Illinois adds 3 state rules for clinical research recruitment

These are the Illinois rules whose wording is about trial ads, participant payment and benefit claims. They run when Illinois is selected in the checker.

1. CG-ILL-002 · Warns · Citation checked against stored text

   Illinois lists solicitation of professional patronage by agents or other persons, and profiting from people who present themselves as a physician's agents, as grounds for discipline. Copy that advertises agents hired to solicit patients points to that. The rule applies to licensees, so this is a warning.

   Source: 225 ILCS 60/22 (A)(24), solicitation of professional patronage by agents or other persons is grounds for discipline

   Safer wording: Take out references to paid patient recruiters or agents. Advertise the practice directly and have counsel review any third-party marketing arrangement.

   225 ILCS 60/22 · Needs counsel review

2. CG-ILL-003 · Warns · Citation checked against stored text

   Illinois bars a physician licensee from dividing, sharing or splitting a professional fee with anyone in exchange for a referral. Breaking that bar is also grounds for discipline. Fee-split and referral-fee offers in recruiting or partner copy fall inside it.

   Source: 225 ILCS 60/22.2 (a), a licensee may not divide or split a professional fee for a referral, and 225 ILCS 60/22 (A)(14)

   Safer wording: Remove fee-sharing and referral-fee offers from the copy. Have counsel review any payment to a referral source.

   225 ILCS 60/22, 225 ILCS 60/22.2 · Needs counsel review

3. CG-ILL-004 · Warns · Citation checked against stored text

   Illinois bars a physician licensee from paying a percentage of professional fees, revenues or profits to anyone for marketing or management of the practice, a preferred provider list, a provider network, fee negotiation, or a patient incentive program. Recruiting copy that offers a percentage-of-revenue marketing deal runs into that.

   Source: 225 ILCS 60/22.2 (f), no percentage of fees, revenues or profits may be paid for marketing, management, network or preferred-provider access

   Safer wording: Offer marketing and management services for a flat fee set in advance. Have counsel confirm any arrangement that pays a percentage.

   225 ILCS 60/22, 225 ILCS 60/22.2 · Needs counsel review

None of our sample wording triggers a Illinois rule, so no example is shown. The rules above are still part of the set.

45 federal and general rules matched to clinical research recruitment run next to the Illinois ones. The ones that weigh most:

1. CG-MED-009 · Blocks approval · Citation checked against stored text

   Medicare marketing that offers free gifts for a Medicare number, claims a plan covers everything, urges action in hours, or switches a plan without consent violates CMS marketing and telemarketing rules.

   Source: 42 CFR 422.2263 (Medicare Advantage marketing); 42 CFR 422.2264 (permitted contact); Telemarketing Sales Rule, 16 CFR Part 310

   Safer wording: Do not use urgency, free-gift offers or coverage absolutes. Never take a Medicare number to enroll or switch without a documented request, and use the CMS required disclaimers.

   42 CFR 422.2263, 42 CFR 422.2264, 16 CFR Part 310 · Needs counsel review

2. CG-OIG-101 · Blocks approval · Citation checked against stored text

   OIG warns that a Medicare Advantage plan paying doctors or their office staff, in gift cards or in kind, to refer or recommend patients for enrollment can violate the federal anti-kickback statute and steer people into plans that do not fit them. CMS also bars a provider acting for a plan from accepting compensation for marketing or enrollment. Applies to plan sponsors, agents and providers.

   Source: OIG Special Fraud Alert (December 2024) on suspect payments in marketing arrangements related to Medicare Advantage and providers, part II; 42 CFR 422.2266(d)(1)(ix); 42 U.S.C. 1320a-7b

   Safer wording: Do not pay or reward providers or their staff for recommending a plan or for enrollments. Describe plans on their merits and tell people they can compare plans at medicare.gov.

   42 CFR 422.2266, 42 CFR 422.2266(d)(1)(ix), 42 U.S.C. 1320a-7b · Needs counsel review

3. CG-OIG-102 · Blocks approval · Citation checked against stored text

   OIG warns about payments from health care professionals to agents and brokers to recommend or refer Medicare Advantage enrollees to the professional, for example to be named an enrollee's primary care provider. Enrollees often do not know about the payment. DOJ settled with Oak Street Health for $60 million over allegations it paid agents about $200 per referred beneficiary. Applies to providers, agents and brokers.

   Source: OIG Special Fraud Alert (December 2024) on suspect payments in marketing arrangements related to Medicare Advantage and providers, part III; 42 U.S.C. 1320a-7b(b); DOJ Oak Street Health settlement (September 18, 2024)

   Safer wording: Do not pay agents or brokers per referral, per enrollee or per patient steered to your practice. If you use an agent, pay only compensation that CMS rules and counsel have cleared, and never tie it to which provider the enrollee picks.

   Oak Street Health settlement, 42 U.S.C. 1320a-7b · Needs counsel review

4. CG-REG-052 · Blocks approval · Citation checked against stored text

   A product labeled "for research use only" but sold with dosing guides, stacks or shipping to consumers is a drug marketed for human use. FDA reads intended use from the circumstances of sale, not from the label disclaimer. Most of these peptides are not approved for any use, and several are on FDA's list of bulk substances that raise safety concerns for compounding.

   Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use is shown by the circumstances of sale); FDA bulk drug substances guidance for compounding (503A); FTC Act section 5

   Safer wording: Do not sell or describe unapproved peptides for human use. If a peptide is a prescription drug that a licensed pharmacy compounds for a patient with a prescription, say that, and make no performance claims.

   21 CFR 201.128 · Needs counsel review

Everything for the industry is on the clinical research recruitment page, and all Illinois rules for any industry are on the Illinois page.