IBD Pediatric Costs & Cannabis Still No Data for IBD

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Happy birthday to my favorite follower!!!

A recent single-center study (AW Fondell et al. Inflamm Bowel Dis 2020; 26: 635-40, editorial by Joel Rosh, 641-2) examined the first-year costs of children with inflammatory bowel disease (IBD) in 2016.  There were 67 patients (43 with Crohn’s disease (CD), and 24 with ulcerative colitis (UC)).

Key findings:

  • Mean cost was $45,753; $43,095 for CD, $50,516 for UC
  • Severe CD (n=11) was $71,176 and severe UC (n=5) was $134,178; it is notable that only one patient with CD had surgery and only one patient with UC had surgery.
  • Overall cost distribution: 37% from infusion costs, 25% hospital costs, 18% outpatient procedures, 10% outpatient oral medications, 7% outpatient imaging and 3% outpatient visits.
  • 69% of CD patients and 33% of UC patients received biologics
  • 21% (n=9) of CD patients and 45% (n=11) of UC patients were hospitalized
  • Private payer reimbursement was a mean of $51,269 compared to $24,610 mean for Medicaid.

Limitations: 

  • In any cost analysis, many assumptions are needed.  For medications, for example, the author used pharmaceutical retail prices.  The actual costs are near-impossible to calculate as every insurance policy and every hospital system has a multitude of charges based on proprietary negotiations.
  • While this data comes from a referral center, all of the patients in the study were from Connecticut.

Due to the expense of care, Dr. Rosh points out that many insurers have often mandated the use of “standard dosing” of biologic therapy, “ignoring that robust data” indicate that this dosing is “the exception rather than the rule in pediatric IBD patients.”  These type of short-sighted interventions could affect long-term medical outcomes.

My take: There clearly are areas where costs can be reduced (eg. lower infusion costs, lower endoscopy costs, biosimilars).  However, no amount of cost cutting will change the conclusion that good care for IBD is expensive.

Briefly noted: TS Kafil et al. Inflamm Bowel Dis 2020; 26: 502-9.   This study examined evidence for cannabis effectiveness in IBD.  After performing a literature search, the authors could only identify five randomized controlled trials (n=185).  Each study used different doses, formulations and routes of administration.  No studies evaluated maintenance treatment and relapse in CD or UC.  Findings: “no firm conclusions can be made regarding the safety and effectiveness of cannabis and cannabionoids in adults with CD and UC.”

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Cobb County -Concord Covered Bridge Historic District

 

NY Times: Why Georgia Isn’t Ready, You Shouldn’t Drink Disinfectants/Bleach, Masks Help

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Correction: Today’s earlier blog post has been updated:

  • For >1000 [calprotectin], the sensitivity 38%, specificity 100%, PPV 98%, and NPV 92%
  • Previously this line started with the following: “For >100”

From NY Times: Why Georgia Isn’t Ready to Reopen

Key points:

  • Georgia’s infection rates have not started to decline
  • Georgia has a low testing rate compared to other states
  • Georgia’s population rate is vulnerable with increased rates of diabetes and the 4th highest rates of uninsured individuals

Narrowing the Workup for Chronic Abdominal Pain –Carlo DiLorenzo Was Right!

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In the good old days when we could have large meetings, Carlo DiLorenzo gave a terrific summary of recurrent abdominal pain (#NASPGHAN19 Postgraduate Course -part 3).  One of the slides, shown below, is supported by a new study (J Zeevenhooven et al. J Pediatr 2020; 219: 76-82)

In this recent reterospective study, the authors examined 853 patients, of whom 102 (12%) had an organic disorder; all had abdominal pain >2 months. The authors compared two diagnostic strategies:

  • Group 1: anti-TTG IgA, fecal calprotectin, Giardia, along with blood tests (hemoglobin, CRP, ESR)
  • Group 2: anti-TTG IgA, fecal calprotectin, and Giardia (if diarrhea)

Calprotectin was considered normal if <50 mcg/g,  “gray zone” if 51-250, mildly elevated if 251-1000, and elevated/active inflammation if >1000.

Key findings:

  • Sensitivity of the strategies was 90% and 88% for Group 1 and Group 2 respectively
  • In the presence of 1 or more alarm symptoms, the sensitivity was 92% for both strategies.
  • The sensitivity/specificity of calprotectin varied based on the cutoff value.
    • For >50, the sensitivity 75%, specificity 87%, PPV 44%, and NPV 96%
    • For >250, the sensitivity 48%, specificity 99%, PPV 82%, and NPV 93%
    • For >1000, the sensitivity 38%, specificity 100%, PPV 98%, and NPV 92%

Alarm symptoms

  • Alarm symptoms that were statistically different in the organic group included the following:
    • Chronic diarrhea (P <.001), occurred in 32% organic compared to 6% functional
    • GI blood loss (P <.001) , occurred in 35% organic compared to 5% functional
    • Recurrent vomiting (P=.029), occurred in 10% organic compared to 5% functional
    • Perianal complications (P=.001), occurred in 6% organic compared to 1% functional
    • Impaired growth (P=.023), occurred in 4% organic compared to 1% functional
  • Interestingly, the study found that having a positive family history of IBD/celiac/FMF did not differentiate functional and organic patients, occuring in 12% and 15% respectively.
  • Pain in RUQ or lower region also did not differentiate functional and organic patients, occuring in 3% and 4% respectively.
  • The authors note that 30 (29%) patients with organic disease did not have an identified alarm symptom -this compares to 479 (64%) patients with functional disease did not have an identified alarm symptom

From my experience with our recent study (Digestive Diseases (Full Text): Diagnostic Yield Variation with Colonoscopy among Pediatric Endoscopists) which focused on diagnostic yield with colonoscopy, it is clear that there are significant limitations with data collection in a retrospective study regarding recurrent abdominal pain.  Even the definition of chronic diarrhea may vary considerably among practitioners.  At the same time, we did find that an abnormal calprotectin had the highest diagnostic yield (See related blog post for summary: Our Study: Provider Level Variability in Colonoscopy Yield)

It is surprising to me that only 10 patients (1%) in their cohort were identified as having impaired growth.

My take: This study shows that anti-TTG testing and calprotectin are the most useful tests in children with persistent abdominal pain.  The addition of hemoglobin, CRP, and ESR “can be left out in the clinical evaluation of chronic abdominal pain in children.”  The authors advocate, as well, for a prospective cohort study to confirm their observations.

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Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

Timely Tweets & NY COVID-19 Study

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From John Pohl Twitter Feed: Article about mortality/comorbidites from COVID-19 in NYC: Link: Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area

Methods: Case series of patients with COVID-19 admitted to 12 hospitals in New York City, Long Island, and Westchester County, New York, within the Northwell Health system. The study included all sequentially hospitalized patients between March 1, 2020, and April 4, 2020, inclusive of these dates.

Key findings:

  • The authors report a 88% fatality rate among patients requiring mechanical ventilation, including >97% among those >65 years of age
  • Comorbidities were present in 94% of the 5700 patients.  Most common comorbities included  hypertension (57%), obesity (42%), and diabetes (34%). Asthma was present in 9%.
  • Among patients who were discharged or died (n = 2634), 14.2% were treated in the intensive care unit, 12.2% received invasive mechanical ventilation, 3.2% were treated with kidney replacement therapy, and 21% died.

 

From Emily Perito:

From The Onion

 

Timing of Upper Endoscopy with GI Bleeding -Is It Safer to Wait a Bit?

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YouTube Video –Adley.TV: What We Should ALL Be Doing Right Now (COVID-19 Humor)

——————-

A recent study (JYW Lau et al. NEJM 2020; 382: 1299-1308, editorial by L Laine 1361-2) indicates that performing an upper endoscopy within the first 6 hours of presentation to the hospital is NOT associated with better outcomes.

516 patients who were predicted to be at high risk for further bleeding or death were randomly assigned to undergo endoscopy within 6 hours or between 6-24 hours. Key findings:

  • 30-day mortality: 8.9% in the <6 hr group (<6G) compared to 6.6% in the 6-24 hr group (6-24G)
  • Endoscopic treatment was administered to 60.1% of <6G compared to 48.4% in 6-24G
  • Re-bleeding within 30 days in 10.9% of <6G compared to 7.8% in 6-24G

The editorial notes that guidelines recommend endoscopy be performed within 24 hours following hemodynamic resuscitation and attention to other coexisting conditions before endoscopy.

My take: This is good news for endoscopists -no need to rush to the endoscopy suite/operating room in the middle of the night!

Link NEJM: Two minute quick take on article

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Brief Updates: COVID-19/Hydroxychloroquine, GALD, Anorexia Nervosa, and Esophaeal-gastric Dissociation Outcomes

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Recent reports indicate that hydroxychloroquine is not likely effective for COVID-19.  Submitted manuscript: Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19 Commentary from Politco: More deaths, no benefit from malaria drug in VA virus study

An excerpt: A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals….The study was posted on an online site for researchers and has been submitted to the New England Journal of Medicine, but has not been reviewed by other scientists….About 28% who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone. About 22% of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival…The NIH and others have more rigorous tests underway.

HS Fischer et al. JPGN 2020; 70: 444-9. This study examined outcomes of 12 patients with gestational alloimmune liver disease over an 11 year period. Key findings:

  • Median age at diagnosis of neonatal acute liver failure (NALF): 2 days
  • All 12 received exchange transfusion ET).  Common signs: hypoglycemia, hyperferritinemia, cholestasis, and coagulopathy. Direct bilirubin typically increased after ET.
  • Outcomes: survival without transplantation occurred in 10 of 12.  Two patients died including one after liver transplantation.
  • “Most cases of NALF are due to GALD and should be timely treated with ET and IVIG.”  Current testing is lacking with regard to sensitivity and specificity, “early ET [and IVIG] before reaching a definitive diagnosis was associated with favorable outcomes.”

Related blog posts:

JE Mitchell, CB Peterson. Anorexia Nervosa (good review). NEJM 2020; 382: 1343-51.

Key points: 

  • Anorexia nervosa is a severe psychiatric disorder
  • Indications for hospitalization include profound hypotension or dehydration, severe electrolyte abnormalities, arrhythmias or severe bradycardia, suicide risk or BMI ≤15

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S Battaglia et al. JPGN 2020; 70: 457-61. This retrospective study examined outcomes in 30 patients with severe neurologic impairment who underwent esophageal-gastric dissociation (E-GD) between 2000-18 and had a median follow-up of 3.5 years. E-GD was completed at a median age of 6.5 years. “Primary” E-GD was done in 23 and “Rescue” (after fundoplication) was done in 7 patients.

  • Hospitalizations and episodes of chest infections significantly decreased; weight improved
  • Vomiting and reflux resolved in all patients
  • 6 (20%) experienced early complications including 3 who needed surgery (1 obstruction, 1 volvulus, and 1 pyloric obstruction); 3 (10%) had late complications (adhesions/obstruction in 1, incisional hernia in 1, large para-esophageal hernia in 1)
  • There were no surgery-related deaths

The authors, in their discussion, compare primary E-GD with fundoplication.  Many of the referenced studies indicate that E-GD may have improved outcomes in the population of children with severe neurologic impairment, but also with a higher frequency of complications.  They conclude that E-GD “is a valid alternative to fundoplication…but is is just as effective and feasible when undertaken as a ‘Rescue’ procedure following failed surgical antireflux treatment.”

My take: The frequency of fundoplication operations have dropped markedly with increasing use of gastrojejunal tube placement.  In my view, I would usually recommend E-GD for ‘rescue’ after fundoplication failure.

A recent yard sign from my wife for neighborhood walkers during the pandemic

 

Get Ready for 2021 Coding Changes

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MDEdge GI Hep News: Prepare for major changes to E/M coding starting in 2021

New Evaluation and Management (E/M) codes are coming in 2021 –this could simplify documentation.

Here’s an excerpt:

1.Elimination of history and physical as elements for code selection

2. Choice of using medical decision making (MDM) or total time as the basis of E/M level documentation

  • MDM. While there will still be three MDM subcomponents (number/complexity of problems, data, and risk), extensive edits were made to the ways in which these elements are defined and tallied.
  • Time. The definition of time is now minimum time, not typical time or “face-to-face” time. Minimum time represents total physician/qualified health care professional time on the date of service

3. Modification of the criteria for MDM:

  • Terms. Removed ambiguous terms (e.g., “mild”) and defined previously ambiguous concepts (e.g., “acute or chronic illness with systemic symptoms”).
  • Definitions. Defined important terms, such as “independent historian.”
  • Data elements. Re-defined the data elements to move away from simply adding up tasks to focusing on how those tasks affect the management of the patient (e.g., independent interpretation of a test performed by another provider and/or discussion of test interpretation with another physician).

4. Modifier/add-on code): GPC1X can be reported with all levels of E/M office/outpatient codes in which care of a patient’s single, serious, or complex chronic condition is the focus. CMS plans to reimburse GPC1X at 0.33 RVUs (about $12).

Resources:

“Contact your Electronic Health Records (EHR) vendor to confirm the system your practice uses will be ready to implement the new E/M coding and guidelines changes on Jan. 1, 2021.”

My take: The intent of these changes is logical.  The goal of coding is to align the reimbursement with the degree of effort and not simply allow pre-formatted templates justify upcoding.  They could lead to simplification of documentation and allow more documentation time for medical decision-making part of the visit.

Related blog posts:

AMA Table 2 for E/M codes 212-215, 202-205

 

 

 

 

 

NY Times: America can afford a world-class health system. Why don’t we have one?

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Yesterday’s NY Times had a terrific review section of the paper with the theme of “The America We Need.”  The section highlighted the interaction between the coronavirus and inequality, unemployment, collective action, and emerging threats (eg. climate change).

The article with the most relevance for medicine was titled: America can afford a world-class health system. Why don’t we have one?

Here’s an excerpt:

The notion of price control is anathema to health care companies. It threatens their basic business model, in which the government grants them approvals and patents, pays whatever they ask, and works hand in hand with them as they deliver the worst health outcomes at the highest costs in the rich world.

The American health care industry is not good at promoting health, but it excels at taking money from all of us for its benefit. It is an engine of inequality…

America is a rich country that can afford a world-class health care system. We should be spending a lot of money on care and on new drugs. But we need to spend to save lives and reduce sickness, not on expensive, income-generating procedures that do little to improve health. Or worst of all, on enriching pharma companies that feed the opioid epidemic.

The first step to reform is to change the way we think…It would be more accurate to think of employer-provided health insurance as a tax….

Employer-based health  insurance is a wrecking ball, destroying the labor market for less-educated workers and contributing to the rise in “deaths of despair.”…

To meet those rising costs, states have cut their financing for roads, bridges and state universities. Without those crucial investments, the path to success for many Americans is cut off. We face a looming trillion-dollar federal deficit caused almost entirely by the rising costs of Medicaid and Medicare, even without the recent coronavirus relief bill…

Americans have too few doctors, too few beds and too few ventilators — but lots of income for providers. While millions suffer, our health care system has turned into an inequality machine, taking from the poor and working class to generate wealth for the already wealthy…

The health care industry has armored itself, employing five lobbyists for each elected member of Congress. But public anger has been building — over drug prices, co-payments, surprise medical bills — and now, over the fragility of our health care system, which has been laid bare by the pandemic…

Employer-based health care is a particular nightmare in this pandemic. In recent weeks, millions have lost their paychecks and their insurance, and will have to face the virus without either.

We are believers in free-market capitalism, but health care is not something it can deliver in a socially tolerable way.

My take: Many health care workers and hospital employees are showing incredible courage and compassion in this pandemic.  This article reminds us of all the work needed to improve our health care system.

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Curbside humor -my wife is leaving different jokes everyday for neighborhood walkers

From CNN:

Bigger Data Needed and Other IBD Updates April 2020

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R Pittayanon et al. Gastroenterol 2020; 158: 930-46.  In this systematic review of the relationship between gut microbiota and inflammatory bowel disease, 48 studies and 45 articles were included from a total of 2631 citations.  Overall, the authors found inconsistent results with differences in the abundances of some bacteria in IBD. My take: These microbiota studies use ‘big data’ to look for abnormal patterns in patients with IBD.  Overall, most of these studies support a reduced diversity among patients with IBD.  Specific variation in microbes varies widely and remains unclear if they are a cause or a consequence of IBD.

J Piercy et al. JPGN 2020; 70: 318-23. Among 90 adolescents with IBD, “perfectionistic concerns (self-critical and socially prescribed perfectionism) were associated with higher rates of adolescent-reported externalizing symptoms” Thus, perfectionism may help with self-management but lead to more stress and psychosocial symptoms.

S Jardine et al. Gastroenterol 2020; 158: 1000-15. This study used both TTC7A-knockout cells and a zebrafish model to screen compounds that have been FDA approved for treatment of inflammatory bowel disease caused by TTC7A deficiency.  The authors identified leflunomide that reduces apotosis and levels of active caspase 3 in TTC-7A-knockout cells and restored gut motility along with improvement of intestinal cell survival in zebrafish. This study has some amazing figures detailing the changes induced by leflunomide. My take: Although some centers have offered hematopoetic stem cell transplant (with dismal results), there is NOT a currently accepted treatment for TTC7A deficiency-induced IBD.  This study suggests an agent which may help.

CLD Prevost et al. AP&T 2020. https://doi.org/10.1111/apt.15681 Key finding:  Among patients exposed to anti‐TNF, the Lémann Index was lower in those who were exposed in the first 2 years of their disease (P = 0.015).  My take: Early treatment with anti-TNF agents can reduce risk of permanent bowel damage. This was seen as well in the RISK study which showed that anti-TNF therapy reduced the development of penetrating disease. (Related post: CCFA Update 2017, Part 3)

Full link: Bowel damage and disability in Crohn’s disease: a prospective study in a tertiary referral centre of the Lémann Index and Inflammatory Bowel Disease Disability Index

Impedance May Help in Borderline Reflux Disease Assessment

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A recent retrospective study (A Rengarajan et al. Clin Gastroenterol Hepatol 2020; 18: 589-95), with a cohort of 371 patients (mean age 54 years) shows how impedance testing may help identify patients who are likely to respond to reflux management when pH probe testing is equivocal.  The cohort included adults with persistent reflux symptoms.  Response to antireflux therapy was defined as >50% improvement in esophageal symptoms.

Key points:

  • 107 (28.8%) had pathologic acid exposure time (AET) (pH<4 for >6%)
  • 234 (63.1%) had abnormal mean nocturnal baseline impedance (MNBI) (<2292 ohms). MNBI was calculated using baseline values at 10-minute periods between 1-3 am from the 5 cm channel to correspond to total distal AET.
  • Figure 1, shows the combined use of AET and MNBI.  Only 106/107 patients with AET>6, had an abnormal MNBI.  In the borderline category of AET 4-6%, 62/68 (91.2%) had abnormal MNBI values. In those with AET <4, MNBI was abnormal in 66/196 (33.7%)

Response to Treatment:

  • Among patients with AET >6, 66/89 (74%) responded to medical therapy and 18/23 (78%) responded to surgical therapy; among patients with AET 4-6%, 37/56 (66%) responded to medical therapy and 14/17 (82%) responded to surgical therapy. In those with AET <4, 39/185 (21%) responded to medical therapy and 16/23 (70%) responded to surgical therapy
  • Among patients with a low MNBI, 119/198 (60%) responded to medical therapy and 41/50 (82%) to surgical therapy.  In those with a normal MNBI, 23/132 (17%) responded to medical therapy and 7/13 (54%) responded to surgical treatment
  • In those with AET >6, 84/111 (76%) responded to treatment. For those with AET 4-6%, of those with low MNBI, 49/67 (73%), responded (similar to those with AET >6%).  In those with low MNBI and AET <4, 27/70 (39%) responded to treatment
  • 28/138 (20.2%) with normal AET <4 and with normal MNBI responded to treatment

My take: The big takeaway is that all of our tests for pathologic reflux are highly flawed; impedance may (to a small degree) help stratify patients with equivocal evaluation based on AET.  Normal tests do not exclude response treatment (especially surgery).

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Island Ford, Sandy Springs