The Laws, They Are A-Changin: Indiana Health Care-Related Laws Update, July 2020

Many new Indiana health care-related laws were finalized after a busy legislative session was cut short in response to the coronavirus pandemic. Several of the changes went into effect on July 1, 2020, or will be implemented in the coming months. Despite the surprise ending to the session, the state legislature made many substantial changes in the health care regulatory universe. This update highlights changes affecting telemedicine, pharmacy practice, controlled substances scheduling, pharmacy benefit managers (PBMs), and insurance. 

Telemedicine

Hoosiers May Obtain Glasses and Contact Lens Prescriptions Through Telemedicine Visits
The Indiana Medical Licensing Board and the Professional Licensing Agency were sued in 2019 by a telemedicine app provider, Visibly, alleging that the state's telemedicine law violated the state constitution by prohibiting the use of telemedicine for eye exams or other vision-related services to prescribe contact lenses. In its suit, Visibly alleged that the purpose of banning its technology for exams that lead to prescriptions was unconstitutional protection from competition for vision care practitioners with physical locations. Visibly dismissed its Indiana lawsuit as a result of the US Food and Drug Administration (FDA) seeking to classify the app as a mobile medical device, and reserved the right to re-file in the future.

While Visibly is currently not on the market (but may return, pending FDA approval), in the meantime, the state telemedicine law has changed. Among other things, the Indiana Senate Enrolled Act, effective July 1, 2020, amended the Indiana Code so that:

• Prescribers may prescribe medical devices, including ophthalmic devices such as glasses and contact lenses, as a result of a telemedicine encounter
• The technology used must be "sufficient to allow the provider to make an informed diagnosis and treatment plan that includes the medical device being prescribed."
• Patients receiving prescriptions for ophthalmic devices must be at least 18 years old and not over 55 years old

In addition, there are in-person visit requirements for the telemedicine-conducted eye exams. Specifically, patients must have a prescription as a result of an in-person eye exam completed within the two years preceding the telemedicine visit, and may not use telemedicine more than two consecutive times within two years without obtaining an in-person eye exam. In addition, the prescriber must provide the patient with continuing access to the prescription online, 24 hours a day.

The final version of the enrolled bill, amending several sections of the Indiana Code and adding new sections, is available here: Senate Enrolled Act No. 19.

Pharmacy Practice

Among other changes, Indiana House Enrolled Act 1207 provides pharmacists with more autonomy when it comes to substituting for epinephrine products and dispensing auto-injectable epinephrine, and allows pharmacists to delegate immunizations to technicians with proper supervision. Below are some key takeaways for Indiana health care providers affected by the new laws.

Dispensing of Auto-injectable Epinephrine
Indiana pharmacists can now—by standing order—dispense auto-injectable epinephrine without examining the patient to whom the epinephrine will be administered if all of the following conditions are met:

Pharmacists’ Obligations:

1. The auto-injectable epinephrine may only be dispensed to a person who:

a. Presents a certificate of completion for a course approved by the Indiana State Department of Health concerning allergies and the administration of auto-injectable epinephrine; and

b. Is or may be in a position to assist another individual who is at risk of experiencing anaphylaxis.

2. The pharmacist must provide instructions concerning how to properly administer auto-injectable epinephrine from the specific device being dispensed at the time of the device's dispensing.

3. The pharmacist must also instruct the individual receiving the auto-injectable epinephrine to summon emergency medical services either immediately before or immediately after administering the auto-injectable epinephrine to an individual experiencing anaphylaxis.

Customers’ Obligations:

The person requesting the auto-injectable epinephrine must complete a course approved by the Indiana State Department of Health (ISDH) concerning allergies and the administration of auto-injectable epinephrine. The Indiana legislature further clarified that the person administering auto-injectable epinephrine will not be liable for civil damages nor be deemed to be practicing medicine without a license in violation of IC 25-22.5-8-2 if the individual, acting in good faith:

1. Obtains auto-injectable epinephrine from a pharmacist by standing order;
2. Administers auto-injectable epinephrine to an individual that the person “reasonably believes” is experiencing anaphylaxis in a manner that is consistent with training he or she received and the instruction provided by the pharmacist at the time of dispensing; and
3. Attempts to summon emergency medical services either immediately before or immediately after administering the auto-injectable epinephrine.

Under the new law, ISDH is required to issue a standing order for the dispensing of auto-injectable epinephrine in Indiana.

Pharmacists May Substitute a Therapeutic Alternative Epinephrine Product
Indiana pharmacists may now substitute a therapeutic alternative for epinephrine products for a patient, unless that substitution would be prohibited by provisions regarding drug regimens in Indiana-licensed health care facilities.

As a reminder, under Indiana law, a therapeutic alternative is a drug that (1) has a different chemical structure from; (2) is of the same pharmacological or therapeutic class as; and (3) usually can be expected to have similar therapeutic effects and adverse reaction profiles when administered to patients in therapeutically equivalent doses as another drug.

New Exceptions to Electronic Controlled Substance Prescriptions
The Indiana legislature added two additional exceptions to the requirement that all controlled substance prescriptions be issued in electronic format. In addition to the exceptions currently in statute, prescribers may now issue a prescription for a controlled substance in a written format, a faxed format, or via oral order if the prescriber:

• Does not have the technological ability to issue a prescription electronically, including the requisite technology; or
• Reasonably determines that it would be impractical for the patient to obtain an electronic prescription in a timely manner, and the delay would adversely affect the patient's medical condition.

Prescription Transfers Between Pharmacies
Pharmacies can now transfer unfilled prescriptions electronically or by facsimile to another pharmacy if the pharmacies do not share a common database, unless otherwise prohibited by federal law. Additionally, pharmacy technicians are also permitted to make these specific transfers.

Technicians May Now Administer the Influenza Immunization
Indiana pharmacy technicians may now administer the Influenza immunization under a drug order, a prescription, or according to a protocol approved by a physician. The new law directs the Indiana Board of Pharmacy (“Board”) to adopt new rules to implement the statute. Those rules must, at a minimum, require the direct supervision of the pharmacy technician by a pharmacist, a physician, a physician assistant, or an advanced practice registered nurse when administering the immunization. The Board will also be required to approve all programs that provide training to pharmacy technicians to administer influenza immunizations. The Board has yet to issue new rules.

Miscellaneous Pharmacy Law Updates
Indiana pharmacies and pharmacists should also be aware of the following additional changes.

• Effective July 1, 2020:
  • No state employee plan, health maintenance organization, insurer, or pharmacy benefits manager may require a pharmacy or pharmacist to collect a higher copayment for a prescription drug from a covered individual than they allow the pharmacy or pharmacist to retain.
  • Pharmacists may prescribe normal saline and sterile water for irrigation for wound care or for injection with a prescription drug or device. Note that previously, pharmacists could only prescribe sterile water for wound care.

The final version of the enrolled bill, amending several sections of the Indiana Code and adding new sections, is available here: House Enrolled Act No. 1207

Indiana Pharmacists Honor Prescription by Out-of-State Physician Assistants and Advanced Practice Nurses
On March 14, 2020, Indiana passed Senate Bill 21, which adds “advanced practice nurses” and “physician assistants” to the list of out-of-state providers from whom pharmacists have the duty of honoring prescriptions. Applicable providers are required to be licensed under the laws of the other state and all other prescription requirements remain the same. The new law provides that pharmacists are still immune from civil liability for denying a prescription, so long as they deny the prescription in good faith because they deem the prescriptions to be contrary to the law, against the best interest of a patient, aiding or abetting an addiction, or contrary to the health or safety of a patient.

Specifically, the law states:

…[a] pharmacist has a duty to honor all prescriptions from a practitioner or from physician, podiatrist, dentist, advanced practice nurse, physician assistant, or veterinarian licensed under the laws of another state. Before honoring a prescription, the pharmacist shall take reasonable steps to determine whether the prescription has been issued in compliance with the laws of the state where it originated. The pharmacist is immune from criminal prosecution or civil liability if he, the pharmacist, in good faith, refuses to honor a prescription because, in his the pharmacist's professional judgment, the honoring of the prescription would:

1. be contrary to law;
2. be against the best interest of the patient;
3. aid or abet an addiction or habit; or
4. be contrary to the health and safety of the patient.

The final version of the enrolled bill is available here: Enrolled Senate Bill 21

Indiana Repeals Law Requiring Prescription for Insulin Products
Indiana recently passed Senate Bill 255 which repealed Ind. Code Ann. § 16-42-19-29, that required an individual to possess a prescription to purchase an insulin drug. Indiana's previous law applied to all insulin products, and included insulin products that were available without a prescription in neighboring states.

In 2014, Indiana passed a law requiring a prescription for all insulin products, including over-the-counter (OTC) insulin products that were available without a prescription in neighboring states. Originally, legislators feared if that if OTC insulin was available, people would obtain products without coordinating with their physician and/or completing important medical evaluations. Since the law passed, opponents have argued that people who are uninsured or underinsured are at greater risk for adverse health effects because they can't afford a doctor’s visit to get a prescription for the insulin products. With this change, Indiana's requirement is more consistent with neighboring states and improves access to the OTC insulin products.

Senate Bill 255 was supported by diabetes organizations, including but not limited to the American Diabetes Association, Children with Diabetes, and the College Diabetes Network, who felt this would greatly improve access to insulin. The law goes into effect on January 1, 2021.

The final version of the enrolled bill can be found here: Enrolled Senate Bill 255

Indiana Passes Law Allowing Physician Assistants and Advanced Practice Nurses to Certify Cause of Death and Sign Death Certificates
On March 18, 2020, the governor signed Indiana House Bill 1392, which allows a physician assistant or advanced practice nurse to certify a cause of death and sign death certificates. The bill is intended to assist grieving families who want to expedite the funeral process for loved ones. 

In addition to allowing a physician assistant or advanced practice nurse to sign the death certificates, the bill requires that there be an advanced practice nurse appointed to Indiana's Board of Nursing, and amends the qualifications for registered nurses and licensed practical nurses on the Board.

Details on the House Bill 1392 are as follows:

• Beginning January 1, 2021, the law allows a physician assistant who: (1) performs under a collaborative agreement that allows the physician assistant to certify the cause of death and submit death records as delegated by the collaborating physician; (2) is last in attendance upon the deceased; and (3) certifies the cause of death of a deceased individual to enter or sign a record on a death into the Indiana Death Registration System (IDRS)
• Beginning January 1, 2021, the law allows an advanced practice nurse who is last in attendance upon the deceased to certify the cause of death of a deceased individual and to enter or sign a record on a death into the IDRS
• Provides that one of the registered nurses appointed to the Indiana State Board of Nursing (Board) must be an advanced practice nurse who has, or has had, prescriptive authority
• Amends the qualifications of registered nurse members and practical nurse members of the Board by requiring that they have practiced within five years immediately preceding their initial appointment to the Board rather than three years

The final enrolled bill can be found here: Enrolled House Bill 1392

In addition to these changes, Indiana also took several actions to grant civil immunity to health care providers who are responding to COVID-19. That change was covered in a previous alert, available here: "Civil Immunity Protections for Health Care Providers Serving to Combat COVID-19"

Controlled Substance Schedule Changes

Through the passing of Senate Enrolled Act No. 194 ("Act 194"), certain changes to Indiana's scheduling of controlled substances went into effect on July 1, 2020. While Indiana's legislature did not remove any drugs from scheduling classifications (or move any into less restrictive schedules from how they were previously scheduled by Indiana), it did add two drugs to its scheduling.

First, Indiana added the novel synthetic stimulant, benzylone (BMDP), to its Schedule I classification (Ind. Code § 35-48-2-4[f]). Benzylone is a synthetic drug that has experienced rapid growth in demand following the US Drug Enforcement Administration's (DEA's) 2019 scheduling of its peer synthetic drug, N-ethylpentylone.

Second, Indiana added the new FDA-approved post-partum depression prescription drug, Zulresso (brexanolone), to its Schedule V classification (Ind. Code § 35-48-2-12[h]). Notably, by adding it as a Schedule V drug, Indiana has taken a less restrictive view of Zulresso than DEA, which classified the drug as Schedule IV (21 CFR § 1308.15 [Docket No. DEA-503]). Registrants must still comply with the DEA scheduling.

Further, Act 194 added a definition for the term "isomer," which has slightly varying definitions when used in relation to hallucinogenic substances and cocaine (Ind. Code § 35-48-1-17.4). Finally, Act 194 contains other changes that, while of little relevance to the prescription drug industry, are nonetheless worth noting, including: (1) a broadening of the definition of "narcotic drugs" to include compounds, mixtures, or preparations containing any opium-related quantities, rather than the previously more narrow reference to "chemically equivalent or identical" compounds, mixtures, or preparations (Ind. Code § 35-48-1-20); (2) a technical correction to schedule "phenazocine" instead of "phenazodine" (Ind. Code § 35-48-2-6[c]); and (3) additions of certain illicit chemical compounds to Indiana's definition of "synthetic drug" (Ind. Code § 35-31.5-2-321).

The final enrolled bill can be found here: Senate Enrolled Act No. 194

Pharmacy Benefit Managers (PBMs)

Pharmacy Benefit Managers, Meet Regulation
In an effort to increase oversight of PBMs, Indiana enactedSB241, which will require all PBMs to obtain licensure from the Indiana Department of Insurance (IDOI) by December 31, 2020 to operate in Indiana, and imposes several audit and other protections for pharmacies. The bill imposes yearly reporting obligations upon PBMs, and it instructs the IDOI commissioner to develop the requirements. It also directs the commissioner to consider requiring disclosure of amounts related to rebates and administrative costs.

SB241 prohibits several practices related to enrollment and reimbursement of pharmacies within PBM networks. For example, pharmacies in Indiana must be allowed to participate in a PBM network if the pharmacy has the licenses required by the Indiana Board of Pharmacy; PBMs are prohibited from requiring any accreditation or credential that is not required by the Indiana Board of Pharmacy. It also prohibits PBMs from reimbursing affiliated pharmacies at a rates that are higher than the reimbursement rates applied to non-affiliated network pharmacies. Affiliated pharmacies are defined, in part, as those owned by the PBM.

Furthermore, it requires PBMs to develop an appeal process for pharmacies to challenge the maximum allowable cost reimbursed for a drug. If the pharmacy prevails, the PBM must reimburse the drug at the increased amount across the entire pharmacy network operating under the same benefit plan as the appealing pharmacy, and allow the same to reverse and resubmit all eligible claims for the increased amount.

The bill also limits the auditing mechanisms for PBMs and demands that PBMs provide a comprehensive review during audits. It prohibits extrapolating overpayment findings; moreover, PBMs must allow pharmacies to recover underpayments, too. Importantly, SB241 limits recovery of overpayments to “recoverable errors” only. While the Bill does not define the term “recoverable error,” this language suggests a move toward preventing overpayment findings for clerical or otherwise minor errors. Application of this language will become clear after the IDOI interprets it through rule and policy.

Lastly, SB241 will allow any contracted pharmacy to demand an audit of its contract once a year. If requested, this will require the PBM to disclose all revenue and fees derived from the pharmacy’s contract with the PBM, which includes all manufacturing rebate amounts secured on prescription drugs.

These are significant changes in the Indiana laws in terms of regulating PBMs as business entities, as well in the relationship between PBMs and Indiana pharmacies. This brings Indiana requirements in line with similar requirements imposed in other states that license and regulate PBM activities. In addition, if pharmacies or PBMs have questions about their obligations during an audit, they will want to consult the new requirements to ensure they are carrying out their roles correctly.

The final enrolled bill can be found here: Senate Enrolled Act No. 241

Insurance

Among other provisions, Indiana aims to limit surprise medical billing with the recently enactedHB1004. The bill regulates out-of-network practitioners and in-network practitioners, provider facilities, and health care carriers to increase price transparency. The law considers whether the above provider types are out-of-network or in-network based upon a covered individual’s insurance coverage. HB1004 first limits the amount that an out-of-network practitioner may charge when operating in an in-network facility. Under this scenario, the law limits the amount of reimbursement that an out-of-network practitioner may receive to the amount that the member would have paid for the same services if the practitioner were in-network unless the practitioner meets the following requirements:

• The practitioner must provide a good-faith estimate of the total charges at least five days before performing the services, which includes the following:

1. A notice explaining that "[Name of practitioner] intends to charge you more for [name or description of health care services] than allowed according to the rate or amount of compensation established by the network plan applying to your coverage. [Name of practitioner] is not entitled to charge this much for [name or description of healthcare services] unless you give your written consent to the charge";

2. A good-faith estimate of the total cost that the practitioner intends to charge; and

3. Include the following notice related to the good faith estimate: "The estimate of our intended charge for [name or description of health care services] set forth in this statement is provided in good faith and is our best estimate of the amount we will charge. If our actual charge for [name or description of health care services] exceeds our estimate, we will explain to you why the charge exceeds the estimate."

• The covered individual must also sign the form to show their consent to the increased charge

For in-network practitioners, provider facilities, and health carriers, HB1004 also requires that each provide a good-faith estimate of the cost of services within five days upon an individual’s request. Examples of the notice requirements include:

• Practitioners
  • Practitioners ordering services for nonemergency care must provide the following notice to the covered individual and also maintain the same in each of their facility waiting rooms and on their websites:
    • “A patient may at any time ask a health care provider for an estimate of the price the health care providers and health facility will charge for providing a nonemergency medical service. The law requires that the estimate be provided within 5 business days."
• Provider facilities
  • Provider facilities must provide the following notice in each of their waiting rooms and on their websites:
    • "A patient may ask for an estimate of the amount the patient will be charged for a nonemergency medical service provided in our facility. The law requires that an estimate be provided within 5 business days."
• Health carriers
  • Health carriers must provide the following notice on their websites:
    • "A covered individual may at any time ask the health carrier for an estimate of the amount the health carrier will pay for or reimburse to a covered individual for nonemergency health care services that have been ordered for the covered individual or the applicable benefit limitations of the ordered nonemergency health care services a covered individual is entitled to receive from the health carrier. The law requires that an estimate be provided within 5 business days."

Provider facilities and health carriers that fail to meet their obligations under HB1004 will be subject to $1,000 civil penalty fine.

The final enrolled bill can be found here: House Enrolled Act No. 1004

For more information on these updates and how they may affect your business, contact your Quarles & Brady attorney or a member of our Indianapolis Health Law Team:

• Katea M. Ravega: (317) 399-2849 / katea.ravega@quarles.com
• Edward L. Holloran, III: (317) 399-2892 / ed.holloran@quarles.com
• Shamika L. Mazyck: (317) 399-2835 / shamika.mazyck@quarles.com
• Ryan L. Torres: (317) 399-2813 / ryan.torres@quarles.com