Required Coverage Without Cost-Sharing for HIV Pre-Exposure and Post-Exposure Prophylaxis; Applicability to HDHPs

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

(217) 782-4515

Chicago Office

122 S. Michigan Ave., 19th Floor

Chicago, Illinois 60603

(312) 814-2420

Illinois Department of Insurance

JB PRITZKER

Governor

ANN GILLESPIE

Acting Director

TO:

All Health Insurance Issuers Writing Individual or Group Accident and Health Insurance,

Health Maintenance Organization Health Care Plans, and Voluntary Health Services

Plans

FROM:

Ann Gillespie, Acting Director

DATE:

December 4, 2024

RE:

COMPANY BULLETIN 2024-18 - Required Coverage Without Cost-Sharing for HIV

Pre-Exposure and Post-Exposure Prophylaxis; Applicability to HDHPs

This Company Bulletin provides guidance and a reminder that all individual and group policies of

accident and health insurance, HMO health care plans, and voluntary health services plans that are

amended, delivered, issued, or renewed in Illinois on or after January 1, 2024 shall provide coverage for

all drugs approved by the United States Food and Drug Administration for HIV Pre-Exposure

Prophylaxis (PrEP) and Post-Exposure Prophylaxis (PEP). Policies also must cover related follow-up

services including, but not limited to, management of side effects, medication self-management or

adherence counseling, risk reduction strategies, and mental health counseling. This coverage shall

include drugs approved by the United States Food and Drug Administration that are prescribed or ordered

for off-label use for the purposes described in 215 ILCS 5/356z.60.

The statute further prohibits a policy from imposing a deductible, coinsurance, copayment, or any other

cost-sharing requirement on PrEP, PEP, or the related follow-up services provided in statute. 215 ILCS

5/356z.60(d).

A policy or certificate shall not impose any restrictions or delays on coverage for PrEP, PEP, or the related

follow-up services provided in statute. 215 ILCS 5/356z.60(e)

The statute further prohibits a policy from imposing a deductible, coinsurance, copayment, or any other

cost-sharing requirement on PrEP, PEP, or the related follow-up services provided in statute. 215 ILCS

5/356z.60(d).

A policy or certificate shall not impose any restrictions or delays on coverage for PrEP, PEP, or the related

follow-up services provided in statute. 215 ILCS 5/356z.60(e). As a result, prior authorization, step

therapy, waiting periods, and preexisting condition exclusions are prohibited for these items and services.

Section 356z.60 contains a subsection referring to therapeutic equivalent version, but that subsection

only applies to abortifacients. See 215 ILCS 5/356z.60(c). For PrEP, PEP, and hormonal therapy

medication to treat gender dysphoria, all FDA-approved drugs must be included on the formulary for the

health insurance coverage, including all therapeutic equivalent versions.

If the FDA approves new drug therapies for PrEP or PEP in the future, those drugs will be subject to the

coverage requirements of 215 ILCS 5/356z.60 even if they are not included in the general preventive

service mandates under Section 2713 of the Public Health Service Act and 215 ILCS 5/356z.62.

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

(217) 782-4515

2

Chicago Office

122 S. Michigan Ave., 19th Floor

Chicago, Illinois 60603

(312) 814-2420

I. PrEP and PEP as Preventive Care for Health Savings Account (HSA) Eligibility

Section 356z.60, which also applies to coverage for abortifacients and for hormonal therapy medication

to treat gender dysphoria, contains a generic exception from the cost-sharing prohibition to the extent

that such coverage for any of the mandated services under a high-deductible health plan (HDHP) would

disqualify the covered individual from eligibility for an HSA pursuant to Section 223 of the federal

Internal Revenue Code. See 215 ILCS 5/356z.60(d)

ients and for hormonal therapy medication

to treat gender dysphoria, contains a generic exception from the cost-sharing prohibition to the extent

that such coverage for any of the mandated services under a high-deductible health plan (HDHP) would

disqualify the covered individual from eligibility for an HSA pursuant to Section 223 of the federal

Internal Revenue Code. See 215 ILCS 5/356z.60(d). However, PrEP and related follow-up services are

preventive care within the meaning of Section 223 of the Internal Revenue Code, so HDHPs must cover

those services without cost-sharing from the first dollar of coverage.

Section 223 contains a safe harbor that prevents ineligibility for an HSA merely because the covered

individual’s health plan lacks a deductible for “preventive care (within the meaning of section 1861 of

the Social Security Act, except as provided by the Secretary [of the Treasury]).” 26 U.S.C. § 223(c)(2)(C).

As explained in Treasury guidance, the scope of preventive care for Section 223 includes, but is not

limited to, the preventive services covered under Section 2713 of the federal Public Health Service Act.1

Section 2713 of the PHS Act requires coverage of items and services under a Grade A or B

recommendation of the United States Preventive Services Task Force (USPSTF). See 42 U.S.C. § 300gg-

13(a). See also 215 ILCS 5/356z.62(a). The USPSTF published a Grade A recommendation that became

a health insurance coverage requirement for plan years beginning on or after June 11, 2020.2 An update

to the recommendation became effective for plan years beginning on or after August 22, 2024.3 The

current USPSTF recommendation for PrEP applies to:

• Oral tenofovir disoproxil fumarate + emtricitabine

• Oral tenofovir alafenamide + emtricitabine

• Injectable cabotegravir, which also may include a 4-week lead-in of oral cabotegravir to assess

tolerability per CDC guidelines incorporated by the USPSTF recommendation4

• As described in described in joint guidance released by the U.S

The

current USPSTF recommendation for PrEP applies to:

• Oral tenofovir disoproxil fumarate + emtricitabine

• Oral tenofovir alafenamide + emtricitabine

• Injectable cabotegravir, which also may include a 4-week lead-in of oral cabotegravir to assess

tolerability per CDC guidelines incorporated by the USPSTF recommendation4

• As described in described in joint guidance released by the U.S. Departments of Health and

Human Services, Labor, and the Treasury5,6, items or services recommended by the USPSTF

1 Treasury guidance expressly states, “Under this notice, preventive care for purposes of section 223(c)(2)(C) of the Code is

anything that is preventive care under Notice 2004-23 and Notice 2004-50 without regard to whether it would constitute

preventive care for purposes of section 2713 of the PHS Act. Preventive care for purposes of section 223(c)(2)(C) also

includes services required to be provided as preventive health services by a group health plan or a health insurance issuer

offering group or individual health insurance coverage under section 2713 of the PHS Act and regulations and other

administrative guidance issued thereunder.” See “IRS Notice 2013-57”. Internal Revenue Service, U.S. Dep’t of Treasury.

Accessed October 22, 2024. https://www.irs.gov/pub/irs-drop/n-13-57.pdf.

2 “Final Recommendation Statement - Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure

Prophylaxis - June 11, 2019”. United States Preventive Services Task Force. Accessed October 23, 2024.

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hivinfection-pre-exposure-prophylaxis-june-2019.

3 “Final Recommendation Statement - Prevention of Acquisition of HIV: Preexposure Prophylaxis -

August 22, 2023”. United States Preventive Services Task Force. Accessed on October 23, 2024.

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hivinfection-pre-exposure-prophylaxis

cy-virus-hivinfection-pre-exposure-prophylaxis-june-2019.

3 “Final Recommendation Statement - Prevention of Acquisition of HIV: Preexposure Prophylaxis -

August 22, 2023”. United States Preventive Services Task Force. Accessed on October 23, 2024.

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/prevention-of-human-immunodeficiency-virus-hivinfection-pre-exposure-prophylaxis.

4 “Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update: A Clinical Practice

Guideline”. Centers for Disease Control and Prevention, U.S. Public Health Service. Accessed October 22, 2024.

https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf.

5 “FAQs About Affordable Care Act Implementation Part 47”. U.S. Dep’t of Labor; U.S. Dep’t of Health and Human

Services; U.S. Dep’t of Treasury. Accessed October 22, 2024. https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/ouractivities/resource-center/faqs/aca-part-47.pdf

6 “FAQs About Affordable Care Act and Women’s Health and Cancer Rights Act Implementation Part 68”. U.S. Dep’t of

Labor; U.S. Dep’t of Health and Human Services; U.S. Dep’t of Treasury. Accessed October 22, 2024.

https://www.cms.gov/files/document/faqs-implementation-part-68.pdf.

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

(217) 782-4515

3

Chicago Office

122 S. Michigan Ave., 19th Floor

Chicago, Illinois 60603

Cancer Rights Act Implementation Part 68”. U.S. Dep’t of

Labor; U.S. Dep’t of Health and Human Services; U.S. Dep’t of Treasury. Accessed October 22, 2024.

https://www.cms.gov/files/document/faqs-implementation-part-68.pdf.

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

(217) 782-4515

3

Chicago Office

122 S. Michigan Ave., 19th Floor

Chicago, Illinois 60603

(312) 814-2420

that:

o a covered individual should receive before being prescribed PrEP; or

o serve

as

ongoing

follow-up

and

monitoring,

including

medication

selfmanagement/adherence counseling, risk reduction strategies, and mental health

counseling.

Unlike the Illinois mandate at 215 ILCS 5/356z.60, the USPSTF PrEP recommendation does not also

apply to PEP. However, if a PEP encounter results in a covered individual being placed on PrEP, the

USPSTF PrEP recommendation will take over for determining preventive status of services that fall

within the scope of that recommendation.

Additionally, some of the PEP-related services other than the drugs, themselves, independently are

“preventive care” under Treasury guidance implementing 26 U.S.C. § 223(c)(2)(C).

Currently, CDC guidelines identify two PEP regimens7:

• Tenofovir disoproxil fumarate + emtricitabine + raltegravir / dolutegravir

• Tenofovir disoproxil fumarate + emtricitabine + darunavir + ritonavir

CDC guidelines8 recommend other health care services integral to an initial PEP evaluation, such as9:

• Screenings for HIV

• Where indicated, screenings for HBV, HCV, other sexually transmitted infections, pregnancy,10

and chemistries11

• Patient education about regimen-specific side effects and adverse events

• Patient counseling about medication adherence

• Prophylaxis for STIs and HBV infection, if indicated

• Patient counseling related to HIV prevention strategies, if indicated

CDC guidelines12 also recommend follow-up evaluations for persons prescribed PEP, such as:

• HIV and other indicated laboratory testing

• Changes

atient education about regimen-specific side effects and adverse events

• Patient counseling about medication adherence

• Prophylaxis for STIs and HBV infection, if indicated

• Patient counseling related to HIV prevention strategies, if indicated

CDC guidelines12 also recommend follow-up evaluations for persons prescribed PEP, such as:

• HIV and other indicated laboratory testing

• Changes to PEP regimen if indicated by side effects or results of initial testing

• Additional counseling and support for medication adherence and HIV prevention, if indicated

IRS Notice 2004-23 states that screening services are preventive care under Section 223 of the Internal

Revenue Code, and it contains a non-exhaustive list of such screening services.13 All screenings for STIs

in the CDC guidelines for PEP appear on the non-exhaustive list in IRS Notice 2004-23.

The CDC guidelines recommend prophylaxis for STIs and Hepatitis B infection for adults and

adolescents with exposures by sexual assault. In some instances, such prophylaxis may independently

fall under a current USPSTF Grade A or B, HRSA, or ACIP recommendation within the scope of Section

7 Id.

8 “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other

Nonoccupational Exposure to HIV - United States, 2016”. Centers for Disease Control and Prevention, U.S. Dep’t of Health

and Human Services. Accessed on October 22, 2024. https://stacks.cdc.gov/view/cdc/38856.

9 Omitted here are non-health care services and services rendered once the patient moves off PEP because they test positive.

10 Id. (“Health care providers should be aware that certain medications are contraindicated for use as nPEP among potentially

or actually pregnant women as follows…”).

11 Id. (“Laboratory testing is required to…(3) identify any conditions that would affect the nPEP medication regimen, and

non-health care services and services rendered once the patient moves off PEP because they test positive.

10 Id. (“Health care providers should be aware that certain medications are contraindicated for use as nPEP among potentially

or actually pregnant women as follows…”).

11 Id. (“Laboratory testing is required to…(3) identify any conditions that would affect the nPEP medication regimen, and

(4) monitor for safety or toxicities related to the regimen prescribed…”).

12 Id.

13 “IRS Notice 2004-23”. Internal Revenue Service, U.S. Dep’t of Treasury. Accessed October 22, 2024.

https://www.irs.gov/pub/irs-drop/n-04-23.pdf.

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

(217) 782-4515

4

Chicago Office

122 S. Michigan Ave., 19th Floor

Chicago, Illinois 60603

(312) 814-2420

2713 of the Public Health Service Act. In those instances, the STI or Hepatitis B prophylaxis must be

covered without cost-sharing even though the PEP prescription, itself, does not fall under Section 2713.

Additionally, for some patients who have a PEP encounter, the CDC’s recommended counseling services

may independently fall under one of the USPSTF Grade A and B and HRSA recommended preventive

services.14,15,16 In those instances, the counseling must be covered without cost-sharing even though the

PEP prescription, itself, does not fall under Section 2713 of the Public Health Service Act.

Therefore, PrEP and related follow-up services, as well as some services arising from a PEP encounter,

are preventive care within the meaning of 26 U.S.C. § 223 either directly under Treasury guidance or

indirectly under Section 2713 of the Public Health Service Act. Preventive care is not subject to any

Illinois exemption for HDHPs related to cost-sharing

3 of the Public Health Service Act.

Therefore, PrEP and related follow-up services, as well as some services arising from a PEP encounter,

are preventive care within the meaning of 26 U.S.C. § 223 either directly under Treasury guidance or

indirectly under Section 2713 of the Public Health Service Act. Preventive care is not subject to any

Illinois exemption for HDHPs related to cost-sharing.

For PPO and Point-of-Service plans that provide out-of-network benefits, this further means that the

Illinois requirement to “apply any third-party payments, financial assistance, discount, product vouchers,

or any other reduction in out-of-pocket expenses made by or on behalf of such insured for prescription

drugs toward a covered individual's deductible, copay, or cost-sharing responsibility or out-of-pocket

maximum” applies from the first dollar of coverage when PrEP medication is furnished by an out-ofnetwork pharmacy provider, even for HDHPs. See 215 ILCS 134/30(d).

This bulletin updates the Department’s comprehensive guidance in Company Bulletin 2022-06 about

HDHP-related exemptions.

II. Billing and Coding for PrEP, PEP, and Integral Services

On October 21, 2024, the federal government released updated guidance on coverage for PrEP without

cost-sharing under Section 2713 of the Public Health Service Act.17 This federal guidance applies in

Illinois except when Illinois law establishes more stringent coverage requirements. Notwithstanding the

federal guidance related to medical management for PrEP, Illinois law prohibits issuers from imposing

prior authorization requirements for PrEP, PEP, and related services under 215 ILCS 5/356z.60(e).

Billing and coding practices may help or hinder accurate, timely coverage determinations for claims

related to PrEP, PEP, and follow-up services under 215 ILCS 5/356z.60

nts. Notwithstanding the

federal guidance related to medical management for PrEP, Illinois law prohibits issuers from imposing

prior authorization requirements for PrEP, PEP, and related services under 215 ILCS 5/356z.60(e).

Billing and coding practices may help or hinder accurate, timely coverage determinations for claims

related to PrEP, PEP, and follow-up services under 215 ILCS 5/356z.60. To prevent the application of

cost-sharing to these services or the application of copay accumulators under circumstances not allowed

by Illinois law, I encourage issuers to disseminate standardized provider reimbursement guidelines. To

the extent that any claims adjudication responsibility is delegated to a third party, including, but not

limited to, a pharmacy benefit manager, third party administrator, third party prescription program

administrator, or preferred provider program administrator, I encourage issuers to work with these

delegates to disseminate standardized provider reimbursement guidelines.

14 E.g., “Final Recommendation Statement - Sexually Transmitted Infections: Behavioral Counseling - August 18, 2020”.

United States Preventive Services Task Force. Accessed October 23, 2024.

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/sexually-transmitted-infections-behavioralcounseling.

15 E.g.,“Final Recommendation Statement - Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral

Counseling Interventions -November 13, 2018”. United States Preventive Services Task Force. Accessed October 24, 2024.

https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adultsscreening-and-behavioral-counseling-interventions.

16 E.g., “Women’s Preventive Service Guidelines”. Health Resources and Services Administration. Accessed October 24,

2024. https://www.hrsa.gov/womens-guidelines.

17 See Footnote 6, supra.

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

force.org/uspstf/recommendation/unhealthy-alcohol-use-in-adolescents-and-adultsscreening-and-behavioral-counseling-interventions.

16 E.g., “Women’s Preventive Service Guidelines”. Health Resources and Services Administration. Accessed October 24,

2024. https://www.hrsa.gov/womens-guidelines.

17 See Footnote 6, supra.

Springfield Office

320 W. Washington Street

Springfield, Illinois 62767

(217) 782-4515

5

Chicago Office

122 S. Michigan Ave., 19th Floor

Chicago, Illinois 60603

(312) 814-2420

As mentioned in the October 21, 2024 federal guidance on PrEP, “the recently added ICD-10-CM code

Z29.81 [Encounter for HIV pre-exposure prophylaxis]…can be used both to denote that an item or

service that was billed as part of a recommended preventive item or service and to identify the furnishing

of the recommended preventive item or service itself.”18

Additionally, the CPT coding system “established modifier 33 in 2010 to provide a standardized means

to communicate that an item or service was furnished as a recommended preventive item or service under

PHS Act section 2713(a).” The modifier “should be used when the primary purpose of the service is the

delivery of an evidence-based service in accordance with the guidelines provided by one of the ACA-

designated organizations…[or] to communicate that an item or service was integral to the furnishing of

a recommended preventive item or service.”19

Any standardized reimbursement guidelines should provide that PrEP encounters and integral services

must be billed with ICD-10 diagnosis code Z29.81 in the primary position.20 Issuers may also incorporate

CPT modifier 33 consistent with ICD-10-CM coding guidelines. PrEP reimbursement policies should

not require any other diagnosis codes, including but not limited to, Z20.6, Z72.51, Z72.52, or Z72.53.

Similarly, for PEP encounters and integral services, ICD-10-CM contains diagnosis code Z20.6 [Contact

with and (suspected) exposure to human immunodeficiency virus [HIV]]

ers may also incorporate

CPT modifier 33 consistent with ICD-10-CM coding guidelines. PrEP reimbursement policies should

not require any other diagnosis codes, including but not limited to, Z20.6, Z72.51, Z72.52, or Z72.53.

Similarly, for PEP encounters and integral services, ICD-10-CM contains diagnosis code Z20.6 [Contact

with and (suspected) exposure to human immunodeficiency virus [HIV]]. The ICD-10-CM distinguishes

this code from Z21 [Asymptomatic human immunodeficiency virus [HIV]] and B20 [Human

immunodeficiency virus [HIV] disease]. This distinction between A) actual or suspected exposure to HIV

versus B) asymptomatic or other confirmed HIV aligns with the CDC recommendation that PEP be

provided when there is actual or suspected exposure but no positive HIV test result.

Any standardized reimbursement guidelines should provide that PEP encounters and integral services

must be billed to include diagnosis code Z20.6 but not Z21 or B20. The Department declines to make

specific recommendations at this time about other diagnosis codes, but I encourage issuers to consult

guidance from authoritative specialized sources, such as the National Association of State and Territorial

AIDS Directors. Because PEP is not an ACA preventive service, CPT modifier 33 should not be used

for PEP-related encounters unless they also fall under a USPSTF Grade A or B, HRSA, or ACIP

recommendation. For PEP (or PrEP) encounters that split a session between preventive and nonpreventive services, such as a counseling appointment when some time is spent on HIV or STI prevention

and other time is spent only on treating the underlying condition, please consult authoritative guidance.

For questions regarding this Company Bulletin, please direct inquiries to DOI.InfoDesk@Illinois.gov.

18 Id.

19 Id.

20 For fuller discussion of this recommendation: “Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), and

Other HIV Prevention Strategies: Billing and Coding Guide”. October 2023

only on treating the underlying condition, please consult authoritative guidance.

For questions regarding this Company Bulletin, please direct inquiries to DOI.InfoDesk@Illinois.gov.

18 Id.

19 Id.

20 For fuller discussion of this recommendation: “Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), and

Other HIV Prevention Strategies: Billing and Coding Guide”. October 2023. National Alliance of State and Territorial AIDS

Directors. Accessed on October 23, 2024. https://nastad.org/sites/default/files/2023-10/PDF-HIV-Prevention-

BillingAndCoding-101223.pdf.