regarding the 4
State Board of Pharmacy's drug database and a 5
program for certain Medicaid recipients found to 6
have over used items or services.7


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

       Section 1. That sections 4729.75, 4729.77, 4729.79, 4729.83, 8
4729.84, and 5111.172 be amended and sections 4729.791, 4729.821, 9
4729.831, 4731.055, 5111.179, and 5111.1710 of the Revised Code be 10
enacted to read as follows:11

       Sec. 4729.75. (A) The state board of pharmacy may establish 12
and maintain a drug database. The board shall use the drug 13
database to monitor the misuse and diversion of controlled 14
substances, as defined in section 3719.01 of the Revised Code, and 15
other dangerous drugs the board includes in the database pursuant 16
to rules adopted under section 4729.83 of the Revised Code. In 17
establishing and maintaining the database, the board shall 18
electronically collect information pursuant to sections 4729.77 19
and 4729.78 of the Revised Code and shall disseminate information 20
as authorized or required by sectionssection 4729.79 and as 21
required by sections 4729.791 and 4729.80 of the Revised Code. The 22
board's collection and dissemination of information shall be 23
conducted in accordance with rules adopted under section 4729.83 24
of the Revised Code.25

       (B) A drug database established under this section shall 26
include both of the following:27

       (1) A process that permits information to be immediately 28
submitted to the database by those required by section 4729.77 of 29
the Revised Code to submit information to the board;30

       (2) The capacity to provide those authorized to view 31
information in the database immediate access to that information. 32

       Sec. 4729.77. (A) If the state board of pharmacy establishes 33
and maintains a drug database pursuant to section 4729.75 of the 34
Revised Code, each pharmacy licensed as a terminal distributor of 35
dangerous drugs that dispenses drugs to patients in this state and 36
is included in the types of pharmacies specified in rules adopted 37
under section 4729.83 of the Revised Code shall submit to the 38
board the following prescription information:39

       (1) Terminal distributor identification;40

        (2) Patient identification;41

        (3) Prescriber identification;42

        (4) Purchaser identification, including any unique identifier 43
established in rules adopted by the board under division (B) of 44
section 4729.83 of the Revised Code;45

       (5) Date prescription was issued by prescriber;46

       (5)(6) Date prescription was dispensed;47

       (6)(7) Indication of whether prescription dispensed is new or 48
a refill;49

       (7)(8) Name, strength, and national drug code of the drug 50
dispensed;51

       (8)(9) Quantity of drug dispensed;52

       (9)(10) Number of days' supply of drug dispensed;53

       (10)(11) Serial or prescription number assigned by the 54
terminal distributor;55

       (11)(12) Source of payment for the prescription.56

       (B) The information shall be transmitted as specified by the 57
board in rules adopted under section 4729.83 of the Revised Code.58

       (1) The information shall be submitted electronically in the 59
format specified by the board, except that the board may grant a 60
waiver allowing the distributor to submit the information in 61
another format.62

       (2) The information shall be submitted in accordance with any 63
time limits specified by the board, except that the board may 64
grant an extension if either of the following occurs:65

       (a) The distributor suffers a mechanical or electronic 66
failure, or cannot meet the deadline for other reasons beyond the 67
distributor's control.68

       (b) The board is unable to receive electronic submissions.69

       (C) This section does not apply to a prescriber personally 70
furnishing or administering dangerous drugs to the prescriber's 71
patient.72

       (D) If, based on review of information in the database, a 73
pharmacist at a pharmacy elects not to dispense a drug to a 74
patient, the pharmacy shall submit to the board the information 75
required by divisions (A)(1), (2), (3), and (5) of this section; 76
the name, strength, national drug code, and quantity of the 77
prescribed drug; and an indication that the drug was not 78
dispensed.79

       Sec. 4729.79. (A) If the state board of pharmacy establishes 80
and maintains a drug database pursuant to section 4729.75 of the 81
Revised Code, the board may provide information from the database 82
in accordance with the following:83

       (1) On receipt of a request from a designated representative 84
of a government entity responsible for the licensure, regulation, 85
or discipline of licensed health care professionals authorized to 86
prescribe drugs, the board may provide to the representative 87
information from the database relating to the professional who is 88
the subject of an active investigation being conducted by the 89
government entity.90

       (2) On receipt of a request from a federal officer, or a 91
state or local officer of this or any other state, whose duties 92
include enforcing laws relating to drugs, the board may provide to 93
the officer information from the database relating to the person 94
who is the subject of an active investigation being conducted by 95
the officer's employing government entity.96

       (3) Pursuant to a subpoena issued by a grand jury, the board 97
may provide to the grand jury information from the database 98
relating to the person who is the subject of an investigation 99
being conducted by the grand jury.100

       (4) On receipt of a request from a pharmacist or prescriber, 101
the board may provide to the requestor information from the 102
database relating to a current patient of the requestor, if the 103
requestor certifies in a form specified by the board that it is 104
for the purpose of providing medical or pharmaceutical treatment 105
to the patient who is the subject of the request.106

       (5) On receipt of a request from an individual seeking the 107
individual's own database information in accordance with the 108
procedure established in rules adopted under section 4729.83 of 109
the Revised Code, the board may provide to the individual the 110
individual's own database information.111

       (5) On receipt of a request from a managed care organization 112
that has entered into a data security agreement with the board 113
required by section 5111.1710 of the Revised Code, the board may 114
provide to the managed care organization information from the 115
database relating to a medicaid recipient enrolled in the managed 116
care organization. 117

       (B) The state board of pharmacy shall maintain a record of 118
each individual or entity that requests information from the 119
database pursuant to this section. In accordance with rules 120
adopted under section 4729.83 of the Revised Code, the board may 121
use the records to document and report statistics and law 122
enforcement outcomes.123

        The board may provide records of an individual's requests for 124
database information to the following:125

        (1) A designated representative of a government entity that 126
is responsible for the licensure, regulation, or discipline of 127
licensed health care professionals authorized to prescribe drugs 128
who is involved in an active investigation being conducted by the 129
government entity of the individual who submitted the requests for 130
database information;131

        (2) A federal officer, or a state or local officer of this or 132
any other state, whose duties include enforcing laws relating to 133
drugs and who is involved in an active investigation being 134
conducted by the officer's employing government entity of the 135
individual who submitted the requests for database information.136

       (C) Information contained in the database and any information 137
obtained from it is not a public record. Information contained in 138
the records of requests for information from the database is not a 139
public record. Information that does not identify a person may be 140
released in summary, statistical, or aggregate form.141

       (D) Nothing in this section requires a pharmacist or 142
prescriber to obtain information about a patient from the 143
database. A pharmacist or prescriber shall not be held liable in 144
damages to any person in any civil action for injury, death, or 145
loss to person or property on the basis that the pharmacist or 146
prescriber did or did not seek or obtain information from the 147
database.148

       Sec. 4729.791. (A) If the state board of pharmacy establishes 149
and maintains a drug database pursuant to section 4729.75 of the 150
Revised Code, the board shall grant access to the information in 151
the database to each licensed health professional authorized to 152
prescribe drugs and to each pharmacist practicing in this state. 153
The board shall grant access to the database in a manner that 154
enables each prescriber and pharmacist to use the database in 155
accordance with division (B) of this section or with rules adopted 156
by the state medical board under section 4731.055 of the Revised 157
Code.158

       (B) Before a prescriber issues a prescription to a patient 159
for a drug included in the database and before a pharmacist 160
dispenses such a drug, the prescriber and pharmacist may review 161
information in the database that pertains to the patient. At any 162
other time, a prescriber or pharmacist may review information in 163
the database pertaining to a patient for the purpose of providing 164
medical treatment or pharmacist services to the patient.165

       (C) A prescriber or pharmacist shall not be held liable in 166
damages to any person in a civil action for injury, death, or loss 167
to person or property on the basis that the prescriber or 168
pharmacist did or did not review information in the database 169
pertaining to a patient.170

       (D) Except as provided in rules adopted under section 171
4731.055 of the Revised Code, nothing in this section requires a 172
pharmacist or prescriber to obtain information about a patient 173
from the database.174

       Sec. 4729.821. If the state board of pharmacy establishes and 175
maintains a drug database pursuant to section 4729.75 of the 176
Revised Code, the department of health, the department of 177
insurance, and the state board of pharmacy shall, to the extent 178
existing eligible funds are available, cooperate to contribute 179
sufficient funds to permit the board to develop and operate in the 180
drug database the capacity to immediately update database 181
information and allow immediate access by authorized users, as 182
provided by section 4729.75 of the Revised Code. The departments 183
and board shall seek funding sources to permit the board to 184
develop and operate the drug database in that manner. In doing so, 185
the departments and board may collaborate to apply for grants or 186
seek federal funds that may be available for developing and 187
operating the drug database. 188

       The director of budget and management may transfer cash 189
between funds of the department of health, the department of 190
insurance, and the state board of pharmacy as necessary to achieve 191
the objectives of this section.192

       Sec. 4729.83. For purposes of establishing and maintaining a 193
drug database pursuant to section 4729.75 of the Revised Code, the 194
state board of pharmacy shall adopt rules in accordance with 195
Chapter 119. of the Revised Code to carry out and enforce sections 196
4729.75 to 4729.82 of the Revised Code. The rules shall specify 197
all of the following:198

       (A) A means of identifying each patient, terminal distributor 199
of dangerous drugs, and each purchase at wholesale of dangerous 200
drugs about which information is entered into the drug database;201

       (B) A means of identifying each purchaser of dangerous drugs, 202
which may include assignment of a unique identifier for each 203
purchaser;204

       (C) A means for a pharmacy to indicate that a pharmacist has 205
elected not to dispense a drug to a patient;206

       (D) Requirements for the transmission of information from 207
terminal distributors and wholesale distributors of dangerous 208
drugs for purposes of the database;209

       (C)(E) An electronic format for the submission of information 210
from terminal distributors and wholesale distributors of dangerous 211
drugs;212

       (D)(F) A procedure whereby a terminal distributor or a 213
wholesale distributor of dangerous drugs unable to submit 214
information electronically may obtain a waiver to submit 215
information in another format;216

       (E)(G) A procedure whereby the board may grant a request from 217
a law enforcement agency or a government entity responsible for 218
the licensure, regulation, or discipline of licensed health care 219
professionals authorized to prescribe drugs that information that 220
has been stored for two years be retained when the information 221
pertains to an open investigation being conducted by the agency or 222
entity;223

       (F)(H) A procedure whereby a terminal or wholesale 224
distributor may apply for an extension to the time by which 225
information must be transmitted to the board;226

       (G)(I) A procedure whereby a person or government entity to 227
which the board is authorized to provide information may submit a 228
request to the board for the information and the board may verify 229
the identity of the requestor;230

       (H)(J) A procedure whereby the board can use the database 231
request records required by division (B) of section 4729.79 of the 232
Revised Code to document and report statistics and law enforcement 233
outcomes;234

       (I)(K) A procedure whereby an individual may request the 235
individual's own database information and the board may verify the 236
identity of the requestor;237

       (J)(L) A reasonable fee that the board may charge under 238
section 4729.82 of the Revised Code for providing an individual 239
with the individual's own database information pursuant to section 240
4729.79 of the Revised Code;241

       (K)(M) The specific dangerous drugs other than controlled 242
substances that must be included in the database;243

       (L)(N) The types of pharmacies licensed as terminal 244
distributors of dangerous drugs that are required to submit 245
prescription information to the board pursuant to section 4729.77 246
of the Revised Code;247

       (O) The manner in which prescribers and pharmacists are to be 248
granted access to the database for purposes of section 4729.791 of 249
the Revised Code.250

       Sec. 4729.831. The state board of pharmacy shall adopt rules 251
in accordance with Chapter 119. of the Revised Code specifying the 252
terms of a data security agreement described in section 5111.1710 253
of the Revised Code. The rules shall comply with privacy and 254
security regulations promulgated under the "Health Insurance 255
Portability and Accountability Act of 1996," Pub. L. No. 104-191, 256
as amended, as specified in 45 C.F.R. Parts 160 and 164, as 257
amended.258

       Sec. 4729.84. (A) If the state board of pharmacy establishes 259
and maintains a drug database pursuant to section 4729.75 of the 260
Revised Code, the board shall present a biennial report to the 261
standing committees of the house of representatives and the senate 262
that are primarily responsible for considering health and human 263
services issues. The initial report shall be presented not later 264
than two years after the database is established.265

       (B) Each report presented under this section shall include 266
all of the following:267

        (1) The cost to the state of establishing and maintaining the 268
database;269

       (2) Information from terminal distributors of dangerous 270
drugs, prescribers, and the board regarding the board's 271
effectiveness in providing information from the database;272

       (3) The board's timeliness in transmitting information from 273
the database;274

       (4) The total number of prescriptions for which drugs were 275
not dispensed due to the election of a pharmacist as indicated by 276
information provided to the board under division (D) of section 277
4729.77 of the Revised Code.278

       Sec. 4731.055. (A) As used in this section:279

       (1) "Dangerous drug" has the same meaning as in section 280
4729.01 of the Revised Code.281

       (2) "Drug database" means a database established by the state 282
board of pharmacy pursuant to section 4729.75 of the Revised Code.283

       (3) "Physician" means an individual authorized under this 284
chapter to practice medicine and surgery or osteopathic medicine 285
and surgery.286

       (B) The state medical board shall adopt rules in accordance 287
with Chapter 119. of the Revised Code that establish standards and 288
procedures to be followed by physicians regarding review of 289
patient information available through the drug database. The rules 290
shall include at least one of the following:291

       (1) A provision under which a physician who prescribes to 292
patients, in total, a quantity of dangerous drugs exceeding an 293
amount specified by the board is required to submit patient 294
information to the drug database and review patient information in 295
it;296

       (2) A provision under which a physician who prescribes to an 297
individual patient a supply of dangerous drugs exceeding an amount 298
specified by the board is required to submit patient information 299
in the drug database and review patient information in it.300

       (C) The rules adopted under this section shall not apply if 301
the state board of pharmacy does not establish a drug database or 302
discontinues operation of a drug database.303

       Sec. 5111.172.  (A) When contracting under section 5111.17 of 304
the Revised Code with a managed care organization that is a health 305
insuring corporation, the department of job and family services 306
may require the health insuring corporation to provide coverage of 307
prescription drugs for medicaid recipients enrolled in the health 308
insuring corporation. In providing the required coverage, the 309
health insuring corporation may, subject to the department's 310
approval, use strategies for the management of drug utilization.311

       (B) As used in this division, "controlled substance" has the 312
same meaning as in section 3719.01 of the Revised Code.313

       If a health insuring corporation is required under this 314
section to provide coverage of prescription drugs, the department 315
shall permit the health insuring corporation to develop and 316
implement a pharmacy utilization management program under which 317
prior authorization through the program is established as a 318
condition of obtaining a controlled substance pursuant to a 319
prescription. TheAny such program may include processes for 320
requiring medicaid recipients at high risk for fraud or abuse 321
involving controlled substances to have their prescriptions for 322
controlled substances filled by a pharmacy, medical provider, or 323
health care facility designated byshall be consistent with the 324
program the health insuring corporation is required to implement 325
under section 5111.179 of the Revised Code.326

       Sec. 5111.179. Not later than one year after the effective 327
date of this section, each contract the department of job and 328
family services enters into with a managed care organization under 329
section 5111.17 of the Revised Code shall require the managed care 330
organization to implement a program consistent with 42 U.S.C. 331
1396n(a)(2) and 42 C.F.R. 431.54(e) for medicaid recipients 332
enrolled in the organization who are found to have utilized items 333
or services under the medicaid program at a frequency or amount 334
that is not medically necessary. The program shall include a 335
component that educates medicaid recipients about proper 336
utilization of items and services provided under the medicaid 337
program.338

       Sec. 5111.1710. Not later than one year after the effective 339
date of this section and if the state board of pharmacy 340
establishes and maintains a drug database pursuant to section 341
4729.75 of the Revised Code, each contract the department of job 342
and family services enters into with a managed care organization 343
under section 5111.17 of the Revised Code shall require the 344
managed care organization to enter into a data security agreement 345
with the board governing the managed care organization's use of 346
the database. The data security agreement shall contain terms 347
specified by the board in rules adopted pursuant to section 348
4729.831 of the Revised Code.349

       Section 2. That existing sections 4729.75, 4729.77, 4729.79, 350
4729.83, 4729.84, and 5111.172 of the Revised Code are hereby 351
repealed.352