*HB1158.2*
Reprinted
January 28, 2022
HOUSE BILL No. 1158
_____
DIGEST OF HB 1158 (Updated January 27, 2022 4:04 pm - DI 77)
Citations Affected: IC 5-10; IC 12-8; IC 12-9; IC 12-11; IC 12-28;
IC 16-18; IC 16-41; IC 21-38; IC 25-26; IC 27-8; IC 34-30; IC 34-46;
IC 35-52; noncode.
Synopsis: Health and human services matters. Allows an advanced
practice registered nurse or physician assistant to sign certain
individualized family service plans. Changes the composition and
duties of the division of disability and rehabilitative services advisory
council. Requires the services for individuals with intellectual and
other developmental disabilities task force to establish a subcommittee
to make certain recommendations to the task force. Modifies provisions
concerning records and information about the human
immunodeficiency virus (HIV) and acquired immune deficiency
syndrome. Repeals provisions concerning the following: (1) Reports to
a health officer about a person who is believed to be a serious and
present risk to the health of others. (2) Physician notification to: (A) a
patient with a serious communicable disease; (B) a health officer; and
(C) a person at risk. Changes the membership on the Indiana board of
pharmacy. Removes the requirement that a qualifying pharmacist is
responsible for the legal operations of a pharmacy. Specifies
responsibilities of pharmacists concerning duties previously
(Continued next page)
Effective: Upon passage; July 1, 2022.
Clere, Olthoff, Davisson J.,
Shackleford
January 6, 2022, read first time and referred to Committee on Public Health.
January 20, 2022, amended, reported — Do Pass.
January 27, 2022, read second time, amended, ordered engrossed.
HB 1158—LS 7067/DI 137 Digest Continued
responsible by a qualifying pharmacist. Allows a qualified pharmacy
technician to administer immunizations delegated by the pharmacist.
(Current law allows pharmacy technicians to administer influenza and
coronavirus disease immunizations.) Amends requirements for remote
pharmacies. Adds an exception to the definition of "wholesale
distribution" for prescription drugs. Repeals certain offenses
concerning: (1) notification, reporting, and investigation related to
communicable diseases; and (2) the donation, sale, or transfer of semen
that contains antibodies for HIV. Makes technical and conforming
changes.
HB 1158—LS 7067/DI 137HB 1158—LS 7067/DI 137 Reprinted
January 28, 2022
Second Regular Session of the 122nd General Assembly (2022)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in this style type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
between statutes enacted by the 2021 Regular Session of the General Assembly.
HOUSE BILL No. 1158
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 5-10-8-7.3, AS AMENDED BY P.L.133-2020,
2 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
3 JULY 1, 2022]: Sec. 7.3. (a) As used in this section, "covered
4 individual" means an individual who is:
5 (1) covered under a self-insurance program established under
6 section 7(b) of this chapter to provide group health coverage; or
7 (2) entitled to services under a contract with a prepaid health care
8 delivery plan that is entered into or renewed under section 7(c) of
9 this chapter.
10 (b) As used in this section, "early intervention services" means
11 services provided to a first steps child under IC 12-12.7-2 and 20
12 U.S.C. 1432(4).
13 (c) As used in this section, "first steps child" means an infant or
14 toddler from birth through two (2) years of age who is enrolled in the
15 Indiana first steps program and is a covered individual.
16 (d) As used in this section, "first steps program" refers to the
17 program established under IC 12-12.7-2 and 20 U.S.C. 1431 et seq. to
HB 1158—LS 7067/DI 137 2
1 meet the needs of:
2 (1) children who are eligible for early intervention services; and
3 (2) their families.
4 The term includes the coordination of all available federal, state, local,
5 and private resources available to provide early intervention services
6 within Indiana.
7 (e) As used in this section, "health benefits plan" means a:
8 (1) self-insurance program established under section 7(b) of this
9 chapter to provide group health coverage; or
10 (2) contract with a prepaid health care delivery plan that is
11 entered into or renewed under section 7(c) of this chapter.
12 (f) A health benefits plan that provides coverage for early
13 intervention services shall reimburse the first steps program a monthly
14 fee established by the division of disability and rehabilitative services
15 established by IC 12-9-1-1. Except when the monthly fee is less than
16 the product determined under IC 12-12.7-2-23(b), the monthly fee shall
17 be provided instead of claims processing of individual claims.
18 (g) The reimbursement required under subsection (f) may not be
19 applied to any annual or aggregate lifetime limit on the first steps
20 child's coverage under the health benefits plan.
21 (h) The first steps program may pay required deductibles,
22 copayments, or other out-of-pocket expenses for a first steps child
23 directly to a provider. A health benefits plan shall apply any payments
24 made by the first steps program to the health benefits plan's
25 deductibles, copayments, or other out-of-pocket expenses according to
26 the terms and conditions of the health benefits plan.
27 (i) A health benefits plan may not require authorization for services
28 specified in the covered individual's individualized family service plan,
29 if those services are a covered benefit under the plan, once the
30 individualized family service plan is signed by a physician, a physician
31 assistant, or an advanced practice registered nurse.
32 (j) The department of insurance shall adopt rules under IC 4-22-2
33 to ensure compliance with this section.
34 SECTION 2. IC 12-8-2.5-3, AS ADDED BY P.L.160-2012,
35 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
36 JULY 1, 2022]: Sec. 3. Unless Except as provided in IC 12-9-4-7, or
37 otherwise provided by a another statute, this chapter applies to the
38 following:
39 (1) The following advisory councils:
40 (A) The division of disability and rehabilitative services
41 advisory council.
42 (B) The division of family resources advisory council.
HB 1158—LS 7067/DI 137 3
1 (C) The division of mental health and addiction advisory
2 council.
3 (2) A body:
4 (A) established by statute for a division; and
5 (B) whose enabling statute makes this chapter applicable to
6 the body.
7 SECTION 3. IC 12-9-4-2, AS AMENDED BY P.L.141-2006,
8 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
9 JULY 1, 2022]: Sec. 2. The division of disability and rehabilitative
10 services advisory council is established to advise and assist the
11 division of disability and rehabilitative services in its effort to
12 develop and sustain a system of supports and services for people
13 with intellectual and developmental disabilities. The council will
14 provide technical expertise and lived experiences and advise on
15 specific areas such as:
16 (1) technology;
17 (2) health;
18 (3) policy;
19 (4) law;
20 (5) marketing;
21 (6) public relations;
22 (7) provider services; and
23 (8) advocacy.
24 SECTION 4. IC 12-9-4-3 IS AMENDED TO READ AS FOLLOWS
25 [EFFECTIVE JULY 1, 2022]: Sec. 3. The council consists of the
26 following eleven (11) sixteen (16) members:
27 (1) The director.
28 (2) Ten (10) individuals:
29 (A) appointed by the secretary; and
30 (B) who have a recognized knowledge of or interest in the
31 programs administered by the division.
32 (2) An individual representing The Arc of Indiana, appointed
33 by The Arc of Indiana.
34 (3) An individual representing the Indiana Association of
35 Rehabilitation Facilities (INARF), appointed by INARF.
36 (4) An individual representing the Self-Advocates of Indiana,
37 appointed by the Self-Advocates of Indiana.
38 (5) A representative of the governor's council for people with
39 disabilities established by IC 4-23-29-7, appointed by the
40 director.
41 (6) A representative of a case management provider
42 contracting with the bureau of developmental disabilities
HB 1158—LS 7067/DI 137 4
1 services established by IC 12-11-1.1-1 to provide family
2 supports Medicaid waiver and community integration
3 habilitation Medicaid waiver case management services,
4 appointed by the director.
5 (7) An individual representing the Indiana Association of
6 Behavior Consultants, appointed by the Indiana Association
7 of Behavior Consultants.
8 (8) An individual representing the Indiana Institute on
9 Disability and Community, appointed by the Indiana Institute
10 on Disability and Community.
11 (9) An individual representing the Indiana Resource Center
12 for Families with Special Needs (INSOURCE), appointed by
13 INSOURCE.
14 (10) An individual representing Indiana Disability Rights,
15 appointed by Indiana Disability Rights.
16 (11) An individual representing Indiana Family to Family,
17 appointed by Indiana Family to Family.
18 (12) Two (2) members, appointed by the director, each of
19 whom is an individual with an intellectual or other
20 developmental disability.
21 (13) Two (2) members, appointed by the director, each of
22 whom is an immediate or extended family member of an
23 individual with an intellectual or other developmental
24 disability.
25 (14) One (1) member, appointed by the director, who is
26 employed by an agency that provides services to people with
27 intellectual or other developmental disabilities.
28 SECTION 5. IC 12-9-4-4, AS AMENDED BY P.L.160-2012,
29 SECTION 23, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
30 JULY 1, 2022]: Sec. 4. Each member of the council appointed under
31 section 3(2) through 3(14) of this chapter has a fixed term as provided
32 in IC 12-8-2.5-4. serves at the will of the appointing authority.
33 SECTION 6. IC 12-9-4-6 IS AMENDED TO READ AS FOLLOWS
34 [EFFECTIVE JULY 1, 2022]: Sec. 6. The council shall meet at least
35 monthly six (6) times annually and is subject to special meetings at the
36 call of its presiding officer.
37 SECTION 7. IC 12-9-4-6.5 IS ADDED TO THE INDIANA CODE
38 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
39 1, 2022]: Sec. 6.5. (a) The division shall provide the council with a
40 quarterly report containing the following information relating to
41 Medicaid waivers:
42 (1) The number of current applications for an emergency
HB 1158—LS 7067/DI 137 5
1 placement priority waiver.
2 (2) The number of individuals served on a particular
3 Medicaid waiver.
4 (3) The number of individuals who are currently on a wait list
5 to be included in a Medicaid waiver.
6 (b) The division shall provide the council with a quarterly
7 report containing the following information relating to vocational
8 rehabilitation services:
9 (1) A status report of the division's effort to fill vocational
10 counselor vacancies.
11 (2) A status report of the order of selection.
12 (3) The number of individuals who submitted applications for
13 vocational rehabilitation services.
14 (4) The number of individuals who are currently on a wait list
15 to obtain vocational rehabilitation services.
16 (5) The number of individuals who are currently receiving
17 vocational rehabilitation services.
18 (c) The division shall provide the council with an annual report
19 summarizing any rate analysis, study, or review conducted by the
20 division.
21 (d) The division shall report to the council prior to any
22 submission of a Medicaid waiver amendment regarding the
23 changes being sought and an explanation of purpose.
24 (e) The division shall report to the council prior to any
25 submission for a renewal of a Medicaid waiver:
26 (1) any changes being proposed to the Medicaid waiver;
27 (2) the current and projected needs of each geographic area
28 of Indiana for residential services for individuals with
29 intellectual or developmental disabilities; and
30 (3) the availability of developmental or vocational services to
31 individuals with an intellectual or developmental disability
32 living in their own home.
33 SECTION 8. IC 12-9-4-7, AS AMENDED BY P.L.160-2012,
34 SECTION 24, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
35 JULY 1, 2022]: Sec. 7. IC 12-8-2.5 applies IC 12-8-2.5-9 through
36 IC 12-8-2.5-11.5 apply to the council.
37 SECTION 9. IC 12-11-15.5-4.5 IS ADDED TO THE INDIANA
38 CODE AS A NEW SECTION TO READ AS FOLLOWS
39 [EFFECTIVE UPON PASSAGE]: Sec. 4.5. (a) The task force shall
40 establish a subcommittee to make recommendations to the task
41 force regarding the:
42 (1) establishment of a statewide training curriculum for
HB 1158—LS 7067/DI 137 6
1 individuals who provide services to individuals with an
2 intellectual or other developmental disability;
3 (2) feasibility of establishing training certification;
4 (3) establishment of a statewide training registry; and
5 (4) feasibility of a pilot project to implement any
6 recommendations made under this section.
7 (b) Not later than September 1, 2022, the subcommittee shall
8 prepare and submit to the task force recommendations made by
9 the subcommittee.
10 (c) This section expires January 1, 2024.
11 SECTION 10. IC 12-11-15.5-4.6 IS ADDED TO THE INDIANA
12 CODE AS A NEW SECTION TO READ AS FOLLOWS
13 [EFFECTIVE UPON PASSAGE]: Sec. 4.6. (a) The task force shall
14 establish a subcommittee to make recommendations to the task
15 force regarding:
16 (1) current trends related to health and safety requests for the
17 community integration habilitation Medicaid waiver or any
18 other service; and
19 (2) the feasibility of the division establishing a pilot program
20 to create special service review teams to assist families or
21 individuals in a crisis situation to identify available resources
22 and sources of assistance.
23 (b) Not later than September 1, 2022, the subcommittee shall
24 prepare and submit to the task force recommendations made by
25 the subcommittee.
26 (c) This section expires January 1, 2024.
27 SECTION 11. IC 12-28-5-10, AS AMENDED BY P.L.210-2015,
28 SECTION 62, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
29 JULY 1, 2022]: Sec. 10. The division of disability and rehabilitative
30 services shall do the following:
31 (1) Determine the current and projected needs of each geographic
32 area of Indiana for residential services for individuals with a
33 developmental disability and, beginning July 1, 2012, annually
34 report the findings to the division of disability and rehabilitative
35 services advisory council established by IC 12-9-4-2.
36 (2) Determine how the provision of developmental or vocational
37 services for residents in these geographic areas affects the
38 availability of developmental or vocational services to individuals
39 with a developmental disability living in their own homes and,
40 beginning July 1, 2012, report the findings to the division of
41 disability and rehabilitative services advisory council established
42 by IC 12-9-4-2.
HB 1158—LS 7067/DI 137 7
1 (3) (1) Develop standards for licensure of supervised group living
2 facilities regarding the following:
3 (A) A sanitary and safe environment for residents and
4 employees.
5 (B) Classification of supervised group living facilities.
6 (C) Any other matters that will ensure that the residents will
7 receive a residential environment.
8 (4) (2) Develop standards for the approval of entities providing
9 supported living services.
10 SECTION 12. IC 12-28-5-12, AS AMENDED BY P.L.210-2015,
11 SECTION 63, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
12 JULY 1, 2022]: Sec. 12. (a) The division may license only those
13 supervised group living facilities that:
14 (1) meet the standards established under section 10 of this
15 chapter; and
16 (2) are necessary to provide adequate services to individuals with
17 a developmental disability in that geographic area.
18 (b) Notwithstanding 460 IAC 9-3-7(c) and 460 IAC 9-3-7(d), the
19 division shall license one (1) supervised group living facility that is
20 located less than one thousand (1,000) feet from another supervised
21 group living facility or a sheltered workshop under the following
22 conditions:
23 (1) Both of the supervised group living facilities meet all
24 standards for licensure as provided in section 10(3) 10(1) of this
25 chapter.
26 (2) Both of the supervised group living facilities are built on land
27 that is owned by one (1) private entity.
28 (3) The supervised group living facilities provides job
29 opportunities for residents of the supervised group living
30 facilities, as appropriate.
31 (c) The division may approve an entity to provide supported living
32 services only if the entity meets the standards established under section
33 10 of this chapter.
34 SECTION 13. IC 16-18-2-275 IS AMENDED TO READ AS
35 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 275. (a) "Person at
36 risk", for purposes of IC 16-41-7-4, has the meaning set forth in
37 IC 16-41-7-4(a).
38 (b) "Person at risk", for purposes of IC 16-41-7-1, and IC 16-41-7-3,
39 has the meaning set forth in IC 16-41-7-1(c).
40 SECTION 14. IC 16-18-2-328, AS AMENDED BY P.L.112-2020,
41 SECTION 10, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
42 JULY 1, 2022]: Sec. 328. "Serious and present risk to the health of
HB 1158—LS 7067/DI 137 8
1 others", for purposes of IC 16-41-7 and IC 16-41-9, has the meaning set
2 forth in IC 16-41-7-2. means an individual with a communicable
3 disease who meets the following conditions:
4 (1) The individual with a communicable disease engages
5 repeatedly in a behavior that has been demonstrated
6 epidemiologically (as defined by rules adopted by the state
7 department under IC 4-22-2) to transmit a serious
8 communicable disease or that indicates a careless disregard
9 for the transmission of the disease to others.
10 (2) The individual with a communicable disease's past
11 behavior or statements indicate an imminent risk that the
12 individual with a communicable disease will engage in
13 behavior that transmits a serious communicable disease to
14 others.
15 (3) The individual with a communicable disease has failed or
16 refused to carry out the individual with a communicable
17 disease's duty to inform under IC 16-41-7-1.
18 SECTION 15. IC 16-41-1-5 IS ADDED TO THE INDIANA CODE
19 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
20 1, 2022]: Sec. 5. Local health officers may submit advisory
21 guidelines to the state department to implement this chapter. The
22 state department shall fully consider such advisory guidelines
23 before adopting a rule under IC 4-22-2-29 implementing this
24 chapter.
25 SECTION 16. IC 16-41-2-3 IS AMENDED TO READ AS
26 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The following
27 persons shall report to the state department each case of human
28 immunodeficiency virus (HIV) infection, including each confirmed
29 case of acquired immune deficiency syndrome (AIDS):
30 (1) A licensed physician.
31 (2) A hospital licensed under IC 16-21.
32 (3) A medical laboratory.
33 (4) The department of correction.
34 The report must comply with rules adopted by the state department.
35 (b) The records of the state department must indicate, if known:
36 (1) whether the individual had undergone any blood transfusions
37 before being diagnosed as having AIDS or HIV or AIDS
38 infection;
39 (2) the place the transfusions took place;
40 (3) the blood center that furnished the blood; and
41 (4) any other known risk factors.
42 (c) A case report concerning HIV infection that does not involve a
HB 1158—LS 7067/DI 137 9
1 confirmed case of AIDS submitted to the state department under this
2 section that involves an individual:
3 (1) enrolled in a formal research project for which a written study
4 protocol has been filed with the state department;
5 (2) who is tested anonymously at a designated counseling or
6 testing site; or
7 (3) who is tested by a health care provider permitted by rule by
8 the state department to use a number identifier code;
9 may not include the name or other identifying characteristics of the
10 individual tested.
11 SECTION 17. IC 16-41-2-5 IS AMENDED TO READ AS
12 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 5. A person who
13 reports information as required by this chapter does not satisfy the
14 duties that exist under IC 16-41-7-3 or in other laws to provide
15 notification to persons identified as being at significant risk of being
16 infected by the individual who is the subject of the report.
17 SECTION 18. IC 16-41-3-1, AS AMENDED BY P.L.112-2020,
18 SECTION 14, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
19 JULY 1, 2022]: Sec. 1. (a) The state department may adopt rules under
20 IC 4-22-2 concerning the compilation for statistical purposes of
21 information collected under IC 16-41-2.
22 (b) The state department shall adopt procedures to gather, monitor,
23 and tabulate case reports of incidents involving serious communicable
24 diseases or unnatural outbreaks of diseases known or suspected to be
25 used as weapons. The state department shall specifically engage in
26 medical surveillance, tabulation, and reporting of confirmed or
27 suspected cases set forth by the Centers for Disease Control and
28 Prevention of the United States Department of Health and Human
29 Services and the United States Public Health Service of the United
30 States Department of Health and Human Services.
31 (c) The state department shall notify the:
32 (1) department of homeland security;
33 (2) Indiana State Police; and
34 (3) county health department and local law enforcement agency
35 having jurisdiction of each unnatural outbreak or reported case
36 described in subsection (b);
37 as soon as possible after the state department receives a report under
38 subsection (b). Notification under this subsection must be made not
39 more than twenty-four (24) hours after receiving a report.
40 (d) Local health officers may submit advisory guidelines to the
41 state department to implement this chapter. The state department
42 shall fully consider such advisory guidelines before adopting a rule
HB 1158—LS 7067/DI 137 10
1 under IC 4-22-2-29 implementing this chapter.
2 SECTION 19. IC 16-41-5-4 IS ADDED TO THE INDIANA CODE
3 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
4 1, 2022]: Sec. 4. Local health officers may submit advisory
5 guidelines to the state department to implement this chapter. The
6 state department shall fully consider such advisory guidelines
7 before adopting a rule under IC 4-22-2-29 implementing this
8 chapter.
9 SECTION 20. IC 16-41-6-11, AS AMENDED BY P.L.112-2020,
10 SECTION 21, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
11 JULY 1, 2022]: Sec. 11. (a) The state department shall adopt rules
12 under IC 4-22-2 that include procedures:
13 (1) to inform the woman of the test results under this chapter,
14 whether they are positive or negative;
15 (2) for explaining the side effects of any treatment for HIV if the
16 test results under this chapter are positive; and
17 (3) to establish a process for a woman who tests positive under
18 this chapter to appeal the woman's status on a waiting list on a
19 treatment program for which the woman is eligible. The rule
20 must:
21 (A) include a requirement that the state department make a
22 determination in the process described in this subdivision not
23 later than seventy-two (72) hours after the state department
24 receives all the requested medical information; and
25 (B) set forth the necessary medical information that must be
26 provided to the state department and reviewed by the state
27 department in the process described in this subdivision.
28 (b) The state department shall maintain rules under IC 4-22-2 that
29 set forth standards to provide to women who are pregnant, before
30 delivery, at delivery, and after delivery, information concerning HIV.
31 The rules must include:
32 (1) an explanation of the nature of AIDS and HIV;
33 (2) information concerning discrimination and legal protections;
34 (3) information concerning the duty to notify persons at risk as
35 described in IC 16-41-7-1;
36 (4) information about risk behaviors for HIV transmission;
37 (5) information about the risk of transmission through breast
38 feeding;
39 (6) notification that if the woman chooses not to be tested for HIV
40 before delivery, at delivery the child will be tested subject to
41 section 4 of this chapter;
42 (7) procedures for obtaining informed, written consent for testing
HB 1158—LS 7067/DI 137 11
1 under this chapter;
2 (8) procedures for post-test counseling by a health care provider
3 when the test results are communicated to the woman, whether
4 the results are positive or negative;
5 (9) procedures for referral for physical and emotional services if
6 the test results are positive;
7 (10) procedures for explaining the importance of immediate entry
8 into medical care if the test results are positive; and
9 (11) procedures for explaining that the use of antiretroviral drugs
10 and other medical interventions lessen the likelihood of
11 transmitting HIV to the child during childbirth.
12 SECTION 21. IC 16-41-7-2 IS REPEALED [EFFECTIVE JULY 1,
13 2022]. Sec. 2. (a) An individual with a communicable disease is a
14 "serious and present risk to the health of others" under the following
15 conditions:
16 (1) The individual with a communicable disease engages
17 repeatedly in a behavior that has been demonstrated
18 epidemiologically (as defined by rules adopted by the state
19 department under IC 4-22-2) to transmit a serious communicable
20 disease or that indicates a careless disregard for the transmission
21 of the disease to others.
22 (2) The individual with a communicable disease's past behavior
23 or statements indicate an imminent risk that the individual with
24 a communicable disease will engage in behavior that transmits a
25 serious communicable disease to others.
26 (3) The individual with a communicable disease has failed or
27 refused to carry out the individual with a communicable disease's
28 duty to inform under section 1 of this chapter.
29 (b) A person who has reasonable cause to believe that a person:
30 (1) is a serious and present risk to the health of others as
31 described in subsection (a);
32 (2) has engaged in noncompliant behavior; or
33 (3) is suspected of being a person at risk (as described in section
34 1 of this chapter);
35 may report that information to a health officer.
36 (c) A person who makes a report under subsection (b) in good faith
37 is not subject to liability in a civil, an administrative, a disciplinary, or
38 a criminal action.
39 (d) A person who knowingly or recklessly makes a false report
40 under subsection (b) is civilly liable for actual damages suffered by a
41 person reported on and for punitive damages.
42 SECTION 22. IC 16-41-7-3 IS REPEALED [EFFECTIVE JULY 1,
HB 1158—LS 7067/DI 137 12
1 2022]. Sec. 3. (a) A licensed physician who diagnoses, treats, or
2 counsels a patient with a serious communicable disease shall inform
3 the patient of the patient's duty under section 1 of this chapter.
4 (b) A physician described in subsection (a) may notify the
5 following:
6 (1) A health officer if the physician has reasonable cause to
7 believe that a patient:
8 (A) is a serious and present risk to the health of others as
9 described in section 2(a) of this chapter;
10 (B) has engaged in noncompliant behavior; or
11 (C) is suspected of being a person at risk (as defined in section
12 1 of this chapter).
13 (2) A person at risk (as defined in section 1 of this chapter) or a
14 person legally responsible for the patient if the physician:
15 (A) has medical verification that the patient is an individual
16 with a communicable disease;
17 (B) knows the identity of the person at risk;
18 (C) has a reasonable belief of a significant risk of harm to the
19 identified person at risk;
20 (D) has reason to believe the identified person at risk has not
21 been informed and will not be informed of the risk by the
22 patient or another person; and
23 (E) has made reasonable efforts to inform the individual with
24 a communicable disease of the physician's intent to make or
25 cause the state department of health to make a disclosure to
26 the person at risk.
27 (c) A physician who notifies a person at risk under this section shall
28 do the following:
29 (1) Identify the serious communicable disease.
30 (2) Inform the person of available health care measures such as
31 counseling and testing.
32 (d) A physician who in good faith provides notification under this
33 section is not subject to liability in a civil, an administrative, a
34 disciplinary, or a criminal action.
35 (e) A patient's privilege with respect to a physician under
36 IC 34-46-3-1 is waived regarding:
37 (1) notification under subsection (b); and
38 (2) information provided about a patient's noncompliant behavior
39 in an investigation or action under this chapter, IC 16-41-2,
40 IC 16-41-3, IC 16-41-5, IC 16-41-6, IC 16-41-8, IC 16-41-9,
41 IC 16-41-13, IC 16-41-14, and IC 16-41-16.
42 (f) A physician's immunity from liability under subsection (d)
HB 1158—LS 7067/DI 137 13
1 applies only to the provision of information reasonably calculated to
2 protect an identified person who is at epidemiological risk of infection.
3 (g) A physician who notifies a person under this section is also
4 required to satisfy the reporting requirements under IC 16-41-2-2
5 through IC 16-41-2-8.
6 SECTION 23. IC 16-41-7-4 IS REPEALED [EFFECTIVE JULY 1,
7 2022]. Sec. 4. (a) As used in this section, "person at risk" means an
8 individual who in the best judgment of a licensed physician:
9 (1) has engaged in high risk activity (as defined in section 1 of
10 this chapter); or
11 (2) is in imminent risk of engaging in high risk activity (as
12 defined in section 1 of this chapter).
13 (b) If a health officer is notified in writing by a physician under
14 section 3(b)(1)(A) of this chapter of a patient:
15 (1) for whom the physician has medical verification that the
16 patient is an individual with a communicable disease; and
17 (2) who, in the best judgment of the physician, is a serious and
18 present risk to the health of others;
19 the health officer shall make an investigation of the individual with a
20 communicable disease as authorized in IC 16-41-5-2 to determine
21 whether the environmental conditions surrounding the individual with
22 a communicable disease or the conduct of the individual with a
23 communicable disease requires the intervention by the health officer or
24 designated health official to prevent the transmission of disease to
25 others.
26 (c) If the state department is requested in writing by a physician who
27 has complied with the requirements of section 3(b)(2) of this chapter
28 to notify a person at risk, the state department shall notify the person
29 at risk unless, in the opinion of the state department, the person at risk:
30 (1) has already been notified;
31 (2) will be notified; or
32 (3) will otherwise be made aware that the person is a person at
33 risk.
34 (d) The state department shall establish a confidential registry of all
35 persons submitting written requests under subsection (c).
36 (e) The state department shall adopt rules under IC 4-22-2 to
37 implement this section. Local health officers may submit advisory
38 guidelines to the state department to implement this chapter,
39 IC 16-41-1, IC 16-41-3, IC 16-41-5, IC 16-41-8, or IC 16-41-9. The
40 state department shall fully consider such advisory guidelines before
41 adopting a rule under IC 4-22-2-29 implementing this chapter,
42 IC 16-41-1, IC 16-41-3, IC 16-41-5, IC 16-41-8, or IC 16-41-9.
HB 1158—LS 7067/DI 137 14
1 SECTION 24. IC 16-41-7-5 IS REPEALED [EFFECTIVE JULY 1,
2 2022]. Sec. 5. (a) Except as provided in IC 35-45-21-3, a person who
3 recklessly violates or fails to comply with this chapter commits a Class
4 B misdemeanor.
5 (b) Each day a violation continues constitutes a separate offense.
6 SECTION 25. IC 16-41-8-7 IS ADDED TO THE INDIANA CODE
7 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
8 1, 2022]: Sec. 7. Local health officers may submit advisory
9 guidelines to the state department to implement this chapter. The
10 state department shall fully consider such advisory guidelines
11 before adopting a rule under IC 4-22-2-29 implementing this
12 chapter.
13 SECTION 26. IC 16-41-9-7, AS AMENDED BY P.L.112-2020,
14 SECTION 36, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
15 JULY 1, 2022]: Sec. 7. (a) An individual with a communicable disease
16 who:
17 (1) poses a serious and present risk to the health of others;
18 (2) has been voluntarily admitted to a hospital or other facility for
19 the treatment of tuberculosis or another serious communicable
20 disease; and
21 (3) who leaves the facility without authorized leave or against
22 medical advice or who fails to return from authorized leave;
23 shall be reported to a health officer by the facility not more than
24 twenty-four (24) hours after discovery of the individual with a
25 communicable disease's absence.
26 (b) If a health officer fails or refuses to institute or complete
27 necessary legal measures to prevent a health threat (as defined in
28 IC 16-41-7-2) by the individual with a communicable disease, the case
29 shall be referred to a designated health official for appropriate action
30 under this article.
31 SECTION 27. IC 16-41-9-16 IS ADDED TO THE INDIANA
32 CODE AS A NEW SECTION TO READ AS FOLLOWS
33 [EFFECTIVE JULY 1, 2022]: Sec. 16. Local health officers may
34 submit advisory guidelines to the state department to implement
35 this chapter. The state department shall fully consider such
36 advisory guidelines before adopting a rule under IC 4-22-2-29
37 implementing this chapter.
38 SECTION 28. IC 16-41-14-17 IS REPEALED [EFFECTIVE JULY
39 1, 2022]. Sec. 17. (a) This section does not apply to a person who
40 transfers for research purposes semen that contains antibodies for the
41 human immunodeficiency virus (HIV).
42 (b) A person who, for the purpose of artificial insemination,
HB 1158—LS 7067/DI 137 15
1 recklessly, knowingly, or intentionally donates, sells, or transfers semen
2 that contains antibodies for the human immunodeficiency virus (HIV)
3 commits transferring contaminated semen, a Level 5 felony. The
4 offense is a Level 4 felony if the offense results in the transmission of
5 the virus to another person.
6 SECTION 29. IC 21-38-6-1, AS AMENDED BY P.L.133-2020,
7 SECTION 18, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
8 JULY 1, 2022]: Sec. 1. (a) An employee health plan that provides
9 coverage for early intervention services shall reimburse the first steps
10 program a monthly fee established by the division of disability and
11 rehabilitative services. Except when the monthly fee is less than the
12 product determined under IC 12-12.7-2-23(b), the monthly fee shall be
13 provided instead of claims processing of individual claims.
14 (b) An employee health plan may not require authorization for
15 services specified in the covered individual's individualized family
16 service plan, if those services are a covered benefit under the plan,
17 once the individualized family service plan is signed by a physician, a
18 physician assistant, or an advanced practice registered nurse.
19 (c) The department of insurance shall adopt rules under IC 4-22-2
20 to ensure compliance with this section.
21 SECTION 30. IC 25-26-13-2, AS AMENDED BY P.L.207-2021,
22 SECTION 30, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
23 UPON PASSAGE]: Sec. 2. As used in this chapter:
24 "Administering" means the direct application of a drug to the body
25 of a person by injection, inhalation, ingestion, or any other means.
26 "Board" means the Indiana board of pharmacy.
27 "Controlled drugs" are those drugs on schedules I through V of the
28 federal Controlled Substances Act or on schedules I through V of
29 IC 35-48-2.
30 "Coronavirus disease" means the disease caused by the severe acute
31 respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
32 "Counseling" means effective communication between a pharmacist
33 and a patient concerning the contents, drug to drug interactions, route,
34 dosage, form, directions for use, precautions, and effective use of a
35 drug or device to improve the therapeutic outcome of the patient
36 through the effective use of the drug or device.
37 "Dispensing" means issuing one (1) or more doses of a drug in a
38 suitable container with appropriate labeling for subsequent
39 administration to or use by a patient.
40 "Drug" means:
41 (1) articles or substances recognized in the official United States
42 Pharmacopoeia, official National Formulary, official
HB 1158—LS 7067/DI 137 16
1 Homeopathic Pharmacopoeia of the United States, or any
2 supplement to any of them;
3 (2) articles or substances intended for use in the diagnosis, cure,
4 mitigation, treatment, or prevention of disease in man or animals;
5 (3) articles other than food intended to affect the structure or any
6 function of the body of man or animals; or
7 (4) articles intended for use as a component of any article
8 specified in subdivisions (1) through (3) and devices.
9 "Drug order" means a written order in a hospital or other health care
10 institution for an ultimate user for any drug or device, issued and
11 signed by a practitioner, or an order transmitted by other means of
12 communication from a practitioner, which is immediately reduced to
13 writing by the pharmacist, registered nurse, or other licensed health
14 care practitioner authorized by the hospital or institution. The order
15 shall contain the name and bed number of the patient; the name and
16 strength or size of the drug or device; unless specified by individual
17 institution policy or guideline, the amount to be dispensed either in
18 quantity or days; adequate directions for the proper use of the drug or
19 device when it is administered to the patient; and the name of the
20 prescriber.
21 "Drug regimen review" means the retrospective, concurrent, and
22 prospective review by a pharmacist of a patient's drug related history
23 that includes the following areas:
24 (1) Evaluation of prescriptions or drug orders and patient records
25 for drug allergies, rational therapy contradictions, appropriate
26 dose and route of administration, appropriate directions for use,
27 or duplicative therapies.
28 (2) Evaluation of prescriptions or drug orders and patient records
29 for drug-drug, drug-food, drug-disease, and drug-clinical
30 laboratory interactions.
31 (3) Evaluation of prescriptions or drug orders and patient records
32 for adverse drug reactions.
33 (4) Evaluation of prescriptions or drug orders and patient records
34 for proper utilization and optimal therapeutic outcomes.
35 "Drug utilization review" means a program designed to measure and
36 assess on a retrospective and prospective basis the proper use of drugs.
37 "Device" means an instrument, apparatus, implement, machine,
38 contrivance, implant, in vitro reagent, or other similar or related article
39 including any component part or accessory, which is:
40 (1) recognized in the official United States Pharmacopoeia,
41 official National Formulary, or any supplement to them;
42 (2) intended for use in the diagnosis of disease or other conditions
HB 1158—LS 7067/DI 137 17
1 or the cure, mitigation, treatment, or prevention of disease in man
2 or other animals; or
3 (3) intended to affect the structure or any function of the body of
4 man or other animals and which does not achieve any of its
5 principal intended purposes through chemical action within or on
6 the body of man or other animals and which is not dependent
7 upon being metabolized for the achievement of any of its
8 principal intended purposes.
9 "Electronic data intermediary" means an entity that provides the
10 infrastructure that connects a computer system or another electronic
11 device used by a prescribing practitioner with a computer system or
12 another electronic device used by a pharmacy to facilitate the secure
13 transmission of:
14 (1) an electronic prescription order;
15 (2) a refill authorization request;
16 (3) a communication; and
17 (4) other patient care information;
18 between a practitioner and a pharmacy.
19 "Electronic signature" means an electronic sound, symbol, or
20 process:
21 (1) attached to or logically associated with a record; and
22 (2) executed or adopted by a person;
23 with the intent to sign the record.
24 "Electronically transmitted" or "electronic transmission" means the
25 transmission of a prescription in electronic form. The term does not
26 include the transmission of a prescription by facsimile.
27 "Investigational or new drug" means any drug which is limited by
28 state or federal law to use under professional supervision of a
29 practitioner authorized by law to prescribe or administer such drug.
30 "Legend drug" has the meaning set forth in IC 16-18-2-199.
31 "License" and "permit" are interchangeable and mean a written
32 certificate from the Indiana board of pharmacy for the practice of
33 pharmacy or the operation of a pharmacy.
34 "Medication therapy management" means a distinct service or group
35 of services that optimize therapeutic outcomes for individuals that are
36 independent of, but may occur in conjunction with, the provision of a
37 medication or medical device. The term includes the following
38 services:
39 (1) Performing or obtaining assessments of an individual's health
40 status.
41 (2) Formulating a medication treatment plan.
42 (3) Selecting, initiating, modifying, or administering medication
HB 1158—LS 7067/DI 137 18
1 therapy.
2 (4) Monitoring and evaluating an individual's response to therapy,
3 including safety and effectiveness.
4 (5) Performing a comprehensive medication review to identify,
5 resolve, and prevent medication related problems, including
6 adverse drug events.
7 (6) Documenting the care delivered and communicating essential
8 information to the patient's other health care providers.
9 (7) Providing education and training designed to enhance patient
10 understanding and appropriate use of the individual's medications.
11 (8) Providing information and support services and resources
12 designed to enhance patient adherence with the individual's
13 therapeutic regimens, including medication synchronization.
14 (9) Coordinating and integrating medication therapy management
15 services within the broader health care services being provided to
16 an individual.
17 (10) Providing other patient care services allowable by law.
18 "Nonprescription drug" means a drug that may be sold without a
19 prescription and that is labeled for use by a patient in accordance with
20 state and federal laws.
21 "Person" means any individual, partnership, copartnership, firm,
22 company, corporation, association, joint stock company, trust, estate,
23 or municipality, or a legal representative or agent, unless this chapter
24 expressly provides otherwise.
25 "Practitioner" has the meaning set forth in IC 16-42-19-5.
26 "Pharmacist" means a person licensed under this chapter.
27 "Pharmacist intern" means a person who is:
28 (1) permitted by the board to engage in the practice of pharmacy
29 while under the personal supervision of a pharmacist and who is
30 satisfactorily progressing toward meeting the requirements for
31 licensure as a pharmacist;
32 (2) a graduate of an approved college of pharmacy or a graduate
33 who has established educational equivalency by obtaining a
34 Foreign Pharmacy Graduate Examination Committee Certificate
35 and who is permitted by the board to obtain practical experience
36 as a requirement for licensure as a pharmacist;
37 (3) a qualified applicant awaiting examination for licensure; or
38 (4) an individual participating in a residency or fellowship
39 program.
40 "Pharmacy" means any facility, department, or other place where
41 prescriptions are filled or compounded and are sold, dispensed, offered,
42 or displayed for sale and which has as its principal purpose the
HB 1158—LS 7067/DI 137 19
1 dispensing of drug and health supplies intended for the general health,
2 welfare, and safety of the public, without placing any other activity on
3 a more important level than the practice of pharmacy.
4 "The practice of pharmacy" or "the practice of the profession of
5 pharmacy" means a patient oriented health care profession in which
6 pharmacists interact with and counsel patients and with other health
7 care professionals concerning drugs and devices used to enhance
8 patients' wellness, prevent illness, and optimize the outcome of a drug
9 or device, by accepting responsibility for performing or supervising a
10 pharmacist intern or an unlicensed person under section 18.5 of this
11 chapter to do the following acts, services, and operations:
12 (1) The offering of or performing of those acts, service operations,
13 or transactions incidental to the interpretation, evaluation, and
14 implementation of prescriptions or drug orders.
15 (2) The compounding, labeling, administering, dispensing, or
16 selling of drugs and devices, including radioactive substances,
17 whether dispensed under a practitioner's prescription or drug
18 order or sold or given directly to the ultimate consumer.
19 (3) The proper and safe storage and distribution of drugs and
20 devices.
21 (4) The maintenance of proper records of the receipt, storage,
22 sale, and dispensing of drugs and devices.
23 (5) Counseling, advising, and educating patients, patients'
24 caregivers, and health care providers and professionals, as
25 necessary, as to the contents, therapeutic values, uses, significant
26 problems, risks, and appropriate manner of use of drugs and
27 devices.
28 (6) Assessing, recording, and reporting events related to the use
29 of drugs or devices.
30 (7) Provision of the professional acts, professional decisions, and
31 professional services necessary to maintain all areas of a patient's
32 pharmacy related care as specifically authorized to a pharmacist
33 under this article.
34 (8) Provision of medication therapy management.
35 "Prescription" means a written order or an order transmitted by other
36 means of communication from a practitioner to or for an ultimate user
37 for any drug or device containing:
38 (1) the name and address of the patient;
39 (2) the date of issue;
40 (3) the name and strength or size (if applicable) of the drug or
41 device;
42 (4) the amount to be dispensed (unless indicated by directions and
HB 1158—LS 7067/DI 137 20
1 duration of therapy);
2 (5) adequate directions for the proper use of the drug or device by
3 the patient;
4 (6) the name of the practitioner; and
5 (7) if the prescription:
6 (A) is in written form, the signature of the practitioner; or
7 (B) is in electronic form, the electronic signature of the
8 practitioner.
9 "Qualifying pharmacist" means the pharmacist who will qualify the
10 pharmacy by being responsible to the board for the legal operations of
11 the pharmacy under the permit.
12 "Record" means all papers, letters, memoranda, notes, prescriptions,
13 drug orders, invoices, statements, patient medication charts or files,
14 computerized records, or other written indicia, documents, or objects
15 which are used in any way in connection with the purchase, sale, or
16 handling of any drug or device.
17 "Sale" means every sale and includes:
18 (1) manufacturing, processing, transporting, handling, packaging,
19 or any other production, preparation, or repackaging;
20 (2) exposure, offer, or any other proffer;
21 (3) holding, storing, or any other possession;
22 (4) dispensing, giving, delivering, or any other supplying; and
23 (5) applying, administering, or any other using.
24 SECTION 31. IC 25-26-13-3, AS AMENDED BY P.L.249-2019,
25 SECTION 113, IS AMENDED TO READ AS FOLLOWS
26 [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of
27 pharmacy is created. The board consists of seven (7) members
28 appointed by the governor for terms under IC 25-1-6.5.
29 (b) Subject to IC 25-1-6.5-3, the board consists of the following:
30 (1) One (1) member of the board, to represent the general public,
31 who is a resident of this state who has never been associated with
32 pharmacy in any way other than as a consumer.
33 (2) Six (6) Five (5) members who are pharmacists in good
34 standing of recognized experience and ability from varied practice
35 settings who hold a current license to practice pharmacy in
36 Indiana, including one (1) member of the board who must be a
37 practicing hospital pharmacist.
38 (3) One (1) member who is a pharmacy technician in good
39 standing, engaged in active practice as a pharmacy technician,
40 and holds a current certification from the Pharmacy
41 Technician Certification Board.
42 (c) A member may be removed under IC 25-1-6.5-4.
HB 1158—LS 7067/DI 137 21
1 (d) Not later than ten (10) days after a member's appointment, the
2 member must subscribe by oath or affirmation to faithfully uphold the
3 duties of the member's office. If a member fails to qualify as provided,
4 a new member shall be appointed in the member's place.
5 (e) At the first meeting of each year the board shall elect from
6 among its members a president and vice president who shall perform
7 duties and have powers as the board prescribes.
8 (f) The board shall meet at least eight (8) times per year at such
9 times and places as the board selects. At each meeting the board shall
10 continue in session from day to day, for not more than five (5) days,
11 until the business of the meeting is complete. Four (4) members of the
12 board shall constitute a quorum.
13 (g) Each member of the board is entitled to compensation as
14 determined by the rules of the budget agency for each day the member
15 is actually engaged in business of the board, together with necessary
16 travel and other expenses incurred in the performance of the member's
17 duties.
18 (h) Approval by a majority of the quorum is required for any action
19 to be taken by the board.
20 SECTION 32. IC 25-26-13-10, AS AMENDED BY P.L.101-2020,
21 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
22 JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a
23 pharmacist intern must furnish proof satisfactory to the board that the
24 applicant:
25 (1) is actively enrolled in a school of pharmacy accredited by the
26 American Council of Pharmaceutical for Pharmacy Education;
27 (2) has obtained the Foreign Pharmacy Graduate Examination
28 Committee Certificate; or
29 (3) is a qualified applicant awaiting the examination for licensure
30 as a pharmacist.
31 (b) A registration issued under subsection (a) is valid for one (1)
32 year and may be renewed by the board in accordance with subsection
33 (c) until the expiration date established by the Indiana professional
34 licensing agency under IC 25-1-5-4.
35 (c) An application for registration or renewal must be accompanied
36 by the appropriate fee and one (1) of the following:
37 (1) Proof of having obtained the Foreign Pharmacy Graduate
38 Examination Committee Certificate.
39 (2) Proof of active enrollment in a school of pharmacy accredited
40 by the American Council of Pharmaceutical for Pharmacy
41 Education.
42 SECTION 33. IC 25-26-13-11, AS AMENDED BY P.L.98-2006,
HB 1158—LS 7067/DI 137 22
1 SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
2 JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a
3 pharmacist, an individual must file such evidence as is required by the
4 board that:
5 (1) the individual is at least eighteen (18) years of age;
6 (2) the individual does not have a conviction for a crime that has
7 a direct bearing on the individual's ability to practice competently;
8 (3) the individual:
9 (A) has graduated with a professional degree from a school of
10 pharmacy accredited by the American Council of
11 Pharmaceutical for Pharmacy Education or the Canadian
12 Council on Pharmacy Accreditation for Accreditation of
13 Pharmacy Programs and approved by the board; or
14 (B) has:
15 (i) graduated with a professional degree from a school of
16 pharmacy located outside the United States and Canada; and
17 (ii) met the requirements under subsection (c); and
18 (4) the individual has satisfactorily completed a pharmacist intern
19 program approved by the board.
20 (b) An applicant who has graduated with a professional degree from
21 a school of pharmacy accredited by the Canadian Council on Pharmacy
22 Accreditation for Accreditation of Pharmacy Programs and
23 approved by the board must obtain the Foreign Pharmacy Graduate
24 Examination Committee Certificate administered by the National
25 Association of Boards of Pharmacy before taking the examination
26 required under subsection (d).
27 (c) An applicant who has graduated with a professional degree from
28 a school of pharmacy located outside the United States and Canada
29 must do the following:
30 (1) Provide the board with verification of the applicant's academic
31 record and graduation.
32 (2) Obtain the Foreign Pharmacy Graduate Examination
33 Committee Certificate administered by the National Association
34 of Boards of Pharmacy.
35 (d) After filing an application on a form provided by the board,
36 submitting the information required in subsection (a), and successfully
37 completing the examination administered by the board, the applicant
38 may be licensed as a pharmacist.
39 SECTION 34. IC 25-26-13-12, AS AMENDED BY P.L.98-2006,
40 SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
41 JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a
42 pharmacist in another state where the requirements for licensure were
HB 1158—LS 7067/DI 137 23
1 not less than those required in this state at the time of original licensure
2 may be issued a license in this state if:
3 (1) the individual has registered with and been approved by the
4 National Association of Boards of Pharmacy;
5 (2) the individual has graduated with a professional degree in
6 pharmacy from a school of pharmacy accredited by the American
7 Council of Pharmaceutical for Pharmacy Education or the
8 Canadian Council on Pharmacy Accreditation for Accreditation
9 of Pharmacy Programs and approved by the board; and
10 (3) the individual has successfully completed an examination
11 administered by the board concerning the federal statutes and
12 regulations and the Indiana statutes and rules governing the
13 practice of pharmacy.
14 (b) An individual who has a professional pharmacy degree from a
15 school of pharmacy located outside the United States and Canada and
16 who is licensed in another state where the requirements for licensure
17 are substantially the same as those in this state may be issued a license
18 under this chapter if:
19 (1) the individual has registered with and been approved by the
20 National Association of Boards of Pharmacy;
21 (2) the individual has provided the board with proof of the
22 applicant's:
23 (A) academic record and graduation with a professional degree
24 from a school of pharmacy; and
25 (B) completion of the requirements for obtaining a Foreign
26 Pharmacy Graduate Examination Committee Certificate
27 administered by the National Association of Boards of
28 Pharmacy; and
29 (3) the individual has successfully completed an examination
30 administered by the board concerning the federal statutes and
31 regulations and the Indiana statutes and rules governing the
32 practice of pharmacy.
33 SECTION 35. IC 25-26-13-20, AS AMENDED BY P.L.207-2021,
34 SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
35 JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish,
36 operate, or maintain a pharmacy shall apply to the board for a
37 pharmacy permit on a form provided by the board. The applicant shall
38 set forth:
39 (1) the name and occupation of the persons desiring the permit;
40 (2) the location, including street address and city, of the
41 pharmacy; and
42 (3) the name of the pharmacist who will qualify the pharmacy by
HB 1158—LS 7067/DI 137 24
1 being responsible to the board for the legal operation of the
2 pharmacy under the permit; and
3 (4) (3) such other information as the board may require.
4 (b) If the applicant desires to open, establish, operate, or maintain
5 more than one (1) pharmacy, the applicant must file a separate
6 application for each. Each pharmacy must be qualified by a different
7 pharmacist.
8 (c) The board shall permit a pharmacist to serve as a qualifying
9 pharmacist for more than one (1) pharmacy holding a Category II
10 pharmacy permit upon the holder of the Category II permit showing
11 circumstances establishing that:
12 (1) the permit holder has made a reasonable effort, without
13 success, to obtain a qualifying pharmacist who is not serving as
14 a qualifying pharmacist at another Category II pharmacy; and
15 (2) the single pharmacist could effectively fulfill all duties and
16 responsibilities of the qualifying pharmacist at both locations.
17 However, the board shall hold the permit holder responsible and may
18 not discipline or otherwise hold the qualifying pharmacist an
19 individual licensed under this chapter responsible for staffing
20 deficiencies of the pharmacy if the qualifying pharmacist individual
21 does not have authority for staffing determinations of the pharmacy.
22 (d) The board shall grant or deny an application for a permit not
23 later than one hundred twenty (120) days after the application and any
24 additional information required by the board are submitted.
25 (e) The board may not issue a pharmacy permit to a person who
26 desires to operate the pharmacy out of a residence.
27 SECTION 36. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021,
28 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
29 JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy
30 shall transfer to another pharmacy a prescription for the patient,
31 including a prescription for a schedule II controlled substance, that the
32 pharmacy has received but not filled unless:
33 (1) prohibited in writing on the prescription by the prescriber; or
34 (2) otherwise prohibited by federal law.
35 (b) Unless prohibited by federal law, a prescription for a patient may
36 be transferred electronically or by facsimile by a pharmacy to another
37 pharmacy if the pharmacies do not share a common data base.
38 (c) A licensed pharmacy technician may transfer a prescription,
39 under subsection (b) including making a verbal transfer, as
40 delegated by a pharmacist.
41 SECTION 37. IC 25-26-13-27 IS AMENDED TO READ AS
42 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 27. (a) If a pharmacy
HB 1158—LS 7067/DI 137 25
1 will be closed for five (5) consecutive days or more, the permit holder
2 shall notify the board and take such steps to secure the drugs in the
3 pharmacy as the board may direct.
4 (b) If a pharmacy is to be permanently closed for any reason, the
5 owner or qualifying pharmacist shall:
6 (1) notify the board not less than twenty (20) days before the
7 transfer of any controlled substances and submit a copy of the
8 inventory form required by the federal drug enforcement
9 administration together with the name, address, and registration
10 number of the person to whom the drugs will be transferred;
11 (2) remove all legend drugs from stock by:
12 (A) returning them to the wholesaler or manufacturer if he
13 consents;
14 (B) transferring them to another pharmacy; or
15 (C) destroying them in the presence of a representative
16 appointed by the board;
17 (3) before disposing of any other merchandise in the pharmacy,
18 dispose of all controlled drugs and legend drugs as provided in
19 clauses (1) and (2) and submit the licensed premises to an
20 inspection by a representative of the board to certify that all
21 legend and controlled drugs have been removed;
22 (4) remove from inside and outside the licensed area all symbols
23 and signs using the words "drugs", "drugstore", "prescriptions",
24 "pharmacy", "pharmacy department", "apothecary", or
25 "apothecary shop", or any combination of such titles; and
26 (5) return the pharmacy permit for cancellation by the board
27 within ten (10) days after all legend drugs, controlled drugs, drugs
28 and devices are removed from the premises.
29 SECTION 38. IC 25-26-13-31.7, AS AMENDED BY P.L.207-2021,
30 SECTION 38, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
31 JULY 1, 2022]: Sec. 31.7. (a) Subject to rules adopted under
32 subsection (c), a pharmacy technician may administer an influenza or
33 coronavirus disease any immunization to an individual under a drug
34 order or prescription, as delegated by the pharmacist.
35 (b) Subject to rules adopted under subsection (c), a pharmacy
36 technician may administer an influenza or coronavirus disease
37 immunization to an individual or a group of individuals under a drug
38 order, under a prescription, or according to a protocol approved by a
39 physician, as delegated by the pharmacist.
40 (c) The board shall adopt rules under IC 4-22-2 to establish
41 requirements applying to a pharmacy technician who administers an
42 influenza or coronavirus disease immunization to an individual or
HB 1158—LS 7067/DI 137 26
1 group of individuals. The rules adopted under this section must provide
2 for the direct supervision of the pharmacy technician by a pharmacist,
3 a physician, a physician assistant, or an advanced practice registered
4 nurse. Before July 1, 2021, the board shall adopt emergency rules
5 under IC 4-22-2-37.1 to establish the requirements described in this
6 subsection. concerning the influenza immunization and the coronavirus
7 disease immunization. Notwithstanding IC 4-22-2-37.1(g), an
8 emergency rule adopted by the board under this subsection and in the
9 manner provided by IC 4-22-2-37.1 expires on the date on which a rule
10 that supersedes the emergency rule is adopted by the board under
11 IC 4-22-2-24 through IC 4-22-2-36.
12 (d) The board must approve all programs that provide training to
13 pharmacy technicians to administer influenza and coronavirus disease
14 immunizations as permitted by this section.
15 SECTION 39. IC 25-26-13.5-6, AS AMENDED BY P.L.207-2021,
16 SECTION 39, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
17 JULY 1, 2022]: Sec. 6. (a) Before a remote dispensing facility may do
18 business in Indiana, the remote dispensing facility must be registered
19 with the board under this chapter and in the manner prescribed by the
20 board.
21 (b) Before a pharmacy licensed under this article may operate a
22 remote dispensing facility, the pharmacy must register with the board
23 under this chapter.
24 (c) A facility must meet the following requirements in order to be
25 registered as a remote dispensing facility under this chapter:
26 (1) If the remote dispensing facility is not jointly owned by the
27 pharmacy, operate under a contract with a supervising pharmacy.
28 (2) Be supervised by a qualifying pharmacist who is licensed
29 under this article and who is designated by the supervising
30 pharmacy to be responsible for oversight of the remote dispensing
31 facility.
32 (3) Be located at least ten (10) miles from an existing retail
33 pharmacy unless:
34 (A) the applicant with the proposed remote dispensing facility
35 demonstrates to the board how the proposed remote dispensing
36 facility will promote public health; or
37 (B) the remote dispensing facility exclusively serves the
38 patients of:
39 (i) a community mental health center established under
40 IC 12-29;
41 (ii) a health care facility (as defined in IC 16-28-13-0.5); or
42 (iii) a physician clinic.
HB 1158—LS 7067/DI 137 27
1 (4) Maintain a patient counseling area.
2 (5) Display a sign visible to the public indicating that the location
3 is a remote dispensing facility. The sign must include the
4 following information:
5 (A) That the facility provides remote services supervised by a
6 pharmacist located in another pharmacy.
7 (B) The identification and address of the supervising
8 pharmacy.
9 (C) Disclosure that a pharmacist is required to speak to the
10 consumer using audio and video communication systems any
11 time a new drug or device is dispensed at the remote
12 dispensing facility.
13 (D) Whether patient counseling is provided on a prescription
14 drug refill at the remote dispensing facility.
15 (E) That the facility is under continuous video surveillance and
16 that the video is recorded.
17 (d) If the remote dispensing facility is operating under a contract
18 with a supervising pharmacy, the contract must:
19 (1) specify the responsibilities of each party to the contract; and
20 (2) be available for review by the board at the board's request.
21 SECTION 40. IC 25-26-13.5-7, AS ADDED BY P.L.202-2017,
22 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
23 JULY 1, 2022]: Sec. 7. A supervising pharmacy shall implement
24 policies and procedures that address each of the following before
25 engaging in the practice of telepharmacy under this chapter:
26 (1) Minimum standards and practices that ensure the safety,
27 accuracy, security, sanitation, record keeping, and patient
28 confidentiality at the remote dispensing facility. The standards
29 and practices must include the following:
30 (A) Identification of personnel authorized to accept delivery of
31 the drugs and to have access to drug storage and dispensing
32 areas at the remote dispensing facility.
33 (B) Procedures for the procurement of drugs and devices at the
34 remote dispensing facility and any automated dispensing
35 machine system used.
36 (C) Criteria for the required inspection of the remote
37 dispensing facility by the qualifying a pharmacist.
38 (2) The adoption of training standards required for personnel
39 employed at a remote dispensing facility to ensure the
40 competence and ability of employees in operating the electronic
41 verification, electronic record keeping, and communication
42 systems.
HB 1158—LS 7067/DI 137 28
1 (3) A written plan for recovery from an event that interrupts or
2 prevents pharmacist supervision of the remote dispensing facility.
3 (4) Policies concerning the dispensing of prescription drugs.
4 SECTION 41. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE JULY
5 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist on
6 duty are responsible for ensuring that the supervising pharmacy and
7 remote dispensing facility are sufficiently staffed to avoid the risk of
8 harm to public health and safety.
9 (b) In order to serve as a qualifying pharmacist, the pharmacist must
10 be in good standing with the board.
11 (c) A qualifying pharmacist may have this designation for only one
12 (1) supervising pharmacy and for one (1) remote dispensing facility at
13 a time.
14 (d) A qualifying pharmacist must be able to be physically at the
15 remote dispensing facility within a certain time set by the board to
16 address emergencies and safety issues that arise. However, in the
17 qualifying pharmacist's absence the qualifying pharmacist may
18 designate another pharmacist to fulfill the qualifying pharmacist's
19 duties at the remote dispensing facility.
20 (e) A qualifying pharmacist shall visit a remote dispensing facility
21 at least as often as required by the board to inspect the facility and
22 address personnel matters. The qualifying pharmacist shall complete
23 any forms required by the board concerning the required inspection and
24 maintain the records in a manner specified by the board.
25 (f) If the remote dispensing facility is located at a hospital or
26 physician clinic and uses an automated dispensing machine, the
27 qualifying pharmacist shall maintain an up to date inventory of any
28 schedule II controlled substances. The qualifying pharmacist shall at
29 least monthly inventory all controlled substances.
30 (g) The qualifying pharmacist shall develop and implement a
31 continuous quality improvement program. The program must include
32 a reporting mechanism for errors that occur concerning the remote
33 dispensing facility. Information concerning the program must be
34 available to the board upon request.
35 SECTION 42. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA
36 CODE AS A NEW SECTION TO READ AS FOLLOWS
37 [EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a
38 remote dispensing facility is responsible for ensuring the following:
39 (1) The remote dispensing facility is sufficiently staffed to
40 avoid the risk of harm to public health and safety.
41 (2) The pharmacist servicing the remote dispensing facility is
42 in good standing with the board.
HB 1158—LS 7067/DI 137 29
1 (3) A pharmacy may not operate more than one (1) remote
2 dispensing facility at a time, unless otherwise approved by the
3 board.
4 (4) A pharmacist must be able to be physically present at the
5 remote dispensing facility within a certain time set by the
6 board to address emergencies and safety issues that arise.
7 (5) A pharmacist shall visit the remote dispensing facility at
8 least as often as required by the board to inspect the facility,
9 address personnel matters, complete any forms required by
10 the board concerning the required inspection, and maintain
11 records in the manner specified by the board.
12 (6) If the remote dispensing facility is located at a hospital or
13 physician clinic and uses an automated dispensing machine,
14 a pharmacist must maintain an up to date inventory of any
15 schedule II controlled substances. An inventory of all
16 controlled substances must be completed at least once a
17 month.
18 (7) The pharmacy must develop a continuous quality
19 improvement program, which must include a reporting
20 mechanism for errors that occur concerning the remote
21 dispensing facility. Information concerning the remote
22 dispensing facility must be made available to the board upon
23 request.
24 SECTION 43. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019,
25 SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
26 JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist
27 working at a remote dispensing facility for every six (6) pharmacist
28 interns, licensed pharmacy technicians, and pharmacy technicians in
29 training at the supervising pharmacy and remote dispensing facility.
30 However, an individual whose only duty is to act as the cashier is not
31 included in the number of employees that may work for one (1)
32 pharmacist under this subsection.
33 (b) A remote dispensing facility that is not staffed by a pharmacist
34 must be staffed by at least one (1) pharmacy technician who meets the
35 following requirements:
36 (1) Is licensed under IC 25-26-19.
37 (2) Has at least two thousand (2,000) hours of experience working
38 as a pharmacy technician in a pharmacy licensed under this article
39 and under the direct supervision of a pharmacist.
40 (3) Has successfully passed a certification examination offered by
41 the Pharmacy Technician Certification Board or another
42 nationally recognized certification body approved by the board.
HB 1158—LS 7067/DI 137 30
1 (4) If the remote dispensing facility is located in a hospital or
2 physician clinic setting, either:
3 (A) has graduated from a pharmacy technician training
4 program accredited by the American Council of
5 Pharmaceutical for Pharmacy Education or the American
6 Society of Health System Pharmacists; or
7 (B) obtained the hours described in subdivision (2) before July
8 1, 2017.
9 (5) Is supervised by a pharmacist at the supervising pharmacy at
10 all times that the remote dispensing facility is operational. As
11 used in this subdivision, supervision does not require that the
12 pharmacist be physically present at the remote dispensing facility
13 as long as the pharmacist is supervising telepharmacy operations
14 electronically through a computer link, video link, and audio link.
15 (6) Is currently in good standing with the board.
16 (c) A pharmacy technician in training may not work at a remote
17 dispensing facility unless a pharmacist is on site.
18 (d) The board shall adopt rules that require pharmacy technicians
19 working at a remote dispensing facility that is not staffed by a
20 pharmacist to complete continuing education requirements established
21 by the board.
22 SECTION 44. IC 25-26-13.5-11, AS AMENDED BY P.L.207-2021,
23 SECTION 40, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
24 JULY 1, 2022]: Sec. 11. (a) A supervising pharmacy of a remote
25 dispensing facility must maintain a video and audio communication
26 system that provides for effective communication between the
27 supervising pharmacy, the remote dispensing facility, and any
28 consumers. The system must do the following:
29 (1) Provide an adequate number of views of the entire remote
30 dispensing facility.
31 (2) Facilitate adequate pharmacist supervision.
32 (3) Allow an appropriate exchange of visual, verbal, and written
33 communications for patient counseling and other matters
34 concerning the lawful transaction of business.
35 (b) The remote dispensing facility must retain a recording of facility
36 surveillance, excluding patient communications, for at least thirty (30)
37 days.
38 (c) A qualifying pharmacist is adequately supervising through the
39 use of video surveillance by maintaining constant visual supervision
40 and auditory communication with the remote dispensing facility and by
41 maintaining full supervisory control of the automated system, if
42 applicable. The auditory communication must be available, as needed,
HB 1158—LS 7067/DI 137 31
1 with the remote dispensing facility and the qualifying pharmacist.
2 (d) A video monitor that is being used to properly identify and
3 communicate with consumers must meet the following requirements:
4 (1) Provide both the supervising pharmacy and the remote
5 dispensing facility with direct visual contact between the
6 pharmacist and the consumer.
7 (2) Be secure and compliant with the federal Health Insurance
8 Portability and Accountability Act (HIPAA).
9 (e) If any component of the communication system is not in
10 operating order, the remote dispensing facility shall remain closed until
11 the communication system is fully operational, unless a pharmacist is
12 located at the remote dispensing facility.
13 SECTION 45. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017,
14 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
15 JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have
16 adequate security. The security must do the following:
17 (1) Record the entrance and exit of individuals to the facility.
18 (2) Use alarms or other comparable monitoring systems that
19 protect the equipment, records, drug supply, devices, and other
20 items from unauthorized access, acquisition, or use.
21 (3) Use at least two (2) factoring credentials for employee entry
22 to the remote dispensing facility, using two (2) of the following:
23 (A) A knowledge factor, including a password.
24 (B) Biometrics.
25 (C) An inanimate object.
26 (b) The qualifying A pharmacist shall periodically review the record
27 of entries into the remote dispensing facility.
28 (c) The prescription storage area may remain open while a
29 pharmacist or pharmacy technician is on duty.
30 SECTION 46. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017,
31 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
32 JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be
33 dispensed at the remote dispensing facility unless:
34 (1) the facility maintains a perpetual inventory of controlled
35 substances; and
36 (2) the supervising pharmacist checks the Indiana scheduled
37 prescription electronic collection and tracking program
38 established by IC 25-1-13-4 or as directed by the board before:
39 (A) verification of the finished controlled substance
40 prescription; and
41 (B) counseling the patient.
42 (b) Drugs may be transported to a remote dispensing facility that
HB 1158—LS 7067/DI 137 32
1 uses an automated dispensing machine only in a sealed container with
2 a list identifying each drug, drug strength, and quantity included in the
3 container.
4 (c) A delivery of drugs may be accepted at the remote dispensing
5 facility only if a pharmacist or a licensed pharmacy technician is
6 present to accept delivery and verify and sign for the receipt of the
7 drugs, unless the drugs are placed in a secured delivery area that
8 complies with federal and state law.
9 (d) If the delivery is received by a pharmacy technician, a
10 pharmacist at the supervising pharmacy shall ensure through the use of
11 the electronic audio and video communication system or bar code
12 technology that the pharmacy technician has accurately restocked the
13 drugs.
14 (e) A remote dispensing facility must store drugs in a manner that:
15 (1) complies with federal and state law;
16 (2) protects the identity, safety, security, and integrity of the drug;
17 and
18 (3) limits access to:
19 (A) a pharmacist employed by the supervising pharmacy; and
20 (B) a pharmacy technician who has written authorization of the
21 qualifying a pharmacist to access the facility.
22 SECTION 47. IC 25-26-14-11, AS AMENDED BY P.L.264-2019,
23 SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
24 JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale
25 distribution" means to distribute legend drugs to persons other than a
26 consumer or patient. The term does not include:
27 (1) a sale or transfer between a division, a subsidiary, a parent, an
28 affiliated, or a related company under the common ownership and
29 control of a corporate entity;
30 (2) the purchase or acquisition by a hospital or other health care
31 entity that is a member of a group purchasing organization of a
32 drug for the hospital's or health care entity's own use from the
33 group purchasing organization or from other hospitals or health
34 care entities that are members of the organization;
35 (3) the sale or transfer of a drug by a charitable organization
36 described in Section 501(c)(3) of the Internal Revenue Code, to:
37 (A) a nonprofit affiliate of the organization; or
38 (B) a nonprofit entity described in Section 501(c)(3) of the
39 Internal Revenue Code that is not affiliated with the
40 organization;
41 to the extent otherwise permitted by law;
42 (4) the sale of a drug among hospitals or other health care entities
HB 1158—LS 7067/DI 137 33
1 that are under common control;
2 (5) the sale of a drug for emergency medical reasons, including
3 transfers of legend drugs by a retail pharmacy to another retail
4 pharmacy to alleviate a temporary shortage, if the gross dollar
5 value of the transfers does not exceed five percent (5%) of the
6 total legend drug sales revenue of either the transferor or
7 transferee pharmacy during any twelve (12) consecutive month
8 period;
9 (6) the sale of a drug or the dispensing of a drug pursuant to a
10 prescription;
11 (7) the distribution of drug samples by manufacturers'
12 representatives or distributors' representatives;
13 (8) the sale of blood and blood components intended for
14 transfusion;
15 (9) the sale of a drug by a retail pharmacy to a practitioner (as
16 defined in IC 25-26-13-2) for office use, if the gross dollar value
17 of the transfers does not exceed five percent (5%) of the retail
18 pharmacy's total legend drug sales during any twelve (12)
19 consecutive months;
20 (10) the sale of a drug by a retail pharmacy that is ending its
21 business and liquidating its inventory to another retail pharmacy;
22 (11) drug returns by a hospital, health care entity, or charitable
23 institution conducted under 21 CFR 203.23;
24 (12) the sale of minimal quantities of drugs by retail pharmacies
25 to licensed practitioners for office use;
26 (13) the distribution of prescription drugs by the original
27 manufacturer of the finished form of the prescription drug or the
28 distribution of the co-licensed products by a partner of the
29 original manufacturer of the finished form of the prescription
30 drug; or
31 (14) drug returns that meet criteria established by rules adopted
32 by the board; or
33 (15) the sale of a drug for research or clinical trial purposes,
34 provided the seller is authorized by the federal Food and Drug
35 Administration to sell the drug for research or clinical trial
36 purposes.
37 SECTION 48. IC 27-8-27-6, AS AMENDED BY P.L.133-2020,
38 SECTION 19, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
39 JULY 1, 2022]: Sec. 6. (a) A health insurance plan that provides
40 coverage for early intervention services shall reimburse the first steps
41 program a monthly fee established by the division of disability and
42 rehabilitative services. Except when the monthly fee is less than the
HB 1158—LS 7067/DI 137 34
1 product determined under IC 12-12.7-2-23(b), the monthly fee shall be
2 provided instead of claims processing of individual claims.
3 (b) A health insurance plan may not require authorization for
4 services specified in the covered individual's individualized family
5 service plan, if those services are a covered benefit under the plan,
6 once the individualized family service plan is signed by a physician, a
7 physician assistant, or an advanced practice registered nurse.
8 (c) The department of insurance shall adopt rules under IC 4-22-2
9 to ensure compliance with this section.
10 SECTION 49. IC 34-30-2-81 IS REPEALED [EFFECTIVE JULY
11 1, 2022]. Sec. 81. (a) IC 16-41-7-2 (Concerning the good faith
12 reporting to a health officer of an individual thought to present a
13 serious and present risk to the health of others, to have engaged in
14 noncompliant behavior, or to be at risk of carrying a serious
15 communicable disease).
16 (b) IC 16-41-7-3 (Concerning a physician who provides notification
17 to certain individuals regarding a patient's serious communicable
18 disease).
19 SECTION 50. IC 34-46-2-10 IS REPEALED [EFFECTIVE JULY
20 1, 2022]. Sec. 10. IC 16-41-7-3 (Concerning warning by physician of
21 serious communicable disease).
22 SECTION 51. IC 35-52-16-42 IS REPEALED [EFFECTIVE JULY
23 1, 2022]. Sec. 42. IC 16-41-7-5 defines a crime concerning
24 communicable diseases.
25 SECTION 52. IC 35-52-16-58 IS REPEALED [EFFECTIVE JULY
26 1, 2022]. Sec. 58. IC 16-41-14-17 defines a crime concerning
27 communicable diseases.
28 SECTION 53. [EFFECTIVE UPON PASSAGE] (a) The terms of
29 members appointed to the division of disability and rehabilitative
30 services advisory council under IC 12-9-4-3, before its amendment
31 by this act, expire June 30, 2022.
32 (b) This SECTION expires July 1, 2023.
33 SECTION 54. An emergency is declared for this act.
HB 1158—LS 7067/DI 137 35
COMMITTEE REPORT
Mr. Speaker: Your Committee on Public Health, to which was
referred House Bill 1158, has had the same under consideration and
begs leave to report the same back to the House with the
recommendation that said bill be amended as follows:
Page 2, line 30, after "physician" insert ", a physician assistant,".
Page 2, delete lines 34 through 38.
Page 6, delete lines 32 through 42.
Page 7, delete lines 1 through 31.
Page 8, delete lines 39 through 42.
Delete pages 9 through 10.
Page 11, delete lines 1 through 16.
Page 18, delete lines 31 through 42.
Page 19, delete lines 1 through 5.
Page 19, line 17, after "physician" insert ", a physician assistant,".
Page 19, delete lines 21 through 42, begin a new paragraph and
insert:
"SECTION 28. IC 25-1-9-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 2. (a) As used in this
chapter, "practitioner" means an individual who holds:
(1) an unlimited license, certificate, or registration;
(2) a limited or probationary license, certificate, or registration;
(3) a temporary license, certificate, registration, or permit;
(4) an intern permit; or
(5) a provisional license;
issued by the board regulating the profession in question, including a
certificate of registration issued under IC 25-20.
(b) The term includes all license statuses, including "active",
"expired", "retired", "inactive", and any other status that a
license may be held in.".
Delete pages 20 through 21.
Page 22, delete lines 1 through 36.
Page 23, delete lines 1 through 9.
Page 28, delete lines 7 through 42, begin a new paragraph and
insert:
"SECTION 30. IC 25-26-13-3, AS AMENDED BY P.L.249-2019,
SECTION 113, IS AMENDED TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of
pharmacy is created. The board consists of seven (7) members
appointed by the governor for terms under IC 25-1-6.5.
(b) Subject to IC 25-1-6.5-3, the board consists of the following:
HB 1158—LS 7067/DI 137 36
(1) One (1) member of the board, to represent the general public,
who is a resident of this state who has never been associated with
pharmacy in any way other than as a consumer.
(2) Six (6) Five (5) members who are pharmacists in good
standing of recognized experience and ability from varied practice
settings who hold a current license to practice pharmacy in
Indiana, including one (1) member of the board who must be a
practicing hospital pharmacist.
(3) One (1) member who is a pharmacy technician in good
standing, engaged in active practice as a pharmacy technician,
and holds a current certification from the Pharmacy
Technician Certification Board.
(c) A member may be removed under IC 25-1-6.5-4.
(d) Not later than ten (10) days after a member's appointment, the
member must subscribe by oath or affirmation to faithfully uphold the
duties of the member's office. If a member fails to qualify as provided,
a new member shall be appointed in the member's place.
(e) At the first meeting of each year the board shall elect from
among its members a president and vice president who shall perform
duties and have powers as the board prescribes.
(f) The board shall meet at least eight (8) times per year at such
times and places as the board selects. At each meeting the board shall
continue in session from day to day, for not more than five (5) days,
until the business of the meeting is complete. Four (4) members of the
board shall constitute a quorum.
(g) Each member of the board is entitled to compensation as
determined by the rules of the budget agency for each day the member
is actually engaged in business of the board, together with necessary
travel and other expenses incurred in the performance of the member's
duties.
(h) Approval by a majority of the quorum is required for any action
to be taken by the board.".
Delete pages 29 through 30.
Page 31, delete lines 1 through 40, begin a new paragraph and
insert:
"SECTION 31. IC 25-26-13-10, AS AMENDED BY P.L.101-2020,
SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a
pharmacist intern must furnish proof satisfactory to the board that the
applicant:
(1) is actively enrolled in a school of pharmacy accredited by the
American Council of Pharmaceutical for Pharmacy Education;
HB 1158—LS 7067/DI 137 37
(2) has obtained the Foreign Pharmacy Graduate Examination
Committee Certificate; or
(3) is a qualified applicant awaiting the examination for licensure
as a pharmacist.
(b) A registration issued under subsection (a) is valid for one (1)
year and may be renewed by the board in accordance with subsection
(c) until the expiration date established by the Indiana professional
licensing agency under IC 25-1-5-4.
(c) An application for registration or renewal must be accompanied
by the appropriate fee and one (1) of the following:
(1) Proof of having obtained the Foreign Pharmacy Graduate
Examination Committee Certificate.
(2) Proof of active enrollment in a school of pharmacy accredited
by the American Council of Pharmaceutical for Pharmacy
Education.
SECTION 32. IC 25-26-13-11, AS AMENDED BY P.L.98-2006,
SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a
pharmacist, an individual must file such evidence as is required by the
board that:
(1) the individual is at least eighteen (18) years of age;
(2) the individual does not have a conviction for a crime that has
a direct bearing on the individual's ability to practice competently;
(3) the individual:
(A) has graduated with a professional degree from a school of
pharmacy accredited by the American Council of
Pharmaceutical for Pharmacy Education or the Canadian
Council on Pharmacy Accreditation for Accreditation of
Pharmacy Programs and approved by the board; or
(B) has:
(i) graduated with a professional degree from a school of
pharmacy located outside the United States and Canada; and
(ii) met the requirements under subsection (c); and
(4) the individual has satisfactorily completed a pharmacist intern
program approved by the board.
(b) An applicant who has graduated with a professional degree from
a school of pharmacy accredited by the Canadian Council on Pharmacy
Accreditation for Accreditation of Pharmacy Programs and
approved by the board must obtain the Foreign Pharmacy Graduate
Examination Committee Certificate administered by the National
Association of Boards of Pharmacy before taking the examination
required under subsection (d).
HB 1158—LS 7067/DI 137 38
(c) An applicant who has graduated with a professional degree from
a school of pharmacy located outside the United States and Canada
must do the following:
(1) Provide the board with verification of the applicant's academic
record and graduation.
(2) Obtain the Foreign Pharmacy Graduate Examination
Committee Certificate administered by the National Association
of Boards of Pharmacy.
(d) After filing an application on a form provided by the board,
submitting the information required in subsection (a), and successfully
completing the examination administered by the board, the applicant
may be licensed as a pharmacist.
SECTION 33. IC 25-26-13-12, AS AMENDED BY P.L.98-2006,
SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a
pharmacist in another state where the requirements for licensure were
not less than those required in this state at the time of original licensure
may be issued a license in this state if:
(1) the individual has registered with and been approved by the
National Association of Boards of Pharmacy;
(2) the individual has graduated with a professional degree in
pharmacy from a school of pharmacy accredited by the American
Council of Pharmaceutical for Pharmacy Education or the
Canadian Council on Pharmacy Accreditation for Accreditation
of Pharmacy Programs and approved by the board; and
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes and
regulations and the Indiana statutes and rules governing the
practice of pharmacy.
(b) An individual who has a professional pharmacy degree from a
school of pharmacy located outside the United States and Canada and
who is licensed in another state where the requirements for licensure
are substantially the same as those in this state may be issued a license
under this chapter if:
(1) the individual has registered with and been approved by the
National Association of Boards of Pharmacy;
(2) the individual has provided the board with proof of the
applicant's:
(A) academic record and graduation with a professional degree
from a school of pharmacy; and
(B) completion of the requirements for obtaining a Foreign
Pharmacy Graduate Examination Committee Certificate
HB 1158—LS 7067/DI 137 39
administered by the National Association of Boards of
Pharmacy; and
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes and
regulations and the Indiana statutes and rules governing the
practice of pharmacy.
SECTION 34. IC 25-26-13-20, AS AMENDED BY P.L.207-2021,
SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish,
operate, or maintain a pharmacy shall apply to the board for a
pharmacy permit on a form provided by the board. The applicant shall
set forth:
(1) the name and occupation of the persons desiring the permit;
(2) the location, including street address and city, of the
pharmacy; and
(3) the name of the pharmacist who will qualify the pharmacy by
being responsible to the board for the legal operation of the
pharmacy under the permit; and
(4) (3) such other information as the board may require.
(b) If the applicant desires to open, establish, operate, or maintain
more than one (1) pharmacy, the applicant must file a separate
application for each. Each pharmacy must be qualified by a different
pharmacist.
(c) The board shall permit a pharmacist to serve as a qualifying
pharmacist for more than one (1) pharmacy holding a Category II
pharmacy permit upon the holder of the Category II permit showing
circumstances establishing that:
(1) the permit holder has made a reasonable effort, without
success, to obtain a qualifying pharmacist who is not serving as
a qualifying pharmacist at another Category II pharmacy; and
(2) the single pharmacist could effectively fulfill all duties and
responsibilities of the qualifying pharmacist at both locations.
However, the board shall hold the permit holder responsible and may
not discipline or otherwise hold the qualifying pharmacist an
individual licensed under this chapter responsible for staffing
deficiencies of the pharmacy if the qualifying pharmacist individual
does not have authority for staffing determinations of the pharmacy.
(d) The board shall grant or deny an application for a permit not
later than one hundred twenty (120) days after the application and any
additional information required by the board are submitted.
(e) The board may not issue a pharmacy permit to a person who
desires to operate the pharmacy out of a residence.
HB 1158—LS 7067/DI 137 40
SECTION 35. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021,
SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy
shall transfer to another pharmacy a prescription for the patient,
including a prescription for a schedule II controlled substance, that the
pharmacy has received but not filled unless:
(1) prohibited in writing on the prescription by the prescriber; or
(2) otherwise prohibited by federal law.
(b) Unless prohibited by federal law, a prescription for a patient may
be transferred electronically or by facsimile by a pharmacy to another
pharmacy if the pharmacies do not share a common data base.
(c) A licensed pharmacy technician may transfer a prescription,
under subsection (b) including making a verbal transfer, as
delegated by a pharmacist.".
Page 33, delete lines 15 through 42.
Page 34, delete lines 1 through 10.
Page 35, line 33, delete "supervising".
Page 35, delete line 42, begin a new paragraph and insert:
"SECTION 40. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE
JULY 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist
on duty are responsible for ensuring that the supervising pharmacy and
remote dispensing facility are sufficiently staffed to avoid the risk of
harm to public health and safety.
(b) In order to serve as a qualifying pharmacist, the pharmacist must
be in good standing with the board.
(c) A qualifying pharmacist may have this designation for only one
(1) supervising pharmacy and for one (1) remote dispensing facility at
a time.
(d) A qualifying pharmacist must be able to be physically at the
remote dispensing facility within a certain time set by the board to
address emergencies and safety issues that arise. However, in the
qualifying pharmacist's absence the qualifying pharmacist may
designate another pharmacist to fulfill the qualifying pharmacist's
duties at the remote dispensing facility.
(e) A qualifying pharmacist shall visit a remote dispensing facility
at least as often as required by the board to inspect the facility and
address personnel matters. The qualifying pharmacist shall complete
any forms required by the board concerning the required inspection and
maintain the records in a manner specified by the board.
(f) If the remote dispensing facility is located at a hospital or
physician clinic and uses an automated dispensing machine, the
qualifying pharmacist shall maintain an up to date inventory of any
HB 1158—LS 7067/DI 137 41
schedule II controlled substances. The qualifying pharmacist shall at
least monthly inventory all controlled substances.
(g) The qualifying pharmacist shall develop and implement a
continuous quality improvement program. The program must include
a reporting mechanism for errors that occur concerning the remote
dispensing facility. Information concerning the program must be
available to the board upon request.
SECTION 41. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a
remote dispensing facility is responsible for ensuring the following:
(1) The remote dispensing facility is sufficiently staffed to
avoid the risk of harm to public health and safety.
(2) The pharmacist servicing the remote dispensing facility is
in good standing with the board.
(3) A pharmacy may not operate more than one (1) remote
dispensing facility at a time, unless otherwise approved by the
board.
(4) A pharmacist must be able to be physically present at the
remote dispensing facility within a certain time set by the
board to address emergencies and safety issues that arise.
(5) A pharmacist shall visit the remote dispensing facility at
least as often as required by the board to inspect the facility,
address personnel matters, complete any forms required by
the board concerning the required inspection, and maintain
records in the manner specified by the board.
(6) If the remote dispensing facility is located at a hospital or
physician clinic and uses an automated dispensing machine,
a pharmacist must maintain an up to date inventory of any
schedule II controlled substances. An inventory of all
controlled substances must be completed at least once a
month.
(7) The pharmacy must develop a continuous quality
improvement program, which must include a reporting
mechanism for errors that occur concerning the remote
dispensing facility. Information concerning the remote
dispensing facility must be made available to the board upon
request.
SECTION 42. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019,
SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist
working at a remote dispensing facility for every six (6) pharmacist
HB 1158—LS 7067/DI 137 42
interns, licensed pharmacy technicians, and pharmacy technicians in
training at the supervising pharmacy and remote dispensing facility.
However, an individual whose only duty is to act as the cashier is not
included in the number of employees that may work for one (1)
pharmacist under this subsection.
(b) A remote dispensing facility that is not staffed by a pharmacist
must be staffed by at least one (1) pharmacy technician who meets the
following requirements:
(1) Is licensed under IC 25-26-19.
(2) Has at least two thousand (2,000) hours of experience working
as a pharmacy technician in a pharmacy licensed under this article
and under the direct supervision of a pharmacist.
(3) Has successfully passed a certification examination offered by
the Pharmacy Technician Certification Board or another
nationally recognized certification body approved by the board.
(4) If the remote dispensing facility is located in a hospital or
physician clinic setting, either:
(A) has graduated from a pharmacy technician training
program accredited by the American Council of
Pharmaceutical for Pharmacy Education or the American
Society of Health System Pharmacists; or
(B) obtained the hours described in subdivision (2) before July
1, 2017.
(5) Is supervised by a pharmacist at the supervising pharmacy at
all times that the remote dispensing facility is operational. As
used in this subdivision, supervision does not require that the
pharmacist be physically present at the remote dispensing facility
as long as the pharmacist is supervising telepharmacy operations
electronically through a computer link, video link, and audio link.
(6) Is currently in good standing with the board.
(c) A pharmacy technician in training may not work at a remote
dispensing facility unless a pharmacist is on site.
(d) The board shall adopt rules that require pharmacy technicians
working at a remote dispensing facility that is not staffed by a
pharmacist to complete continuing education requirements established
by the board.".
Page 36, delete lines 1 through 34.
Page 37, delete lines 26 through 42, begin a new paragraph and
insert:
"SECTION 44. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017,
SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have
HB 1158—LS 7067/DI 137 43
adequate security. The security must do the following:
(1) Record the entrance and exit of individuals to the facility.
(2) Use alarms or other comparable monitoring systems that
protect the equipment, records, drug supply, devices, and other
items from unauthorized access, acquisition, or use.
(3) Use at least two (2) factoring credentials for employee entry
to the remote dispensing facility, using two (2) of the following:
(A) A knowledge factor, including a password.
(B) Biometrics.
(C) An inanimate object.
(b) The qualifying A pharmacist shall periodically review the record
of entries into the remote dispensing facility.
(c) The prescription storage area may remain open while a
pharmacist or pharmacy technician is on duty.
SECTION 45. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017,
SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be
dispensed at the remote dispensing facility unless:
(1) the facility maintains a perpetual inventory of controlled
substances; and
(2) the supervising pharmacist checks the Indiana scheduled
prescription electronic collection and tracking program
established by IC 25-1-13-4 or as directed by the board before:
(A) verification of the finished controlled substance
prescription; and
(B) counseling the patient.
(b) Drugs may be transported to a remote dispensing facility that
uses an automated dispensing machine only in a sealed container with
a list identifying each drug, drug strength, and quantity included in the
container.
(c) A delivery of drugs may be accepted at the remote dispensing
facility only if a pharmacist or a licensed pharmacy technician is
present to accept delivery and verify and sign for the receipt of the
drugs, unless the drugs are placed in a secured delivery area that
complies with federal and state law.
(d) If the delivery is received by a pharmacy technician, a
pharmacist at the supervising pharmacy shall ensure through the use of
the electronic audio and video communication system or bar code
technology that the pharmacy technician has accurately restocked the
drugs.
(e) A remote dispensing facility must store drugs in a manner that:
(1) complies with federal and state law;
HB 1158—LS 7067/DI 137 44
(2) protects the identity, safety, security, and integrity of the drug;
and
(3) limits access to:
(A) a pharmacist employed by the supervising pharmacy; and
(B) a pharmacy technician who has written authorization of the
qualifying a pharmacist to access the facility.
SECTION 46. IC 25-26-14-11, AS AMENDED BY P.L.264-2019,
SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale
distribution" means to distribute legend drugs to persons other than a
consumer or patient. The term does not include:
(1) a sale or transfer between a division, a subsidiary, a parent, an
affiliated, or a related company under the common ownership and
control of a corporate entity;
(2) the purchase or acquisition by a hospital or other health care
entity that is a member of a group purchasing organization of a
drug for the hospital's or health care entity's own use from the
group purchasing organization or from other hospitals or health
care entities that are members of the organization;
(3) the sale or transfer of a drug by a charitable organization
described in Section 501(c)(3) of the Internal Revenue Code, to:
(A) a nonprofit affiliate of the organization; or
(B) a nonprofit entity described in Section 501(c)(3) of the
Internal Revenue Code that is not affiliated with the
organization;
to the extent otherwise permitted by law;
(4) the sale of a drug among hospitals or other health care entities
that are under common control;
(5) the sale of a drug for emergency medical reasons, including
transfers of legend drugs by a retail pharmacy to another retail
pharmacy to alleviate a temporary shortage, if the gross dollar
value of the transfers does not exceed five percent (5%) of the
total legend drug sales revenue of either the transferor or
transferee pharmacy during any twelve (12) consecutive month
period;
(6) the sale of a drug or the dispensing of a drug pursuant to a
prescription;
(7) the distribution of drug samples by manufacturers'
representatives or distributors' representatives;
(8) the sale of blood and blood components intended for
transfusion;
(9) the sale of a drug by a retail pharmacy to a practitioner (as
HB 1158—LS 7067/DI 137 45
defined in IC 25-26-13-2) for office use, if the gross dollar value
of the transfers does not exceed five percent (5%) of the retail
pharmacy's total legend drug sales during any twelve (12)
consecutive months;
(10) the sale of a drug by a retail pharmacy that is ending its
business and liquidating its inventory to another retail pharmacy;
(11) drug returns by a hospital, health care entity, or charitable
institution conducted under 21 CFR 203.23;
(12) the sale of minimal quantities of drugs by retail pharmacies
to licensed practitioners for office use;
(13) the distribution of prescription drugs by the original
manufacturer of the finished form of the prescription drug or the
distribution of the co-licensed products by a partner of the
original manufacturer of the finished form of the prescription
drug; or
(14) drug returns that meet criteria established by rules adopted
by the board; or
(15) the sale of a drug for research or clinical trial purposes,
provided the seller is authorized by the federal Food and Drug
Administration to sell the drug for research or clinical trial
purposes.".
Delete pages 38 through 39.
Page 40, delete lines 1 through 23.
Page 40, line 35, after "physician" insert ", a physician assistant,".
Page 40, delete lines 39 through 42.
Delete pages 41 through 43.
Page 44, delete lines 1 through 27.
Page 44, delete lines 37 through 42.
Delete page 45.
Page 46, delete lines 1 through 17.
Page 46, delete lines 21 through 27.
Page 46, delete lines 39 through 42.
Page 47, delete lines 1 through 7.
Renumber all SECTIONS consecutively.
and when so amended that said bill do pass.
(Reference is to HB 1158 as introduced.)
BARRETT
Committee Vote: yeas 11, nays 0.
HB 1158—LS 7067/DI 137 46
HOUSE MOTION
Mr. Speaker: I move that House Bill 1158 be amended to read as
follows:
Page 15, delete lines 21 through 33.
Renumber all SECTIONS consecutively.
(Reference is to HB 1158 as printed January 20, 2022.)
CLERE
HB 1158—LS 7067/DI 137