Kentucky adds 3 state rules for clinics and medical practices

These are the Kentucky rules whose wording is about licensed practitioners, boards and clinics. They run when Kentucky is selected in the checker.

1. CG-KYS-001 · Warns · Citation checked against stored text

   Kentucky counts grossly improbable or extravagant statements that tend to deceive the public as unprofessional conduct for a licensed physician. Guaranteed-cure and miracle claims are the usual form. This reaches licensees and the text leaves room for argument, so it is a warning.

   Source: KRS 311.597(2) ("grossly improbable or extravagant statements are made which have a tendency to deceive or defraud the public")

   Safer wording: Say what the treatment involves and who it is for, cite a source for any outcome data, and state that results vary by patient.

   KRS 311.597 · Needs counsel review

2. CG-KYS-002 · Warns · Citation checked against stored text

   Kentucky lists a licensee claiming to cure or treat diseases by a method with little or no therapeutic value as unprofessional conduct. Cure-all claims are the clearest example, because no single treatment cures every disease.

   Source: KRS 311.597(2)(a) ("claims that he can cure or treat diseases, ailments, or infirmities by any method, procedure, treatment, or medicine which the licensee knows or has reason to know has little or no therapeutic value")

   Safer wording: Name the specific condition the treatment is studied for and cite the evidence. Do not suggest it works for everything.

   KRS 311.597 · Needs counsel review

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

   For Medicaid patients Kentucky bars a provider from knowingly making, offering or receiving a payment, rebate of a fee or charge for referring a recipient to another provider, and from taking a kickback. Offers of referral fees in recruiting or partner copy are the ad form of this.

   Source: KRS 205.8461(2)(a) ("shall knowingly make, offer, or receive a payment, a rebate of a fee, or a charge for referring a recipient to another provider")

   Safer wording: Remove payment for referrals from the copy and have counsel review any patient referral reward, especially if Medicaid patients are involved.

   KRS 205.8461 · Needs counsel review

Sample wording we wrote, run through the engine with Kentucky selected. Only samples where a Kentucky rule fires are shown.

109 federal and general rules matched to clinics and medical practices run next to the Kentucky ones. The ones that weigh most:

1. CG-ABS-003 · Blocks approval · Citation checked against stored text

   Claims of no risk or no side effects are unsubstantiated safety claims.

   Source: FTC Act section 5; FTC Health Products Compliance Guidance; 21 CFR 202.1 (prescription drug advertising, fair balance)

   Safer wording: State known risks and side effects fairly, or say who should talk to a clinician first.

   21 CFR 202.1 · Needs counsel review

2. CG-CSR-001 · Blocks approval · Citation checked against stored text

   Prescribing a controlled substance without a real evaluation, records or follow-up violates the Controlled Substances Act and DEA telemedicine rules.

   Source: 21 U.S.C. 829 and 841(h); 21 CFR 1306.04 (prescription issued for a legitimate medical purpose); 21 CFR 1306.05 (manner of issuance, so a prescription must carry the patient and practitioner details); FTC Act section 5

   Safer wording: Do not advertise controlled substances. A licensed clinician must decide whether to prescribe after a real evaluation.

   21 CFR 1306.04, 21 U.S.C. 829, 21 CFR 1306.05 · Needs counsel review

3. CG-DEA-003 · Blocks approval · Citation checked against stored text

   Offering to fill a prescription for a controlled substance based only on an online questionnaire is a listed example of an internet distribution violation.

   Source: 21 U.S.C. 841 subsection (h) lists offering to fill a controlled substance prescription based solely on a consumer's online medical questionnaire as an example of a violation

   Safer wording: Do not tie a controlled substance prescription to a questionnaire alone. Describe a live evaluation by a licensed practitioner who decides if a prescription is appropriate.

   21 U.S.C. 841 · Needs counsel review

4. CG-EFF-014 · Blocks approval · Citation checked against stored text

   Claims of instant, one-visit or universal results, or of working where all else fails, promise outcomes no clinic can substantiate.

   Source: FTC Act section 5; FTC Health Products Compliance Guidance; FTC Endorsement Guides, 16 CFR Part 255

   Safer wording: Remove the promise of speed or certainty. Say what the service is and that results vary.

   16 CFR Part 255 · Needs counsel review

Everything for the industry is on the clinics and medical practices page, and all Kentucky rules for any industry are on the Kentucky page.