1. 2014 Health Law Legislative Update IHA Annual Membership Meeting Legal Forum October 30, 2014 Renaissance Indianapolis North Hotel Allison L. Taylor Hannah K. Brown Hall, Render, Killian, Heath & Lyman, P.C. One American Square, Suite 2000 Indianapolis, IN 46282 ataylor@hallrender.com hbrown@hallrender.com

2. 2014 Legislative Session “Short” session - adjourned March 13 th Hot topics: – Same-sex marriage - HJR 3 – Business personal property tax – Removing Indiana from Common Core requirements – Daycare reform – Mass transit

3. Introduced Bills House Bills – 447 Senate Bills – 423 Bills Becoming Law House Bills –116 Senate Bills –107 *Short Session Filing Limits

4. 2014 Legislative Topics Reimbursement and Reporting Administration and Delivery of Health Care Pharmaceutical and Controlled Substances Professional Licensure and Workforce Public Health Mental Health and Addiction Regulatory and Other 4

5. 2014 Reimbursement & Reporting 5

6. 2014 Reimbursement and Reporting SEA 408: Neonatal abstinence syndrome (Sen. Becker) As introduced, would have: – Required ISDH to adopt emergency rules to establish standards and procedures for mandatory reporting by hospitals of NAS data. – The rules must have included an appropriate definition of NAS, appropriate methodology for testing NAS newborns, and appropriate screening practices to detect drug abuse by pregnant women. – No funding or reimbursement for hospitals or providers (neither commercial nor Medicaid). 6

7. 2014 Reimbursement and Reporting SB 408: Neonatal abstinence syndrome (cont’d) Revised to “do homework” before mandated reporting begins Before Nov. 1, 2014, ISDH and stakeholders must report on: –the appropriate standard clinical definition of NAS; –development of a uniform process of identifying NAS; –estimated time and resources needed to educate hospitals and staff to implement these policies; –review of both existing and new data reporting mechanisms; and –whether payment methodologies for identifying NAS and the reporting of NAS data are currently available, or needed. Before June 1, 2015, ISDH may establish hospital pilot programs with models for NAS identification, data collection and reporting. Draft report being circulated 7

8. 2014 Reimbursement and Reporting SB 294: Worker’s Compensation (Sen. Boots) – As introduced, cut reimbursement to 150% of Medicare or 125% of cost. – Efforts to limit reimbursement to amount “not to exceed” a percentage of Medicare. HEA 1320 passed last session, doesn’t take effect until July 1, 2014 – Reduced hospital reimbursement to 200% of Medicare – Made other changes on drugs, implants – Cuts could be as much as $38 million per year for hospitals Hospitals able to avoid further cuts. 8

9. 2014 Reimbursement and Reporting SB 290: Medical Debt Collection Procedures. (Sen. Tallian) – This bill would have defined "medical collection case" and prohibits the collection of prejudgment interest – Would have permitted defendants to remove such cases to a circuit or superior court – Would have shortened the current six-year statute of limitations to two years – Would have allowed a defendant in multiple medical collection cases in the same county to consolidate them – See HFMA best practices: http://www.hfma.org/medicaldebt/http://www.hfma.org/medicaldebt/ 9

10. 2014 Administration & Delivery of Health Care 10

11. 2014 Administration and Delivery of Health Care HEA 1258: Telehealth Pilot Program (Rep. Shackleford) Before August 1, 2014, requires MLB to establish a telehealth services pilot program, including the following: 1.Physician must have established practice in Indiana; 2.MLB must create standards and procedures for the pilot, which will include storage of patient medical records and technology/HIPAA concerns; 3.May allow issuance of medically necessary prescriptions (no controlled substances); 4.MLB must prohibit inclusion of emergency care; 5.MLB will also set geographic limitations and duration of pilot. By February 1, 2015, the MLB will report details of the pilot program to the legislature, including # patients served, prescriptions issued, number of in-person follow-up care required, overall physician and patient satisfaction.

12. 2014 Administration and Delivery of Health Care SEA 44: Electronic Health Data Work Group (Sen. Breaux) ISDH to work with FSSA to study and report by August 1, 2014 on issues concerning electronic health data. Study to include: – Patient and legal consent for sharing information; – Public health integration into the health care sector; – Health care provider use of HIT; – Uniform access to electronic health data by health care providers in Indiana; – Sharing of health data between ISDH and FSSA, and opportunities to improve collaboration; – Potential opportunities to use health data to improve health and delivery – including w/in Medicaid; and – Potential opportunities to facilitate and encourage entrepreneurial uses of health data.

14. Administration and Delivery of Health Care HEA 1391: Community Living Pilot Program (Rep. Clere) Establishes Community Living Pilot Program beginning Jan. 1, 2015. Four AAAs will participate in pilot program for those “at risk” of losing independence. Will establish policy and standards for better meeting needs of this population. So called “Nursing Home Moratorium” was removed from this legislation. The current moratorium on Medicaid beds ends June 30 th. Requires ISDH, FSSA and OMB to : – By December 1, 2014 – review excess skilled nursing facility bed capacity and analyze previous IN policies for reducing excess capacity. – By October 1, 2015 – review all current LTC services, and analyze home and community based services, review Medicaid reimbursement, etc. Requires FSSA to report on RBMC pilot program for ABD by December 1, 2016. 14

15. 2014 Administration and Delivery of Health Care HEA 1358: Office of Minority Health (Rep. C Brown) –Repeals ISDH’s health facility advisory council –Allows up to 50% of funding from Traumatic Brain Injury Fund for development of statewide trauma system. –By January 1, 2015, ISDH to establish a license and provide regulations for a facility that provides specialized treatment and services for traumatic brain injuries. HEA 1336: EMS State Medical Director (Rep. T Brown) –Requires Dept. of Homeland Security to appoint an EMS Medical Director to oversee medical aspects of EMS system. 15

16. 2014 Administration and Delivery of Health Care HEA 1190: Treatment of Miscarried Remains (Rep. Slager) –Parent or parents of miscarried fetus may determine final disposition of miscarried fetus remains. –Within 24 hours, health care facilities must: disclose to parents, both orally and in writing, the parent’s right to determine final disposition; provide parents with written information on available options for disposition of miscarried fetus; inform parents of available counseling services. –If parents choose final disposition that is not usual and customary for the health care facility, the parents are financially responsible. 16

17. 2014 Administration and Delivery of Health Care HB 1392: Retention of Blood Samples (Rep. Morris) – Would have required a hospital or facility that obtains or receives a bodily substance sample taken at the direction of a law enforcement officer to retain the sample until told otherwise by law enforcement. – After 60 days, hospital could charge law enforcement a reasonable storage fee. 17

18. 2014 Professional Licensure and Workforce 18

19. 2014 Professional Licensure & Workforce Pharmacy technicians (SB 233) – Grooms – Changes certification to licensure and specifies education and training requirements. Anesthesiologist Assistants (SB 233) – Grooms – New provider type, assisting anesthesiologist Occupational therapists (HB 1045) – Kirchhofer – Amends the scope of practice of occupational therapists. Certified registered nurse anesthetists (HB 1060) – Frizzell – Recognition as “Advanced Practice Nurse” under Indiana law. Diabetes educators (HB 1259) - Shackleford – Provides for licensure of diabetes educators. Art therapists (HEA 1272) – Stemler – Provides for the licensure of professional art therapists. 19

20. 2014 Professional Licensure & Workforce SB 244: Health care professional registry (Sen. Pat Miller) – Would have allowed health care professionals who are not otherwise licensed, certified, or registered by the State of Indiana to practice within the state. – Would have required that a health care professional on the list be permitted to provide services under the federal Medicare or Medicaid programs and meet certain other requirements, such as filing a registration with the Professional Licensing Agency’s new registry. – Ultimately, SEA 244 requires a PLA study. 20

21. 2014 Pharmaceutical and Controlled Substances 21

22. 2014 Pharmaceutical and Drug Reporting HEA 1218: Drug treatment and reporting (Rep. Davisson) Makes insulin prescription only. INSPECT enhancements: – Before July 1, 2015 – INSPECT information transmitted w/in 7 days – Between July 1, 2015 and December 31, 2015 – w/in 3 days – After January 1, 2016, not more than 24 hours later INSPECT study: – Before October 1, 2014, PLA to study impact of including all prescription drugs in INSPECT. Study must include:  efficacy of including all legend drugs, analysis of security concerns, technology requirements, regulatory impact analysis, fiscal analysis, etc. 22

23. 2014 Pharmaceutical and Drug Reporting SEA 262: Biosimilar Drugs (Sen. Hershman) Under certain conditions, allows a pharmacist to substitute an interchangeable biosimilar drug for a prescribed brand-name product if: – FDA deems a drug interchangeable; – Physician indicates “may substitute” on prescription; – Pharmacist informs patient of substitution; – Pharmacist must notify physician of name and manufacturer of the biologic product w/in 10 days of dispensing; – Both pharmacist and physician must keep a record of the substitution. 23

24. 2014 Mental Health & Addiction 24

25. HEA 1360: Addiction and Treatment Services. (Rep. C. Brown) Adds psychiatrists with training and certification in addiction, addiction counselors and mental health professionals to those eligible for loan forgiveness SEA 248: Psychiatric Crisis Intervention Services. (Sen. Crider) FSSA to study available services and resources and make recommendations on the need for, or better use of, intervention services. SEA 235: Mental Health Pilot Project. (Sen. M. Young) 3-year pilot program in Marion County to reduce recidivism by providing mental health and forensic treatment services. 2014 Mental Health and Addiction

26. 2014 Regulatory & Other 26

27. Pending regulations… High Breast Density Rules Anesthesiology Assistants Diabetes Educators Telehealth Attorney General Access to Records Rule Controlled Substance Final Regulations Indiana Medical Licensing Board

28. SCR 005: Health Insurance Exchanges – Federal Funding. (Sen. Leising) This resolution urges Congress to defund planning grants for state insurance exchanges under the Patient Protection and Affordable Care Act (this is a model resolution from American Legislative Exchange Council, or ALEC). The resolution received a very short hearing. However, there will be a joint hearing of the House Public Health and Insurance Committees on March 5 th for an update on the status of Federal Health Care.

31. Interim Study Committee on Public Health, Behavioral Health and Human Services (ISCPHBHHS) High-Cost Management Program (PD 3186) Integrity and security of INSPECT Take-home supplies of Opioid Treatment programs Chronic eye disease (PD 3188) Vision impairment and blindness in First Steps program Housing all EMS programs and trauma system in one state agency Barriers and benefits of expanding telemedicine for addiction and mental health treatment 2014 Interim Study Committee

32. 119 th General Assembly (To Be Determined): November 4, 2014: General Election −All 100 House seats −25 Senate seats November 18, 2014: Organization Day January 12, 2015: First Day of Session 2015 Legislative Session: Long “budget-writing” session Education Ethics Reform Public Safety 2015 Legislative Session Preview

33. Expected Legislation Affecting Health Care Pseudoephedrine and ephedrine −Re-energized efforts to make PSE and Ephedrine Rx-only. −Creation of meth offender registry, similar to Oklahoma policy. Attorney General’s consumer protection efforts −Expansion of federal Fair Debt Collection Practices Act at state level. High cost health management program −Ways and Means Chairman Tim Brown’s proposed Medicaid pilot program providing intensive case management for the care of certain high-cost patients. INSPECT −Expansion of reporting requirements to include all legend drugs—not only controlled substances. Med Mal Caps −Efforts to address caps? 2015 Legislative Session Preview

34. Questions?