Case IV — Active
Katelynn K.
Allentown, Pennsylvania · Highmark · Pennsylvania Act 146 Violation
This case is ongoing. The appeal and regulatory escalation documented here are active. This case is presented because it demonstrates the Clinical Integrity Amendment § 2 violation happening in real time — not as a closed record, but as a reason the law needs to change before more families have to write these letters.
The Story
Katelynn K., 32, was prescribed Zepbound (tirzepatide) by Dr. Nicole Sully, DO — a board-certified physician specializing in bariatric medicine at LVPG Bariatric Medicine who treats adult patients exclusively for obesity and weight-related metabolic conditions. The medication was working. Dr. Sully's clinical notes documented it clearly: weight loss, neuropathy improving, sleep improving, metabolic markers moving in the right direction.
Highmark denied it. Then denied it again. Then again, with new reasons each time. The physician Highmark used to override Dr. Sully's recommendation was a pediatrician.
The Blood Work — It Was Working
Dr. Sully's records document measurable, objective metabolic improvement while Katelynn was on Zepbound:
While on Zepbound — October 2025
- Weight: 6.5% loss
- Neuropathy: "Her neuropathy is feeling much better!!"
- Sleep: Improved to 7–8 hours restful sleep
- Dr. Sully's assessment: "Patient is making great progress!"
- HbA1c: Reduced from 5.5% toward 5.1% — moving away from prediabetes threshold
Five Weeks After Forced Cessation — November 2025
- Weight: 8lbs regained like most patients in medication abrupt cessation- in one month, erasing half of all treatment progress
- "Her mood has been worse"
- "The pain in her legs/back has returned (this resolved when on Zepbound)" A documented benefit that has been remarked about in medical literature and is not just anecdotal.
- "Her hunger is intense and she is craving sweets"
- Forced onto Bupropion/Naltrexone — an inferior medication with known cardiovascular risks
This deterioration is not speculative. It is documented, measurable, and directly attributable to Highmark's denial. Every day the denial continues, the metabolic disease progresses and the risk of developing Type 2 Diabetes increases. The whole reason for starting treatment.
The Pediatrician Problem — § 2 in Real Life
Highmark's denial letter stated the reviewing physician was "a medical director who specializes in Pediatrics with special training and experience."
Katelynn is a 32-year-old adult woman. Zepbound is FDA-approved for chronic weight management in adults. Dr. Sully is a board-certified bariatric specialist who treats adult obesity patients daily. The reviewing physician is a pediatrician whose clinical practice centers on treating children.
Pennsylvania Act 146 — the state law that the Clinical Integrity Amendment codifies at the federal level — requires reviewing physicians to hold board certification in the same or directly relevant specialty as the treating physician. A pediatrician reviewing an adult bariatric medicine case does not meet this standard. If that pediatrician were to directly treat Katelynn for obesity, they would be practicing outside their scope of practice. Yet Highmark permitted them to override the specialist who is qualified to treat her.
"Would Highmark permit a pediatrician to override an oncologist's chemotherapy recommendations? A cardiologist's stent placement decision? Of course not. Yet they have done exactly that here."
— Michael & Katelynn Kissling, Formal Appeal to Highmark, December 9, 2025
The Moving Goalposts — Five Denials, Five Different Reasons
Initial denial — blank reason. No rationale provided. A procedural defect that alone warrants reversal.
Detailed physician denial — cites a 7.5% weight loss threshold and 6 months of documented lifestyle changes "prior to initiation." Katelynn had already achieved 6.5% weight loss — exceeding the evidence-based 5% clinical significance threshold. FDA does not require pre-treatment weight loss before prescribing Zepbound. Highmark's 7.5% threshold is not supported by any medical literature, clinical guideline, or peer-reviewed evidence. They have never provided a citation for it.
Saxenda denial — the "preferred alternative" Highmark steered her toward — using the identical arbitrary 7.5% threshold. The alternative pathway was an illusion.
False claim that internal appeals weren't exhausted — obstructing access to the Independent Review Entity.
New requirements never previously mentioned: OSA severity documentation, organ dysfunction evidence, dietary plans for continuation — despite the fact that all of this documentation had already been submitted, and despite the fact that Katelynn was already on the treatment when the denial began. Each time evidence is provided, Highmark shifts the rationale or adds new requirements.
The Arbitrary Threshold — Where Did 7.5% Come From?
Highmark's repeated denial rationale is that Katelynn failed to achieve 7.5% weight loss. She achieved 6.5% — losing 16 pounds from 243 lbs to 227 lbs. Highmark has never provided a single medical citation, clinical guideline, or peer-reviewed study supporting 7.5% as a meaningful threshold. Here is what the actual regulatory and medical record says:
FDA Drug Approval Standard
The FDA's guidance for approving obesity medications — both the 2007 guidance and the current draft guidance — requires that a drug demonstrate at least 5% decrease in body weight versus the control group after one year of treatment to be deemed effective. This is the federal standard the FDA itself uses to evaluate whether an anti-obesity medication works. Katelynn achieved 6.5% — 30% above the FDA's own efficacy threshold.
FDA Guidance: Obesity and Overweight — Developing Drugs and Biological Products for Weight Reduction →The FDA's Own Clinical Trial Endpoint for Zepbound
The SURMOUNT-1 phase 3 trial — the clinical trial on which the FDA based Zepbound's approval — used "weight reduction of 5% or more" as one of its two co-primary endpoints. In that trial, 85–91% of patients on Zepbound achieved ≥5% weight loss. The FDA approved the drug based on this threshold. Highmark's 7.5% threshold is more restrictive than the standard the FDA used to approve the medication they're denying.
HCPLive — FDA Approves Tirzepatide (Zepbound), SURMOUNT trial endpoints →Peer-Reviewed Medical Literature
Multiple peer-reviewed studies confirm the 5% threshold as clinically significant. A review published in Current Obesity Reports states: weight loss of ≥5% results in significant improvements in cardiometabolic risk factors — and this degree of weight loss is also required for the approval of novel anti-obesity medications by the FDA. The same threshold appears in the ACC/AHA/TOS and AACE/ACE clinical practice guidelines as the standard for evaluating treatment response.
Peer review: "What is clinically relevant weight loss?" — Taylor & Francis →Dr. Sully's Own Clinical Protocol
Katelynn's treating physician, Dr. Nicole Sully, documented in her October 3, 2025 treatment notes: "5–10% reduction in body weight is clinically significant and beneficial for overall health." This reflects the established medical consensus. The board-certified bariatric specialist treating the patient confirmed the evidence-based threshold. The pediatrician reviewing the case applied one that is 50% higher — without citation.
The bottom line: Highmark created a threshold — 7.5% — that is more restrictive than the FDA's drug approval standard, more restrictive than the clinical trial endpoints used to approve Zepbound, more restrictive than ACC/AHA/TOS and AACE/ACE clinical practice guidelines, and directly contradicted by the documented opinion of the treating specialist. They have never provided a citation for it. It is not a medical standard. It is an insurance-administrative standard invented to deny coverage of a medication the federal government has already determined is safe and effective — at a lower threshold than the one Highmark invented.
What This Case Means for the Amendment
The Clinical Integrity Amendment § 2 — the Act 146 Standard — was drafted in direct response to the UHC prosthetic denial documented in Case III. But the Highmark case proves the problem is not one insurer. It is not one drug. It is not one state. The mechanism is identical:
- A specialist physician recommends a treatment that is working
- An insurer assigns a reviewer outside that specialty to override the recommendation
- The patient deteriorates while the appeals process functions as a delay weapon
- The rationale shifts each time evidence is provided
Pennsylvania Act 146 already prohibits this. The Clinical Integrity Amendment would prohibit it federally. The case for the Amendment does not rest on one family's experience. It rests on the fact that two different families, two different insurers, two different states, and two different medical specialties produced the same documented mechanism — in the same household.
Case Status
Formal appeal submitted December 9, 2025. Case escalated to the Independent Review Entity, Pennsylvania Insurance Department, U.S. Department of Labor EBSA, and Patient Advocate Foundation. The complete appeal documentation — including Dr. Sully's clinical notes, the blood work timeline, and the full record of shifting denial rationales — has been submitted to regulatory bodies and is available to journalists, legislative staff, and legal counsel upon request.
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