Options If Coverage Denied by Insurance

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From GI & Hepatology News (3/27/21): Fighting back against payer coverage policies

  • Ask for the credentials of the payer representative who initially denied the request. Even when payer representatives are physicians, they are often not gastroenterologists. Ask to speak with a representative actively practicing gastroenterology.
  • Ask to record your conversation with the payer representative for documentation purposes.Ask to speak directly to the payer’s medical director.
  • Bring the complaint to the payer’s attention on social media. Using social media to bring attention to a denial can sometimes elicit quick, personal outreach from the payer to address the issue.
  • Let the AGA know what’s happening. Reach out to the AGA via the AGA Community, via Twitter, or by emailing Leslie Narramore, the director of regulatory affairs at AGA (lnarramore@gastro.org).
  • File a complaint with the State Insurance Commissioner. State Insurance Commissioners are responsible for regulating the insurance industry in their state and can investigate to ensure the laws in their state are being followed and providers and patients are being treated fairly. While insurance law and regulation are established at the state level, the insurance commissioners are members of the National Association of Insurance Commissioners (NAIC), which allows them to coordinate insurance regulation among the states and territories. Find out your state’s complaint process because many state insurance commissioners have on online complaint forms. Keep records of all interactions with the insurance company to document that you have attempted to resolve the matter with the payer first.
  • File a complaint at the federal level for states without an external review process. If your state doesn’t have an external review process that meets the minimum consumer protection standards, the federal government’s Department of Health & Human Services oversees an external review process for health insurance companies in your state. See www.healthcare.gov/appeal-insurance-company-decision/external-review/ for more information. In states where the federal government oversees the process, insurance companies may choose to participate in an HHS-administered process or contract with independent review organizations. If your plan doesn’t participate in a state or HHS-Administered Federal External Review Process, your health plan must contract with an independent review organization.

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4-14-4 Rule: More Biopsies Needed For Eosinophilic Esophagitis

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Briefly noted: AL Krarup et al. Endoscopy. 2021 Jan;53(1):15-24. doi: 10.1055/a-1206-0852. Implementation of a biopsy protocol to improve detection of esophageal eosinophilia: a Danish registry-based study

In 2011, leaders of regional endoscopy units in Northern Denmark reached a consensus on a protocol to take eight biopsy samples in dysphagia patients (four biopsies from 4 cm and 14 cm above the esophagogastric junction-“4-14-4 rule”) regardless of the macroscopic appearance.

Key finding:  The number of patients with esophageal eosinophilia detected per year increased 50-fold after the protocol was implemented in 2011 (median of 1 [interquartile range 0-3] vs. 52 [47-56]; P < 0.001), and the number of biopsy samples per patient doubled (median 4 [4-5] vs. 8 [6-9]; P < 0.04). In total, there were 309 with esophageal eosinophilia identified from 2007-2017.

My take: This study provides more data that more biopsies help identify more cases of eosinophilic esophagitis.

Related blog posts:

  • Best Approach for Identifying Eosinophilic Esophagitis Prior studies have shown higher yield when taking 5 or 6 biopsies rather than fewer biopsies; thus, the location of biopsies may not be as important as the number of specimens. Also, prior studies have shown that having another pathologist review the slides can increase the yield by ~20%; this indicates that careful review of specimens by itself is helpful.  Perhaps, more specimen containers will increase the time that a pathologist reviews the biopsies.
  • Looking Twice for Eosinophilic Esophagitis

Real-World Experience with Proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

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A recent large retrospective pediatric study provides further evidence that therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) results in better clinical outcomes. One of my partners, Chelly Dykes, is a coauthor and leads our ImproveCareNow team.

JL Lyles et al. Inflamm Bowel Dis 2021; 27: 482-492. Effect of a Practice-wide Anti-TNF Proactive Therapeutic Drug Monitoring Program on Outcomes in Pediatric Patients with Inflammatory Bowel Disease

This single center implemented a practice wide TDM approach in 2014. This study compared a historical pre-TDM group (n=108) to the TDM group (n=206). The primary outcome was sustained clinical remission (SCR22-52), defined as physician global assessment (PGA) of inactive from 22 to 52 weeks and off corticosteroids at 52 weeks. Key findings:

  • The SCR22-52 was achieved in 42% of pre-TDM and 59% of TDM patients (risk difference, 17.6%; 95% CI, 5.4–29%; P = 0.004)
  • The TDM group had an increased adjusted odds of achieving SCR22-52 (odds ratio, 2.03; 95% CI, 1.27–3.26; P = 0.003)
  • The adjusted risk of developing high titer antidrug antibodies (ADAs) was lower in the post-TDM group (hazard ratio, 0.18; 95% CI, 0.09–0.35; P < 0.001)
  • The SCBR22-52 (which was defined by normal CRP along with SCR22-52) was 24.7% in pre-TDM and 42.7% in the TDM group
  • The authors did not identify a significantly higher rate of anti-TNF cessation in either group
  • Only 12% of patients in their practice were receiving combination therapy

In the discussion, the authors review three pivotal studies which also support proactive TDM: TAXIT, TAILORIX, and PAILOT.

My take: While this was an observational study with historical controls, the findings are convincing that proactive TDM is helpful, particularly in patients who are not receiving combination therapy.

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March 31, 2021

Lubiprostone Study: Ineffective for Pediatric Functional Constipation

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MA Benninga et al. DOI:https://doi.org/10.1016/j.cgh.2021.04.005 Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-blind Study With Long-term Extension

Key finding: 606 patients were randomized to treatment (placebo: n=202; lubiprostone: n=404). No statistically significant difference in overall SBM (spontaneous bowel movement) response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245).

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How Sharing Clinical Notes Affects the Patient-Physician Relationship

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When I was in training as a pediatric gastroenterology fellow, one of my mentors relayed a story (perhaps embellished) that a parent had confronted him: “Doctor, I know you are lying to me. You told me my son had Crohn’s disease but the chart said he had TERMINAL ileitis.”

I think many physicians are worried that the mandatory rollout of “open notes” will result in many other questions about documentation that have to be explained. A recent article (R Rubin et al. JAMA. Published online April 7, 2021. doi:10.1001/jama.2021.4755) explains (Full text link) “How Sharing Clinical Notes Affects the Patient-Physician Relationship.”

Key points:

  • In their survey of patients in the Boston, Seattle, and rural Pennsylvania health systems, …among the respondents, 22 947 said they had read at least 1 clinical note and half said they had read at least 4 notes. Only 737 patients said the notes were very confusing.”
    • 11% said they felt judged or offended or both. Those reactions were more common among women and people who reported poor health, unemployment, or inability to work. Among patients’ comments about why they felt judged or offended, the researchers identified 3 main themes: errors and surprises, labeling, and disrespect.
  • Another recent publication based on the patient survey reported that 96% of the patients said they understood all or nearly all of a note they selected from a recent visit…93% agreed or somewhat agreed that the note accurately described the visit, while 6% said something important was missing.
  • One of the researcher’s advice to physicians is to write the note as if the patient were sitting beside them, collaborating.
  • Physicians shouldn’t write anything in the health record that the patient doesn’t already know.
  • Many patients don’t even know that notes are available for them to read.

My take: As noted in the article, office notes have been used mainly for communication between physicians and to support billing. Whether open notes can lead to more engagement of patients and provide health benefits is uncertain. What is certain is that the availability of these notes is going to alter what becomes part of the medical record.

For more information: Link to OpenNotes website:

From OpenNotes website

More advice from OpenNotes website:

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Chicago Classification of J Pouch Outcomes

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S Akiyama et al. Clin Gastroenterol Hepatol 2021; https://doi.org/10.1016/j.cgh.2021.02.010 Endoscopic Phenotype of the J Pouch in Patients With Inflammatory Bowel Disease: A New Classification for Pouch Outcomes

The authors retrospectively reviewed 1359 pouchoscopies and classified them into 7 main pouch phenotypes: (1) normal, (2) afferent limb involvement, (3) inlet involvement, (4) diffuse, (5) focal inflammation of the pouch body, (6) cuffitis, and (7) pouch with fistulas noted 6 months after ileostomy takedown.

Key finding: Diffuse inflammation was associated independently with pouch excision (hazard ratio, 2.69; 95% CI, 1.34–5.41; P = .005).

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Improvement in Liver Fibrosis with DAA Treatment of Hepatitis C in Adolescents

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A recent study showed improvements in measures of liver fibrosis at 12 months after treatment of Hepatitis C in Egyptian adolescents (DM Fahmy et al. J Pediatr 2021; 231: 110-116. Changes in Liver Stiffness and Noninvasive Fibrosis Scores in Egyptian Adolescents Successfully Treated with Ledipasvir-Sofosbuvir for Chronic Hepatitis C Virus Infection).

Methods: N=85. Liver stiffness measurement (LSM), by vibration-controlled transient elastography and noninvasive fibrosis scores (Firbosis-4, aspartate aminotransferase-platelet ratio index), were obtained before and 12 months after eradication with ledipasvir-sofosbuvir.

Key findings:

  • Overall, median baseline LSM was 5.8 (IQR, 4.2-6.5) and at follow-up 5.1 kPa (IQR, 4-6 kPa) (P = .045)
  • 16 patients (19%) experienced regression, and 46 (54%) nonprogression of LSM
  • The median baseline FIB-4 and aspartate aminotransferase-platelet ratio index scores were 0.34 (IQR, 0.22-0.47) and 0.35 (0.24-0.57), and at follow-up 0.3 (IQR, 0.22-0.34) and 0.2 (0.18-2.8) (P < .001, <.001), respectively

Limitations: In Egypt, HCV genotype 4 is predominant; thus, findings could be different with other HCV genotypes. In addition, the ‘gold’ standard in assessing fibrosis remains a liver biopsy.

In many liver conditions, effective therapy has been associated with histologic improvement/regression. So, while the findings in this study are expected, it is still nice to see more evidence of this outcome.

My take: This study supports the notion that elimination of HCV is associated with either regression or non-progression of liver fibrosis. Treatment prior to extensive liver damage is likely both effective and cost-effective.

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Gibbs Gardens, 4/3/21

Early Assessment of Acute Ulcerative Colitis with ACE (Albumin, CRP, & Endoscopy)

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A recent study showed that admission albumin, CRP and early endoscopy were predictive of outcomes with ulcerative colitis patients admitted for a corticosteroids: RK Grant et al. Inflamm Bowel Dis 2021; 27: 451-457. Full text (free) The ACE (Albumin, CRP and Endoscopy) Index in Acute Colitis: A Simple Clinical Index on Admission that Predicts Outcome in Patients With Acute Ulcerative Colitis

This retrospective study had 235 patients (median age 38 years). 90% had endoscopy at a median of 2 days from admission. Key findings:

  • 155 of the 235 patients (66.0%) responded to steroids
  • 78.1% (25 of 32) of patients with concurrent CRP ≥50 mg/L, albumin ≤30 g/L, and increased endoscopic severity (severe on physician’s global assessment) (maximum score = 3) did not respond to IV steroids (positive predictive value [PPV] 78.1%, negative predictive value [NPV] 87.1%).
  • Comparison with Truelove and Witts Score: 56 of 119 (47.1%) of those classed TWS severe did not respond to steroids. Previously TWS score of acute severe ulcerative colitis (ASUC), defined by at least 6 bloody stools per day plus at least 1 marker of systemic disturbance has been associated with a 19% risk of colectomy during admission.

My take: In patients with ulcerative colitis who present with low albumin and high CRP values, early escalation of medical therapy is highly likely; don’t forget to check a PPD or quantiferon Gold assay early on.

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Azalea bush (March 2021)

NY Times: Crohn’s Disease is On the Rise (4/26/21)

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NY Times: Crohn’s Disease Is on the Rise

Some excepts:

Dr. Joseph D. Feuerstein, gastroenterologist at Beth Israel Deaconess Medical Center in Boston… “It’s rising in incidence and prevalence throughout the world,” he said, and gastroenterologists are still trying to figure out why it shows up when it does in different people.

Crohn’s disease was first described in 1932 by Dr. Burrill B. Crohn…

Prompt diagnosis and appropriate therapy to suppress inflammation in the digestive tract are extremely important because a delay can result in scar tissue and strictures that are not reversed by medication…

Crohn’s is not curable and most patients have to stay on medication indefinitely. That can create yet another stumbling block. The biologics are very costly…

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Is A Gastric Emptying Study Helpful in Children?

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A recent prospective study (n=104, median age 12.8) examined the relationship between symptoms in children with dyspepsia and the presence/absence of gastroparesis: L Febo-Rodriguez et al. J Pediatr 2021; 213: 117-123. Meal-Induced Symptoms in Children with Dyspepsia-Relationships to Sex and the Presence of Gastroparesis

The authors hypothesized that the presence of gastroparesis would be associated with increased severity of symptoms in children with dyspepsia. They defined gastroparesis as having at least 10% retention of standardized radiolabeled meal after 4 hrs(2 eggs, 2 pieces of toast, strawberry jam, and 120 mL of water).

Key findings:

  • Bloating was the only symptom significantly worse in youth with gastroparesis (n=52, 50%); other symptoms that were compared included nausea, satiety, chest burning, pain and fullness.
  • In those with gastroparesis, only nausea correlated with retention (4 hours.; rs = 0.275, P < .05).
  • Girls with gastroparesis had significantly worse symptoms (except satiety) when compared with boys with gastroparesis (P < .05).

Key limitation: there are no established normative data in children; data extrapolated from adults suggest having >60% retention at 2 hours and >10% at 4 hours is abnormal; the latter is supported by a large retrospective pediatric study (n=1041, Ng et al. Am J Gastroenterol 2020; 115: 1830-9)

Comment:

  • In clinical practice, a GES rarely helps with clinical management. Prokinetic agents have limited effectiveness and may be used regardless of a GES result. Even in those with abnormal values, the effects of recent infections and malnutrition could contribute to an abnormal study.

My take: It is a little surprising that symptom severity was similar between children with and without abnormal GES. Given the limited clinical impact, most GES studies have limited value.

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