CT
Connecticut Senate Bill SB00202

Connecticut 2024 Regular Session

Connecticut Senate Bill SB00202 Compare Versions

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7+General Assembly Substitute Bill No. 202
8+February Session, 2024
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4-Substitute Senate Bill No. 202
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6-Public Act No. 24-80
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914 AN ACT CONCERNING THE DEPARTMENT OF CONSUMER
10-PROTECTION'S RECOMMENDATIONS REGARDING
11-PRESCRIPTION DRUG CONTROL.
15+PROTECTION'S RECOMMENDATIONS REGARDING PRESCRIPTION
16+DRUG CONTROL.
1217 Be it enacted by the Senate and House of Representatives in General
1318 Assembly convened:
1419
15-Section 1. Subsection (a) of section 21a-65 of the 2024 supplement to
16-the general statutes is repealed and the following is substituted in lieu
17-thereof (Effective from passage):
18-(a) A licensed manufacturer or licensed wholesaler may sell
19-hypodermic needles and syringes only to the following: (1) To a licensed
20-manufacturer, licensed wholesaler or licensed pharmacy; (2) to [a] an
21-advanced practice registered nurse, dentist, embalmer, optometrist,
22-physician, [dentist,] physician assistant, podiatrist, scientific
23-investigator or veterinarian [, embalmer, podiatrist or scientific
24-investigator] licensed to practice in this state; (3) to a person in charge of
25-a care-giving institution, as defined in section 20-571, incorporated
26-college or scientific institution, but only for use by or in such care-giving
27-institution, college or institution for medical or scientific purposes; (4)
28-to a person in charge of a licensed or registered laboratory, but only for
29-use in that laboratory for scientific and medical purposes; (5) to a farmer
30-but only for use on the farmer's own animals or poultry; (6) to a business
31-authorized in accordance with the regulations adopted under section Substitute Senate Bill No. 202
20+Section 1. Subsection (a) of section 21a-65 of the 2024 supplement to 1
21+the general statutes is repealed and the following is substituted in lieu 2
22+thereof (Effective from passage): 3
23+(a) A licensed manufacturer or licensed wholesaler may sell 4
24+hypodermic needles and syringes only to the following: (1) To a licensed 5
25+manufacturer, licensed wholesaler or licensed pharmacy; (2) to [a] an 6
26+advanced practice registered nurse, dentist, embalmer, optometrist, 7
27+physician, [dentist,] physician assistant, podiatrist, scientific 8
28+investigator or veterinarian [, embalmer, podiatrist or scientific 9
29+investigator] licensed to practice in this state; (3) to a person in charge of 10
30+a care-giving institution, as defined in section 20-571, incorporated 11
31+college or scientific institution, but only for use by or in such care-giving 12
32+institution, college or institution for medical or scientific purposes; (4) 13
33+to a person in charge of a licensed or registered laboratory, but only for 14
34+use in that laboratory for scientific and medical purposes; (5) to a farmer 15
35+but only for use on the farmer's own animals or poultry; (6) to a business 16
36+authorized in accordance with the regulations adopted under section 17 Substitute Bill No. 202
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33-Public Act No. 24-80 2 of 10
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35-21a-66 to purchase hypodermic needles and syringes but only for
36-legitimate industrial or medical use within that business; and (7) to a
37-syringe services program established pursuant to section 19a-124.
38-Sec. 2. Section 21a-70h of the 2024 supplement to the general statutes
39-is repealed and the following is substituted in lieu thereof (Effective from
40-passage):
41-For the purposes of this section and sections 21a-70i to 21a-70k, as
42-amended by this act:
43-(1) "Commissioner" means the Commissioner of Consumer
44-Protection or the commissioner's authorized representative;
45-(2) "Contact" means any communication transmitted in person or by
46-telephone, electronic mail, text message or other electronic means
47-between a pharmaceutical representative and a prescribing practitioner
48-or pharmacist, to promote or provide information relating to a legend
49-drug;
50-(3) "Department" means the Department of Consumer Protection;
51-(4) "Legend drug" has the same meaning as provided in section 20-
52-571;
53-(5) "Pharmaceutical manufacturer" (A) means a [(A)] (i) person,
54-whether within or without the boundaries of the state of Connecticut,
55-that (I) produces, prepares, cultivates, grows, propagates, compounds,
56-converts or processes a drug, [device or cosmetic,] directly or indirectly,
57-by extraction from substances of natural origin, by means of chemical
58-synthesis or by a combination of extraction and chemical synthesis, or
59-[that] (II) packages, repackages, labels or relabels a drug container under
60-such manufacturer's own trademark or label, or any other trademark or
61-label, [or a drug, device or cosmetic] for the purpose of selling the drug,
62-[device or cosmetic,] or [(B)] (ii) sterile compounding pharmacy, as Substitute Senate Bill No. 202
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43+21a-66 to purchase hypodermic needles and syringes but only for 18
44+legitimate industrial or medical use within that business; and (7) to a 19
45+syringe services program established pursuant to section 19a-124. 20
46+Sec. 2. Section 21a-70h of the 2024 supplement to the general statutes 21
47+is repealed and the following is substituted in lieu thereof (Effective from 22
48+passage): 23
49+For the purposes of this section and sections 21a-70i to 21a-70k, as 24
50+amended by this act: 25
51+(1) "Commissioner" means the Commissioner of Consumer 26
52+Protection or the commissioner's authorized representative; 27
53+(2) "Contact" means any communication transmitted in person or by 28
54+telephone, electronic mail, text message or other electronic means 29
55+between a pharmaceutical representative and a prescribing practitioner 30
56+or pharmacist, to promote or provide information relating to a legend 31
57+drug; 32
58+(3) "Department" means the Department of Consumer Protection; 33
59+(4) "Legend drug" has the same meaning as provided in section 20-34
60+571; 35
61+(5) "Pharmaceutical manufacturer" (A) means a [(A)] (i) person, 36
62+whether within or without the boundaries of the state of Connecticut, 37
63+that (I) produces, prepares, cultivates, grows, propagates, compounds, 38
64+converts or processes a drug, [device or cosmetic,] directly or indirectly, 39
65+by extraction from substances of natural origin, by means of chemical 40
66+synthesis or by a combination of extraction and chemical synthesis, or 41
67+[that] (II) packages, repackages, labels or relabels a drug container under 42
68+such manufacturer's own trademark or label, or any other trademark or 43
69+label, [or a drug, device or cosmetic] for the purpose of selling the drug, 44
70+[device or cosmetic,] or [(B)] (ii) sterile compounding pharmacy, as 45
71+defined in section 20-633b that dispenses sterile pharmaceuticals 46
72+without a prescription or a patient-specific medical order intended for 47 Substitute Bill No. 202
6573
66-defined in section 20-633b that dispenses sterile pharmaceuticals
67-without a prescription or a patient-specific medical order intended for
68-use in humans, and (B) includes, but is not limited to, a virtual
69-manufacturer, as defined in section 20-571;
70-[(6) "Pharmaceutical manufacturer" includes a virtual manufacturer,
71-as defined in section 20-571;]
72-[(7)] (6) "Pharmaceutical marketing firm" means a pharmaceutical
73-manufacturer that employs or compensates pharmaceutical
74-representatives;
75-[(8)] (7) "Pharmaceutical representative" means any person,
76-including, but not limited to, a sales representative, who markets,
77-promotes or provides information regarding a legend drug for human
78-use to a prescribing practitioner and is employed or compensated by a
79-pharmaceutical manufacturer;
80-[(9)] (8) "Pharmacist" has the same meaning as provided in section 20-
81-571; and
82-[(10)] (9) "Prescribing practitioner" has the same meaning as provided
83-in section 20-571.
84-Sec. 3. Section 21a-70i of the 2024 supplement to the general statutes
85-is repealed and the following is substituted in lieu thereof (Effective from
86-passage):
87-(a) On and after October 1, 2023, a pharmaceutical manufacturer that
88-employs [an individual to perform the duties of] a pharmaceutical
89-[sales] representative shall register annually with the department as a
90-pharmaceutical marketing firm, in a form and manner prescribed by the
91-commissioner. No pharmaceutical manufacturer shall authorize an
92-individual to perform [such] the duties of a pharmaceutical
93-representative on such manufacturer's behalf unless such manufacturer Substitute Senate Bill No. 202
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97-has obtained a pharmaceutical marketing firm registration from the
98-department pursuant to this section. Registrations issued pursuant to
99-this section shall expire annually on June thirtieth.
100-(b) The nonrefundable fee for registration as a pharmaceutical
101-marketing firm and for annual renewal of such registration shall be one
102-hundred fifty dollars. Any pharmaceutical marketing firm that fails to
103-renew its registration on or before June thirtieth shall pay a late fee of
104-one hundred dollars for each year that such firm did not renew, in
105-addition to the annual renewal fee required under this section.
106-(c) On the date of its initial registration, and annually thereafter, each
107-pharmaceutical marketing firm shall provide to the department a list of
108-all [individuals] pharmaceutical representatives employed or
109-compensated by such firm. [as a pharmaceutical sales representative.]
110-Each pharmaceutical marketing firm shall notify the department, in a
111-form and manner prescribed by the commissioner, of each individual
112-who is no longer employed or compensated as a pharmaceutical [sales]
113-representative or who was hired or compensated as a pharmaceutical
114-representative after the date on which such firm provided such annual
115-list, not later than two weeks after such individual leaves employment
116-or was hired or otherwise compensated.
117-(d) The department shall prominently post on its Internet web site the
118-most recent list provided by each pharmaceutical marketing firm
119-pursuant to subsection (c) of this section.
120-(e) Any person who is not identified to the department pursuant to
121-subsection (c) of this section shall not perform the duties of a
122-pharmaceutical [sales] representative on behalf of the pharmaceutical
123-marketing firm. [for any prescribing practitioner in this state.]
124-(f) Not later than July 1, 2024, and annually thereafter, each
125-pharmaceutical marketing firm shall provide the commissioner with the Substitute Senate Bill No. 202
79+use in humans, and (B) includes, but is not limited to, a virtual 48
80+manufacturer, as defined in section 20-571; 49
81+[(6) "Pharmaceutical manufacturer" includes a virtual manufacturer, 50
82+as defined in section 20-571;] 51
83+[(7)] (6) "Pharmaceutical marketing firm" means a pharmaceutical 52
84+manufacturer that employs or compensates pharmaceutical 53
85+representatives; 54
86+[(8)] (7) "Pharmaceutical representative" means any person, 55
87+including, but not limited to, a sales representative, who markets, 56
88+promotes or provides information regarding a legend drug for human 57
89+use to a prescribing practitioner and is employed or compensated by a 58
90+pharmaceutical manufacturer; 59
91+[(9)] (8) "Pharmacist" has the same meaning as provided in section 20-60
92+571; and 61
93+[(10)] (9) "Prescribing practitioner" has the same meaning as provided 62
94+in section 20-571. 63
95+Sec. 3. Section 21a-70i of the 2024 supplement to the general statutes 64
96+is repealed and the following is substituted in lieu thereof (Effective from 65
97+passage): 66
98+(a) On and after October 1, 2023, a pharmaceutical manufacturer that 67
99+employs [an individual to perform the duties of] a pharmaceutical 68
100+[sales] representative shall register annually with the department as a 69
101+pharmaceutical marketing firm, in a form and manner prescribed by the 70
102+commissioner. No pharmaceutical manufacturer shall authorize an 71
103+individual to perform [such] the duties of a pharmaceutical 72
104+representative on such manufacturer's behalf unless such manufacturer 73
105+has obtained a pharmaceutical marketing firm registration from the 74
106+department pursuant to this section. Registrations issued pursuant to 75
107+this section shall expire annually on June thirtieth. 76 Substitute Bill No. 202
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129-following information regarding the performance for the previous
130-calendar year of each of its pharmaceutical [sales] representatives
131-identified to the department pursuant to subsection (c) of this section at
132-any time during the previous calendar year, in a form and manner
133-prescribed by the commissioner:
134-(1) The aggregate number of contacts such pharmaceutical [sales]
135-representative had with prescribing practitioners and pharmacists;
136-(2) The specialty of [each] such prescribing practitioner and each
137-pharmacist with whom such pharmaceutical [sales] representative
138-made contact;
139-(3) Whether product samples, materials or gifts of any value were
140-provided to a prescribing practitioner or such practitioner's staff in a
141-prescribing practitioner's office or to a pharmacist; and
142-(4) An aggregate report of all free samples, by drug name and
143-strength, in a form and manner prescribed by the commissioner.
144-(g) The department shall annually [analyze the information
145-submitted pursuant to this section and] compile a report on the activities
146-of pharmaceutical [sales representatives] marketing firms in the state.
147-Not later than December [1] 31, 2024, and annually thereafter, the
148-department shall post such report on its Internet web site and submit
149-such report to the Secretary of the Office of Policy and Management.
150-Sec. 4. Section 21a-70j of the 2024 supplement to the general statutes
151-is repealed and the following is substituted in lieu thereof (Effective from
152-passage):
153-Each pharmaceutical marketing firm that employs or compensates a
154-pharmaceutical representative who is engaged in marketing, promoting
155-or providing information regarding a legend drug [marketing] for
156-human use in this state shall [disclose] ensure that such pharmaceutical Substitute Senate Bill No. 202
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114+(b) The nonrefundable fee for registration as a pharmaceutical 77
115+marketing firm and for annual renewal of such registration shall be one 78
116+hundred fifty dollars. Any pharmaceutical marketing firm that fails to 79
117+renew its registration on or before June thirtieth shall pay a late fee of 80
118+one hundred dollars for each year that such firm did not renew, in 81
119+addition to the annual renewal fee required under this section. 82
120+(c) On the date of its initial registration, and annually thereafter, each 83
121+pharmaceutical marketing firm shall provide to the department a list of 84
122+all [individuals] pharmaceutical representatives employed or 85
123+compensated by such firm. [as a pharmaceutical sales representative.] 86
124+Each pharmaceutical marketing firm shall notify the department, in a 87
125+form and manner prescribed by the commissioner, of each individual 88
126+who is no longer employed or compensated as a pharmaceutical [sales] 89
127+representative or who was hired or compensated as a pharmaceutical 90
128+representative after the date on which such firm provided such annual 91
129+list, not later than two weeks after such individual leaves employment 92
130+or was hired or otherwise compensated. 93
131+(d) The department shall prominently post on its Internet web site the 94
132+most recent list provided by each pharmaceutical marketing firm 95
133+pursuant to subsection (c) of this section. 96
134+(e) Any person who is not identified to the department pursuant to 97
135+subsection (c) of this section shall not perform the duties of a 98
136+pharmaceutical [sales] representative on behalf of the pharmaceutical 99
137+marketing firm. [for any prescribing practitioner in this state.] 100
138+(f) Not later than July 1, 2024, and annually thereafter, each 101
139+pharmaceutical marketing firm shall provide the commissioner with the 102
140+following information regarding the performance for the previous 103
141+calendar year of each of its pharmaceutical [sales] representatives 104
142+identified to the department pursuant to subsection (c) of this section at 105
143+any time during the previous calendar year, in a form and manner 106
144+prescribed by the commissioner: 107 Substitute Bill No. 202
159145
160-representative discloses, in writing, to a prescribing practitioner or
161-pharmacist, [at the] each time [of each] such pharmaceutical
162-representative makes contact with [such] the prescribing practitioner or
163-pharmacist: [, the following information:]
164-(1) The list price of a legend drug when such pharmaceutical
165-representative provides information concerning [such] the legend drug
166-to [the] such prescribing practitioner or pharmacist based on the dose
167-and quantity of such legend drug as described in the medication
168-package insert; and
169-(2) Information on the variation efficacy of the legend drug marketed
170-to different racial and ethnic groups, if such information is available.
171-Sec. 5. Section 19a-17d of the 2024 supplement to the general statutes
172-is repealed and the following is substituted in lieu thereof (Effective from
173-passage):
174-If a [pharmacist or] health care professional who is currently licensed
175-or was previously licensed in another state or jurisdiction is subject to
176-automatic reciprocal discipline for a disciplinary action in such state or
177-jurisdiction, such automatic reciprocal discipline shall be automatically
178-rescinded and shall not be entered into the licensing record of the
179-[pharmacist or] health care professional if the discipline was based
180-solely on the termination of pregnancy under conditions that would not
181-violate the general statutes or the regulations of Connecticut state
182-agencies. The provisions of this section shall not preclude or affect the
183-ability of an agency or board of the state to seek or impose any discipline
184-pursuant to the general statutes against a [pharmacist or other] health
185-care professional licensed by the state.
186-Sec. 6. Subsection (a) of section 21a-70k of the 2024 supplement to the
187-general statutes is repealed and the following is substituted in lieu
188-thereof (Effective from passage): Substitute Senate Bill No. 202
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192-(a) The commissioner may (1) refuse to authorize the issuance or
193-renewal of a registration to operate as a pharmaceutical marketing firm,
194-(2) revoke, suspend or place conditions on a registration to operate as a
195-pharmaceutical marketing firm, and (3) assess a penalty of up to one
196-thousand dollars for each violation of any provision of section 21a-70i,
197-as amended by this act, or 21a-70j, as amended by this act, or take other
198-action permitted by [subdivision (7) of subsection (a) of section 21a-7]
199-section 21a-11, if the applicant or holder of the registration fails to
200-comply with the requirements set forth in section 21a-70i, as amended
201-by this act, or 21a-70j, as amended by this act.
202-Sec. 7. Section 21a-322 of the general statutes is repealed and the
203-following is substituted in lieu thereof (Effective from passage):
204-(a) The [commissioner] Commissioner of Consumer Protection may
205-suspend, revoke or refuse to renew a registration, place a registration on
206-probation, place conditions on a registration and assess a civil penalty
207-of not more than one thousand dollars per violation of this chapter, for
208-sufficient cause. Any of the following shall be sufficient cause for such
209-action by the commissioner: (1) The furnishing of false or fraudulent
210-information in any application filed under this chapter; (2) conviction of
211-a crime under any state or federal law relating to the registrant's
212-profession, controlled substances or drugs or fraudulent practices,
213-including, but not limited to, fraudulent billing practices; (3) failure to
214-maintain effective controls against diversion of controlled substances
215-into other than duly authorized legitimate medical, scientific, or
216-commercial channels; (4) the suspension, revocation, expiration or
217-surrender of the practitioner's federal controlled substance registration;
218-(5) prescribing, distributing, administering or dispensing a controlled
219-substance in schedules other than those specified in the practitioner's
220-state or federal registration or in violation of any condition placed on
221-the practitioner's registration; (6) suspension, revocation, expiration,
222-surrender or other disciplinary action taken against any professional Substitute Senate Bill No. 202
151+(1) The aggregate number of contacts such pharmaceutical [sales] 108
152+representative had with prescribing practitioners and pharmacists; 109
153+(2) The specialty of [each] such prescribing practitioner and each 110
154+pharmacist with whom such pharmaceutical [sales] representative 111
155+made contact; 112
156+(3) Whether product samples, materials or gifts of any value were 113
157+provided to a prescribing practitioner or such practitioner's staff in a 114
158+prescribing practitioner's office or to a pharmacist; and 115
159+(4) An aggregate report of all free samples, by drug name and 116
160+strength, in a form and manner prescribed by the commissioner. 117
161+(g) The department shall annually [analyze the information 118
162+submitted pursuant to this section and] compile a report on the activities 119
163+of pharmaceutical [sales representatives] marketing firms in the state. 120
164+Not later than December [1] 31, 2024, and annually thereafter, the 121
165+department shall post such report on its Internet web site and submit 122
166+such report to the Secretary of the Office of Policy and Management. 123
167+Sec. 4. Section 21a-70j of the 2024 supplement to the general statutes 124
168+is repealed and the following is substituted in lieu thereof (Effective from 125
169+passage): 126
170+Each pharmaceutical marketing firm that employs or compensates a 127
171+pharmaceutical representative who is engaged in marketing, promoting 128
172+or providing information regarding a legend drug [marketing] for 129
173+human use in this state shall [disclose] ensure that such pharmaceutical 130
174+representative discloses, in writing, to a prescribing practitioner or 131
175+pharmacist, [at the] each time [of each] such pharmaceutical 132
176+representative makes contact with [such] the prescribing practitioner or 133
177+pharmacist: [, the following information:] 134
178+(1) The list price of a legend drug when such pharmaceutical 135
179+representative provides information concerning [such] the legend drug 136
180+to [the] such prescribing practitioner or pharmacist based on the dose 137 Substitute Bill No. 202
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226-license or registration held by the practitioner; (7) abuse or excessive use
227-of drugs; (8) possession, use, prescription for use or distribution of
228-controlled substances or legend drugs, except for therapeutic or other
229-proper medical or scientific purpose; (9) a practitioner's failure to
230-account for disposition of controlled substances as determined by an
231-audit of the receipt and disposition records of said practitioner; (10)
232-failure to keep records of medical evaluations of patients and all
233-controlled substances dispensed, administered or prescribed to patients
234-by a practitioner; (11) failure to establish and implement administrative
235-safeguards for the protection of electronic protected health information
236-pursuant to 45 CFR 164.308, as amended from time to time; and (12)
237-breach of any such safeguards by a prescribing practitioner's authorized
238-agent.
239-(b) If a practitioner dispenses, administers or prescribes any
240-controlled substance to a patient, the practitioner shall make available
241-to the Department of Consumer Protection, for inspection by the
242-department, records of medical evaluations associated with dispensing,
243-administering or prescribing such controlled substance. Such records
244-shall be confidential and not be subject to disclosure under the Freedom
245-of Information Act, as defined in section 1-200. The department may
246-inspect such records solely for the purpose of investigating any violation
247-or suspected violation, or enforcing any provision, of this chapter or any
248-regulation promulgated under this chapter. Nothing in this subsection
249-shall be construed to require disclosure of any substance abuse
250-treatment record that is protected from disclosure under 42 USC 290dd-
251-2, as amended from time to time, or other applicable federal law.
252-Sec. 8. Subparagraphs (A) and (B) of subdivision (10) of subsection (j)
253-of section 21a-254 of the general statutes are repealed and the following
254-is substituted in lieu thereof (Effective from passage):
255-(10) (A) A prescribing practitioner may designate an authorized
256-agent to review the electronic prescription drug monitoring program Substitute Senate Bill No. 202
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187+and quantity of such legend drug as described in the medication 138
188+package insert; and 139
189+(2) Information on the variation efficacy of the legend drug marketed 140
190+to different racial and ethnic groups, if such information is available. 141
191+Sec. 5. Section 19a-17d of the 2024 supplement to the general statutes 142
192+is repealed and the following is substituted in lieu thereof (Effective from 143
193+passage): 144
194+If a [pharmacist or] health care professional who is currently licensed 145
195+or was previously licensed in another state or jurisdiction is subject to 146
196+automatic reciprocal discipline for a disciplinary action in such state or 147
197+jurisdiction, such automatic reciprocal discipline shall be automatically 148
198+rescinded and shall not be entered into the licensing record of the 149
199+[pharmacist or] health care professional if the discipline was based 150
200+solely on the termination of pregnancy under conditions that would not 151
201+violate the general statutes or the regulations of Connecticut state 152
202+agencies. The provisions of this section shall not preclude or affect the 153
203+ability of an agency or board of the state to seek or impose any discipline 154
204+pursuant to the general statutes against a [pharmacist or other] health 155
205+care professional licensed by the state. 156
206+Sec. 6. Subsection (a) of section 21a-70k of the 2024 supplement to the 157
207+general statutes is repealed and the following is substituted in lieu 158
208+thereof (Effective from passage): 159
209+(a) The commissioner may (1) refuse to authorize the issuance or 160
210+renewal of a registration to operate as a pharmaceutical marketing firm, 161
211+(2) revoke, suspend or place conditions on a registration to operate as a 162
212+pharmaceutical marketing firm, and (3) assess a penalty of up to one 163
213+thousand dollars for each violation of any provision of section 21a-70i, 164
214+as amended by this act, or 21a-70j, as amended by this act, or take other 165
215+action permitted by [subdivision (7) of subsection (a) of section 21a-7] 166
216+section 21a-11, if the applicant or holder of the registration fails to 167
217+comply with the requirements set forth in section 21a-70i, as amended 168 Substitute Bill No. 202
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260-and patient controlled substance prescription information on behalf of
261-the prescribing practitioner. The prescribing practitioner shall ensure
262-that any authorized agent's access to such program and patient
263-controlled substance prescription information is limited to the purposes
264-described in this section and occurs in a manner that protects the
265-confidentiality of information that is accessed through such program.
266-The prescribing practitioner and any authorized agent shall be subject
267-to the provisions of 45 CFR 164.308, as amended from time to time,
268-concerning administrative safeguards for the protection of electronic
269-protected health information. A prescribing practitioner may be subject
270-to disciplinary action for acts of the authorized agent as provided in
271-subsection (a) of section 21a-322, as amended by this act.
272-(B) Notwithstanding the provisions of subparagraph (A) of this
273-subdivision, a prescribing practitioner who is employed by or provides
274-professional services to a hospital shall, prior to designating an
275-authorized agent to review the electronic prescription drug monitoring
276-program and patient controlled substance prescription information on
277-behalf of the prescribing practitioner, (i) submit a request to designate
278-one or more authorized agents for such purposes and a written protocol
279-for oversight of the authorized agent or agents to the commissioner, in
280-the form and manner prescribed by the commissioner, and (ii) receive
281-the commissioner's approval to designate such authorized agent or
282-agents and of such written protocol. Such written protocol shall
283-designate either the hospital's medical director, a hospital department
284-head, who is a prescribing practitioner, or another prescribing
285-practitioner as the person responsible for ensuring that the authorized
286-agent's or agents' access to such program and patient controlled
287-substance prescription information is limited to the purposes described
288-in this section and occurs in a manner that protects the confidentiality
289-of information that is accessed through such program. A hospital
290-medical director, a hospital department head, who is a prescribing
291-practitioner, or another prescribing practitioner designated as the Substitute Senate Bill No. 202
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295-person responsible for overseeing an authorized agent's or agents'
296-access to such program and information in the written protocol
297-approved by the commissioner may be subject to disciplinary action for
298-acts of the authorized agent or agents as provided in subsection (a) of
299-section 21a-322, as amended by this act. The commissioner may inspect
300-hospital records to determine compliance with written protocols
301-approved in accordance with this section.
224+by this act, or 21a-70j, as amended by this act. 169
225+Sec. 7. Section 21a-322 of the general statutes is repealed and the 170
226+following is substituted in lieu thereof (Effective from passage): 171
227+(a) The [commissioner] Commissioner of Consumer Protection may 172
228+suspend, revoke or refuse to renew a registration, place a registration on 173
229+probation, place conditions on a registration and assess a civil penalty 174
230+of not more than one thousand dollars per violation of this chapter, for 175
231+sufficient cause. Any of the following shall be sufficient cause for such 176
232+action by the commissioner: (1) The furnishing of false or fraudulent 177
233+information in any application filed under this chapter; (2) conviction of 178
234+a crime under any state or federal law relating to the registrant's 179
235+profession, controlled substances or drugs or fraudulent practices, 180
236+including, but not limited to, fraudulent billing practices; (3) failure to 181
237+maintain effective controls against diversion of controlled substances 182
238+into other than duly authorized legitimate medical, scientific, or 183
239+commercial channels; (4) the suspension, revocation, expiration or 184
240+surrender of the practitioner's federal controlled substance registration; 185
241+(5) prescribing, distributing, administering or dispensing a controlled 186
242+substance in schedules other than those specified in the practitioner's 187
243+state or federal registration or in violation of any condition placed on 188
244+the practitioner's registration; (6) suspension, revocation, expiration, 189
245+surrender or other disciplinary action taken against any professional 190
246+license or registration held by the practitioner; (7) abuse or excessive use 191
247+of drugs; (8) possession, use, prescription for use or distribution of 192
248+controlled substances or legend drugs, except for therapeutic or other 193
249+proper medical or scientific purpose; (9) a practitioner's failure to 194
250+account for disposition of controlled substances as determined by an 195
251+audit of the receipt and disposition records of said practitioner; (10) 196
252+failure to keep records of medical evaluations of patients and all 197
253+controlled substances dispensed, administered or prescribed to patients 198
254+by a practitioner; (11) failure to establish and implement administrative 199
255+safeguards for the protection of electronic protected health information 200
256+pursuant to 45 CFR 164.308, as amended from time to time; and (12) 201 Substitute Bill No. 202
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263+breach of any such safeguards by a prescribing practitioner's authorized 202
264+agent. 203
265+(b) If a practitioner dispenses, administers or prescribes any 204
266+controlled substance to a patient, the practitioner shall make available 205
267+to the Department of Consumer Protection, for inspection by the 206
268+department, records of medical evaluations associated with dispensing, 207
269+administering or prescribing such controlled substance. Such records 208
270+shall be confidential and not be subject to disclosure under the Freedom 209
271+of Information Act, as defined in section 1-200. The department may 210
272+inspect such records solely for the purpose of investigating any violation 211
273+or suspected violation, or enforcing any provision, of this chapter or any 212
274+regulation promulgated under this chapter. Nothing in this subsection 213
275+shall be construed to require disclosure of any substance abuse 214
276+treatment record that is protected from disclosure under 42 USC 290dd-215
277+2, as amended from time to time, or other applicable federal law. 216
278+Sec. 8. Subparagraphs (A) and (B) of subdivision (10) of subsection (j) 217
279+of section 21a-254 of the general statutes are repealed and the following 218
280+is substituted in lieu thereof (Effective from passage): 219
281+(10) (A) A prescribing practitioner may designate an authorized 220
282+agent to review the electronic prescription drug monitoring program 221
283+and patient controlled substance prescription information on behalf of 222
284+the prescribing practitioner. The prescribing practitioner shall ensure 223
285+that any authorized agent's access to such program and patient 224
286+controlled substance prescription information is limited to the purposes 225
287+described in this section and occurs in a manner that protects the 226
288+confidentiality of information that is accessed through such program. 227
289+The prescribing practitioner and any authorized agent shall be subject 228
290+to the provisions of 45 CFR 164.308, as amended from time to time, 229
291+concerning administrative safeguards for the protection of electronic 230
292+protected health information. A prescribing practitioner may be subject 231
293+to disciplinary action for acts of the authorized agent as provided in 232
294+subsection (a) of section 21a-322, as amended by this act. 233 Substitute Bill No. 202
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301+(B) Notwithstanding the provisions of subparagraph (A) of this 234
302+subdivision, a prescribing practitioner who is employed by or provides 235
303+professional services to a hospital shall, prior to designating an 236
304+authorized agent to review the electronic prescription drug monitoring 237
305+program and patient controlled substance prescription information on 238
306+behalf of the prescribing practitioner, (i) submit a request to designate 239
307+one or more authorized agents for such purposes and a written protocol 240
308+for oversight of the authorized agent or agents to the commissioner, in 241
309+the form and manner prescribed by the commissioner, and (ii) receive 242
310+the commissioner's approval to designate such authorized agent or 243
311+agents and of such written protocol. Such written protocol shall 244
312+designate either the hospital's medical director, a hospital department 245
313+head, who is a prescribing practitioner, or another prescribing 246
314+practitioner as the person responsible for ensuring that the authorized 247
315+agent's or agents' access to such program and patient controlled 248
316+substance prescription information is limited to the purposes described 249
317+in this section and occurs in a manner that protects the confidentiality 250
318+of information that is accessed through such program. A hospital 251
319+medical director, a hospital department head, who is a prescribing 252
320+practitioner, or another prescribing practitioner designated as the 253
321+person responsible for overseeing an authorized agent's or agents' 254
322+access to such program and information in the written protocol 255
323+approved by the commissioner may be subject to disciplinary action for 256
324+acts of the authorized agent or agents as provided in subsection (a) of 257
325+section 21a-322, as amended by this act. The commissioner may inspect 258
326+hospital records to determine compliance with written protocols 259
327+approved in accordance with this section. 260
328+This act shall take effect as follows and shall amend the following
329+sections:
330+
331+Section 1 from passage 21a-65(a)
332+Sec. 2 from passage 21a-70h
333+Sec. 3 from passage 21a-70i
334+Sec. 4 from passage 21a-70j
335+Sec. 5 from passage 19a-17d Substitute Bill No. 202
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342+Sec. 6 from passage 21a-70k(a)
343+Sec. 7 from passage 21a-322
344+Sec. 8 from passage 21a-254(j)(10)(A) and (B)
345+
346+Statement of Legislative Commissioners:
347+In Section 7(b), ", as amended from time to time," was added for
348+consistency with standard drafting conventions.
349+
350+GL Joint Favorable Subst.
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