*HB1005.2*

ReprintedJanuary 30, 2020

HOUSE BILL No. 1005_____

DIGEST OF HB 1005 (Updated January 29, 2020 3:03 pm - DI 77)

Citations Affected: IC 5-14; IC 12-26; IC 16-18; IC 16-21;IC 16-24.5; IC 16-47; IC 16-51; IC 25-22.5; IC 25-26; IC 27-1;IC 27-2; IC 27-4; IC 27-8; IC 27-13; IC 36-2.

Synopsis: Health and insurance matters. Establishes the importationof prescription drugs program (program) for the importation ofprescription drugs to be administered by the state department of health(state department). Requires the state department to apply to the federalgovernment for approval of the program. Sets forth requirements forthe vendor of the program. Sets requirements for suppliers, importers,and wholesale drug distributors of the program. Requires the statedepartment to submit reports to the governor and the general assemblyconcerning the program. Establishes for participants in the program aninternational export pharmacy permit and wholesale drug distributorpermit administered by the Indiana board of pharmacy. Provides thata facility is an off-campus location of a hospital if: (1) the operationsof the facility are directly or indirectly owned or controlled by, oraffiliated with, the hospital; (2) the facility provides services that areorganizationally and functionally integrated with the services of thehospital; and (3) the facility provides preventive services, diagnosticservices, treatment services, or emergency services. Requires hospitals,ambulatory surgical outpatient centers, and urgent care facilities to postcertain health care services pricing information by billing code on the

(Continued next page)

Effective: Upon passage; July 1, 2020; January 1, 2021.

Schaibley, Lehman, Carbaugh,Shackleford

January 6, 2020, read first time and referred to Committee on Public Health.January 23, 2020, amended, reported — Do Pass.January 29, 2020, read second time, amended, ordered engrossed.

HB 1005—LS 6902/DI 104

Digest Continued

hospital's Internet web site and sets forth requirements. Requires: (1)a provider facility (including a hospital) in which a nonemergencyhealth care service will be performed; or (2) a practitioner (includinga physician) who will perform a nonemergency health care service;upon request from the individual for whom the nonemergency healthcare service has been ordered, scheduled, or referred, to provide a goodfaith estimate of the price for the nonemergency health care service notmore than three business days after receiving the individual's request.Requires a provider facility or practitioner to include the address of theservice facility location to obtain reimbursement for a commercialclaim for health care services. Requires a health carrier (including aninsurer or a health maintenance organization) to provide to anindividual who is entitled to coverage from the health carrier, not morethan three business days after the individual requests the information,a good faith estimate of: (1) the amount of the cost of thenonemergency health care service that the health carrier will pay for orreimburse to the covered individual; or (2) the extent and nature of theordered nonemergency health care service a covered individual isentitled to receive. Requires the department of insurance to submit arequest for information and a request for proposal concerning theestablishment and implementation of an all payer claims data base andsets forth requirements. Provides that if a health carrier providescoverage to the individual through a network plan, the health carriershall inform the individual whether the provider facility in which thenonemergency health care service will be provided and thepractitioners who will provide the nonemergency health care serviceare included in the health carrier's network plan. Requires providerfacilities to post signs in waiting rooms and to provide Internet web sitenotices about the availability of estimates of the amount the patient willbe charged for medical services. Requires practitioners to providenotice about the availability of estimates of the amount the patient willbe charged for medical services when the practitioner has ordered,scheduled, or referred the individual for a nonemergency health careservice. Requires health carriers to provide Internet web site noticesabout the availability of good faith estimates of coverage fornonemergency health care services. Provides penalties fornoncompliance by provider facilities, practitioners, and health carriers.Requires an insurance producer to disclose commission information.Prohibits health provider contracts and contracts between a providerand a pharmacy benefits manager from including provisions thatprohibit the disclosure of health care service claims data to employersproviding the health coverage and makes a violation an unfair anddeceptive act. Provides that a fully credentialed provider shall bereimbursed by an insurer or health maintenance organization foreligible services provided at an in-network hospital if certainconditions are met.

HB 1005—LS 6902/DI 104HB 1005—LS 6902/DI 104

ReprintedJanuary 30, 2020

Second Regular Session of the 121st General Assembly (2020)

PRINTING CODE. Amendments: Whenever an existing statute (or a section of the IndianaConstitution) 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 constitutionalprovision adopted), the text of the new provision will appear in this style type. Also, theword NEW will appear in that style type in the introductory clause of each SECTION that addsa 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 conflictsbetween statutes enacted by the 2019 Regular Session of the General Assembly.

HOUSE BILL No. 1005

A BILL FOR AN ACT to amend the Indiana Code concerninghealth.

Be it enacted by the General Assembly of the State of Indiana:

1 SECTION 1. IC 5-14-3-2, AS AMENDED BY P.L.85-2017,2 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE3 JULY 1, 2020]: Sec. 2. (a) The definitions set forth in this section apply4 throughout this chapter.5 (b) "Copy" includes transcribing by handwriting, photocopying,6 xerography, duplicating machine, duplicating electronically stored data7 onto a disk, tape, drum, or any other medium of electronic data storage,8 and reproducing by any other means.9 (c) "Criminal intelligence information" means data that has been

10 evaluated to determine that the data is relevant to:11 (1) the identification of; and12 (2) the criminal activity engaged in by;13 an individual who or organization that is reasonably suspected of14 involvement in criminal activity.15 (d) "Direct cost" means one hundred five percent (105%) of the sum

HB 1005—LS 6902/DI 104

2

1 of the cost of:2 (1) the initial development of a program, if any;3 (2) the labor required to retrieve electronically stored data; and4 (3) any medium used for electronic output;5 for providing a duplicate of electronically stored data onto a disk, tape,6 drum, or other medium of electronic data retrieval under section 8(g)7 of this chapter, or for reprogramming a computer system under section8 6(c) of this chapter.9 (e) "Electronic map" means copyrighted data provided by a public

10 agency from an electronic geographic information system.11 (f) "Enhanced access" means the inspection of a public record by a12 person other than a governmental entity and that:13 (1) is by means of an electronic device other than an electronic14 device provided by a public agency in the office of the public15 agency; or16 (2) requires the compilation or creation of a list or report that does17 not result in the permanent electronic storage of the information.18 (g) "Facsimile machine" means a machine that electronically19 transmits exact images through connection with a telephone network.20 (h) "Inspect" includes the right to do the following:21 (1) Manually transcribe and make notes, abstracts, or memoranda.22 (2) In the case of tape recordings or other aural public records, to23 listen and manually transcribe or duplicate, or make notes,24 abstracts, or other memoranda from them.25 (3) In the case of public records available:26 (A) by enhanced access under section 3.5 of this chapter; or27 (B) to a governmental entity under section 3(c)(2) of this28 chapter;29 to examine and copy the public records by use of an electronic30 device.31 (4) In the case of electronically stored data, to manually transcribe32 and make notes, abstracts, or memoranda or to duplicate the data33 onto a disk, tape, drum, or any other medium of electronic34 storage.35 (i) "Investigatory record" means information compiled in the course36 of the investigation of a crime.37 (j) "Law enforcement activity" means:38 (1) a traffic stop;39 (2) a pedestrian stop;40 (3) an arrest;41 (4) a search;42 (5) an investigation;

HB 1005—LS 6902/DI 104

3

1 (6) a pursuit;2 (7) crowd control;3 (8) traffic control; or4 (9) any other instance in which a law enforcement officer is5 enforcing the law.6 The term does not include an administrative activity, including the7 completion of paperwork related to a law enforcement activity, or a8 custodial interrogation conducted in a place of detention as described9 in Indiana Evidence Rule 617, regardless of the ultimate admissibility

10 of a statement made during the custodial interrogation.11 (k) "Law enforcement recording" means an audio, visual, or12 audiovisual recording of a law enforcement activity captured by a13 camera or other device that is:14 (1) provided to or used by a law enforcement officer in the scope15 of the officer's duties; and16 (2) designed to be worn by a law enforcement officer or attached17 to the vehicle or transportation of a law enforcement officer.18 (l) "Offender" means a person confined in a penal institution as the19 result of the conviction for a crime.20 (m) "Patient" has the meaning set out in IC 16-18-2-272(d).21 (n) "Person" means an individual, a corporation, a limited liability22 company, a partnership, an unincorporated association, or a23 governmental entity.24 (o) "Private university police department" means the police officers25 appointed by the governing board of a private university under26 IC 21-17-5.27 (p) "Provider" has the meaning set out in IC 16-18-2-295(b)28 IC 16-18-2-295(c) and includes employees of the state department of29 health or local boards of health who create patient records at the30 request of another provider or who are social workers and create31 records concerning the family background of children who may need32 assistance.33 (q) "Public agency", except as provided in section 2.1 of this34 chapter, means the following:35 (1) Any board, commission, department, division, bureau,36 committee, agency, office, instrumentality, or authority, by37 whatever name designated, exercising any part of the executive,38 administrative, judicial, or legislative power of the state.39 (2) Any:40 (A) county, township, school corporation, city, or town, or any41 board, commission, department, division, bureau, committee,42 office, instrumentality, or authority of any county, township,

HB 1005—LS 6902/DI 104

4

1 school corporation, city, or town;2 (B) political subdivision (as defined by IC 36-1-2-13); or3 (C) other entity, or any office thereof, by whatever name4 designated, exercising in a limited geographical area the5 executive, administrative, judicial, or legislative power of the6 state or a delegated local governmental power.7 (3) Any entity or office that is subject to:8 (A) budget review by either the department of local9 government finance or the governing body of a county, city,

10 town, township, or school corporation; or11 (B) an audit by the state board of accounts that is required by12 statute, rule, or regulation.13 (4) Any building corporation of a political subdivision that issues14 bonds for the purpose of constructing public facilities.15 (5) Any advisory commission, committee, or body created by16 statute, ordinance, or executive order to advise the governing17 body of a public agency, except medical staffs or the committees18 of any such staff.19 (6) Any law enforcement agency, which means an agency or a20 department of any level of government that engages in the21 investigation, apprehension, arrest, or prosecution of alleged22 criminal offenders, such as the state police department, the police23 or sheriff's department of a political subdivision, prosecuting24 attorneys, members of the excise police division of the alcohol25 and tobacco commission, conservation officers of the department26 of natural resources, gaming agents of the Indiana gaming27 commission, gaming control officers of the Indiana gaming28 commission, and the security division of the state lottery29 commission.30 (7) Any license branch operated under IC 9-14.1.31 (8) The state lottery commission established by IC 4-30-3-1,32 including any department, division, or office of the commission.33 (9) The Indiana gaming commission established under IC 4-33,34 including any department, division, or office of the commission.35 (10) The Indiana horse racing commission established by IC 4-31,36 including any department, division, or office of the commission.37 (11) A private university police department. The term does not38 include the governing board of a private university or any other39 department, division, board, entity, or office of a private40 university.41 (r) "Public record" means any writing, paper, report, study, map,42 photograph, book, card, tape recording, or other material that is

HB 1005—LS 6902/DI 104

5

1 created, received, retained, maintained, or filed by or with a public2 agency and which is generated on paper, paper substitutes,3 photographic media, chemically based media, magnetic or machine4 readable media, electronically stored data, or any other material,5 regardless of form or characteristics.6 (s) "Standard-sized documents" includes all documents that can be7 mechanically reproduced (without mechanical reduction) on paper8 sized eight and one-half (8 1/2) inches by eleven (11) inches or eight9 and one-half (8 1/2) inches by fourteen (14) inches.

10 (t) "Trade secret" has the meaning set forth in IC 24-2-3-2.11 (u) "Work product of an attorney" means information compiled by12 an attorney in reasonable anticipation of litigation. The term includes13 the attorney's:14 (1) notes and statements taken during interviews of prospective15 witnesses; and16 (2) legal research or records, correspondence, reports, or17 memoranda to the extent that each contains the attorney's18 opinions, theories, or conclusions.19 This definition does not restrict the application of any exception under20 section 4 of this chapter.21 SECTION 2. IC 12-26-2-5, AS AMENDED BY P.L.1-2007,22 SECTION 126, IS AMENDED TO READ AS FOLLOWS23 [EFFECTIVE JULY 1, 2020]: Sec. 5. (a) This section applies under the24 following statutes:25 (1) IC 12-26-6.26 (2) IC 12-26-7.27 (3) IC 12-26-12.28 (4) IC 12-26-15.29 (b) A petitioner may be represented by counsel.30 (c) The court may appoint counsel for a petitioner upon a showing31 of the petitioner's indigency and the court shall pay for such counsel if32 appointed.33 (d) A petitioner, including a petitioner who is a health care provider34 under IC 16-18-2-295(b), IC 16-18-2-295(c), in the petitioner's35 individual capacity or as a corporation is not required to be represented36 by counsel. If a petitioner who is a corporation elects not to be37 represented by counsel, the individual representing the corporation at38 the commitment hearing must present the court with written39 authorization from:40 (1) an officer;41 (2) a director;42 (3) a principal; or

HB 1005—LS 6902/DI 104

6

1 (4) a manager;2 of the corporation that authorizes the individual to represent the interest3 of the corporation in the proceedings.4 (e) The petitioner is required to prove by clear and convincing5 evidence that:6 (1) the individual is mentally ill and either dangerous or gravely7 disabled; and8 (2) detention or commitment of that individual is appropriate.9 SECTION 3. IC 16-18-2-46.5 IS ADDED TO THE INDIANA

10 CODE AS A NEW SECTION TO READ AS FOLLOWS11 [EFFECTIVE JULY 1, 2020]: Sec. 46.5. "Canadian supplier", for12 purposes of IC 16-47-3, has the meaning set forth in IC 16-47-3-1.13 SECTION 4. IC 16-18-2-88.3 IS ADDED TO THE INDIANA14 CODE AS A NEW SECTION TO READ AS FOLLOWS15 [EFFECTIVE JULY 1, 2020]: Sec. 88.3. "Covered individual", for16 purposes of IC 16-21-15, has the meaning set forth in17 IC 16-21-15-1.18 SECTION 5. IC 16-18-2-148.7 IS ADDED TO THE INDIANA19 CODE AS A NEW SECTION TO READ AS FOLLOWS20 [EFFECTIVE JULY 1, 2020]: Sec. 148.7. "Good faith estimate", for21 purposes of IC 16-21-15, has the meaning set forth in22 IC 16-21-15-2.23 SECTION 6. IC 16-18-2-163.6 IS ADDED TO THE INDIANA24 CODE AS A NEW SECTION TO READ AS FOLLOWS25 [EFFECTIVE JULY 1, 2020]: Sec. 163.6. "Health care services", for26 purposes of IC 16-51-1, has the meaning set forth in IC 16-51-1-1.27 SECTION 7. IC 16-18-2-163.8 IS ADDED TO THE INDIANA28 CODE AS A NEW SECTION TO READ AS FOLLOWS29 [EFFECTIVE JULY 1, 2020]: Sec. 163.8. "Health carrier", for30 purposes of IC 16-21-15, has the meaning set forth in31 IC 16-21-15-3.32 SECTION 8. IC 16-18-2-190.5 IS ADDED TO THE INDIANA33 CODE AS A NEW SECTION TO READ AS FOLLOWS34 [EFFECTIVE JULY 1, 2020]: Sec. 190.5. "In network", for purposes35 of IC 16-21-15, has the meaning set forth in IC 16-21-15-4.36 SECTION 9. IC 16-18-2-216 IS AMENDED TO READ AS37 FOLLOWS [EFFECTIVE JULY 1, 2020]: Sec. 216. (a)38 "Manufacturer", for purposes of IC 16-42-19 and IC 16-42-21, means39 a person who by compounding, cultivating, harvesting, mixing, or other40 process produces or prepares legend drugs. The term includes a person41 who:42 (1) prepares legend drugs in dosage forms by mixing,

HB 1005—LS 6902/DI 104

7

1 compounding, encapsulating, entableting, or other process; or2 (2) packages or repackages legend drugs.3 (b) The term does not include pharmacists or practitioners (as4 defined in section 288(a) 288(b) and 288(c) 288(d) of this chapter) in5 the practice of their profession.6 SECTION 10. IC 16-18-2-247.5 IS ADDED TO THE INDIANA7 CODE AS A NEW SECTION TO READ AS FOLLOWS8 [EFFECTIVE JULY 1, 2020]: Sec. 247.5. "Network", for purposes9 of IC 16-21-15, has the meaning set forth in IC 16-21-15-5.

10 SECTION 11. IC 16-18-2-247.6 IS ADDED TO THE INDIANA11 CODE AS A NEW SECTION TO READ AS FOLLOWS12 [EFFECTIVE JULY 1, 2020]: Sec. 247.6. "Network plan", for13 purposes of IC 16-21-15, has the meaning set forth in14 IC 16-21-15-6.15 SECTION 12. IC 16-18-2-250.5 IS ADDED TO THE INDIANA16 CODE AS A NEW SECTION TO READ AS FOLLOWS17 [EFFECTIVE JULY 1, 2020]: Sec. 250.5. "Nonemergency health18 care service", for purposes of IC 16-21-15, has the meaning set19 forth in IC 16-21-15-7.20 SECTION 13. IC 16-18-2-254.4 IS ADDED TO THE INDIANA21 CODE AS A NEW SECTION TO READ AS FOLLOWS22 [EFFECTIVE JULY 1, 2020]: Sec. 254.4. "Off-campus location of a23 hospital", for purposes of IC 16-21-16, has the meaning set forth24 in IC 16-21-16-3.25 SECTION 14. IC 16-18-2-288, AS AMENDED BY P.L.96-2014,26 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE27 JULY 1, 2020]: Sec. 288. (a) "Practitioner", for purposes of28 IC 16-21-15, has the meaning set forth in IC 16-21-15-8.29 (a) (b) "Practitioner", for purposes of IC 16-42-19, has the meaning30 set forth in IC 16-42-19-5.31 (b) (c) "Practitioner", for purposes of IC 16-41-14, has the meaning32 set forth in IC 16-41-14-4.33 (c) (d) "Practitioner", for purposes of IC 16-42-21, has the meaning34 set forth in IC 16-42-21-3.35 (d) (e) "Practitioner", for purposes of IC 16-42-22 and IC 16-42-25,36 has the meaning set forth in IC 16-42-22-4.5.37 (f) "Practitioner", for purposes of IC 16-51-1, has the meaning38 set forth in IC 16-51-1-4.39 SECTION 15. IC 16-18-2-294.5, AS AMENDED BY P.L.208-2015,40 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE41 JULY 1, 2020]: Sec. 294.5. (a) "Program", for purposes of IC 16-40-4,42 has the meaning set forth in IC 16-40-4-3.

HB 1005—LS 6902/DI 104

8

1 (b) "Program", for purposes of IC 16-41-7.5, has the meaning set2 forth in IC 16-41-7.5-2.3 (c) "Program", for purposes of IC 16-47-1, has the meaning set forth4 in IC 16-47-1-3.5 (d) "Program", for purposes of IC 16-47-3, has the meaning set6 forth in IC 16-47-3-2.7 SECTION 16. IC 16-18-2-295, AS AMENDED BY P.L.161-2014,8 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE9 JULY 1, 2020]: Sec. 295. (a) "Provider", for purposes of IC 16-21-8,

10 has the meaning set forth in IC 16-21-8-0.2.11 (b) "Provider", for purposes of IC 16-21-15, has the meaning set12 forth in IC 16-21-15-9.13 (b) (c) "Provider", for purposes of IC 16-38-5, IC 16-39 (except for14 IC 16-39-7), and IC 16-41-1 through IC 16-41-9, means any of the15 following:16 (1) An individual (other than an individual who is an employee or17 a contractor of a hospital, a facility, or an agency described in18 subdivision (2) or (3)) who is licensed, registered, or certified as19 a health care professional, including the following:20 (A) A physician.21 (B) A psychotherapist.22 (C) A dentist.23 (D) A registered nurse.24 (E) A licensed practical nurse.25 (F) An optometrist.26 (G) A podiatrist.27 (H) A chiropractor.28 (I) A physical therapist.29 (J) A psychologist.30 (K) An audiologist.31 (L) A speech-language pathologist.32 (M) A dietitian.33 (N) An occupational therapist.34 (O) A respiratory therapist.35 (P) A pharmacist.36 (Q) A sexual assault nurse examiner.37 (2) A hospital or facility licensed under IC 16-21-2 or IC 12-25 or38 described in IC 12-24-1 or IC 12-29.39 (3) A health facility licensed under IC 16-28-2.40 (4) A home health agency licensed under IC 16-27-1.41 (5) An employer of a certified emergency medical technician, a42 certified advanced emergency medical technician, or a licensed

HB 1005—LS 6902/DI 104

9

1 paramedic.2 (6) The state department or a local health department or an3 employee, agent, designee, or contractor of the state department4 or local health department.5 (c) (d) "Provider", for purposes of IC 16-39-7-1, has the meaning set6 forth in IC 16-39-7-1(a).7 (d) (e) "Provider", for purposes of IC 16-48-1, has the meaning set8 forth in IC 16-48-1-3.9 SECTION 17. IC 16-18-2-295.5 IS ADDED TO THE INDIANA

10 CODE AS A NEW SECTION TO READ AS FOLLOWS11 [EFFECTIVE JULY 1, 2020]: Sec. 295.5. "Provider facility", for12 purposes of IC 16-21-15, has the meaning set forth in13 IC 16-21-15-10.14 SECTION 18. IC 16-18-2-328.7 IS ADDED TO THE INDIANA15 CODE AS A NEW SECTION TO READ AS FOLLOWS16 [EFFECTIVE JULY 1, 2020]: Sec. 328.7. "Service facility location",17 for purposes of IC 16-51-1, has the meaning set forth in18 IC 16-51-1-6.19 SECTION 19. IC 16-18-2-353.3 IS ADDED TO THE INDIANA20 CODE AS A NEW SECTION TO READ AS FOLLOWS21 [EFFECTIVE JULY 1, 2020]: Sec. 353.3. "Track-and-trace", for22 purposes of IC 16-47-3, has the meaning set forth in IC 16-47-3-3.23 SECTION 20. IC 16-18-2-362.1 IS ADDED TO THE INDIANA24 CODE AS A NEW SECTION TO READ AS FOLLOWS25 [EFFECTIVE JULY 1, 2020]: Sec. 362.1. "Urgent care facility", for26 purposes of IC 16-24.5-1, has the meaning set forth in27 IC 16-24.5-1-1.28 SECTION 21. IC 16-18-2-363.5 IS ADDED TO THE INDIANA29 CODE AS A NEW SECTION TO READ AS FOLLOWS30 [EFFECTIVE JULY 1, 2020]: Sec. 363.5. "Vendor", for purposes of31 IC 16-47-3, has the meaning set forth in IC 16-47-3-4.32 SECTION 22. IC 16-21-3-2, AS AMENDED BY P.L.197-2011,33 SECTION 61, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE34 JULY 1, 2020]: Sec. 2. (a) The state health commissioner may take35 action under section 1 of this chapter on any of the following grounds:36 (1) Violation of any of the provisions of this chapter or of the37 rules adopted under this chapter.38 (2) Permitting, aiding, or abetting the commission of any illegal39 act in an institution.40 (3) Knowingly collecting or attempting to collect from a41 subscriber (as defined in IC 27-13-1-32) or an enrollee (as defined42 in IC 27-13-1-12) of a health maintenance organization (as

HB 1005—LS 6902/DI 104

10

1 defined in IC 27-13-1-19) any amounts that are owed by the2 health maintenance organization.3 (4) Conduct or practice found by the state department to be4 detrimental to the welfare of the patients of an institution.5 (b) The state health commissioner may take action:6 (1) under section 1(1) or 1(2) of this chapter for an initial7 violation or isolated violations of IC 16-21-15; or8 (2) under section 1(4) or 1(5) of this chapter for repeated or9 persistent violations of IC 16-21-15;

10 concerning the providing of a good faith estimate within three (3)11 business days to an individual for whom a nonemergency health12 care service has been ordered.13 SECTION 23. IC 16-21-15 IS ADDED TO THE INDIANA CODE14 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE15 JULY 1, 2020]:16 Chapter 15. Provider Facility Good Faith Estimates17 Sec. 0.5. Nothing in this chapter prohibits:18 (1) a self-funded health benefit plan that complies with the19 federal Employee Retirement Income Security Act (ERISA)20 of 1974 (29 U.S.C. 1001 et seq.); or21 (2) a self-insurance program established to provide group22 health coverage as described in IC 5-10-8-7(b), or a contract23 for health services as described in IC 5-10-8-7(c);24 from providing information requested by a practitioner or25 provider facility under this chapter.26 Sec. 1. As used in this chapter, "covered individual" means an27 individual who is entitled to be provided health care services28 according to a health carrier's network plan.29 Sec. 2. As used in this chapter, "good faith estimate" means a30 reasonable estimate of the total price a provider anticipates31 charging for one (1) or more nonemergency health care services32 that:33 (1) is made by a provider under this chapter upon the request34 of the individual for whom the nonemergency health care35 service has been ordered; and36 (2) is not binding upon the provider.37 Sec. 3. (a) As used in this chapter, "health carrier" means an38 entity:39 (1) that is subject to IC 27 and the administrative rules40 adopted under IC 27; and41 (2) that enters into a contract to:42 (A) provide health care services;

HB 1005—LS 6902/DI 104

11

1 (B) deliver health care services;2 (C) arrange for health care services; or3 (D) pay for or reimburse any of the costs of health care4 services.5 (b) The term includes the following:6 (1) An insurer, as defined in IC 27-1-2-3(x), that issues a7 policy of accident and sickness insurance, as defined in8 IC 27-8-5-1(a).9 (2) A health maintenance organization, as defined in

10 IC 27-13-1-19.11 (3) An administrator (as defined in IC 27-1-25-1(a)) that is12 licensed under IC 27-1-25.13 (4) Any other entity that provides a plan of health insurance,14 health benefits, or health care services.15 Sec. 4. As used in this chapter, "in network", when used in16 reference to a provider, means that the health care services17 provided by the provider are subject to a health carrier's network18 plan.19 Sec. 5. (a) As used in this chapter, "network" means a group of20 provider facilities and practitioners that:21 (1) provide health care services to covered individuals; and22 (2) have agreed to, or are otherwise subject to, maximum23 limits on the fees and charges for the health care services to be24 provided to the covered individuals.25 (b) The term includes the following:26 (1) A network described in subsection (a) that is established27 pursuant to a contract between an insurer providing coverage28 under a group health policy and:29 (A) individual provider facilities and practitioners;30 (B) a preferred provider organization; or31 (C) an entity that employs or represents providers,32 including:33 (i) an independent practice association; and34 (ii) a physician-hospital organization.35 (2) A health management organization, as defined in36 IC 27-13-1-19.37 Sec. 6. As used in this chapter, "network plan" means a plan of38 a health carrier that:39 (1) requires a covered person to receive; or40 (2) creates incentives, including financial incentives, for a41 covered person to receive;42 health care services from one (1) or more providers that are under

HB 1005—LS 6902/DI 104

12

1 contract with, managed by, or owned by the health carrier.2 Sec. 7. (a) As used in this chapter, "nonemergency health care3 service" means a service or series of services ordered, scheduled,4 or referred by a practitioner for the purpose of:5 (1) diagnosis;6 (2) prevention;7 (3) treatment;8 (4) cure; or9 (5) relief;

10 of a physical, mental, or behavioral health condition, illness, injury,11 or disease that is not provided on an emergency basis.12 Sec. 8. As used in this chapter, "practitioner" means:13 (1) an individual who holds a license, certificate, registration,14 or permit under:15 (A) IC 25-22.5 (physicians);16 (B) IC 25-27 (physical therapists); or17 (C) IC 25-33 (psychologists); or18 (2) an organization consisting of or employing two (2) or more19 individuals described in subdivision (1).20 Sec. 8.5. As used in this chapter, "price" means the negotiated21 rate between the:22 (1) provider facility and practitioner; and23 (2) covered individual's health carrier.24 Sec. 9. As used in this chapter, "provider" means:25 (1) a provider facility; or26 (2) a practitioner.27 Sec. 10. As used in this chapter, "provider facility"means any of28 the following:29 (1) A hospital licensed under IC 16-21-2.30 (2) An ambulatory outpatient surgery center licensed under31 IC 16-21-2.32 (3) An abortion clinic licensed under IC 16-21-2.33 (4) A birthing center licensed under IC 16-21-2.34 (5) A facility that provides diagnostic services to the medical35 profession or the general public, including outpatient36 facilities.37 (6) A laboratory where clinical pathology tests are carried out38 on specimens to obtain information about the health of a39 patient.40 (7) A facility where radiologic and electromagnetic images are41 made to obtain information about the health of a patient.42 (8) An infusion center that administers intravenous

HB 1005—LS 6902/DI 104

13

1 medications.2 Sec. 11. (a) This section does not:3 (1) apply to a individual who is a Medicaid recipient; or4 (2) limit the authority of a legal representative of the patient.5 (b) An individual for whom a nonemergency health care service6 has been ordered may request from the provider facility in which7 the health care service will be provided a good faith estimate of the8 total price that will be charged as a result of the nonemergency9 health care service.

10 (c) A provider facility that receives a request from an individual11 under subsection (b) shall, not more than three (3) business days12 after receiving the request, provide to the individual a good faith13 estimate of:14 (1) the total price that the provider facility in which the health15 care service will be performed will impose for:16 (A) the use of the provider facility to care for the17 individual before, during, and after the nonemergency18 health care service;19 (B) the services rendered by the staff of the provider20 facility in connection with the nonemergency health care21 service; and22 (C) medication, supplies, equipment, and material items to23 be provided to or used by the individual while the24 individual is present in the provider facility in connection25 with the nonemergency health care service; and26 (2) fees charged for the services of all practitioners, support27 staff, and other persons who provide professional health28 services:29 (A) who will provide services to or for the individual30 during the individual's presence in the provider facility for31 the nonemergency health care service; and32 (B) for whose services the individual will be charged33 separately from the charge of the provider facility.34 (d) The charges that must be included in a good faith estimate35 under this section include all charges under subsection (c)(1) or36 (c)(2) for imaging, laboratory services, diagnostic services, therapy,37 observation services, and other services expected to be provided to38 the individual.39 (e) A provider facility must ensure that a good faith estimate40 provided to an individual under this section is accompanied by a41 notice stating that:42 (1) an estimate provided under this section is not binding on

HB 1005—LS 6902/DI 104

14

1 the provider facility; and2 (2) the price the provider facility charges the individual may3 vary from the estimate based on the individual's medical4 needs.5 (f) A provider facility may not charge a patient for information6 provided under this section.7 Sec. 12. (a) If:8 (1) the individual who requests a good faith estimate from a9 provider facility under this chapter and has been verified as

10 a covered individual with respect to a network plan; and11 (2) the provider facility from which the individual requests12 the good faith estimate is in network with respect to the same13 network plan;14 the good faith estimate that the provider facility provides to the15 individual under this chapter must be based on the negotiated16 charges to which the provider facility and any practitioners17 referred to in section 11(c)(2) of this chapter have agreed as in18 network providers.19 (b) If the individual who requests a good faith estimate from a20 provider facility under this chapter:21 (1) is not a covered individual with respect to any network22 plan; or23 (2) is not a covered individual with respect to a network plan24 with respect to which the provider facility is in network;25 the good faith estimate that the provider facility provides to the26 individual under this chapter must be based on the amounts that27 the provider facility and any practitioners referred to in section28 11(c)(2) of this chapter charge for the nonemergency health care29 services in the absence of any network plan.30 Sec. 13. A provider facility may provide a good faith estimate to31 an individual under this chapter:32 (1) in a writing delivered to the individual;33 (2) by electronic mail; or34 (3) through a mobile application;35 according to the preference expressed by the individual.36 Sec. 14. (a) A good faith estimate provided by a provider facility37 to an individual under this chapter must:38 (1) state the services and material items that the good faith39 estimate is based on;40 (2) set forth the estimated price for the services and material41 items referred to in subdivision (1); and42 (3) include a total figure that is a sum of the estimated prices

HB 1005—LS 6902/DI 104

15

1 referred to in subdivision (2).2 (b) Subsection (a) does not prohibit a provider facility from3 providing to an individual a good faith estimate that indicates how4 much of the total figure stated under subsection (a)(3) will be the5 individual's out-of-pocket expense after the health carrier's6 payment of charges.7 (c) A health carrier must provide a provider facility with timely8 information needed by the provider facility to comply with the9 requirements under this chapter.

10 Sec. 15. (a) As used in this section, "waiting room" means a11 space in a building used by a provider facility in which people12 check in or register to:13 (1) be seen by practitioners; or14 (2) meet with members of the staff of the provider facility.15 (b) A provider facility shall ensure that each waiting room of the16 provider facility includes at least one (1) printed notice that:17 (1) is designed, lettered, and positioned within the waiting18 room so as to be conspicuous to and readable by any19 individual with normal vision who visits the waiting room;20 and21 (2) states the following, or words to the same effect: "A22 patient may ask for an estimate of the amount the patient will23 be charged for a nonemergency medical service provided in24 this facility. The law requires that an estimate be provided25 within 3 business days.".26 (c) If a provider facility maintains an Internet web site, the27 provider facility shall ensure that the Internet web site includes at28 least one (1) printed notice that:29 (1) is designed, lettered, and featured on the Internet web site30 so as to be conspicuous to and readable by any individual with31 normal vision who visits the Internet web site; and32 (2) states the following, or words to the same effect: "A33 patient may ask for an estimate of the amount the patient will34 be charged for a nonemergency medical service provided in35 our facility. The law requires that an estimate be provided36 within 3 business days.".37 SECTION 24. IC 16-21-17 IS ADDED TO THE INDIANA CODE38 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE39 JULY 1, 2020]:40 Chapter 17. Health Care Pricing Information41 Sec. 1. (a) Not later than March 31, 2021, a hospital and an42 ambulatory surgical center shall post on the Internet web site of

HB 1005—LS 6902/DI 104

16

1 the hospital or ambulatory outpatient surgical center pricing and2 other information specified in this chapter for the following:3 (1) For as many of the seventy (70) shoppable services4 specified in 45 CFR 180 (as published August 9, 2019, and as5 subsequently amended) that are provided by the hospital or6 ambulatory outpatient surgical center.7 (2) In addition to the services specified in subdivision (1), the8 thirty (30) most common services that are provided by the9 hospital or ambulatory outpatient surgical center.

10 (b) The following information must be included on the Internet11 web site by a hospital and an ambulatory outpatient surgical center12 for each billing code, including, if relevant, each diagnosis related13 group (DRG) billing code and each health care common procedure14 coding system (HCPCS) billing code:15 (1) The number of services provided for the code.16 (2) A description of the service.17 (3) The weighted average prices paid per service per provider18 type for each of the following categories:19 (A) Employer sponsored insurance.20 (B) Individually purchased insurance.21 (C) Medicare, including fee for service and Medicare22 Advantage.23 (D) Self pay without charitable assistance from the hospital24 or ambulatory surgical center.25 (E) Self pay with charitable assistance from the hospital or26 ambulatory surgical center.27 Sec. 2. (a) The information displayed on the Internet web site28 must be in an easy to read, understandable format, and include the29 prices for each billing code by provider type.30 (b) A hospital and an ambulatory outpatient surgical center31 shall update the information on the Internet web site on a32 quarterly basis.33 SECTION 25. IC 16-24.5 IS ADDED TO THE INDIANA CODE34 AS A NEW ARTICLE TO READ AS FOLLOWS [EFFECTIVE JULY35 1, 2020]:36 ARTICLE 24.5. OTHER HEALTH CARE FACILITIES37 Chapter 1. Urgent Care Facilities38 Sec. 1. (a) As used in this chapter, "urgent care facility" means39 a free standing health care facility that offers episodic, walk-in care40 for the treatment of acute, but not life-threatening, health41 conditions.42 (b) The term does not include an emergency department of a

HB 1005—LS 6902/DI 104

17

1 hospital or a nonprofit or government operated health clinic.2 Sec. 2. (a) Not later than March 31, 2021, an urgent care facility3 shall post on the Internet web site of the urgent care facility pricing4 and other information specified in this chapter for the fifteen (15)5 most common services that are provided by the urgent care6 facility.7 (b) The following information must be included on the Internet8 web site by an urgent care facility for each billing code, including,9 if relevant, each diagnosis related group (DRG) billing code and

10 each health care common procedure coding system (HCPCS)11 billing code:12 (1) The number of services provided for the code.13 (2) A description of the service.14 (3) The weighted average prices paid per service per provider15 type for each of the following categories:16 (A) Employer sponsored insurance.17 (B) Individually purchased insurance.18 (C) Medicare, including fee for service and Medicare19 Advantage.20 (D) Self pay without charitable assistance from the hospital21 or ambulatory surgical center.22 (E) Self pay with charitable assistance from the hospital or23 ambulatory surgical center.24 Sec. 3. (a) The information displayed on the Internet web site25 must be in an easy to read, understandable format, and include the26 prices for each billing code by provider type.27 (b) An urgent care facility shall update the information on the28 Internet web site on a quarterly basis.29 SECTION 26. IC 16-47-3 IS ADDED TO THE INDIANA CODE30 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE31 JULY 1, 2020]:32 Chapter 3. Importation of Prescription Drugs Program33 Sec. 1. As used in this chapter, "Canadian supplier" means a:34 (1) manufacturer;35 (2) wholesale drug distributor; or36 (3) pharmacy;37 appropriately licensed or permitted under Canadian law to38 manufacture, distribute, or dispense prescription drugs.39 Sec. 2. As used in this chapter, "program" refers to the40 importation of prescription drugs program established by section41 5 of this chapter.42 Sec. 3. As used in this chapter, "track-and-trace" means the

HB 1005—LS 6902/DI 104

18

1 product-tracing process for the components of the pharmaceutical2 distribution supply chain, as described in Title II of the federal3 Drug Quality and Security Act (21 U.S.C. 351 et seq.).4 Sec. 4. As used in this chapter, "vendor" means an entity that5 contracts with the state department to manage specified functions6 of the program.7 Sec. 5. (a) The importation of prescription drugs program is8 established.9 (b) The state department shall administer the program.

10 (c) The state department shall contract with a vendor to provide11 services under the program. The vendor must comply with the12 requirements of this chapter.13 (d) The state department shall require a bond from the vendor14 to mitigate the financial consequences of potential acts of15 malfeasance or misfeasance, potential fraudulent acts, or potential16 dishonest acts committed by the vendor, an employee of the17 vendor, or a contractor or subcontractor of the vendor.18 (e) Before July 1, 2021, the state department shall apply to the19 United States Department of Health and Human Services for20 approval of the program under 21 U.S.C. 384(1). The state21 department shall implement the program not later than six (6)22 months after the state department receives approval for the23 program. The request must include the following:24 (1) A description of the state department's plan for operating25 the program.26 (2) A demonstration of how the prescription drugs imported27 into Indiana under the program will meet the applicable28 federal and state standards for safety and effectiveness.29 (3) A demonstration of how the prescription drugs imported30 into Indiana under the program will comply with federal31 track-and-trace procedures.32 (4) A list of proposed prescription drugs that have the highest33 potential for cost savings to the state through importation at34 the time that the request is submitted.35 (5) An estimate of the total cost savings attributable to the36 program.37 (6) The costs of program implementation to the state.38 (7) A list of potential Canadian suppliers from which the state39 would import the prescription drugs and a demonstration that40 the suppliers are in full compliance with relevant Canadian41 federal and provincial laws and regulations, as well as all42 applicable federal and state laws and regulations.

HB 1005—LS 6902/DI 104

19

1 (f) Upon receipt of federal approval of the program, the state2 department shall notify the following:3 (1) The speaker of the house of representatives.4 (2) The president pro tempore of the senate.5 (3) The members of the health and provider services6 committee in the senate.7 (4) The members of the public health committee in the house8 of representatives.9 (g) Before the start of the general assembly session following

10 receipt of the federal approval, the state department shall submit11 to the individuals described in subsection (f) a proposal for the12 implementation of funding of the program.13 Sec. 6. (a) Before December 1, 2020, and by December 1 of each14 subsequent year, the vendor shall develop a wholesale prescription15 drug importation list identifying the prescription drugs that have16 the highest potential for cost savings to the state.17 (b) In developing the list, the vendor shall consider at least the18 following in determining whether a prescription drug should be19 included on the list:20 (1) Prescription drugs that, if included on the list, would21 provide the highest potential for cost savings in state22 administered programs.23 (2) Prescription drugs for which there is a shortage in Indiana24 or the United States.25 (3) Specialty prescription drugs.26 (4) High volume prescription drugs.27 (c) The state department shall review the wholesale prescription28 drug importation list at least every three (3) months to ensure that29 the list continues to meet the requirements of the program. The30 state department may direct the vendor to revise the list as31 necessary.32 Sec. 7. (a) The vendor shall identify Canadian suppliers that:33 (1) are in full compliance with:34 (A) relevant Canadian federal and provincial laws and35 regulations; and36 (B) the federal Drug Quality and Security Act;37 (2) have agreed to export prescription drugs identified on the38 list described in section 6 of this chapter at prices that will39 provide cost savings to the state; and40 (3) have obtained an international export pharmacy permit41 under IC 25-26-14.5.42 (b) The vendor must verify that the Canadian suppliers meet all

HB 1005—LS 6902/DI 104

20

1 of the requirements of the program while meeting or exceeding the2 federal and state track-and-trace laws and regulations.3 (c) The vendor shall:4 (1) contract with an eligible Canadian supplier; or5 (2) facilitate contracts between eligible importers and6 Canadian suppliers;7 to import drugs under the program.8 (d) The vendor shall maintain a list of all registered importers9 that participate in the program.

10 (e) The vendor shall ensure compliance with Title II of the11 federal Drug Quality and Security Act by all suppliers, importers,12 distributors, and participants in the program.13 Sec. 8. (a) The vendor shall provide to the state department the14 following:15 (1) An annual financial audit of the vendor's operations.16 (2) Quarterly financial reports specific to the program,17 including information on the performance of the vendor and18 the vendor's subcontractors for the program.19 (b) The state department shall determine the format and20 contents of the reports described in this section.21 Sec. 9. (a) A Canadian supplier is eligible to participate in the22 program if the Canadian supplier meets the following23 requirements:24 (1) Is in full compliance with relevant Canadian federal and25 provincial laws and regulations.26 (2) Is identified by the vendor as eligible to participate in the27 program.28 (3) Submits an attestation that the supplier has a registered29 agent in the United States, including the name and United30 States business address of the registered agent.31 (b) An importer that meets the requirements of this chapter32 may import a prescription drug from an eligible Canadian supplier33 if the following conditions are met:34 (1) The prescription drug meets the United States Food and35 Drug Administration's standards concerning safety,36 effectiveness, misbranding, and adulteration.37 (2) The importation of the drug would not violate federal38 patent laws.39 (3) The importation of the drug is expected to generate cost40 savings to the state.41 (4) The drug is not any of the following:42 (A) A controlled substance.

HB 1005—LS 6902/DI 104

21

1 (B) A biological product.2 (C) An infused drug.3 (D) An intravenously injected drug.4 (E) A drug that is inhaled during surgery.5 (F) A drug that is a parenteral drug, the importation of6 which is determined by the United States Secretary of7 Health and Human Services to pose a threat to the public8 health.9 Sec. 10. (a) The following entities may import prescription drugs

10 under the program from a Canadian supplier that meets the11 requirements of this chapter:12 (1) A pharmacist or wholesale drug distributor employed by13 or under contract with the state department for distribution14 to a county health department for dispensing to the patients15 of the county health department.16 (2) A pharmacist or wholesale drug distributor employed by17 or under contract with a pharmacy that is a Medicaid18 provider, for dispensing to the pharmacy's Medicaid19 recipients.20 (3) A pharmacist or wholesale drug distributor employed by21 or under contract with the department of correction, for22 dispensing to inmates in the custody of the department of23 correction.24 (b) A Canadian supplier that meets the requirements of this25 chapter and an eligible importer described in subsection (a) that is26 participating in the program:27 (1) must comply with all track-and-trace requirements; and28 (2) may not distribute, dispense, or sell prescription drugs29 imported under this program outside Indiana.30 Sec. 11. (a) The vendor shall ensure the safety and quality of31 drugs imported under the program.32 (b) The vendor shall do the following:33 (1) For an initial imported shipment of a specific drug by an34 importer, ensure that each batch of the drug in the shipment35 is statistically sampled and tested for authenticity and36 degradation in a manner consistent with federal law.37 (2) For every subsequent imported shipment of that drug by38 that importer, ensure that a statistically valid sample of the39 shipment is tested for authenticity and degradation in a40 manner consistent with federal law.41 (3) Certify that the drug:42 (A) is approved for marketing in the United States and is

HB 1005—LS 6902/DI 104

22

1 not adulterated or misbranded; and2 (B) meets all of the labeling requirements under 21 U.S.C.3 352.4 (4) Maintain qualified laboratory records, including complete5 data derived from all tests necessary to ensure that the drug6 is in compliance with the requirements of this section.7 (5) Maintain documentation demonstrating that the testing8 required by this section was conducted at a qualified9 laboratory in accordance with federal and state laws and

10 regulations governing laboratory qualifications.11 (c) All testing required by this section must be conducted in a12 qualified laboratory that meets the standards under federal and13 state laws and regulations governing laboratory qualifications for14 drug testing.15 (d) The vendor shall maintain information and documentation16 submitted under this section for at least seven (7) years.17 Sec. 12. An importer participating in the program must submit18 all of the following information to the vendor concerning drugs19 provided for the program:20 (1) The name and quantity of the active ingredients of the21 drug.22 (2) A description of the dosage form of the drug.23 (3) The date on which the drug is received.24 (4) The quantity of the drug that is received.25 (5) The point of origin and destination of the drug.26 (6) The price paid by the importer for the drug.27 Sec. 13. (a) A Canadian supplier participating in the program28 must submit the following information and documentation to the29 vendor specifying all of the following concerning drugs provided30 for the program:31 (1) The original source of the drug, including:32 (A) the name of the manufacturer of the drug;33 (B) the date on which the drug was manufactured; and34 (C) the location, including the country, state or province,35 and city, where the drug was manufactured.36 (2) The date on which the drug is shipped.37 (3) The quantity of the drug that is shipped.38 (4) The quantity of each lot of the drug originally received and39 the source of the lot.40 (5) The lot or control number and the batch number assigned41 to the drug by the manufacturer.42 (b) The state department may require that the vendor collect

HB 1005—LS 6902/DI 104

23

1 additional information from the Canadian supplier that is2 necessary to ensure the protection of the public health.3 Sec. 14. (a) The state department shall immediately suspend the4 importation of a specific drug or the importation of drugs by a5 specific importer if the state department discovers that any drug6 or importer activity is in violation of this chapter or any federal or7 state law or regulation.8 (b) The state department may revoke the suspension under9 subsection (a) of the importation of a specific drug or the

10 importation of drugs by a specific importer if the state department11 determines that the public is adequately protected from counterfeit12 or unsafe drugs being imported into Indiana.13 Sec. 15. Before December 1 of each year, the state department14 shall submit a report to the governor and the general assembly in15 an electronic format under IC 5-14-6 on the operation of the16 program during the previous fiscal year. The report must include17 at least the following:18 (1) A list of the prescription drugs that were imported under19 the program.20 (2) The number of participating persons.21 (3) The number of prescriptions dispensed through the22 program.23 (4) The estimated cost savings to the state during the previous24 fiscal year and to date that are attributable to the program.25 (5) A description of the methodology used to determine which26 drugs should be included on the wholesale prescription drug27 importation list.28 (6) Documentation on how the program ensures the following:29 (A) Canadian suppliers participating in the program are of30 high quality and high performance and in full compliance31 with relevant:32 (i) Canadian federal and provincial laws and33 regulations; and34 (ii) federal and state laws, regulations, and rules.35 (B) Prescription drugs imported under the program are36 not shipped, sold, or dispensed outside Indiana once in the37 possession of the importer.38 (C) Prescription drugs imported under the program are39 pure, unadulterated, potent, and safe.40 (D) The program does not place consumers at a higher41 health and safety risk than if the consumers did not42 participate.

HB 1005—LS 6902/DI 104

24

1 (E) The program provides cost savings to the state on2 imported prescription drugs.3 Sec. 16. The state department shall adopt rules under IC 4-22-24 necessary to implement this chapter.5 SECTION 27. IC 16-51 IS ADDED TO THE INDIANA CODE AS6 A NEW ARTICLE TO READ AS FOLLOWS [EFFECTIVE JULY 1,7 2020]:8 ARTICLE 51. HEALTH CARE REQUIREMENTS9 Chapter 1. Health Care Billing

10 Sec. 1. (a) As used in this chapter, "health care services" means11 health care related services or products rendered or sold by a12 provider within the scope of the provider's license or legal13 authorization.14 (b) The term includes hospital, medical, surgical, dental, vision,15 and pharmaceutical services or products.16 Sec. 2. As used in this chapter, "health maintenance17 organization" has the meaning set forth in IC 27-13-1-19.18 Sec. 3. As used in this chapter, "insurer" has the meaning set19 forth in IC 27-8-11-1(e).20 Sec. 4. As used in this chapter, "practitioner" means an21 individual or entity duly licensed or legally authorized to provide22 health care services.23 Sec. 5. As used in this chapter, "provider facility" means any of24 the following:25 (1) A hospital.26 (2) A skilled nursing facility.27 (3) An end stage renal disease provider.28 (4) A home health agency.29 (5) A hospice organization.30 (6) An outpatient physical therapy, occupational therapy, or31 speech pathology service provider.32 (7) A comprehensive outpatient rehabilitation facility.33 (8) A community mental health center.34 (9) A critical access hospital.35 (10) A federally qualified health center.36 (11) A histocompatibility laboratory.37 (12) An Indian health service facility.38 (13) An organ procurement organization.39 (14) A religious nonmedical health care institution.40 (15) A rural health clinic.41 Sec. 6. As used in this chapter, "service facility location" means42 the address where the services of a provider facility or practitioner

HB 1005—LS 6902/DI 104

25

1 were provided. The term consists of exact address and place of2 service codes as required on CMS forms 1500 and 1450, including3 an office, on-campus location of a hospital, and off-campus location4 of a hospital.5 Sec. 7. (a) A provider facility or practitioner shall include the6 address of the service facility location in order to obtain7 reimbursement for a commercial claim for health care services8 from an insurer, health maintenance organization, employer, or9 other person responsible for the payment of the cost of health care

10 services.11 (b) An insurer, health maintenance organization, employer, or12 other person responsible for the payment of the cost of health care13 services is not required to accept a bill for health care services that14 does not contain the service facility location.15 Sec. 8. A patient is not liable for any additional payment that is16 the result of a practitioner or provider facility filing an incorrect17 form or not including the correct service facility location as18 required under this chapter.19 SECTION 28. IC 25-22.5-16 IS ADDED TO THE INDIANA20 CODE AS A NEW CHAPTER TO READ AS FOLLOWS21 [EFFECTIVE JULY 1, 2020]:22 Chapter 16. Practitioner Good Faith Estimates23 Sec. 1. As used in this chapter, "covered individual" means an24 individual who is entitled to be provided health care services25 according to a health carrier's network plan.26 Sec. 2. As used in this chapter, "good faith estimate" means a27 reasonable estimate of the total price a practitioner anticipates28 charging for one (1) or more nonemergency health care services29 that:30 (1) is made by a practitioner under this chapter upon the31 request of:32 (A) the individual for whom the nonemergency health care33 service has been ordered; or34 (B) the provider facility in which the nonemergency health35 care service will be provided; and36 (2) is not binding upon the practitioner.37 Sec. 3. (a) As used in this chapter, "health carrier" means an38 entity:39 (1) that is subject to IC 27 and the administrative rules40 adopted under IC 27; and41 (2) that enters into a contract to:42 (A) provide health care services;

HB 1005—LS 6902/DI 104

26

1 (B) deliver health care services;2 (C) arrange for health care services; or3 (D) pay for or reimburse any of the costs of health care4 services.5 (b) The term includes the following:6 (1) An insurer, as defined in IC 27-1-2-3(x), that issues a7 policy of accident and sickness insurance, as defined in8 IC 27-8-5-1(a).9 (2) A health maintenance organization, as defined in

10 IC 27-13-1-19.11 (3) An administrator (as defined in IC 27-1-25-1(a)) that is12 licensed under IC 27-1-25.13 (4) Any other entity that provides a plan of health insurance,14 health benefits, or health care services.15 Sec. 4. As used in this chapter, "in network", when used in16 reference to a practitioner, means that the health care services17 provided by the practitioner are subject to a health carrier's18 network plan.19 Sec. 5. (a) As used in this chapter, "network" means a group of20 provider facilities and practitioners that:21 (1) provide health care services to covered individuals; and22 (2) have agreed to, or are otherwise subject to, maximum23 limits on the fees and charges for the health care services to be24 provided to the covered individuals.25 (b) The term includes the following:26 (1) A network described in subsection (a) that is established27 pursuant to a contract between an insurer providing coverage28 under a group health policy and:29 (A) individual provider facilities and practitioners;30 (B) a preferred provider organization; or31 (C) an entity that employs or represents providers,32 including:33 (i) an independent practice association; and34 (ii) a physician-hospital organization.35 (2) A health management organization, as defined in36 IC 27-13-1-19.37 Sec. 6. As used in this chapter, "network plan" means a plan of38 a health carrier that:39 (1) requires a covered person to receive; or40 (2) creates incentives, including financial incentives, for a41 covered person to receive;42 health care services from one (1) or more providers that are under

HB 1005—LS 6902/DI 104

27

1 contract with, managed by, or owned by the health carrier.2 Sec. 7. (a) As used in this chapter, "nonemergency health care3 service" means a service or series of services ordered, scheduled,4 or referred by a practitioner for the:5 (1) diagnosis;6 (2) prevention;7 (3) treatment;8 (4) cure; or9 (5) relief;

10 of a physical, mental, or behavioral health condition, illness, injury,11 or disease that is not provided on an emergency basis.12 Sec. 8. As used in this chapter, "practitioner" means:13 (1) an individual who holds a license, certificate, registration,14 or permit under:15 (A) IC 25-22.5 (physicians);16 (B) IC 25-27 (physical therapists); or17 (C) IC 25-33 (psychologists); or18 (2) an organization consisting of or employing two (2) or more19 individuals described in subdivision (1).20 Sec. 8.5. As used in this chapter, "price" means the negotiated21 rate between the:22 (1) provider facility and practitioner; and23 (2) covered individual's health carrier.24 Sec. 9. As used in this chapter, "provider" means:25 (1) a provider facility; or26 (2) a practitioner.27 Sec. 10. As used in this chapter, "provider facility"means any of28 the following:29 (1) A hospital licensed under IC 16-21-2.30 (2) An ambulatory outpatient surgery center licensed under31 IC 16-21-2.32 (3) An abortion clinic licensed under IC 16-21-2.33 (4) A birthing center licensed under IC 16-21-2.34 (5) A facility that provides diagnostic services to the medical35 profession or the general public.36 (6) A laboratory where clinical pathology tests are carried out37 on specimens to obtain information about the health of a38 patient.39 (7) A facility where radiologic and electromagnetic images are40 made to obtain information about the health of a patient.41 (8) An infusion center that administers intravenous42 medications.

HB 1005—LS 6902/DI 104

28

1 Sec. 11. (a) This section does not apply to a individual who is a2 Medicaid recipient.3 (b) An individual for whom a nonemergency health care service4 has been ordered may request from the practitioner who will5 provide the nonemergency health care service a good faith estimate6 of the total price the practitioner will charge for providing the7 nonemergency health care service.8 (c) A practitioner who receives a request from a patient under9 subsection (b) shall, not more than three (3) business days after

10 receiving the request, provide to the individual a good faith11 estimate of the total price that the practitioner will charge for12 providing the nonemergency health care service.13 (d) A practitioner must ensure that a good faith estimate14 provided to an individual under this section is accompanied by a15 notice stating that:16 (1) an estimate provided under this section is not binding on17 the practitioner; and18 (2) the amount the practitioner charges the individual may19 vary from the estimate based on the individual's medical20 needs.21 (e) A practitioner may not charge an individual for information22 provided under this section.23 Sec. 12. (a) If:24 (1) the individual who requests a good faith estimate from a25 practitioner under this chapter is a covered individual with26 respect to a network plan; and27 (2) the practitioner from which the individual requests the28 good faith estimate is in network with respect to the same29 network plan;30 the good faith estimate that the practitioner provides to the31 individual under this chapter must be based on the negotiated32 charges to which the practitioner has agreed as an in network33 provider.34 (b) If the individual who requests a good faith estimate from a35 practitioner under this chapter:36 (1) is not a covered individual with respect to any network37 plan; or38 (2) is not a covered individual with respect to a network plan39 with respect to which the practitioner is in network;40 the good faith estimate that the practitioner provides to the41 individual under this chapter must be based on the amounts that42 the practitioner charges for the nonemergency health care service

HB 1005—LS 6902/DI 104

29

1 in the absence of any network plan.2 Sec. 13. A practitioner may provide a good faith estimate to an3 individual under this chapter:4 (1) in a writing delivered to the individual;5 (2) by electronic mail; or6 (3) through a mobile application;7 according to the preference expressed by the individual.8 Sec. 14. (a) A good faith estimate provided by a practitioner to9 an individual under this chapter must:

10 (1) state the services and material items that the good faith11 estimate is based on;12 (2) set forth the estimated price for the services and material13 items referred to in subdivision (1); and14 (3) include a total figure that is a sum of the estimated prices15 referred to in subdivision (2).16 (b) Subsection (a) does not prohibit a practitioner from17 providing to an individual a good faith estimate that indicates how18 much of the total figure stated under subsection (a)(3) will be the19 individual's out-of-pocket expense after the health carrier's20 payment of charges.21 (c) A health carrier must provide a practitioner with timely22 information needed by the practitioner to comply with the23 requirements under this chapter.24 Sec. 15. If:25 (1) a practitioner is expected to provide a nonemergency26 health care service to an individual in a provider facility; and27 (2) the provider facility receives a request from an individual28 for a good faith estimate under IC 16-21-15;29 the practitioner, upon request from the provider facility, shall30 provide to the provider facility a good faith estimate of the31 practitioner's charge for providing the nonemergency health care32 service to enable the provider facility to comply with33 IC 16-21-15-11.34 Sec. 16. (a) A practitioner that has ordered, scheduled, or35 referred the individual for a nonemergency health care service36 shall provide to the individual an electronic or paper copy of a37 written notice that states the following, or words to the same effect:38 "A patient may at any time ask a practitioner for an estimate of the39 amount the practitioner will charge for providing a nonemergency40 medical service. The law requires that the estimate be provided41 within 3 business days.".42 (b) The state department may adopt rules under IC 4-22-2 to

HB 1005—LS 6902/DI 104

30

1 establish requirements for practitioners to provide additional2 charging information under this section.3 Sec. 17. The appropriate board (as defined in IC 25-1-9-1) may4 take action against a practitioner:5 (1) under IC 25-1-9-9(a)(3) or IC 25-1-9-9(a)(4) for an initial6 violation or isolated violations of this chapter; or7 (2) under IC 25-1-9-9(a)(1), IC 25-1-9-9(a)(2), or8 IC 25-1-9-9(a)(6) for repeated or persistent violations of this9 chapter;

10 concerning the providing of a good faith estimate to an individual11 for whom a nonemergency health care service has been ordered or12 the providing of notice in the practitioner's office or on the13 practitioner's Internet web site that a patient may at any time ask14 for an estimate of the amount that the patient will be charged for15 a medical service.16 SECTION 29. IC 25-26-13-4, AS AMENDED BY P.L.5-2016,17 SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE18 JULY 1, 2020]: Sec. 4. (a) The board may:19 (1) adopt rules under IC 4-22-2 for implementing and enforcing20 this chapter;21 (2) establish requirements and tests to determine the moral,22 physical, intellectual, educational, scientific, technical, and23 professional qualifications for applicants for pharmacists'24 licenses;25 (3) refuse to issue, deny, suspend, or revoke a license or permit or26 place on probation or fine any licensee or permittee under this27 chapter;28 (4) regulate the sale of drugs and devices in the state of Indiana;29 (5) impound, embargo, confiscate, or otherwise prevent from30 disposition any drugs, medicines, chemicals, poisons, or devices31 which by inspection are deemed unfit for use or would be32 dangerous to the health and welfare of the citizens of the state of33 Indiana; the board shall follow those embargo procedures found34 in IC 16-42-1-18 through IC 16-42-1-31, and persons may not35 refuse to permit or otherwise prevent members of the board or36 their representatives from entering such places and making such37 inspections;38 (6) prescribe minimum standards with respect to physical39 characteristics of pharmacies, as may be necessary to the40 maintenance of professional surroundings and to the protection of41 the safety and welfare of the public;42 (7) subject to IC 25-1-7, investigate complaints, subpoena

HB 1005—LS 6902/DI 104

31

1 witnesses, schedule and conduct hearings on behalf of the public2 interest on any matter under the jurisdiction of the board;3 (8) prescribe the time, place, method, manner, scope, and subjects4 of licensing examinations which shall be given at least twice5 annually; and6 (9) perform such other duties and functions and exercise such7 other powers as may be necessary to implement and enforce this8 chapter.9 (b) The board shall adopt rules under IC 4-22-2 for the following:

10 (1) Establishing standards for the competent practice of11 pharmacy.12 (2) Establishing the standards for a pharmacist to counsel13 individuals regarding the proper use of drugs.14 (3) Establishing standards and procedures before January 1, 2006,15 to ensure that a pharmacist:16 (A) has entered into a contract that accepts the return of17 expired drugs with; or18 (B) is subject to a policy that accepts the return of expired19 drugs of;20 a wholesaler, manufacturer, or agent of a wholesaler or21 manufacturer concerning the return by the pharmacist to the22 wholesaler, the manufacturer, or the agent of expired legend drugs23 or controlled drugs. In determining the standards and procedures,24 the board may not interfere with negotiated terms related to cost,25 expenses, or reimbursement charges contained in contracts26 between parties, but may consider what is a reasonable quantity27 of a drug to be purchased by a pharmacy. The standards and28 procedures do not apply to vaccines that prevent influenza,29 medicine used for the treatment of malignant hyperthermia, and30 other drugs determined by the board to not be subject to a return31 policy. An agent of a wholesaler or manufacturer must be32 appointed in writing and have policies, personnel, and facilities33 to handle properly returns of expired legend drugs and controlled34 substances.35 (4) The following concerning the issuance of a permit under36 IC 25-26-14.5:37 (A) Inspection report requirements described under38 IC 25-26-14.5-1.39 (B) The financial responsibility of entities that hold any40 permit under IC 25-26-14.5.41 (c) The board may grant or deny a temporary variance to a rule it42 has adopted if:

HB 1005—LS 6902/DI 104

32

1 (1) the board has adopted rules which set forth the procedures and2 standards governing the grant or denial of a temporary variance;3 and4 (2) the board sets forth in writing the reasons for a grant or denial5 of a temporary variance.6 (d) The board shall adopt rules and procedures, in consultation with7 the medical licensing board, concerning the electronic transmission of8 prescriptions. The rules adopted under this subsection must address the9 following:

10 (1) Privacy protection for the practitioner and the practitioner's11 patient.12 (2) Security of the electronic transmission.13 (3) A process for approving electronic data intermediaries for the14 electronic transmission of prescriptions.15 (4) Use of a practitioner's United States Drug Enforcement16 Agency registration number.17 (5) Protection of the practitioner from identity theft or fraudulent18 use of the practitioner's prescribing authority.19 (e) The governor may direct the board to develop:20 (1) a prescription drug program that includes the establishment of21 criteria to eliminate or significantly reduce prescription fraud; and22 (2) a standard format for an official tamper resistant prescription23 drug form for prescriptions (as defined in IC 16-42-19-7(1)).24 The board may adopt rules under IC 4-22-2 necessary to implement25 this subsection.26 (f) The standard format for a prescription drug form described in27 subsection (e)(2) must include the following:28 (1) A counterfeit protection bar code with human readable29 representation of the data in the bar code.30 (2) A thermochromic mark on the front and the back of the31 prescription that:32 (A) is at least one-fourth (1/4) of one (1) inch in height and33 width; and34 (B) changes from blue to clear when exposed to heat.35 (g) The board may contract with a supplier to implement and36 manage the prescription drug program described in subsection (e). The37 supplier must:38 (1) have been audited by a third party auditor using the SAS 7039 audit or an equivalent audit for at least the three (3) previous40 years; and41 (2) be audited by a third party auditor using the SAS 70 audit or42 an equivalent audit throughout the duration of the contract;

HB 1005—LS 6902/DI 104

33

1 in order to be considered to implement and manage the program.2 (h) The board shall adopt rules under IC 4-22-2, or emergency rules3 in the manner provided under IC 4-22-2-37.1 that take effect on July 1,4 2016, concerning:5 (1) professional determinations made under IC 35-48-4-14.7(d);6 and7 (2) the determination of a relationship on record with the8 pharmacy under IC 35-48-4-14.7.9 (i) The board may:

10 (1) review professional determinations made by a pharmacist; and11 (2) take appropriate disciplinary action against a pharmacist who12 violates a rule adopted under subsection (h) concerning a13 professional determination made;14 under IC 35-48-4-14.7 concerning the sale of ephedrine and15 pseudoephedrine.16 SECTION 30. IC 25-26-13-29, AS AMENDED BY P.L.209-2018,17 SECTION 10, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE18 JULY 1, 2020]: Sec. 29. (a) It is unlawful:19 (1) For any person to display or permit to be displayed, a20 pharmacy permit in any facility or place of business other than21 that for which it was issued.22 (2) For any person to accept a prescription for filling or23 compounding at any place or facility for which there is not a valid24 pharmacy permit.25 (3) For any person to operate a pharmacy or to take, assume,26 exhibit, display, or advertise by any medium, the title "drugs",27 "prescriptions", "medicine", "drug store", "pharmacy", or28 "apothecary shop", or any combination of such titles or any other29 title, symbol, term, or description of like import intended to cause30 the public to believe that it is a pharmacy unless the person holds31 a valid pharmacy permit.32 (4) For any person to engage or offer to engage in the practice of33 pharmacy or to hold himself or herself out as a pharmacist34 without a valid pharmacist's license that is classified as active by35 the board.36 (b) A person who violates a provision of subsection (a) commits a37 Level 6 felony.38 (c) Nothing in this chapter shall apply to, nor in any manner39 interfere with the business of a general merchant in selling and40 distributing nonnarcotic, nonprescription medicines or drugs which are41 prepackaged, fully prepared by the manufacturer for use by the42 consumer, and labeled in accordance with the requirements of the state

HB 1005—LS 6902/DI 104

34

1 and federal food and drug acts.2 (d) This chapter does not apply to, or in any manner interfere with,3 the business of a manufacturer in selling and delivering a dialysate4 drug or a device that is necessary for home peritoneal renal dialysis for5 a patient who has end stage renal disease if all of the following apply:6 (1) The dialysate drug or device is approved by the federal Food7 and Drug Administration under federal law.8 (2) The dialysate drug or device is held by the manufacturer, a9 third party logistics provider, or a wholesale drug distributor in

10 accordance with the requirements of IC 25-26-14.11 (3) The dialysate drug or device is delivered in the manufacturer's12 original, sealed packaging.13 (4) The dialysate drug or device is delivered only upon:14 (A) receipt of a physician's prescription by a pharmacy that15 holds a pharmacy permit under this chapter; and16 (B) the transmittal of an order from the pharmacy described in17 clause (A) to the manufacturer, third party logistics provider,18 or wholesale drug distributor.19 (5) The manufacturer, third party logistics provider, or wholesale20 drug distributor delivers the dialysate drug or device directly to:21 (A) the patient or the patient's designee for self-administration22 of the dialysis therapy; or23 (B) a health care provider for administration of the dialysis24 therapy to the patient.25 (e) This chapter does not apply to the purchase of prescription26 drugs through and in compliance with the importation of27 prescription drugs program established under IC 16-47-3.28 SECTION 31. IC 25-26-14-17.8, AS AMENDED BY P.L.98-2006,29 SECTION 22, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE30 JULY 1, 2020]: Sec. 17.8. (a) This section does not apply to31 purchase of prescription drugs through and in compliance with the32 importation of prescription drugs program established under33 IC 16-47-3. A wholesale drug distributor licensed under this chapter34 that purchases legend drugs from a wholesale drug distributor that is35 not licensed under this chapter shall act with due diligence as required36 under this section and rules adopted by the board. However, the due37 diligence requirements of this section do not apply to purchases from38 an unlicensed wholesale drug distributor that has obtained39 accreditation through the National Association of Boards of Pharmacy's40 Verified-Accredited Wholesale Distributors program.41 (b) Before the initial purchase of legend drugs from the unlicensed42 wholesale drug distributor, the licensed wholesale drug distributor shall

HB 1005—LS 6902/DI 104

35

1 obtain the following information from the unlicensed wholesale drug2 distributor:3 (1) A list of states in which the unlicensed wholesale drug4 distributor is licensed.5 (2) A list of states into which the unlicensed wholesale drug6 distributor ships legend drugs.7 (3) Copies of all state and federal regulatory licenses and8 registrations held by the unlicensed wholesale drug distributor.9 (4) The unlicensed wholesale drug distributor's most recent

10 facility inspection reports.11 (5) Information regarding general and product liability insurance12 maintained by the unlicensed wholesale drug distributor,13 including copies of relevant policies.14 (6) A list of other names under which the unlicensed wholesale15 drug distributor does business or has been previously known.16 (7) A list of corporate officers and managerial employees of the17 unlicensed wholesale drug distributor.18 (8) A list of all owners of the unlicensed wholesale drug19 distributor that own more than ten percent (10%) of the20 unlicensed wholesale drug distributor, unless the unlicensed21 wholesale drug distributor is publicly traded.22 (9) A list of all disciplinary actions taken against the unlicensed23 wholesale drug distributor by state and federal agencies.24 (10) A description, including the address, dimensions, and other25 relevant information, of each facility used by the unlicensed26 wholesale drug distributor for legend drug storage and27 distribution.28 (11) A description of legend drug import and export activities of29 the unlicensed wholesale drug distributor.30 (12) A description of the unlicensed wholesale drug distributor's31 procedures to ensure compliance with this chapter.32 (13) A statement:33 (A) as to whether; and34 (B) of the identity of each manufacturer for which;35 the unlicensed wholesale drug distributor is an authorized36 distributor.37 (c) Before the initial purchase of legend drugs from an unlicensed38 wholesale drug distributor, the licensed wholesale drug distributor39 shall:40 (1) request that the board obtain and consider the results of a41 national criminal history background check (as defined in42 IC 10-13-3-12) through the state police department of all

HB 1005—LS 6902/DI 104

36

1 individuals associated with the unlicensed wholesale drug2 distributor as specified for licensure of a wholesale drug3 distributor under section 16(b) of this chapter; and4 (2) verify the unlicensed wholesale drug distributor's status as an5 authorized distributor, if applicable.6 (d) If an unlicensed wholesale drug distributor's facility has not been7 inspected by the board or the board's agent within three (3) years after8 a contemplated purchase described in subsection (a), the licensed9 wholesale drug distributor shall conduct an inspection of the

10 unlicensed wholesale drug distributor's facility:11 (1) before the initial purchase of legend drugs from the unlicensed12 wholesale drug distributor; and13 (2) at least once every three (3) years unless the unlicensed14 wholesale drug distributor's facility has been inspected by the15 board, or the board's agent, during the same period;16 to ensure compliance with applicable laws and regulations relating to17 the storage and handling of legend drugs. A third party may be engaged18 to conduct the site inspection on behalf of the licensed wholesale drug19 distributor.20 (e) At least annually, a licensed wholesale drug distributor that21 purchases legend drugs from an unlicensed wholesale drug distributor22 shall ensure that the unlicensed wholesale drug distributor maintains23 a record keeping system that meets the requirements of section 17(3)24 of this chapter.25 (f) If a licensed wholesale drug distributor that purchases legend26 drugs from an unlicensed wholesale drug distributor has reason to27 believe that a legend drug purchased from the unlicensed wholesale28 drug distributor is misbranded, adulterated, counterfeit, or suspected29 counterfeit, the licensed wholesale drug distributor shall conduct a for30 cause authentication of each distribution of the legend drug back to the31 manufacturer.32 (g) An unlicensed wholesale drug distributor that has engaged in the33 distribution of a legend drug for which a licensed wholesale drug34 distributor conducts a for cause authentication under subsection (f)35 shall provide, upon request, detailed information regarding the36 distribution of the legend drug, including the:37 (1) date of purchase of the legend drug;38 (2) lot number of the legend drug;39 (3) sales invoice number of the legend drug; and40 (4) contact information, including name, address, telephone41 number, and any electronic mail address of the unlicensed42 wholesale drug distributor that sold the legend drug.

HB 1005—LS 6902/DI 104

37

1 (h) If a licensed wholesale drug distributor conducts a for cause2 authentication under subsection (f) and is unable to authenticate each3 distribution of the legend drug, the licensed wholesale drug distributor4 shall quarantine the legend drug and report the circumstances to the5 board and the federal Food and Drug Administration within ten (10)6 business days after completing the attempted authentication.7 (i) If a licensed wholesale drug distributor authenticates the8 distribution of a legend drug back to the manufacturer under subsection9 (f), the licensed wholesale drug distributor shall maintain records of the

10 authentication for three (3) years and shall provide the records to the11 board upon request.12 (j) A licensed wholesale drug distributor that purchases legend13 drugs from an unlicensed wholesale drug distributor shall, at least14 annually, conduct random authentications of required pedigrees on at15 least ten percent (10%) of sales units of distributions of legend drugs16 that were purchased from unlicensed wholesale drug distributors.17 (k) An unlicensed wholesale drug distributor from which a licensed18 wholesale drug distributor has purchased legend drugs shall cooperate19 with the random authentications of pedigrees under this section and20 provide requested information in a timely manner.21 (l) If a wholesale drug distributor conducts a random authentication22 under subsection (j) and is unable to authenticate each distribution of23 the legend drug, the wholesale drug distributor shall quarantine the24 legend drug and report the circumstances to the board and the federal25 Food and Drug Administration not more than ten (10) business days26 after completing the attempted authentication.27 SECTION 32. IC 25-26-14.5 IS ADDED TO THE INDIANA28 CODE AS A NEW CHAPTER TO READ AS FOLLOWS29 [EFFECTIVE JULY 1, 2020]:30 Chapter 14.5. International Export Pharmacy Permit and31 Wholesale Drug Distributor Permit32 Sec. 1. (a) To participate as an exporter of prescription drugs33 into Indiana under the importation of prescription drugs program34 established by IC 16-47-3-5, a pharmacy located outside the United35 States must meet the following requirements:36 (1) Hold an international export pharmacy permit issued37 under this chapter.38 (2) Maintain at all times an active and unencumbered license39 or permit to operate a pharmacy:40 (A) in compliance with the laws and rules of the41 jurisdiction in which the pharmacy is located and from42 which the prescription drugs will be exported; and

HB 1005—LS 6902/DI 104

38

1 (B) in a country with which the United States has a current2 mutual recognition agreement, cooperation agreement,3 memorandum of understanding, or other federal4 mechanism recognizing the country's adherence to current5 good manufacturing practices for pharmaceutical6 products.7 (3) Submit an application for an international export8 pharmacy permit on a form developed and provided by the9 board.

10 (b) An applicant for an international export pharmacy permit11 must submit the following to the board with the application12 required under subsection (a)(3):13 (1) Proof of an active and unencumbered license or permit to14 operate a pharmacy in compliance with the laws and rules of15 the jurisdiction in which the dispensing facility is located and16 from which the prescription drugs will be exported.17 (2) Documentation demonstrating that the country in which18 the pharmacy operates has a current mutual recognition19 agreement, cooperation agreement, memorandum of20 understanding, or other federal mechanism recognizing the21 country's adherence to current good manufacturing practices22 for pharmaceutical products.23 (3) The location, names, and title of all principal corporate24 officers and the pharmacist who serves as the prescription25 department manager for prescription drugs exported into26 Indiana under the importation of prescription drugs program.27 (4) A written attestation by an owner or officer of the28 applicant and by the applicant's prescription drug manager29 containing the following affirmations:30 (A) That the individual has read and understands the laws31 and rules governing the manufacture, distribution, and32 dispensing of prescription drugs in Indiana.33 (B) That prescription drugs shipped, mailed, or delivered34 into Indiana:35 (i) will meet or exceed Indiana's standards for safety and36 efficacy; and37 (ii) will not have been, and may not be, manufactured or38 distributed in violation of the laws and rules of the39 jurisdiction in which the applicant is located and from40 which the prescription drugs will be exported.41 (5) A current inspection report from an inspection conducted42 by the regulatory or licensing agency of the jurisdiction in

HB 1005—LS 6902/DI 104

39

1 which the applicant is located. The inspection report must2 reflect compliance with this section. An inspection report is3 current if the inspection was conducted not earlier than six (6)4 months before the submission of the application for an initial5 permit or not earlier than one (1) year for the renewal of a6 permit.7 (c) If an applicant is not able to submit an inspection report that8 meets the requirements of subsection (b)(5), the board must do one9 (1) of the following:

10 (1) Conduct, or contract with a person to conduct, an onsite11 inspection at the cost of the applicant.12 (2) Accept a current inspection report from an entity that:13 (A) meets requirements adopted by the board under14 IC 4-22-2 for entities to perform inspections; and15 (B) has been approved by the board.16 (3) Accept a current inspection report from the United States17 Food and Drug Administration conducted under the federal18 Drug Quality and Security Act.19 Sec. 2. To participate as an exporter of prescription drugs into20 Indiana under the importation of prescription drugs program21 established by IC 16-47-3, a nonresident prescription drug22 manufacturer located outside the United States must register with23 the board and obtain the international export pharmacy permit24 under this chapter.25 Sec. 3. (a) The board shall adopt rules under IC 4-22-226 governing the financial responsibility of a pharmacy that holds a27 permit under this chapter. The rules must include at least the28 following:29 (1) Financial reporting requirements.30 (2) Standards for financial capability to perform the functions31 governed by the permit.32 (3) Requirements for ensuring that the permit holder and the33 permit holder's contractors can be held accountable for the34 financial consequences of any act of malfeasance or35 misfeasance or fraudulent or dishonest acts committed by the36 permit holder or the permit holder's contractors.37 (b) The board shall adopt rules under IC 4-22-2 concerning38 inspection report requirements described in section 1 of this39 chapter.40 Sec. 4. (a) A wholesale drug distributor located outside the41 United States must obtain an international prescription drug42 wholesale drug distributor permit under this chapter to engage in

HB 1005—LS 6902/DI 104

40

1 the wholesale exportation and distribution of prescription drugs in2 Indiana under the importation of prescription drugs program3 established by IC 16-47-3-5.4 (b) A wholesale drug distributor must meet the following in5 order to obtain a wholesale drug distributor permit:6 (1) Be licensed or permitted to operate in a country with7 which the United States has:8 (A) a current mutual recognition agreement;9 (B) a current cooperation agreement;

10 (C) a current memorandum of understanding; or11 (D) another federal mechanism recognizing the country's12 adherence to current good manufacturing practices for13 pharmaceutical products.14 (2) Maintain at all times a license or permit to engage in the15 wholesale distribution of prescription drugs in compliance16 with the laws and rules of the jurisdiction in which the17 wholesale drug distributor operates.18 (c) The board shall adopt rules under IC 4-22-2 governing the19 financial responsibility of a wholesale drug distributor that holds20 a permit under this chapter. The rules must include at least the21 following:22 (1) Financial reporting requirements.23 (2) Standards for financial capability to perform the functions24 governed by the permit.25 (3) Requirements for ensuring that a wholesale drug26 distributor holding a permit under this chapter and the27 wholesale drug distributor's contractors are held accountable28 for the financial consequences of any act of malfeasance or29 misfeasance or fraudulent or dishonest acts committed by the30 permit holder or the permit holder's contractors.31 SECTION 33. IC 27-1-15.6-13.5 IS ADDED TO THE INDIANA32 CODE AS A NEW SECTION TO READ AS FOLLOWS33 [EFFECTIVE JULY 1, 2020]: Sec. 13.5. (a) An insurance producer34 shall disclose to any prospective and current clients on a separate35 written notification any commission, service fee, brokerage fee, or36 other valuable consideration, including whether the amount is37 based on a percentage of total plan premiums or a flat per member38 fee, concerning:39 (1) a health insurance contract that is signed directly with the40 insurance producer; or41 (2) a health insurance contract signed with a third party42 administrator or insurer that will compensate the insurance

HB 1005—LS 6902/DI 104

41

1 producer.2 (b) A copy of the written notification required under this section3 must be signed by the client.4 SECTION 34. IC 27-1-37-7 IS ADDED TO THE INDIANA CODE5 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY6 1, 2020]: Sec. 7. (a) This section applies to:7 (1) health provider contracts; and8 (2) contracts between a provider and a pharmacy benefits9 manager;

10 entered into or renewed, including contracts that automatically11 renew after the expiry date, after June 30, 2020.12 (b) A health provider contract may not contain a provision that13 prohibits the disclosure of health care service claims data to14 employers providing the coverage. However, any disclosure of15 claims data must comply with health privacy laws, including the16 federal Health Insurance Portability and Accountability Act17 (HIPAA) (P.L. 104-191).18 (c) A violation of this section constitutes an unfair or deceptive19 act or practice in the business of insurance under IC 27-4-1-4.20 SECTION 35. IC 27-1-45 IS ADDED TO THE INDIANA CODE21 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE22 UPON PASSAGE]:23 Chapter 45. All Payer Claims Data Base24 Sec. 1. As used in this chapter, "data base" refers to the all25 payer claims data base created under this chapter.26 Sec. 2. As used in this chapter, "health payer" includes the27 following:28 (1) Medicare.29 (2) Medicaid or a managed care organization (as defined in30 IC 12-7-2-126.9) that has contracted with Medicaid to provide31 services to a Medicaid recipient.32 (3) An insurer that issues a policy of accident and sickness33 insurance (as defined in IC 27-8-5-1).34 (4) A health maintenance organization (as defined in35 IC 27-13-1-19).36 (5) A pharmacy benefit manager (as defined in37 IC 27-1-24.8-3).38 (6) A third party administrator.39 (7) An insurer (as defined in IC 27-1-26-1), excluding insurers40 of life insurance.41 (8) Any other person identified by the commissioner for42 participation in the data base described in this chapter.

HB 1005—LS 6902/DI 104

42

1 Sec. 3. (a) Before July 1, 2020, the department shall issue a2 request for information in compliance with IC 5-23-4.5 concerning3 the creation, operation, and maintenance of a data base.4 (b) The request for information must include the following5 questions:6 (1) How the person would collect all relevant claims data for7 the data base from a health payer in a manner that would8 minimize technical barriers for a health payer to submit a9 claim.

10 (2) How the person would promote and encourage self funded11 plans to voluntarily submit claims data for inclusion in the12 data base.13 (3) What funding sources the person would seek to offset costs14 to implement and maintain the data base.15 (4) How the person would make data from the data base16 available, including what sufficient fee would need to be17 assessed, to researchers, companies, and other interested18 parties in analyzing the data.19 (5) How the person would ensure the following:20 (A) That data is submitted and released in a21 machine-readable format.22 (B) That the data from the data base is used in an ethical23 manner.24 (C) That the data is not personally identifiable and is25 properly secured and maintained, and that the person26 complies with federal and state health care privacy laws.27 (6) How the person would establish a public web portal for28 individuals to quickly and easily compare prices for the full29 spectrum of medical billing codes as well as check quality30 ratings of providers.31 (7) What threshold should be set for health payers to submit32 data for the data base.33 (8) How the person would work with other states and relevant34 stakeholders to either:35 (A) use a data language that is already available; or36 (B) facilitate the establishment of a common data language37 to be used by states for the data.38 (9) Whether any changes to state law would increase the39 functionality and effectiveness of the data base and40 recommendations of the statutes and necessary changes.41 (10) Whatever other questions the department determines is42 relevant to the implementation of a robust and transparent

HB 1005—LS 6902/DI 104

43

1 data base.2 (c) The department shall set the deadline for submissions of the3 request for information under this section that may be not later4 than November 30, 2020.5 Sec. 4. (a) After May 30, 2021, but before June 15, 2021, the6 department shall issue a request for proposals for a person to7 create, operate, and maintain the data base under this chapter. In8 addition to the requirements of IC 5-22-9, the request for proposals9 must include the considerations contained in the request for

10 information under section 3 of this chapter.11 (b) The request for proposals must state that the data base's12 purpose is to facilitate the following:13 (1) Identifying health care needs and informing health care14 policy.15 (2) Comparing costs between various treatment settings and16 approaches.17 (3) Providing information to consumers and purchasers of18 health care.19 (4) Improving the quality and affordability of patient health20 care and health care coverage.21 (c) Submissions for the request for proposals under this section22 must occur not later than September 30, 2021.23 (d) The department shall publish the department's decision24 concerning the submissions not later than November 30, 2021.25 (e) If the department accepts a submission for the request for26 proposals, the department shall enter into a contract with the27 person to act as administrator of the data base and develop the28 data base not later than June 30, 2022.29 (f) The administrator shall ensure that the data base is secure30 and compliant with the federal Health Insurance Portability and31 Accountability Act (HIPAA).32 Sec. 5. A health payer shall begin submitting the required data33 in a format specified by the administrator of the data base not later34 than three (3) months from the first day the department declares35 the data base to be fully operational.36 SECTION 36. IC 27-2-25 IS ADDED TO THE INDIANA CODE37 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE38 JULY 1, 2020]:39 Chapter 25. Health Carrier Good Faith Estimates40 Sec. 1. As used in this chapter, "coverage" means the right of an41 individual to receive:42 (1) health care services; or

HB 1005—LS 6902/DI 104

44

1 (2) payment or reimbursement for health care services;2 from a health carrier.3 Sec. 2. As used in this chapter, "covered individual" means an4 individual who is entitled to coverage from a health carrier.5 Sec. 3. As used in this chapter, "good faith estimate" means a6 health carrier's reasonable estimate of:7 (1) the amount of the cost of a nonemergency health care8 service that the health carrier will:9 (A) pay for; or

10 (B) reimburse to;11 a covered individual; or12 (2) the extent and nature of the nonemergency health care13 service a covered individual is entitled to receive;14 that a health carrier provides upon request to a covered individual15 for whom a nonemergency health care service has been ordered.16 Sec. 4. (a) As used in this chapter, "health carrier" means an17 entity:18 (1) that is subject to this title and the administrative rules19 adopted under this title; and20 (2) that enters into a contract to:21 (A) provide health care services;22 (B) deliver health care services;23 (C) arrange for health care services; or24 (D) pay for or reimburse any of the costs of health care25 services.26 (b) The term includes the following:27 (1) An insurer, as defined in IC 27-1-2-3(x), that issues a28 policy of accident and sickness insurance, as defined in29 IC 27-8-5-1(a).30 (2) A health maintenance organization, as defined in31 IC 27-13-1-19.32 (3) An administrator (as defined in IC 27-1-25-1(a)) that is33 licensed under IC 27-1-25.34 (4) Any other entity that provides a plan of health insurance,35 health benefits, or health care services.36 Sec. 5. As used in this chapter, "in network", when used in37 reference to a practitioner, means that the health care services38 provided by the practitioner are subject to a health carrier's39 network plan.40 Sec. 6. (a) As used in this chapter, "network" means a group of41 provider facilities and practitioners that:42 (1) provide health care services to covered individuals; and

HB 1005—LS 6902/DI 104

45

1 (2) have agreed to, or are otherwise subject to, maximum2 limits on the fees and charges for the health care services to be3 provided to the covered individuals.4 (b) The term includes the following:5 (1) A network described in subsection (a) that is established6 pursuant to a contract between an insurer providing coverage7 under a group health policy and:8 (A) individual provider facilities and practitioners;9 (B) a preferred provider organization; or

10 (C) an entity that employs or represents providers,11 including:12 (i) an independent practice association; and13 (ii) a physician-hospital organization.14 (2) A health management organization, as defined in15 IC 27-13-1-19.16 Sec. 7. As used in this chapter, "network plan" means a plan of17 a health carrier that:18 (1) requires a covered person to receive; or19 (2) creates incentives, including financial incentives, for a20 covered person to receive;21 health care services from one (1) or more providers that are under22 contract with, managed by, or owned by the health carrier.23 Sec. 8. (a) As used in this chapter, "nonemergency health care24 service" means a service or series of services ordered, scheduled,25 or referred by a practitioner for the:26 (1) diagnosis;27 (2) prevention;28 (3) treatment;29 (4) cure; or30 (5) relief;31 of a physical, mental, or behavioral health condition, illness, injury,32 or disease that is not provided on an emergency basis.33 Sec. 9. As used in this chapter, "practitioner" means:34 (1) an individual who holds a license, certificate, registration,35 or permit under:36 (A) IC 25-22.5 (physicians);37 (B) IC 25-27 (physical therapists); or38 (C) IC 25-33 (psychologists); or39 (2) an organization consisting of or employing two (2) or more40 individuals described in subdivision (1).41 Sec. 9.5. As used in this chapter, "price" means the negotiated42 rate between the:

HB 1005—LS 6902/DI 104

46

1 (1) provider facility and practitioner; and2 (2) covered individual's health carrier;3 minus the amount that the health carrier will pay.4 Sec. 10. As used in this chapter, "provider" means:5 (1) a provider facility; or6 (2) a practitioner.7 Sec. 11. As used in this chapter, "provider facility"means any of8 the following:9 (1) A hospital licensed under IC 16-21-2.

10 (2) An ambulatory outpatient surgery center licensed under11 IC 16-21-2.12 (3) An abortion clinic licensed under IC 16-21-2.13 (4) A birthing center licensed under IC 16-21-2.14 (5) A facility that provides diagnostic services to the medical15 profession or the general public.16 (6) A laboratory where clinical pathology tests are carried out17 on specimens to obtain information about the health of a18 patient.19 (7) A facility where radiologic and electromagnetic images are20 made to obtain information about the health of a patient.21 (8) An infusion center that administers intravenous22 medications.23 Sec. 12. (a) A covered individual for whom a nonemergency24 health care service has been ordered may request from the health25 carrier a good faith estimate of:26 (1) the amount of the cost of the nonemergency health care27 service that the health carrier will:28 (A) pay for; or29 (B) reimburse to;30 the covered individual; or31 (2) the extent and nature of the ordered nonemergency health32 care service a covered individual is entitled to receive from33 the health carrier.34 (b) If:35 (1) a health carrier provides coverage to a covered individual36 through a network plan; and37 (2) the health carrier receives a request for a good faith38 estimate from a covered individual for whom a nonemergency39 health care service has been ordered;40 the health carrier shall inform the covered individual whether the41 provider facility in which the nonemergency health care service42 will be provided is in network and whether each scheduled

HB 1005—LS 6902/DI 104

47

1 practitioner who will provide the nonemergency health care2 service is in network.3 (c) A health carrier that receives a request from a covered4 individual patient under subsection (b) shall, not more than three5 (3) business days after receiving the request, provide to the6 individual a good faith estimate as described in section 14 of this7 chapter.8 (d) A health carrier must ensure that a good faith estimate9 provided to an individual under this section is accompanied by a

10 notice stating that:11 (1) the amount that the health carrier will:12 (A) pay; or13 (B) reimburse;14 for or to the covered individual for the nonemergency health15 care services the individual receives; and16 (2) the nature and extent of the nonemergency health care17 services the individual will receive;18 may vary from the health carrier's good faith estimate based on19 the individual's medical needs.20 (e) A health carrier may not charge an individual for21 information provided under this section.22 (f) A practitioner and provider facility must provide a health23 carrier with timely information needed by the health carrier to24 comply with the requirements under this chapter.25 Sec. 13. A health carrier may provide a good faith estimate to an26 individual under this chapter:27 (1) in a writing delivered to the individual; or28 (2) by electronic mail;29 according to the preference expressed by the individual.30 Sec. 14. (a) A good faith estimate provided by a health carrier31 to an individual under this chapter must:32 (1) in the case of an insurer or another health carrier that33 pays or reimburses the cost of health care services:34 (A) state the services and material items that the good faith35 estimate is based on;36 (B) set forth for the services and material items referred to37 in clause (A) the amount that the health carrier will:38 (i) pay; or39 (ii) reimburse;40 for or to the covered individual for the service or material41 item;42 (C) include a total figure that is a sum of the amounts

HB 1005—LS 6902/DI 104

48

1 referred to in clause (B); and2 (D) state the out-of-pocket costs the covered individual will3 incur, if any, beyond the amount that the health carrier4 will pay or reimburse; and5 (2) in the case of a health maintenance organization or6 another health carrier that provides health care services:7 (A) state the nature and extent of the health care services8 to which the covered individual is entitled; and9 (B) state the out-of-pocket costs the covered individual will

10 incur, if any, beyond being provided the health care11 services referred to in clause (A).12 (b) A practitioner and provider facility must provide a health13 carrier with timely information needed by the health carrier14 comply to with the requirements under this chapter.15 Sec. 15. A health carrier that provides an Internet web site for16 the use of its covered individuals shall ensure that the Internet web17 site includes a printed notice that:18 (1) is designed, lettered, and featured on the Internet web site19 so as to be conspicuous to and readable by any individual with20 normal vision who visits the Internet web site; and21 (2) states the following, or words to the same effect: "A22 covered individual may at any time ask the health carrier for23 an estimate of the amount the health carrier will pay for or24 reimburse to a covered individual for nonemergency health25 care services that have been ordered for the covered26 individual or the nature and extent of the ordered27 nonemergency health care services a covered individual is28 entitled to receive from the health carrier. The law requires29 that an estimate be provided within 3 business days.".30 Sec. 16. (a) If a health carrier fails or refuses:31 (1) to provide a good faith estimate as required by this32 chapter; or33 (2) to provide notice on the health carrier's Internet web site34 as required by section 15 of this chapter;35 the insurance commissioner may, after notice and hearing under36 IC 4-21.5, impose on the health carrier a civil penalty of not more37 than one thousand dollars ($1,000) for each day of noncompliance.38 (b) A civil penalty collected under this section shall be deposited39 in the department of insurance fund established by IC 27-1-3-28.40 SECTION 37. IC 27-4-1-4, AS AMENDED BY P.L.124-2018,41 SECTION 64, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE42 JULY 1, 2020]: Sec. 4. (a) The following are hereby defined as unfair

HB 1005—LS 6902/DI 104

49

1 methods of competition and unfair and deceptive acts and practices in2 the business of insurance:3 (1) Making, issuing, circulating, or causing to be made, issued, or4 circulated, any estimate, illustration, circular, or statement:5 (A) misrepresenting the terms of any policy issued or to be6 issued or the benefits or advantages promised thereby or the7 dividends or share of the surplus to be received thereon;8 (B) making any false or misleading statement as to the9 dividends or share of surplus previously paid on similar

10 policies;11 (C) making any misleading representation or any12 misrepresentation as to the financial condition of any insurer,13 or as to the legal reserve system upon which any life insurer14 operates;15 (D) using any name or title of any policy or class of policies16 misrepresenting the true nature thereof; or17 (E) making any misrepresentation to any policyholder insured18 in any company for the purpose of inducing or tending to19 induce such policyholder to lapse, forfeit, or surrender the20 policyholder's insurance.21 (2) Making, publishing, disseminating, circulating, or placing22 before the public, or causing, directly or indirectly, to be made,23 published, disseminated, circulated, or placed before the public,24 in a newspaper, magazine, or other publication, or in the form of25 a notice, circular, pamphlet, letter, or poster, or over any radio or26 television station, or in any other way, an advertisement,27 announcement, or statement containing any assertion,28 representation, or statement with respect to any person in the29 conduct of the person's insurance business, which is untrue,30 deceptive, or misleading.31 (3) Making, publishing, disseminating, or circulating, directly or32 indirectly, or aiding, abetting, or encouraging the making,33 publishing, disseminating, or circulating of any oral or written34 statement or any pamphlet, circular, article, or literature which is35 false, or maliciously critical of or derogatory to the financial36 condition of an insurer, and which is calculated to injure any37 person engaged in the business of insurance.38 (4) Entering into any agreement to commit, or individually or by39 a concerted action committing any act of boycott, coercion, or40 intimidation resulting or tending to result in unreasonable41 restraint of, or a monopoly in, the business of insurance.42 (5) Filing with any supervisory or other public official, or making,

HB 1005—LS 6902/DI 104

50

1 publishing, disseminating, circulating, or delivering to any person,2 or placing before the public, or causing directly or indirectly, to3 be made, published, disseminated, circulated, delivered to any4 person, or placed before the public, any false statement of5 financial condition of an insurer with intent to deceive. Making6 any false entry in any book, report, or statement of any insurer7 with intent to deceive any agent or examiner lawfully appointed8 to examine into its condition or into any of its affairs, or any9 public official to which such insurer is required by law to report,

10 or which has authority by law to examine into its condition or into11 any of its affairs, or, with like intent, willfully omitting to make a12 true entry of any material fact pertaining to the business of such13 insurer in any book, report, or statement of such insurer.14 (6) Issuing or delivering or permitting agents, officers, or15 employees to issue or deliver, agency company stock or other16 capital stock, or benefit certificates or shares in any common law17 corporation, or securities or any special or advisory board18 contracts or other contracts of any kind promising returns and19 profits as an inducement to insurance.20 (7) Making or permitting any of the following:21 (A) Unfair discrimination between individuals of the same22 class and equal expectation of life in the rates or assessments23 charged for any contract of life insurance or of life annuity or24 in the dividends or other benefits payable thereon, or in any25 other of the terms and conditions of such contract. However,26 in determining the class, consideration may be given to the27 nature of the risk, plan of insurance, the actual or expected28 expense of conducting the business, or any other relevant29 factor.30 (B) Unfair discrimination between individuals of the same31 class involving essentially the same hazards in the amount of32 premium, policy fees, assessments, or rates charged or made33 for any policy or contract of accident or health insurance or in34 the benefits payable thereunder, or in any of the terms or35 conditions of such contract, or in any other manner whatever.36 However, in determining the class, consideration may be given37 to the nature of the risk, the plan of insurance, the actual or38 expected expense of conducting the business, or any other39 relevant factor.40 (C) Excessive or inadequate charges for premiums, policy41 fees, assessments, or rates, or making or permitting any unfair42 discrimination between persons of the same class involving

HB 1005—LS 6902/DI 104

51

1 essentially the same hazards, in the amount of premiums,2 policy fees, assessments, or rates charged or made for:3 (i) policies or contracts of reinsurance or joint reinsurance,4 or abstract and title insurance;5 (ii) policies or contracts of insurance against loss or damage6 to aircraft, or against liability arising out of the ownership,7 maintenance, or use of any aircraft, or of vessels or craft,8 their cargoes, marine builders' risks, marine protection and9 indemnity, or other risks commonly insured under marine,

10 as distinguished from inland marine, insurance; or11 (iii) policies or contracts of any other kind or kinds of12 insurance whatsoever.13 However, nothing contained in clause (C) shall be construed to14 apply to any of the kinds of insurance referred to in clauses (A)15 and (B) nor to reinsurance in relation to such kinds of insurance.16 Nothing in clause (A), (B), or (C) shall be construed as making or17 permitting any excessive, inadequate, or unfairly discriminatory18 charge or rate or any charge or rate determined by the department19 or commissioner to meet the requirements of any other insurance20 rate regulatory law of this state.21 (8) Except as otherwise expressly provided by law, knowingly22 permitting or offering to make or making any contract or policy23 of insurance of any kind or kinds whatsoever, including but not in24 limitation, life annuities, or agreement as to such contract or25 policy other than as plainly expressed in such contract or policy26 issued thereon, or paying or allowing, or giving or offering to pay,27 allow, or give, directly or indirectly, as inducement to such28 insurance, or annuity, any rebate of premiums payable on the29 contract, or any special favor or advantage in the dividends,30 savings, or other benefits thereon, or any valuable consideration31 or inducement whatever not specified in the contract or policy; or32 giving, or selling, or purchasing or offering to give, sell, or33 purchase as inducement to such insurance or annuity or in34 connection therewith, any stocks, bonds, or other securities of any35 insurance company or other corporation, association, limited36 liability company, or partnership, or any dividends, savings, or37 profits accrued thereon, or anything of value whatsoever not38 specified in the contract. Nothing in this subdivision and39 subdivision (7) shall be construed as including within the40 definition of discrimination or rebates any of the following41 practices:42 (A) Paying bonuses to policyholders or otherwise abating their

HB 1005—LS 6902/DI 104

52

1 premiums in whole or in part out of surplus accumulated from2 nonparticipating insurance, so long as any such bonuses or3 abatement of premiums are fair and equitable to policyholders4 and for the best interests of the company and its policyholders.5 (B) In the case of life insurance policies issued on the6 industrial debit plan, making allowance to policyholders who7 have continuously for a specified period made premium8 payments directly to an office of the insurer in an amount9 which fairly represents the saving in collection expense.

10 (C) Readjustment of the rate of premium for a group insurance11 policy based on the loss or expense experience thereunder, at12 the end of the first year or of any subsequent year of insurance13 thereunder, which may be made retroactive only for such14 policy year.15 (D) Paying by an insurer or insurance producer thereof duly16 licensed as such under the laws of this state of money,17 commission, or brokerage, or giving or allowing by an insurer18 or such licensed insurance producer thereof anything of value,19 for or on account of the solicitation or negotiation of policies20 or other contracts of any kind or kinds, to a broker, an21 insurance producer, or a solicitor duly licensed under the laws22 of this state, but such broker, insurance producer, or solicitor23 receiving such consideration shall not pay, give, or allow24 credit for such consideration as received in whole or in part,25 directly or indirectly, to the insured by way of rebate.26 (9) Requiring, as a condition precedent to loaning money upon the27 security of a mortgage upon real property, that the owner of the28 property to whom the money is to be loaned negotiate any policy29 of insurance covering such real property through a particular30 insurance producer or broker or brokers. However, this31 subdivision shall not prevent the exercise by any lender of the32 lender's right to approve or disapprove of the insurance company33 selected by the borrower to underwrite the insurance.34 (10) Entering into any contract, combination in the form of a trust35 or otherwise, or conspiracy in restraint of commerce in the36 business of insurance.37 (11) Monopolizing or attempting to monopolize or combining or38 conspiring with any other person or persons to monopolize any39 part of commerce in the business of insurance. However,40 participation as a member, director, or officer in the activities of41 any nonprofit organization of insurance producers or other42 workers in the insurance business shall not be interpreted, in

HB 1005—LS 6902/DI 104

53

1 itself, to constitute a combination in restraint of trade or as2 combining to create a monopoly as provided in this subdivision3 and subdivision (10). The enumeration in this chapter of specific4 unfair methods of competition and unfair or deceptive acts and5 practices in the business of insurance is not exclusive or6 restrictive or intended to limit the powers of the commissioner or7 department or of any court of review under section 8 of this8 chapter.9 (12) Requiring as a condition precedent to the sale of real or

10 personal property under any contract of sale, conditional sales11 contract, or other similar instrument or upon the security of a12 chattel mortgage, that the buyer of such property negotiate any13 policy of insurance covering such property through a particular14 insurance company, insurance producer, or broker or brokers.15 However, this subdivision shall not prevent the exercise by any16 seller of such property or the one making a loan thereon of the17 right to approve or disapprove of the insurance company selected18 by the buyer to underwrite the insurance.19 (13) Issuing, offering, or participating in a plan to issue or offer,20 any policy or certificate of insurance of any kind or character as21 an inducement to the purchase of any property, real, personal, or22 mixed, or services of any kind, where a charge to the insured is23 not made for and on account of such policy or certificate of24 insurance. However, this subdivision shall not apply to any of the25 following:26 (A) Insurance issued to credit unions or members of credit27 unions in connection with the purchase of shares in such credit28 unions.29 (B) Insurance employed as a means of guaranteeing the30 performance of goods and designed to benefit the purchasers31 or users of such goods.32 (C) Title insurance.33 (D) Insurance written in connection with an indebtedness and34 intended as a means of repaying such indebtedness in the35 event of the death or disability of the insured.36 (E) Insurance provided by or through motorists service clubs37 or associations.38 (F) Insurance that is provided to the purchaser or holder of an39 air transportation ticket and that:40 (i) insures against death or nonfatal injury that occurs during41 the flight to which the ticket relates;42 (ii) insures against personal injury or property damage that

HB 1005—LS 6902/DI 104

54

1 occurs during travel to or from the airport in a common2 carrier immediately before or after the flight;3 (iii) insures against baggage loss during the flight to which4 the ticket relates; or5 (iv) insures against a flight cancellation to which the ticket6 relates.7 (14) Refusing, because of the for-profit status of a hospital or8 medical facility, to make payments otherwise required to be made9 under a contract or policy of insurance for charges incurred by an

10 insured in such a for-profit hospital or other for-profit medical11 facility licensed by the state department of health.12 (15) Refusing to insure an individual, refusing to continue to issue13 insurance to an individual, limiting the amount, extent, or kind of14 coverage available to an individual, or charging an individual a15 different rate for the same coverage, solely because of that16 individual's blindness or partial blindness, except where the17 refusal, limitation, or rate differential is based on sound actuarial18 principles or is related to actual or reasonably anticipated19 experience.20 (16) Committing or performing, with such frequency as to21 indicate a general practice, unfair claim settlement practices (as22 defined in section 4.5 of this chapter).23 (17) Between policy renewal dates, unilaterally canceling an24 individual's coverage under an individual or group health25 insurance policy solely because of the individual's medical or26 physical condition.27 (18) Using a policy form or rider that would permit a cancellation28 of coverage as described in subdivision (17).29 (19) Violating IC 27-1-22-25, IC 27-1-22-26, or IC 27-1-22-26.130 concerning motor vehicle insurance rates.31 (20) Violating IC 27-8-21-2 concerning advertisements referring32 to interest rate guarantees.33 (21) Violating IC 27-8-24.3 concerning insurance and health plan34 coverage for victims of abuse.35 (22) Violating IC 27-8-26 concerning genetic screening or testing.36 (23) Violating IC 27-1-15.6-3(b) concerning licensure of37 insurance producers.38 (24) Violating IC 27-1-38 concerning depository institutions.39 (25) Violating IC 27-8-28-17(c) or IC 27-13-10-8(c) concerning40 the resolution of an appealed grievance decision.41 (26) Violating IC 27-8-5-2.5(e) through IC 27-8-5-2.5(j) (expired42 July 1, 2007, and removed) or IC 27-8-5-19.2 (expired July 1,

HB 1005—LS 6902/DI 104

55

1 2007, and repealed).2 (27) Violating IC 27-2-21 concerning use of credit information.3 (28) Violating IC 27-4-9-3 concerning recommendations to4 consumers.5 (29) Engaging in dishonest or predatory insurance practices in6 marketing or sales of insurance to members of the United States7 Armed Forces as:8 (A) described in the federal Military Personnel Financial9 Services Protection Act, P.L.109-290; or

10 (B) defined in rules adopted under subsection (b).11 (30) Violating IC 27-8-19.8-20.1 concerning stranger originated12 life insurance.13 (31) Violating IC 27-2-22 concerning retained asset accounts.14 (32) Violating IC 27-8-5-29 concerning health plans offered15 through a health benefit exchange (as defined in IC 27-19-2-8).16 (33) Violating a requirement of the federal Patient Protection and17 Affordable Care Act (P.L. 111-148), as amended by the federal18 Health Care and Education Reconciliation Act of 2010 (P.L.19 111-152), that is enforceable by the state.20 (34) After June 30, 2015, violating IC 27-2-23 concerning21 unclaimed life insurance, annuity, or retained asset account22 benefits.23 (35) Willfully violating IC 27-1-12-46 concerning a life insurance24 policy or certificate described in IC 27-1-12-46(a).25 (36) Violating IC 27-1-37-7 concerning prohibiting the26 disclosure of health care services claims data.27 (b) Except with respect to federal insurance programs under28 Subchapter III of Chapter 19 of Title 38 of the United States Code, the29 commissioner may, consistent with the federal Military Personnel30 Financial Services Protection Act (10 U.S.C. 992 note), adopt rules31 under IC 4-22-2 to:32 (1) define; and33 (2) while the members are on a United States military installation34 or elsewhere in Indiana, protect members of the United States35 Armed Forces from;36 dishonest or predatory insurance practices.37 SECTION 38. IC 27-8-11-13 IS ADDED TO THE INDIANA38 CODE AS A NEW SECTION TO READ AS FOLLOWS39 [EFFECTIVE JANUARY 1, 2021]: Sec. 13. (a) A fully credentialed40 provider shall be reimbursed for eligible services provided at any41 in-network hospital if the following conditions are met:42 (1) The provider submits the documentation required by the

HB 1005—LS 6902/DI 104

56

1 insurer to be loaded under the provider group or hospital.2 (2) The provider, provider group, or hospital is a network3 provider with the insurer.4 (3) The services are provided in accordance with all terms and5 conditions of the provider's, group provider's, or hospital's6 agreement or contract with the insurer.7 (4) Prior authorization is obtained in accordance with8 IC 27-1-37.5 when required by the insurer for an eligible9 service.

10 (b) The insurer shall reimburse the provider or hospital for11 services described in subsection (a) at the rates determined by the12 contract between the provider and the insurer.13 (c) An insurer is not required to credential a provider. However,14 if:15 (1) a provider is employed by a hospital that is part of the16 hospital's network that is covered by the insurer; and17 (2) the provider meets the insurer's credentialing18 requirements;19 the insurer shall reimburse the provider for any reimbursable20 services from the date that the provider was employed by the21 hospital.22 SECTION 39. IC 27-13-43-4 IS ADDED TO THE INDIANA23 CODE AS A NEW SECTION TO READ AS FOLLOWS24 [EFFECTIVE JANUARY 1, 2021]: Sec. 4. (a) A fully credentialed25 provider shall be reimbursed for eligible services provided at any26 in-network hospital if the following conditions are met:27 (1) The provider submits the documentation required by the28 health maintenance organization to be loaded under the29 provider group or hospital.30 (2) The provider, provider group, or hospital is a network31 provider with the health maintenance organization.32 (3) The services are provided in accordance with all terms and33 conditions of the provider's, group provider's, or hospital's34 agreement or contract with the health maintenance35 organization.36 (4) Prior authorization is obtained in accordance with37 IC 27-1-37.5 when required by the health maintenance38 organization for an eligible service.39 (b) The health maintenance organization shall reimburse the40 provider or hospital for services described in subsection (a) at the41 rates determined by the contract between the provider and the42 health maintenance organization.

HB 1005—LS 6902/DI 104

57

1 (c) A health maintenance organization is not required to2 credential a provider. However, if:3 (1) a provider is employed by a hospital that is part of the4 hospital's network that is covered by the health maintenance5 organization; and6 (2) the provider meets the health maintenance organization's7 credentialing requirements;8 the health maintenance organization shall reimburse the provider9 for any reimbursable services from the date that the provider was

10 employed by the hospital.11 SECTION 40. IC 36-2-14-21, AS AMENDED BY P.L.1-2007,12 SECTION 240, IS AMENDED TO READ AS FOLLOWS13 [EFFECTIVE JULY 1, 2020]: Sec. 21. (a) As used in this section,14 "health records" means written, electronic, or printed information15 possessed by a provider concerning any diagnosis, treatment, or16 prognosis of the patient. The term includes mental health records,17 alcohol and drug abuse records, and emergency ambulance service18 records.19 (b) As used in this section, "provider" has the meaning set forth in20 IC 16-18-2-295(b). IC 16-18-2-295(c).21 (c) As part of a medical examination or autopsy conducted under22 this chapter, a coroner may obtain a copy of the decedent's health23 records.24 (d) Except as provided in subsection (e), health records obtained25 under this section are confidential.26 (e) The coroner may provide the health records of a decedent that27 were obtained under this section to a prosecuting attorney or law28 enforcement agency that is investigating the individual's death. Health29 records received from a coroner under this subsection are confidential.30 (f) A person who receives confidential records or information under31 this section and knowingly or intentionally discloses the records or32 information to an unauthorized person commits a Class A33 misdemeanor.34 SECTION 41. An emergency is declared for this act.

HB 1005—LS 6902/DI 104

58

COMMITTEE REPORT

Mr. Speaker: Your Committee on Public Health, to which wasreferred House Bill 1005, has had the same under consideration andbegs leave to report the same back to the House with therecommendation that said bill be amended as follows:

Page 6, delete lines 19 through 23, begin a new paragraph andinsert:

"SECTION 5. IC 16-18-2-163.6 IS ADDED TO THE INDIANACODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]: Sec. 163.6. "Health care services", forpurposes of IC 16-51-1, has the meaning set forth in IC 16-51-1-1.".

Page 6, line 26, after "163.8." insert "(a)".Page 6, between lines 28 and 29, begin a new paragraph and insert:"(b) "Health carrier", for purposes of IC 16-51-2, has the

meaning set forth in IC 16-51-2-1.".Page 7, delete lines 3 through 7.Page 7, between lines 38 and 39, begin a new paragraph and insert:"(f) "Practitioner", for purposes of IC 16-51-1, has the meaning

set forth in IC 16-51-1-4.".Page 8, between lines 40 and 41, begin a new paragraph and insert:"(f) "Provider", for purposes of IC 16-51-2, has the meaning set

forth in IC 16-51-2-2.".Page 9, delete lines 4 through 40, begin a new paragraph and insert:"SECTION 17. IC 16-18-2-328.7 IS ADDED TO THE INDIANA

CODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]: Sec. 328.7. "Service facility location",for purposes of IC 16-51-1, has the meaning set forth inIC 16-51-1-6.

SECTION 18. IC 16-18-2-362.1 IS ADDED TO THE INDIANACODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]: Sec. 362.1. "Urgent care facility", forpurposes of IC 16-24.5-1, has the meaning set forth inIC 16-24.5-1-1.".

Page 10, line 19, after "estimate" insert "within three (3) businessdays".

Page 10, line 20, delete "or" and insert ".".Page 10, delete lines 21 through 24.Page 10, between lines 28 and 29, begin a new paragraph and insert:"Sec. 0.5. Nothing in this chapter prohibits:

(1) a self-funded health benefit plan that complies with thefederal Employee Retirement Income Security Act (ERISA)

HB 1005—LS 6902/DI 104

59

of 1974 (29 U.S.C. 1001 et seq.); or(2) a self-insurance program established to provide grouphealth coverage as described in IC 5-10-8-7(b), or a contractfor health services as described in IC 5-10-8-7(c);

from providing information requested by a practitioner orprovider facility under this chapter.".

Page 10, line 33, delete "realistic, honest" and insert "reasonable".Page 10, line 33, delete "amount" and insert "price".Page 12, line 6, after "services" insert "ordered, scheduled, or

referred by a practitioner".Page 12, line 6, delete "the:" and insert "the purpose of:".Page 12, line 18, after "therapists);" insert "or".Page 12, delete line 19.Page 12, line 20, delete "(D)" and insert "(C)".Page 12, delete line 21.Page 12, between lines 23 and 24, begin a new paragraph and insert:"Sec. 8.5. As used in this chapter, "price" means the negotiated

rate between the:(1) provider facility and practitioner; and(2) covered individual's health carrier.".

Page 12, line 35, delete "." and insert ", including outpatientfacilities.".

Page 12, between lines 40 and 41, begin a new line block indentedand insert:

"(8) An infusion center that administers intravenousmedications.".

Page 12, line 41, after "not" insert ":(1)".

Page 12, line 42, delete "recipient." and insert "recipient; or(2) limit the authority of a legal representative of the patient.".

Page 13, line 4, delete "amount" and insert "price".Page 13, line 7, delete "seventy-two (72) hours" and insert "three

(3) business days".Page 13, line 10, delete "charge" and insert "price".Page 13, line 22, delete "and" and insert ",".Page 13, line 23, delete ":" and insert ", and other persons who

provide professional health services:".Page 13, line 39, delete "amount" and insert "price".Page 14, line 4, delete "is" and insert "and has been verified as".Page 14, line 27, delete "or".Page 14, line 28, after "mail;" insert "or

(3) through a mobile application;".

HB 1005—LS 6902/DI 104

60

Page 14, line 34, delete "charge" and insert "price".Page 14, line 36, delete "charges" and insert "prices".Page 14, after line 42, begin a new paragraph and insert:"(c) A health carrier must provide a provider facility with

timely information needed by the provider facility to comply withthe requirements under this chapter.".

Page 15, line 2, delete "wait" and insert "check in or register".Page 15, line 14, after "for a" insert "nonemergency".Page 15, line 14, delete "In".Page 15, line 15, delete "nonemergency situations, the" and insert

"The".Page 15, line 16, delete "72 hours." and insert "3 business days.".Page 15, line 24, delete "at any time".Page 15, line 25, after "for a" insert "nonemergency".Page 15, line 26, delete "In nonemergency situations, the" and insert

"The".Page 15, line 27, delete "72 hours." and insert "3 business days.".Page 15, delete lines 28 through 42.Page 16, delete lines 1 through 25.Page 16, line 33, delete "chapter." and insert "chapter for the

following:(1) For as many of the seventy (70) shoppable servicesspecified in 45 CFR 180 (as published August 9, 2019, and assubsequently amended) that are provided by the hospital orambulatory outpatient surgical center.(2) In addition to the services specified in subdivision (1), thethirty (30) most common services that are provided by thehospital or ambulatory outpatient surgical center.".

Page 17, delete lines 3 through 5.Page 17, line 6, delete "(E)" and insert "(C)".Page 17, line 8, delete "(F)" and insert "(D)".Page 17, line 8, delete "." and insert "without charitable assistance

from the hospital or ambulatory surgical center.(E) Self pay with charitable assistance from the hospital orambulatory surgical center.".

Page 17, between lines 14 and 15, begin a new paragraph and insert:"SECTION 22. IC 16-24.5 IS ADDED TO THE INDIANA CODE

AS A NEW ARTICLE TO READ AS FOLLOWS [EFFECTIVE JULY1, 2020]:

ARTICLE 24.5. OTHER HEALTH CARE FACILITIESChapter 1. Urgent Care FacilitiesSec. 1. (a) As used in this chapter, "urgent care facility" means

HB 1005—LS 6902/DI 104

61

a free standing health care facility that offers episodic, walk-in carefor the treatment of acute, but not life-threatening, healthconditions.

(b) The term does not include an emergency department of ahospital or a nonprofit or government operated health clinic.

Sec. 2. (a) Not later than March 31, 2021, an urgent care facilityshall post on the Internet web site of the urgent care facility pricingand other information specified in this chapter for the fifteen (15)most common services that are provided by the urgent carefacility.

(b) The following information must be included on the Internetweb site by an urgent care facility for each billing code, including,if relevant, each diagnosis related group (DRG) billing code andeach health care common procedure coding system (HCPCS)billing code:

(1) The number of services provided for the code.(2) A description of the service.(3) The weighted average prices paid per service per providertype for each of the following categories:

(A) Employer sponsored insurance.(B) Individually purchased insurance.(C) Medicare, including fee for service and MedicareAdvantage.(D) Self pay without charitable assistance from the hospitalor ambulatory surgical center.(E) Self pay with charitable assistance from the hospital orambulatory surgical center.

Sec. 3. (a) The information displayed on the Internet web sitemust be in an easy to read, understandable format, and include theprices for each billing code by provider type.

(b) An urgent care facility shall update the information on theInternet web site on a quarterly basis.

SECTION 23. IC 16-51 IS ADDED TO THE INDIANA CODE ASA NEW ARTICLE TO READ AS FOLLOWS [EFFECTIVE JULY 1,2020]:

ARTICLE 51. HEALTH CARE REQUIREMENTSChapter 1. Health Care BillingSec. 1. (a) As used in this chapter, "health care services" means

health care related services or products rendered or sold by aprovider within the scope of the provider's license or legalauthorization.

(b) The term includes hospital, medical, surgical, dental, vision,

HB 1005—LS 6902/DI 104

62

and pharmaceutical services or products.Sec. 2. As used in this chapter, "health maintenance

organization" has the meaning set forth in IC 27-13-1-19.Sec. 3. As used in this chapter, "insurer" has the meaning set

forth in IC 27-8-11-1(e).Sec. 4. As used in this chapter, "practitioner" means an

individual or entity duly licensed or legally authorized to providehealth care services.

Sec. 5. As used in this chapter, "provider facility" means any ofthe following:

(1) A hospital.(2) A skilled nursing facility.(3) An end stage renal disease provider.(4) A home health agency.(5) A hospice organization.(6) An outpatient physical therapy, occupational therapy, orspeech pathology service provider.(7) A comprehensive outpatient rehabilitation facility.(8) A community mental health center.(9) A critical access hospital.(10) A federally qualified health center.(11) A histocompatibility laboratory.(12) An Indian health service facility.(13) An organ procurement organization.(14) A religious nonmedical health care institution.(15) A rural health clinic.

Sec. 6. As used in this chapter, "service facility location" meansthe address where the services of a provider facility or practitionerwere provided. The term consists of exact address and place ofservice codes as required on CMS forms 1500 and 1450, includingan office, on-campus location of a hospital, and off-campus locationof a hospital.

Sec. 7. (a) A provider facility or practitioner shall include theaddress of the service facility location in order to obtainreimbursement for a commercial claim for health care servicesfrom an insurer, health maintenance organization, employer, orother person responsible for the payment of the cost of health careservices.

(b) An insurer, health maintenance organization, employer, orother person responsible for the payment of the cost of health careservices is not required to accept a bill for health care services thatdoes not contain the service facility location.

HB 1005—LS 6902/DI 104

63

Sec. 8. A patient is not liable for any additional payment that isthe result of a practitioner or provider facility filing an incorrectform or not including the correct service facility location asrequired under this chapter.

Chapter 2. Centralized CredentialingSec. 1. (a) As used in this chapter, "health carrier" means an

entity:(1) that is subject to IC 27 and the administrative rulesadopted under IC 27; and(2) that enters into a contract to:

(A) provide health care services;(B) deliver health care services;(C) arrange for health care services; or(D) pay for or reimburse any of the costs of health careservices.

(b) The term includes the following:(1) An insurer, as defined in IC 27-1-2-3(x), that issues apolicy of accident and sickness insurance, as defined inIC 27-8-5-1(a).(2) A health maintenance organization, as defined inIC 27-13-1-19.(3) An administrator (as defined in IC 27-1-25-1(a)) that islicensed under IC 27-1-25.(4) Any other entity that provides a plan of health insurance,health benefits, or health care services.

Sec. 2. As used in this chapter, "provider" has the meaning setforth in IC 16-18-2-295(c)(1).

Sec. 3. (a) The department shall implement a centralizedcredentials verification organization and credentialing processthat:

(1) uses a common application, as determined by providertype;(2) issues a single credentialing decision applicable to allhealth carriers, except as determined by the department;(3) recredentials and revalidates provider information not lessthan once every three (3) years;(4) requires attestation of enrollment and credentialinginformation every six (6) months; and(5) is certificated or accredited by the National Committee forQuality Assurance or its successor organization.

(b) A health carrier may not require additional credentialingrequirements in order to participate in a health carrier's network.

HB 1005—LS 6902/DI 104

64

However, a health carrier may collect additional information fromthe provider in order to complete a contract or provideragreement.

(c) A health carrier is not required to contract with a provider.However, if a provider is employed by a health care facility that iscovered by the health carrier or in the health carrier's network andthe provider meets the credentialing requirements under thischapter, the health carrier shall reimburse the provider for anyreimbursable services from the date that the provider wasemployed by the health care facility.

(d) A credentialed provider may be employed by multiple healthcare facilities.

(e) Except when a provider's professional license is no longervalid, a credential acquired under this chapter is valid untilrecredentialing is required.

(f) An adverse action under this section is subject to IC 4-21.5.(g) The department may adopt rules under IC 4-22-2 to

implement this section.(h) The department may adopt emergency rules to implement

this section. However, an emergency rule adopted under thissection expires the earlier of:

(1) one (1) year after the rule was accepted for filing underIC 4-22-2-37.1(e); or(2) June 30, 2021.

This subsection expires July 1, 2021.".Page 17, line 23, delete "realistic, honest" and insert "reasonable".Page 17, line 23, delete "amount" and insert "price".Page 18, line 41, after "services" insert "ordered, scheduled, or

referred by a practitioner".Page 19, line 11, after "therapists);" insert "or".Page 19, delete line 12.Page 19, line 13, delete "(D)" and insert "(C)".Page 19, delete line 14.Page 19, between lines 16 and 17, begin a new paragraph and insert:"Sec. 8.5. As used in this chapter, "price" means the negotiated

rate between the:(1) provider facility and practitioner; and(2) covered individual's health carrier.".

Page 19, between lines 33 and 34, begin a new line block indentedand insert:

"(8) An infusion center that administers intravenousmedications.".

HB 1005—LS 6902/DI 104

65

Page 19, line 39, delete "amount" and insert "price".Page 19, line 42, delete "seventy-two (72) hours" and insert "three

(3) business days".Page 20, line 2, after "total" insert "price".Page 20, line 37, delete "or".Page 20, line 38, after "mail;" insert "or

(3) through a mobile application;".Page 21, line 2, delete "charge" and insert "price".Page 21, line 4, delete "charges" and insert "prices".Page 21, between lines 10 and 11, begin a new paragraph and insert:"(c) A health carrier must provide a practitioner with timely

information needed by the practitioner to comply with therequirements under this chapter.".

Page 21, delete lines 21 through 42, begin a new paragraph andinsert:

"Sec. 16. (a) A practitioner that has ordered, scheduled, orreferred the individual for a nonemergency health care serviceshall provide to the individual an electronic or paper copy of awritten notice that states the following, or words to the same effect:"A patient may at any time ask a practitioner for an estimate of theamount the practitioner will charge for providing a nonemergencymedical service. The law requires that the estimate be providedwithin 3 business days.".

(b) The state department may adopt rules under IC 4-22-2 toestablish requirements for practitioners to provide additionalcharging information under this section.".

Page 22, delete lines 1 through 2.Page 22, line 18, after "13.5." insert "(a)".Page 22, between lines 28 and 29, begin a new paragraph and insert:"(b) A copy of the written notification required under this

section must be signed by the client.".Page 22, line 31, after "to" insert ":

(1)".Page 22, line 31, after "contracts" insert "; and

(2) contracts between a provider and a pharmacy benefitsmanager;".

Page 22, line 32, after "renewed" insert ", including contracts thatautomatically renew after the expiry date,".

Page 23, delete lines 3 through 4.Page 23, line 5, delete "2." and insert "1.".Page 23, line 6, delete "established under section 4 of" and insert

"created under".

HB 1005—LS 6902/DI 104

66

Page 23, line 7, delete "3." and insert "2.".Page 23, delete lines 24 through 31.Page 23, line 32, delete "5." and insert "3.".Page 24, line 36, delete "6. (a) Before May 30, 2021," and insert "4.

(a) After May 30, 2021, but before June 15, 2021,".Page 24, line 41, delete "5" and insert "3".Page 25, line 2, delete "forming" and insert "informing".Page 25, line 21, delete "7." and insert "5.".Page 25, line 37, after "carrier's" insert "reasonable".Page 27, line 13, after "services" insert "ordered, scheduled, or

referred by a practitioner".Page 27, line 25, after "therapists);" insert "or".Page 27, delete line 26.Page 27, line 27, delete "(D)" and insert "(C)".Page 27, delete line 28.Page 27, between lines 30 and 31, begin a new paragraph and insert:"Sec. 9.5. As used in this chapter, "price" means the negotiated

rate between the:(1) provider facility and practitioner; and(2) covered individual's health carrier;

minus the amount that the health carrier will pay.".Page 28, between lines 5 and 6, begin a new line block indented and

insert:"(8) An infusion center that administers intravenousmedications.".

Page 28, line 25, after "each" insert "scheduled".Page 28, line 29, delete "twenty-four (24) hours" and insert "three

(3) business days".Page 29, between lines 3 and 4, begin a new paragraph and insert:"(f) A practitioner and provider facility must provide a health

carrier with timely information needed by the health carrier tocomply with the requirements under this chapter.".

Page 29, line 9, after "14." insert "(a)".Page 29, between lines 32 and 33, begin a new paragraph and insert:"(b) A practitioner and provider facility must provide a health

carrier with timely information needed by the health carriercomply to with the requirements under this chapter.".

Page 29, line 34, delete "include on the Internet web" and insert"ensure that the Internet web site includes a printed notice that:

(1) is designed, lettered, and featured on the Internet web siteso as to be conspicuous to and readable by any individual withnormal vision who visits the Internet web site; and

HB 1005—LS 6902/DI 104

67

(2) states the following, or words to the same effect: "Acovered individual may at any time ask the health carrier foran estimate of the amount the health carrier will pay for orreimburse to a covered individual for nonemergency healthcare services that have been ordered for the coveredindividual or the nature and extent of the orderednonemergency health care services a covered individual isentitled to receive from the health carrier. The law requiresthat an estimate be provided within 3 business days.".".

Page 29, delete lines 35 through 42.Page 30, delete lines 1 through 4.Renumber all SECTIONS consecutively.

and when so amended that said bill do pass.

(Reference is to HB 1005 as introduced.)

KIRCHHOFER

Committee Vote: yeas 8, nays 0.

_____

HOUSE MOTION

Mr. Speaker: I move that House Bill 1005 be amended to read asfollows:

Page 6, line 25, delete "(a)".Page 6, delete lines 28 through 29.Page 8, delete lines 39 through 40.Page 18, delete lines 25 through 42.Delete page 19.Page 20, delete lines 1 through 3.Page 40, between lines 6 and 7, begin a new paragraph and insert:"SECTION 29. IC 27-8-11-13 IS ADDED TO THE INDIANA

CODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JANUARY 1, 2021]: Sec. 13. (a) A fully credentialedprovider shall be reimbursed for eligible services provided at anyin-network hospital if the following conditions are met:

(1) The provider submits the documentation required by theinsurer to be loaded under the provider group or hospital.(2) The provider, provider group, or hospital is a networkprovider with the insurer.(3) The services are provided in accordance with all terms and

HB 1005—LS 6902/DI 104

68

conditions of the provider's, group provider's, or hospital'sagreement or contract with the insurer.(4) Prior authorization is obtained in accordance withIC 27-1-37.5 when required by the insurer for an eligibleservice.

(b) The insurer shall reimburse the provider or hospital forservices described in subsection (a) at the rates determined by thecontract between the provider and the insurer.

(c) An insurer is not required to credential a provider. However,if:

(1) a provider is employed by a hospital that is part of thehospital's network that is covered by the insurer; and(2) the provider meets the insurer's credentialingrequirements;

the insurer shall reimburse the provider for any reimbursableservices from the date that the provider was employed by thehospital.

SECTION 30. IC 27-13-43-4 IS ADDED TO THE INDIANACODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JANUARY 1, 2021]: Sec. 4. (a) A fully credentialedPROVIDER shall be reimbursed for eligible services provided atany in-network hospital if the following conditions are met:

(1) The provider submits the documentation required by thehealth maintenance organization to be loaded under theprovider group or hospital.(2) The provider, provider group, or hospital is a networkprovider with the health maintenance organization.(3) The services are provided in accordance with all terms andconditions of the provider's, group provider's, or hospital'sagreement or contract with the health maintenanceorganization.(4) Prior authorization is obtained in accordance withIC 27-1-37.5 when required by the health maintenanceorganization for an eligible service.

(b) The health maintenance organization shall reimburse theprovider or hospital for services described in subsection (a) at therates determined by the contract between the provider and thehealth maintenance organization.

(c) A health maintenance organization is not required tocredential a provider. However, if:

(1) a provider is employed by a hospital that is part of thehospital's network that is covered by the health maintenance

HB 1005—LS 6902/DI 104

69

organization; and(2) the provider meets the health maintenance organization'scredentialing requirements;

the health maintenance organization shall reimburse the providerfor any reimbursable services from the date that the provider wasemployed by the hospital.".

Renumber all SECTIONS consecutively.

(Reference is to HB 1005 as printed January 24, 2020.)

LEHMAN

_____

HOUSE MOTION

Mr. Speaker: I move that House Bill 1005 be amended to read asfollows:

Page 6, between lines 8 and 9, begin a new paragraph and insert:"SECTION 3. IC 16-18-2-46.5 IS ADDED TO THE INDIANA

CODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]: Sec. 46.5. "Canadian supplier", forpurposes of IC 16-47-3, has the meaning set forth in IC 16-47-3-1.".

Page 7, between lines 36 and 37, begin a new paragraph and insert:"SECTION 15. IC 16-18-2-294.5, AS AMENDED BY

P.L.208-2015, SECTION 4, IS AMENDED TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]: Sec. 294.5. (a) "Program", for purposesof IC 16-40-4, has the meaning set forth in IC 16-40-4-3.

(b) "Program", for purposes of IC 16-41-7.5, has the meaning setforth in IC 16-41-7.5-2.

(c) "Program", for purposes of IC 16-47-1, has the meaning set forthin IC 16-47-1-3.

(d) "Program", for purposes of IC 16-47-3, has the meaning setforth in IC 16-47-3-2.".

Page 9, between lines 8 and 9, begin a new paragraph and insert:"SECTION 17. IC 16-18-2-353.3 IS ADDED TO THE INDIANA

CODE AS A NEW SECTION TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]: Sec. 353.3. "Track-and-trace", forpurposes of IC 16-47-3, has the meaning set forth in IC 16-47-3-3.".

Page 9, between lines 13 and 14, begin a new paragraph and insert:"SECTION 19. IC 16-18-2-363.5 IS ADDED TO THE INDIANA

CODE AS A NEW SECTION TO READ AS FOLLOWS

HB 1005—LS 6902/DI 104

70

[EFFECTIVE JULY 1, 2020]: Sec. 363.5. "Vendor", for purposes ofIC 16-47-3, has the meaning set forth in IC 16-47-3-4.".

Page 17, between lines 10 and 11, begin a new paragraph and insert:"SECTION 24. IC 16-47-3 IS ADDED TO THE INDIANA CODE

AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVEJULY 1, 2020]:

Chapter 3. Importation of Prescription Drugs ProgramSec. 1. As used in this chapter, "Canadian supplier" means a:

(1) manufacturer;(2) wholesale drug distributor; or(3) pharmacy;

appropriately licensed or permitted under Canadian law tomanufacture, distribute, or dispense prescription drugs.

Sec. 2. As used in this chapter, "program" refers to theimportation of prescription drugs program established by section5 of this chapter.

Sec. 3. As used in this chapter, "track-and-trace" means theproduct-tracing process for the components of the pharmaceuticaldistribution supply chain, as described in Title II of the federalDrug Quality and Security Act (21 U.S.C. 351 et seq.).

Sec. 4. As used in this chapter, "vendor" means an entity thatcontracts with the state department to manage specified functionsof the program.

Sec. 5. (a) The importation of prescription drugs program isestablished.

(b) The state department shall administer the program.(c) The state department shall contract with a vendor to provide

services under the program. The vendor must comply with therequirements of this chapter.

(d) The state department shall require a bond from the vendorto mitigate the financial consequences of potential acts ofmalfeasance or misfeasance, potential fraudulent acts, or potentialdishonest acts committed by the vendor, an employee of thevendor, or a contractor or subcontractor of the vendor.

(e) Before July 1, 2021, the state department shall apply to theUnited States Department of Health and Human Services forapproval of the program under 21 U.S.C. 384(1). The statedepartment shall implement the program not later than six (6)months after the state department receives approval for theprogram. The request must include the following:

(1) A description of the state department's plan for operatingthe program.

HB 1005—LS 6902/DI 104

71

(2) A demonstration of how the prescription drugs importedinto Indiana under the program will meet the applicablefederal and state standards for safety and effectiveness.(3) A demonstration of how the prescription drugs importedinto Indiana under the program will comply with federaltrack-and-trace procedures.(4) A list of proposed prescription drugs that have the highestpotential for cost savings to the state through importation atthe time that the request is submitted.(5) An estimate of the total cost savings attributable to theprogram.(6) The costs of program implementation to the state.(7) A list of potential Canadian suppliers from which the statewould import the prescription drugs and a demonstration thatthe suppliers are in full compliance with relevant Canadianfederal and provincial laws and regulations, as well as allapplicable federal and state laws and regulations.

(f) Upon receipt of federal approval of the program, the statedepartment shall notify the following:

(1) The speaker of the house of representatives.(2) The president pro tempore of the senate.(3) The members of the health and provider servicescommittee in the senate.(4) The members of the public health committee in the houseof representatives.

(g) Before the start of the general assembly session followingreceipt of the federal approval, the state department shall submitto the individuals described in subsection (f) a proposal for theimplementation of funding of the program.

Sec. 6. (a) Before December 1, 2020, and by December 1 of eachsubsequent year, the vendor shall develop a wholesale prescriptiondrug importation list identifying the prescription drugs that havethe highest potential for cost savings to the state.

(b) In developing the list, the vendor shall consider at least thefollowing in determining whether a prescription drug should beincluded on the list:

(1) Prescription drugs that, if included on the list, wouldprovide the highest potential for cost savings in stateadministered programs.(2) Prescription drugs for which there is a shortage in Indianaor the United States.(3) Specialty prescription drugs.

HB 1005—LS 6902/DI 104

72

(4) High volume prescription drugs.(c) The state department shall review the wholesale prescription

drug importation list at least every three (3) months to ensure thatthe list continues to meet the requirements of the program. Thestate department may direct the vendor to revise the list asnecessary.

Sec. 7. (a) The vendor shall identify Canadian suppliers that:(1) are in full compliance with:

(A) relevant Canadian federal and provincial laws andregulations; and(B) the federal Drug Quality and Security Act;

(2) have agreed to export prescription drugs identified on thelist described in section 6 of this chapter at prices that willprovide cost savings to the state; and(3) have obtained an international export pharmacy permitunder IC 25-26-14.5.

(b) The vendor must verify that the Canadian suppliers meet allof the requirements of the program while meeting or exceeding thefederal and state track-and-trace laws and regulations.

(c) The vendor shall:(1) contract with an eligible Canadian supplier; or(2) facilitate contracts between eligible importers andCanadian suppliers;

to import drugs under the program.(d) The vendor shall maintain a list of all registered importers

that participate in the program.(e) The vendor shall ensure compliance with Title II of the

federal Drug Quality and Security Act by all suppliers, importers,distributors, and participants in the program.

Sec. 8. (a) The vendor shall provide to the state department thefollowing:

(1) An annual financial audit of the vendor's operations.(2) Quarterly financial reports specific to the program,including information on the performance of the vendor andthe vendor's subcontractors for the program.

(b) The state department shall determine the format andcontents of the reports described in this section.

Sec. 9. (a) A Canadian supplier is eligible to participate in theprogram if the Canadian supplier meets the followingrequirements:

(1) Is in full compliance with relevant Canadian federal andprovincial laws and regulations.

HB 1005—LS 6902/DI 104

73

(2) Is identified by the vendor as eligible to participate in theprogram.(3) Submits an attestation that the supplier has a registeredagent in the United States, including the name and UnitedStates business address of the registered agent.

(b) An importer that meets the requirements of this chaptermay import a prescription drug from an eligible Canadian supplierif the following conditions are met:

(1) The prescription drug meets the United States Food andDrug Administration's standards concerning safety,effectiveness, misbranding, and adulteration.(2) The importation of the drug would not violate federalpatent laws.(3) The importation of the drug is expected to generate costsavings to the state.(4) The drug is not any of the following:

(A) A controlled substance.(B) A biological product.(C) An infused drug.(D) An intravenously injected drug.(E) A drug that is inhaled during surgery.(F) A drug that is a parenteral drug, the importation ofwhich is determined by the United States Secretary ofHealth and Human Services to pose a threat to the publichealth.

Sec. 10. (a) The following entities may import prescription drugsunder the program from a Canadian supplier that meets therequirements of this chapter:

(1) A pharmacist or wholesale drug distributor employed byor under contract with the state department for distributionto a county health department for dispensing to the patientsof the county health department.(2) A pharmacist or wholesale drug distributor employed byor under contract with a pharmacy that is a Medicaidprovider, for dispensing to the pharmacy's Medicaidrecipients.(3) A pharmacist or wholesale drug distributor employed byor under contract with the department of correction, fordispensing to inmates in the custody of the department ofcorrection.

(b) A Canadian supplier that meets the requirements of thischapter and an eligible importer described in subsection (a) that is

HB 1005—LS 6902/DI 104

74

participating in the program:(1) must comply with all track-and-trace requirements; and(2) may not distribute, dispense, or sell prescription drugsimported under this program outside Indiana.

Sec. 11. (a) The vendor shall ensure the safety and quality ofdrugs imported under the program.

(b) The vendor shall do the following:(1) For an initial imported shipment of a specific drug by animporter, ensure that each batch of the drug in the shipmentis statistically sampled and tested for authenticity anddegradation in a manner consistent with federal law.(2) For every subsequent imported shipment of that drug bythat importer, ensure that a statistically valid sample of theshipment is tested for authenticity and degradation in amanner consistent with federal law.(3) Certify that the drug:

(A) is approved for marketing in the United States and isnot adulterated or misbranded; and(B) meets all of the labeling requirements under 21 U.S.C.352.

(4) Maintain qualified laboratory records, including completedata derived from all tests necessary to ensure that the drugis in compliance with the requirements of this section.(5) Maintain documentation demonstrating that the testingrequired by this section was conducted at a qualifiedlaboratory in accordance with federal and state laws andregulations governing laboratory qualifications.

(c) All testing required by this section must be conducted in aqualified laboratory that meets the standards under federal andstate laws and regulations governing laboratory qualifications fordrug testing.

(d) The vendor shall maintain information and documentationsubmitted under this section for at least seven (7) years.

Sec. 12. An importer participating in the program must submitall of the following information to the vendor concerning drugsprovided for the program:

(1) The name and quantity of the active ingredients of thedrug.(2) A description of the dosage form of the drug.(3) The date on which the drug is received.(4) The quantity of the drug that is received.(5) The point of origin and destination of the drug.

HB 1005—LS 6902/DI 104

75

(6) The price paid by the importer for the drug.Sec. 13. (a) A Canadian supplier participating in the program

must submit the following information and documentation to thevendor specifying all of the following concerning drugs providedfor the program:

(1) The original source of the drug, including:(A) the name of the manufacturer of the drug;(B) the date on which the drug was manufactured; and(C) the location, including the country, state or province,and city, where the drug was manufactured.

(2) The date on which the drug is shipped.(3) The quantity of the drug that is shipped.(4) The quantity of each lot of the drug originally received andthe source of the lot.(5) The lot or control number and the batch number assignedto the drug by the manufacturer.

(b) The state department may require that the vendor collectadditional information from the Canadian supplier that isnecessary to ensure the protection of the public health.

Sec. 14. (a) The state department shall immediately suspend theimportation of a specific drug or the importation of drugs by aspecific importer if the state department discovers that any drugor importer activity is in violation of this chapter or any federal orstate law or regulation.

(b) The state department may revoke the suspension undersubsection (a) of the importation of a specific drug or theimportation of drugs by a specific importer if the state departmentdetermines that the public is adequately protected from counterfeitor unsafe drugs being imported into Indiana.

Sec. 15. Before December 1 of each year, the state departmentshall submit a report to the governor and the general assembly inan electronic format under IC 5-14-6 on the operation of theprogram during the previous fiscal year. The report must includeat least the following:

(1) A list of the prescription drugs that were imported underthe program.(2) The number of participating persons.(3) The number of prescriptions dispensed through theprogram.(4) The estimated cost savings to the state during the previousfiscal year and to date that are attributable to the program.(5) A description of the methodology used to determine which

HB 1005—LS 6902/DI 104

76

drugs should be included on the wholesale prescription drugimportation list.(6) Documentation on how the program ensures the following:

(A) Canadian suppliers participating in the program are ofhigh quality and high performance and in full compliancewith relevant:

(i) Canadian federal and provincial laws andregulations; and(ii) federal and state laws, regulations, and rules.

(B) Prescription drugs imported under the program arenot shipped, sold, or dispensed outside Indiana once in thepossession of the importer.(C) Prescription drugs imported under the program arepure, unadulterated, potent, and safe.(D) The program does not place consumers at a higherhealth and safety risk than if the consumers did notparticipate.(E) The program provides cost savings to the state onimported prescription drugs.

Sec. 16. The state department shall adopt rules under IC 4-22-2necessary to implement this chapter.".

Page 24, after line 42, begin a new paragraph and insert:"SECTION 26. IC 25-26-13-4, AS AMENDED BY P.L.5-2016,

SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVEJULY 1, 2020]: Sec. 4. (a) The board may:

(1) adopt rules under IC 4-22-2 for implementing and enforcingthis chapter;(2) establish requirements and tests to determine the moral,physical, intellectual, educational, scientific, technical, andprofessional qualifications for applicants for pharmacists'licenses;(3) refuse to issue, deny, suspend, or revoke a license or permit orplace on probation or fine any licensee or permittee under thischapter;(4) regulate the sale of drugs and devices in the state of Indiana;(5) impound, embargo, confiscate, or otherwise prevent fromdisposition any drugs, medicines, chemicals, poisons, or deviceswhich by inspection are deemed unfit for use or would bedangerous to the health and welfare of the citizens of the state ofIndiana; the board shall follow those embargo procedures foundin IC 16-42-1-18 through IC 16-42-1-31, and persons may notrefuse to permit or otherwise prevent members of the board or

HB 1005—LS 6902/DI 104

77

their representatives from entering such places and making suchinspections;(6) prescribe minimum standards with respect to physicalcharacteristics of pharmacies, as may be necessary to themaintenance of professional surroundings and to the protection ofthe safety and welfare of the public;(7) subject to IC 25-1-7, investigate complaints, subpoenawitnesses, schedule and conduct hearings on behalf of the publicinterest on any matter under the jurisdiction of the board;(8) prescribe the time, place, method, manner, scope, and subjectsof licensing examinations which shall be given at least twiceannually; and(9) perform such other duties and functions and exercise suchother powers as may be necessary to implement and enforce thischapter.

(b) The board shall adopt rules under IC 4-22-2 for the following:(1) Establishing standards for the competent practice ofpharmacy.(2) Establishing the standards for a pharmacist to counselindividuals regarding the proper use of drugs.(3) Establishing standards and procedures before January 1, 2006,to ensure that a pharmacist:

(A) has entered into a contract that accepts the return ofexpired drugs with; or(B) is subject to a policy that accepts the return of expireddrugs of;

a wholesaler, manufacturer, or agent of a wholesaler ormanufacturer concerning the return by the pharmacist to thewholesaler, the manufacturer, or the agent of expired legend drugsor controlled drugs. In determining the standards and procedures,the board may not interfere with negotiated terms related to cost,expenses, or reimbursement charges contained in contractsbetween parties, but may consider what is a reasonable quantityof a drug to be purchased by a pharmacy. The standards andprocedures do not apply to vaccines that prevent influenza,medicine used for the treatment of malignant hyperthermia, andother drugs determined by the board to not be subject to a returnpolicy. An agent of a wholesaler or manufacturer must beappointed in writing and have policies, personnel, and facilitiesto handle properly returns of expired legend drugs and controlledsubstances.(4) The following concerning the issuance of a permit under

HB 1005—LS 6902/DI 104

78

IC 25-26-14.5:(A) Inspection report requirements described underIC 25-26-14.5-1.(B) The financial responsibility of entities that hold anypermit under IC 25-26-14.5.

(c) The board may grant or deny a temporary variance to a rule ithas adopted if:

(1) the board has adopted rules which set forth the procedures andstandards governing the grant or denial of a temporary variance;and(2) the board sets forth in writing the reasons for a grant or denialof a temporary variance.

(d) The board shall adopt rules and procedures, in consultation withthe medical licensing board, concerning the electronic transmission ofprescriptions. The rules adopted under this subsection must address thefollowing:

(1) Privacy protection for the practitioner and the practitioner'spatient.(2) Security of the electronic transmission.(3) A process for approving electronic data intermediaries for theelectronic transmission of prescriptions.(4) Use of a practitioner's United States Drug EnforcementAgency registration number.(5) Protection of the practitioner from identity theft or fraudulentuse of the practitioner's prescribing authority.

(e) The governor may direct the board to develop:(1) a prescription drug program that includes the establishment ofcriteria to eliminate or significantly reduce prescription fraud; and(2) a standard format for an official tamper resistant prescriptiondrug form for prescriptions (as defined in IC 16-42-19-7(1)).

The board may adopt rules under IC 4-22-2 necessary to implementthis subsection.

(f) The standard format for a prescription drug form described insubsection (e)(2) must include the following:

(1) A counterfeit protection bar code with human readablerepresentation of the data in the bar code.(2) A thermochromic mark on the front and the back of theprescription that:

(A) is at least one-fourth (1/4) of one (1) inch in height andwidth; and(B) changes from blue to clear when exposed to heat.

(g) The board may contract with a supplier to implement and

HB 1005—LS 6902/DI 104

79

manage the prescription drug program described in subsection (e). Thesupplier must:

(1) have been audited by a third party auditor using the SAS 70audit or an equivalent audit for at least the three (3) previousyears; and(2) be audited by a third party auditor using the SAS 70 audit oran equivalent audit throughout the duration of the contract;

in order to be considered to implement and manage the program.(h) The board shall adopt rules under IC 4-22-2, or emergency rules

in the manner provided under IC 4-22-2-37.1 that take effect on July 1,2016, concerning:

(1) professional determinations made under IC 35-48-4-14.7(d);and(2) the determination of a relationship on record with thepharmacy under IC 35-48-4-14.7.

(i) The board may:(1) review professional determinations made by a pharmacist; and(2) take appropriate disciplinary action against a pharmacist whoviolates a rule adopted under subsection (h) concerning aprofessional determination made;

under IC 35-48-4-14.7 concerning the sale of ephedrine andpseudoephedrine.

SECTION 27. IC 25-26-13-29, AS AMENDED BY P.L.209-2018,SECTION 10, IS AMENDED TO READ AS FOLLOWS [EFFECTIVEJULY 1, 2020]: Sec. 29. (a) It is unlawful:

(1) For any person to display or permit to be displayed, apharmacy permit in any facility or place of business other thanthat for which it was issued.(2) For any person to accept a prescription for filling orcompounding at any place or facility for which there is not a validpharmacy permit.(3) For any person to operate a pharmacy or to take, assume,exhibit, display, or advertise by any medium, the title "drugs","prescriptions", "medicine", "drug store", "pharmacy", or"apothecary shop", or any combination of such titles or any othertitle, symbol, term, or description of like import intended to causethe public to believe that it is a pharmacy unless the person holdsa valid pharmacy permit.(4) For any person to engage or offer to engage in the practice ofpharmacy or to hold himself or herself out as a pharmacistwithout a valid pharmacist's license that is classified as active bythe board.

HB 1005—LS 6902/DI 104

80

(b) A person who violates a provision of subsection (a) commits aLevel 6 felony.

(c) Nothing in this chapter shall apply to, nor in any mannerinterfere with the business of a general merchant in selling anddistributing nonnarcotic, nonprescription medicines or drugs which areprepackaged, fully prepared by the manufacturer for use by theconsumer, and labeled in accordance with the requirements of the stateand federal food and drug acts.

(d) This chapter does not apply to, or in any manner interfere with,the business of a manufacturer in selling and delivering a dialysatedrug or a device that is necessary for home peritoneal renal dialysis fora patient who has end stage renal disease if all of the following apply:

(1) The dialysate drug or device is approved by the federal Foodand Drug Administration under federal law.(2) The dialysate drug or device is held by the manufacturer, athird party logistics provider, or a wholesale drug distributor inaccordance with the requirements of IC 25-26-14.(3) The dialysate drug or device is delivered in the manufacturer'soriginal, sealed packaging.(4) The dialysate drug or device is delivered only upon:

(A) receipt of a physician's prescription by a pharmacy thatholds a pharmacy permit under this chapter; and(B) the transmittal of an order from the pharmacy described inclause (A) to the manufacturer, third party logistics provider,or wholesale drug distributor.

(5) The manufacturer, third party logistics provider, or wholesaledrug distributor delivers the dialysate drug or device directly to:

(A) the patient or the patient's designee for self-administrationof the dialysis therapy; or(B) a health care provider for administration of the dialysistherapy to the patient.

(e) This chapter does not apply to the purchase of prescriptiondrugs through and in compliance with the importation ofprescription drugs program established under IC 16-47-3.

SECTION 28. IC 25-26-14-17.8, AS AMENDED BY P.L.98-2006,SECTION 22, IS AMENDED TO READ AS FOLLOWS [EFFECTIVEJULY 1, 2020]: Sec. 17.8. (a) This section does not apply topurchase of prescription drugs through and in compliance with theimportation of prescription drugs program established underIC 16-47-3. A wholesale drug distributor licensed under this chapterthat purchases legend drugs from a wholesale drug distributor that isnot licensed under this chapter shall act with due diligence as required

HB 1005—LS 6902/DI 104

81

under this section and rules adopted by the board. However, the duediligence requirements of this section do not apply to purchases froman unlicensed wholesale drug distributor that has obtainedaccreditation through the National Association of Boards of Pharmacy'sVerified-Accredited Wholesale Distributors program.

(b) Before the initial purchase of legend drugs from the unlicensedwholesale drug distributor, the licensed wholesale drug distributor shallobtain the following information from the unlicensed wholesale drugdistributor:

(1) A list of states in which the unlicensed wholesale drugdistributor is licensed.(2) A list of states into which the unlicensed wholesale drugdistributor ships legend drugs.(3) Copies of all state and federal regulatory licenses andregistrations held by the unlicensed wholesale drug distributor.(4) The unlicensed wholesale drug distributor's most recentfacility inspection reports.(5) Information regarding general and product liability insurancemaintained by the unlicensed wholesale drug distributor,including copies of relevant policies.(6) A list of other names under which the unlicensed wholesaledrug distributor does business or has been previously known.(7) A list of corporate officers and managerial employees of theunlicensed wholesale drug distributor.(8) A list of all owners of the unlicensed wholesale drugdistributor that own more than ten percent (10%) of theunlicensed wholesale drug distributor, unless the unlicensedwholesale drug distributor is publicly traded.(9) A list of all disciplinary actions taken against the unlicensedwholesale drug distributor by state and federal agencies.(10) A description, including the address, dimensions, and otherrelevant information, of each facility used by the unlicensedwholesale drug distributor for legend drug storage anddistribution.(11) A description of legend drug import and export activities ofthe unlicensed wholesale drug distributor.(12) A description of the unlicensed wholesale drug distributor'sprocedures to ensure compliance with this chapter.(13) A statement:

(A) as to whether; and(B) of the identity of each manufacturer for which;

the unlicensed wholesale drug distributor is an authorized

HB 1005—LS 6902/DI 104

82

distributor.(c) Before the initial purchase of legend drugs from an unlicensed

wholesale drug distributor, the licensed wholesale drug distributorshall:

(1) request that the board obtain and consider the results of anational criminal history background check (as defined inIC 10-13-3-12) through the state police department of allindividuals associated with the unlicensed wholesale drugdistributor as specified for licensure of a wholesale drugdistributor under section 16(b) of this chapter; and(2) verify the unlicensed wholesale drug distributor's status as anauthorized distributor, if applicable.

(d) If an unlicensed wholesale drug distributor's facility has not beeninspected by the board or the board's agent within three (3) years aftera contemplated purchase described in subsection (a), the licensedwholesale drug distributor shall conduct an inspection of theunlicensed wholesale drug distributor's facility:

(1) before the initial purchase of legend drugs from the unlicensedwholesale drug distributor; and(2) at least once every three (3) years unless the unlicensedwholesale drug distributor's facility has been inspected by theboard, or the board's agent, during the same period;

to ensure compliance with applicable laws and regulations relating tothe storage and handling of legend drugs. A third party may be engagedto conduct the site inspection on behalf of the licensed wholesale drugdistributor.

(e) At least annually, a licensed wholesale drug distributor thatpurchases legend drugs from an unlicensed wholesale drug distributorshall ensure that the unlicensed wholesale drug distributor maintainsa record keeping system that meets the requirements of section 17(3)of this chapter.

(f) If a licensed wholesale drug distributor that purchases legenddrugs from an unlicensed wholesale drug distributor has reason tobelieve that a legend drug purchased from the unlicensed wholesaledrug distributor is misbranded, adulterated, counterfeit, or suspectedcounterfeit, the licensed wholesale drug distributor shall conduct a forcause authentication of each distribution of the legend drug back to themanufacturer.

(g) An unlicensed wholesale drug distributor that has engaged in thedistribution of a legend drug for which a licensed wholesale drugdistributor conducts a for cause authentication under subsection (f)shall provide, upon request, detailed information regarding the

HB 1005—LS 6902/DI 104

83

distribution of the legend drug, including the:(1) date of purchase of the legend drug;(2) lot number of the legend drug;(3) sales invoice number of the legend drug; and(4) contact information, including name, address, telephonenumber, and any electronic mail address of the unlicensedwholesale drug distributor that sold the legend drug.

(h) If a licensed wholesale drug distributor conducts a for causeauthentication under subsection (f) and is unable to authenticate eachdistribution of the legend drug, the licensed wholesale drug distributorshall quarantine the legend drug and report the circumstances to theboard and the federal Food and Drug Administration within ten (10)business days after completing the attempted authentication.

(i) If a licensed wholesale drug distributor authenticates thedistribution of a legend drug back to the manufacturer under subsection(f), the licensed wholesale drug distributor shall maintain records of theauthentication for three (3) years and shall provide the records to theboard upon request.

(j) A licensed wholesale drug distributor that purchases legenddrugs from an unlicensed wholesale drug distributor shall, at leastannually, conduct random authentications of required pedigrees on atleast ten percent (10%) of sales units of distributions of legend drugsthat were purchased from unlicensed wholesale drug distributors.

(k) An unlicensed wholesale drug distributor from which a licensedwholesale drug distributor has purchased legend drugs shall cooperatewith the random authentications of pedigrees under this section andprovide requested information in a timely manner.

(l) If a wholesale drug distributor conducts a random authenticationunder subsection (j) and is unable to authenticate each distribution ofthe legend drug, the wholesale drug distributor shall quarantine thelegend drug and report the circumstances to the board and the federalFood and Drug Administration not more than ten (10) business daysafter completing the attempted authentication.

SECTION 29. IC 25-26-14.5 IS ADDED TO THE INDIANACODE AS A NEW CHAPTER TO READ AS FOLLOWS[EFFECTIVE JULY 1, 2020]:

Chapter 14.5. International Export Pharmacy Permit andWholesale Drug Distributor Permit

Sec. 1. (a) To participate as an exporter of prescription drugsinto Indiana under the importation of prescription drugs programestablished by IC 16-47-3-5, a pharmacy located outside the UnitedStates must meet the following requirements:

HB 1005—LS 6902/DI 104

84

(1) Hold an international export pharmacy permit issuedunder this chapter.(2) Maintain at all times an active and unencumbered licenseor permit to operate a pharmacy:

(A) in compliance with the laws and rules of thejurisdiction in which the pharmacy is located and fromwhich the prescription drugs will be exported; and(B) in a country with which the United States has a currentmutual recognition agreement, cooperation agreement,memorandum of understanding, or other federalmechanism recognizing the country's adherence to currentgood manufacturing practices for pharmaceuticalproducts.

(3) Submit an application for an international exportpharmacy permit on a form developed and provided by theboard.

(b) An applicant for an international export pharmacy permitmust submit the following to the board with the applicationrequired under subsection (a)(3):

(1) Proof of an active and unencumbered license or permit tooperate a pharmacy in compliance with the laws and rules ofthe jurisdiction in which the dispensing facility is located andfrom which the prescription drugs will be exported.(2) Documentation demonstrating that the country in whichthe pharmacy operates has a current mutual recognitionagreement, cooperation agreement, memorandum ofunderstanding, or other federal mechanism recognizing thecountry's adherence to current good manufacturing practicesfor pharmaceutical products.(3) The location, names, and title of all principal corporateofficers and the pharmacist who serves as the prescriptiondepartment manager for prescription drugs exported intoIndiana under the importation of prescription drugs program.(4) A written attestation by an owner or officer of theapplicant and by the applicant's prescription drug managercontaining the following affirmations:

(A) That the individual has read and understands the lawsand rules governing the manufacture, distribution, anddispensing of prescription drugs in Indiana.(B) That prescription drugs shipped, mailed, or deliveredinto Indiana:

(i) will meet or exceed Indiana's standards for safety and

HB 1005—LS 6902/DI 104

85

efficacy; and(ii) will not have been, and may not be, manufactured ordistributed in violation of the laws and rules of thejurisdiction in which the applicant is located and fromwhich the prescription drugs will be exported.

(5) A current inspection report from an inspection conductedby the regulatory or licensing agency of the jurisdiction inwhich the applicant is located. The inspection report mustreflect compliance with this section. An inspection report iscurrent if the inspection was conducted not earlier than six (6)months before the submission of the application for an initialpermit or not earlier than one (1) year for the renewal of apermit.

(c) If an applicant is not able to submit an inspection report thatmeets the requirements of subsection (b)(5), the board must do one(1) of the following:

(1) Conduct, or contract with a person to conduct, an onsiteinspection at the cost of the applicant.(2) Accept a current inspection report from an entity that:

(A) meets requirements adopted by the board underIC 4-22-2 for entities to perform inspections; and(B) has been approved by the board.

(3) Accept a current inspection report from the United StatesFood and Drug Administration conducted under the federalDrug Quality and Security Act.

Sec. 2. To participate as an exporter of prescription drugs intoIndiana under the importation of prescription drugs programestablished by IC 16-47-3, a nonresident prescription drugmanufacturer located outside the United States must register withthe board and obtain the international export pharmacy permitunder this chapter.

Sec. 3. (a) The board shall adopt rules under IC 4-22-2governing the financial responsibility of a pharmacy that holds apermit under this chapter. The rules must include at least thefollowing:

(1) Financial reporting requirements.(2) Standards for financial capability to perform the functionsgoverned by the permit.(3) Requirements for ensuring that the permit holder and thepermit holder's contractors can be held accountable for thefinancial consequences of any act of malfeasance ormisfeasance or fraudulent or dishonest acts committed by the

HB 1005—LS 6902/DI 104

86

permit holder or the permit holder's contractors.(b) The board shall adopt rules under IC 4-22-2 concerning

inspection report requirements described in section 1 of thischapter.

Sec. 4. (a) A wholesale drug distributor located outside theUnited States must obtain an international prescription drugwholesale drug distributor permit under this chapter to engage inthe wholesale exportation and distribution of prescription drugs inIndiana under the importation of prescription drugs programestablished by IC 16-47-3-5.

(b) A wholesale drug distributor must meet the following inorder to obtain a wholesale drug distributor permit:

(1) Be licensed or permitted to operate in a country withwhich the United States has:

(A) a current mutual recognition agreement;(B) a current cooperation agreement;(C) a current memorandum of understanding; or(D) another federal mechanism recognizing the country'sadherence to current good manufacturing practices forpharmaceutical products.

(2) Maintain at all times a license or permit to engage in thewholesale distribution of prescription drugs in compliancewith the laws and rules of the jurisdiction in which thewholesale drug distributor operates.

(c) The board shall adopt rules under IC 4-22-2 governing thefinancial responsibility of a wholesale drug distributor that holdsa permit under this chapter. The rules must include at least thefollowing:

(1) Financial reporting requirements.(2) Standards for financial capability to perform the functionsgoverned by the permit.(3) Requirements for ensuring that a wholesale drugdistributor holding a permit under this chapter and thewholesale drug distributor's contractors are held accountablefor the financial consequences of any act of malfeasance ormisfeasance or fraudulent or dishonest acts committed by thepermit holder or the permit holder's contractors.".

Renumber all SECTIONS consecutively.

(Reference is to HB 1005 as printed January 24, 2020.)

HATFIELD

HB 1005—LS 6902/DI 104