Cost Transparency Rules Not Implemented for GI Procedures

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GastroEndoNews 3/28/24: (Open Access!) Mandated Cost Transparency Requirement For GI Procedures Is Not Being Met

Excerpts:

Three years after the Hospital Price Transparency Rule was implemented by the Centers for Medicare & Medicaid Services, a large proportion of hospitals are not complying when it comes to gastrointestinal services, according to two studies presented at the 2023 annual meeting of the American College of Gastroenterology.

When institutions do list their prices, they are often hard to find, and the wide variety of charges are frequently listed in a format that is “not patient-friendly,” according to investigator Kevin Brittan, MD, an internal medicine resident at the University of Nebraska Medical Center, in Omaha…

All hospitals are expected to be in compliance with the rule and report prices for these and other procedures as of Jan. 1, 2021. However, in one study, Dr. Brittan and his co-investigators found that only two of 25 [top-rated] hospitals surveyed (8%) reported costs for all eight procedures evaluated (abstract P4083). In the other study, from Howard University researchers, 14 of 30 hospitals (47%) provided some costs for four procedures, but only 10 (30%) provided cost information for all of them (abstract P4091)...

[They] also found “extreme variance” between institutions in the costs cited, raising the question of whether the reported data are even reliable. “There was a 51-fold difference found in the price for an upper endoscopy and a greater than 80-fold difference for a colonoscopy,” Dr. Bhayana reported. Self-pay colonoscopy prices, for example, ranged from $440 to more than $36,000...

Approximately 11 million colonoscopies and 6.1 million upper endoscopies performed each year in the United States, Dr. Brittan said. He calculated that the price differences would equate to billions of dollars if procedures were performed at top centers offering the lowest prices relative to top centers asking the highest prices.

My take: So far, the hospital price transparency has been ineffective. Patients should be able to find out more readily what the costs are prior to receiving a bill. Unfortunately, this appears to be years away. To implement price transparency will require either enforcement (penalties) and/or litigation.

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Long Duration of Eosinophilic Esophagitis Associated with a Stiff Esophagus

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IK Araujo et al. Clin Gastroenterol Hepatol 2024; 22: 513-522. The Severity of Reduced Esophageal Distensibility Parallels Eosinophilic Esophagitis Disease Duration

This study of 171 adult patients (mean age 38 years) who had FLIP at time of an EGD determined the degree of esophageal distensibility and its association with eosinophilic esophagitis disease duration.

Key findings:

  • The median symptom duration was 8 (interquartile range, 3–15) years and diagnostic delay was 4 (interquartile range, 1–12) years
  • Symptom duration and diagnostic delay were negatively correlated with distensibility plateau (DP) (rho = –0.326 and –0.309; P values < .001)
  • Abnormal esophageal distensibility (DP ≤17 mm) was more prevalent with increased duration of symptoms (P < .004): 23% at <5 years to 64% at ≥25 years
  • Patients with ≥15 eos/hpf had significantly lower DP with greater symptom duration (P = .004), while there was not a significant difference among patients with <15 eos/hpf (P = .060).

My take: Longer duration of disease increases the risk of esophageal fibrosis and lack of distensibility. We need better tools to predict who is at most risk for developing fibrosis.

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Pictograms for Gastroduodenal Symptoms Fall Short

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G Humphrey et al. J Pediatr 2024; 267: 113922. Open Access! Designing, Developing, and Validating a Set of Standardized Pictograms to Support Pediatric-Reported Gastroduodenal Symptoms

The authors attempted to develop useful pictograms to help enable standardization of symptom reporting in children with gastroduodenal disorders.

Figure 2: Pediatric gastroduodenal symptom pictograms. A, stomach burn; B, upper gut pain; C, heartburn; D, nausea; E, reflux; F, vomiting; G, belching; H, bloating; I, excessively full; and J, early satiety. (The same images were used to create the animated set).

Key findings:

  • Face and content validity were higher for the pediatric static and animated pictogram sets compared with pre-existing adult pictograms (78% vs 78% vs 61%).
  • Participants with worse gastric symptoms had superior comprehension of the pediatric pictograms (χ2 [8, N = 118] P < .001)
  • “Little significant comprehension was gained by having the animated pictograms.”

My take: Some research while worthwhile does not pan out. This is what I was thinking when I read this study. Upper GI symptoms are difficult to convey in pictures; in addition, some patients will have multiple overlapping symptoms. This is why the validity percentages are not higher. I don’t foresee using these pictograms in clinical practice.

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Upadacitinib vs Ustekinumab for Ulcerative Colitis

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RS Dalal et al. Clin Gastroenterol Hepatol 2024; 22: 666-668. Comparative Effectiveness of Upadacitinib vs Ustekinumab for Ulcerative Colitis: A Multicenter Retrospective Cohort Study

This was a multicenter retrospective cohort study of adults with ulcerative colitis comparing upadacitinib (n=70) to ustekinumab (n=148). The upadacitinib-treated patients were all bio-exposed, had more advanced therapy failures, and higher baseline SCCAI (simple clinical colitis activity index).

Key findings:

  • Upadacitinib-treated patients had better outcomes: Clinical response of 82.9% vs. 63.5%, Steroid-free clinical remission 62.1 % vs. 34.7%, improvement in arthralgia 64.3% (9 of 14) vs 23.4% (11 of 47), and endoscopic remission 37.5% (9 of 24) compared with 15.9% (7 of 44).
  • The odds ratio (OR) after inverse probability of treatment-weighting were in favor of upadacitinib: Clinical response OR 2.39, SFCR OR 3.17, and endoscopic remission OR 5.10
  • Similar amounts of adverse effects were reported in each group

My take: Upadacitinib had better response rates within 52 weeks even though the patients receiving this medication had more advanced therapy failures. However, it is important to keep in mind the limitations of this retrospective study. The improved outcomes are in contrast to a study comparing another JAK inhibitor (tofacitinib) to ustekinumab in which the outcomes appeared equivalent (Tofacitinib vs Ustekinumab -Which is Better for Ulcerative Colitis?).

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Heron at Azalea Park (Sandy Springs, GA)

What is Mild Crohn’s Disease and How to Treat It

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S Elmasry, C Ha. Clin Gastroenterol Hepatol 2024; 22: 480-483. Evidence-Based Approach to the Management of Mild Crohn’s Disease

This article provides guidance on what is mild Crohn’s disease (CD) and suggested management. The authors note that there are limited randomized controlled trial data focusing on patients with mild CD.

Key points:

  • “Maintenance strategies often fall under the realm of supportive care. Therapeutic approaches need to factor clinical effectiveness, prevention of disease-related complications, risks of adverse events resulting from undertreatment or overtreatment and costs of care.”
  • For induction, the authors suggest budesonide 9 mg per day for 8 weeks with tapering, a tapering course of prednisone or sulfasalazine for colonic CD
  • In those with response to induction, the authors recommend supportive care including anti-diarrheal agents and dietary modifications. Ongoing monitoring is suggested including clinical symptoms and objective labs/biomarkers (every 12 weeks if CD activity and every year during remission)
  • In those without response or early relapse, the authors advocate for further evaluation for disease activity and alternative etiologies along with consideration of advanced therapies (f objective evidence of persistent activity)
  • “Accumulating evidence supports diets rich in fruits and vegetables with limited intake of foodstuffs containing saturated fats, ultraprocessed foods, artificial sweeteners, and emulsifiers.”
  • Advanced therapies “such as vedolizumab, ustekinumab, and risankizumab may be considered owing to favorable effectiveness and safety profiles…may be too cost-prohibitive to justify use for mild CD.”

My take: As younger patients are at increased risk for disease progression, the approach recommended in this article would have very limited application in the pediatric age group.

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Twenty-Five Years After Columbine –What to Do About Firearms and Public Health

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D Hemenway. NEJM 2024; 390:1352-1353 Twenty-Five Years after Columbine — Firearms and Public Health in the United States

This commentary notes that in the aftermath of Columbine, Smith and Weston had agreed “to upgrade its products and practices to help reduce the harms caused by its guns. Since a common cause of unintentional shootings is incorrectly believing that the gun is unloaded, its pistols would have chamber load indicators, and magazine disconnects would be available. The company would provide “ballistic fingerprints” on new firearms to help law-enforcement agencies trace guns. It would sell its guns only to dealers who had a plan for preventing gun theft and — to reduce gun trafficking — would agree to limit multiple-handgun sales to any individual buyer. The dealers would also have to agree not to sell large-capacity magazines.1 But the firearms industry immediately began boycotting the company, and its chief executive officer was forced to retire.”

This article offers the following advice to reduce firearm mortality, the number one killer of children:

  • “The Surgeon General could provide biannual reports on guns and suicide; the federal government could both conduct and fund research into smart guns and safer means of home protection than owning a handgun”
  • “Police could have social workers embedded in precincts”
  • “The faith community could make it clear that it is a cardinal sin to sell a gun to a stranger without a background check”
  • “Probably the most important thing our country can do is to elect more officials who will help make changes where the effect will be greatest — in the gun industry and the gun culture”
  • “To achieve a huge reduction in gun deaths will probably require mandating what is common for car drivers in the United States and for gun owners in other high-income countries: gun licensing, gun training, and handgun registration, along with universal background checks. These requirements are supported by most Americans”
  • “PLCAA (Protection of Lawful Commerce in Arms Act) protections should be eliminated, and the gun industry treated like other industries”
  • “And just as car manufacturers had to be forced to put seat belts, airbags, collapsible steering columns, and safety glass into their vehicles, the gun industry should be forced to take the types of steps that Smith and Wesson was willing to take 25 years ago”

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‘Physicians Are Not the Victims’ (Plus One)

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A recent blog post (Is Medicine a “Calling?”) reviewed a commentary about whether physicians have become ‘cogs of capitalism’ leading to dissatisfaction.

A recent response letter (RL Albin. N Engl J Med. 2024 Apr 18;390(15):1444. doi: 10.1056/NEJMc2403045) offered some useful insights:

  • Before WWII, physicians were paid directly by patients. Afterwards, “taxpayer-subsidized, employment-based health care and social insurance guaranteed healthy incomes. Generous subsidies for higher education lowered barriers to professional entry…”
  • Due to “clever political lobbying, physicians enjoyed these considerable subsidies without major sacrifices of sovereignty.2 This system was economically unsustainable…”
  • “Physician lobbying played a sizable role in defeating efforts toward rational public control, unwittingly advancing corporatization with its gross inefficiency, multiple inequities, and erosion of physician sovereignty. Physicians are “cogs of capitalism,” but we continue to be well-paid, respected professionals. The real victims are the many Americans who lack access to decent health care”

A related article: K Schulman, B Richman. NEJM 2024; 390: 1445-1447. Hospital Consolidation and Physician Unionization. This article describes the increase in physician unionization that is taking place and makes the following points:

  • “Since the 1990s, hospitals have been consolidating to form health systems that now exert monopolistic leverage in many health care markets in the United States”
  • “In 2012, only 5.6% of U.S. physicians were directly employed by a hospital,1 and another 23% were in a practice that was at least partially owned by a hospital…By January 2022, the proportion of hospital-employed physicians had risen to 52%, with another 22% of physicians being employed by other corporate entities”
  • [Unionization] “is a natural consequence of hospital consolidation and the corporatization of health care delivery… Executives may also consider physicians to be largely interchangeable…Amid shifts in practice structures, physicians may experience a deterioration in their working conditions, job satisfaction, and — most important — involvement in the governance of health care delivery”
  • [Unionization provides] “the opportunity to negotiate over wages with monopolists…Unions often express workers’ concerns about non–wage-related matters, including issues affecting job satisfaction, professional meaning, and workplace conditions”
  • “Physicians supporting these drives have emphasized concerns about staffing, burnout, and the quality of patient care as motivations for unionization. Collective bargaining has been a direct response to the most negative consequences of hospital consolidation”

My take: Doctoring can be sacred work. While physicians need to work to improve workplace environments and enhance personal interactions with patients, it is sobering to realize that many patients have been harmed much more than physicians with the changes in healthcare delivery and costs.

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Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study)

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LCMJ Goltstein et al. Gastroenterolog 2024; 166: 690-703. Open Access! Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial

Methods: The study was designed as a multicenter, open-label, randomized controlled trial. Patients with angiodysplasia bleeding were required to have had at least 4 red blood cell (RBC) units or parental iron infusions, or both, in the year preceding randomization. Patients were allocated (1:1) to 40-mg octreotide long-acting release intramuscular every 28 days or standard of care, including endoscopic therapy.

Key findings:

  • Baseline: Patients (n=62, with mean age 72 years) required a mean number of 20.3 transfusion units and 2.4 endoscopic procedures in the year before enrollment.
  • During Study: The total number of transfusions was lower with octreotide (11.0) compared with standard of care (21.2). Octreotide reduced the annual volume of endoscopic procedures by 0.9.
  • Adverse events: Octreotide-related AEs were common (65%);however, these AEs were mild and self-limiting nature. They “rarely elicit treatment discontinuation.”
mean number of transfusion units patients in the octreotide
group and standard of care group

My take: Fortunately (for me), angiodysplasia is quite rare in the pediatric age group. In adults, octreotide helps reduce transfusions and need for endoscopy.

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Are Kids Different? TB Testing in Patients Receiving Biologics

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SL Lapp et. al. Clin Gastroenterol Hepatol 2024; 22: 420-422. Open Access! Yield of Serial Testing for Tuberculosis Exposure in Patients With Inflammatory Bowel Diseases: One Test is Not Enough

This “retrospective cohort study was conducted using data acquired from SPARC IBD, a component of the Crohn’s & Colitis Foundation’s IBD Plexus research platform. SPARC IBD is a prospective cohort study conducted at 18 US centers and includes more than 4000 patients.” The median patient age was 37 years.

Key findings:

  • Following an initial negative result in 687 patients, 269 patients received a second test (after an initial negative test), of which 5 were positive (1.9%), which was not significantly different from the prevalence with the first test
  • Oral steroids were associated with an increased proportion of indeterminate results, although not achieving statistical significance
  • The authors did not identify any potential risk factors for latent tuberculosis among the covariates investigated

Overall, the authors found “found that there is continued utility for the use of IGRA tests with patients receiving medication for IBD despite the declining incidence of tuberculosis in the United States. In addition to testing before administration of treatment, this study suggests serial testing may still be necessary because of a substantial rate of positive conversions among patients in the cohort.”

After reading this study, I did an informal survey from the physicians/APP in my group. As a group, we take care of approximately 1000 children with inflammatory bowel disease. Over the last 20 years, only one of my partners recollects having a true positive test result after an initial negative result. This particular patient who was asymptomatic received a 9 month course of isoniazid.

My take: There is a low yield of follow-up testing for tuberculosis, especially in pediatric patients with no exposure history or travel history. For our practice, this would be a good summer research project for a premed student, a resident or even a fellow. I would expect the yearly and cumulative costs of screening for latent tuberculosis in our practice to be quite high. A quick web search suggests that a single blood test costs ~$150 which would be $105,000 for 700 tests. However, the costs are much greater due to additional investigations related to indeterminate results.

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NPR: Drugmakers Claim to Lose Money in US In Order to Avoid Taxes

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NPR 4/15/24: Drugmakers’ low U.S. taxes belie their high sales

Some excerpts:

Corporations are supposed to pay a nominal tax rate of 21%. But in recent years, the biggest pharmaceutical companies had an average effective tax rate of less than 12%, according to an analysis by the Senate Finance Committee….

An NPR examination of financial records for the top five drug companies in the U.S. showed that in 2023, all but Eli LIlly reported losing money in the US.

However, drug companies make most of their sales in the U.S., thanks in large part to its unique health care system and the higher prices Americans pay for drugs. The top five American pharmaceutical companies all had more drug sales in the U.S. than they did in all the other countries in the world put together…

“How do they do it? You license your intellectual property to an offshore subsidiary,” Setser tells NPR. “You produce the high value-added active ingredients in a factory in Ireland or Singapore, and you pretend like the profit is accrued to these offshore subsidiaries, even though the sales are back to the United States…”

The drug industry isn’t the only one that moves its income around to pay lower taxes, but the U.S. market’s role in driving the drug industry’s overall revenue makes the tax strategy stand out, says Ameet Sarpatwari, assistant director of the Program on Regulation, Therapeutics and Law at Harvard Medical School.

“These findings are striking because they show that the companies want to benefit from the high prices and the high sales in the U.S. market, but are doing everything possible to not contribute to the taxes that make that system and market function” 

My take: Despite earning top dollar and receiving all sorts of research support, the pharmaceutical industry (like other industries) are taking advantage of US tax laws and not paying their fair share. Yet, I doubt there will be legislation passed in the near future to address this. “The pharmaceutical and health product industry spent $381 million lobbying Congress in 2023 – more than any other industry that year”.

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Recently I went to the Piedmont Arts Festival.
This piece by Laura Gutzwiller was done completely with felt.