Bill Text: OH HB582 | 2009-2010 | 128th General Assembly | Introduced

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Bill Title: Regarding the State Board of Pharmacy's drug database and a program for certain Medicaid recipients found to have over used items or services.

Spectrum: Partisan Bill (Republican 2-0)

Status: (Introduced - Dead) 2010-09-16 - To Health [HB582 Detail]

Download: Ohio-2009-HB582-Introduced.html

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As Introduced

128th General Assembly Regular Session 2009-2010

H. B. No. 582

Representatives Burke, Bubp 

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A BILL

To amend sections 4729.75, 4729.77, 4729.79, 4729.83,

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4729.84, and 5111.172 and to enact sections

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4729.791, 4729.821, 4729.831, 4731.055, 5111.179,

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and 5111.1710 of the Revised Code regarding the

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State Board of Pharmacy's drug database and a

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program for certain Medicaid recipients found to

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have over used items or services.

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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;

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

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(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:

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(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