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Recon takes an analytical look behind select developments in healthcare

An opinionated take on NEJM highlights for May 2022

A step forward for kidney xenotransplantation A report on the recent, well-publicized, temporary transplantation of kidneys from genetically modified pigs in two deceased individuals at NYU. The kidneys functioned well and there was no sign of acute rejection, but because these experiments took place over only 54 hours, this is not indicative of longer term compatibility of the transplant of kidneys from this particular strain of pigs. A question in my mind is why there have not been kidney xenotransplants in live patients yet – especially given a recent porcine

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Advances in AI for Health in 2021: An Analysis of the Clinicaltrials.gov Registry

The role of artificial intelligence (AI) and machine learning (ML) in healthcare spans a vast range of potential applications. A view of AI development on clinicaltrials.gov helps to focus this landscape, giving a sense of trends and near-term applications. Following last year’s review of AI development, we have updated our analysis to include registered studies starting in 2021.[1] The analysis revealed continued strong growth of studies across the field, especially in patient engagement and research. Within patient engagement, the tools studied (mostly chatbots) have increased in complexity, tracking with advancements

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An opinionated take on NEJM highlights for March-April 2022

The opioid crisis and patient abandonment A perspective from a February issue that I originally missed highlighting the plight of patients who have been on a long-term opioid regimen for chronic pain. They are often stable, but it is when their physician retires or leaves that all hell breaks loose because, in this day and age, they cannot find another physician to continue the regimen. For someone who has been taking large doses of opioid for many years, going cold-turkey, or even tapering, is just not an option. These folks

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The coming site-of-care shock for infusions

There’s a major disruption looming in how the site-of-care for infusions is managed which will have repercussions for plan competition, delivery system economics, PE hunting for healthcare opportunity and biopharma commercialization strategy. Plans have long been frustrated by the growth of infusion care in expensive hospital outpatient department (HOPD) settings. HOPD infusion services can cost health plans on average 70% more than a physician office for the same infusion. But because patients on infusion therapy are often very sick and the therapies hard to tolerate, plans have historically been reluctant

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The growth of small molecule drug classes over time

Modern drug discovery is largely based on the identification and validation of a biochemical target, and then screening and optimizing molecules that engage that target. Over time, this has given rise to an extensive set of small molecule drugs approved for human use with activity at specific biological targets. We wanted to answer the question of how many different targets are addressed by existing agents, and how the rate of addition of newly addressed-target has varied over time. To do this, we reviewed every small molecule drug approved since 1970

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An opinionated take on NEJM highlights for January-February 2021

Gene therapy in beta-thalassemia and sickle cell anemia Beta-thalassemia and sickle cell anemia are common genetic diseases of hemoglobin (Hb) which manifest themselves in the former through transfusion dependence, in the latter through painful vaso-occlusive crises that frequently land patients in the hospital in a pitiful state. BlueBird’s lentiglobin therapy is an ex-vivo gene therapy in which autologous stem cells are harvested, transfected with new HbA gene, and then returned to the patient. Because the HbA is slightly modified via a single amino-acid substitution (HbAT87Q), expression is trackable.  Now in

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Wrapping up 2021: An opinionated take on NEJM highlights for November-December 2021

In search of a diagnosis: deploying genomics at scale A substantial number of children have a disease identified as “rare” without having any kind of causative diagnosis (autism is not a causative diagnosis!). In a UK pilot study, 2,183 proband children were referred for exome sequencing with additional sequencing of family members if warranted. The overall diagnostic yield was surprisingly high, about 25% overall. Of the approximately half of probands who had neurological or sensory disorder, an explanatory diagnosis was reached in almost 40% of the cases. Two thoughts: 1)

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The road ahead for genomic testing

New molecular diagnostics, especially tests based on next-generation sequencing and gene-panels, could revolutionize how diseases are evaluated. But experience shows that insurers won’t cover these tests just because they’re available – they need to improve clinical care. Here, we explore how researchers and test developers can prove value, and improve their chances at broad clinical uptake. Outside the niche realm of self-pay (where buyers have very different expectations[1]), the business opportunity of new molecular tests is driven by payer-coverage and reimbursement. Payers are beginning to manage[2] high-cost (>$1,000) lab tests

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The ongoing physician affiliation land grab in Pennsylvania’s Capital District

Closed vs. open Hospitals can compete for patient referrals either by exclusively affiliating with a subset of physicians (“closed model”) or by collaborating with as many qualified physicians as possible irrespective of competing affiliations (“open model”). (Both of these strategies are from the perspective of the facility, of course. A population health strategy would still focus on affiliating with physicians to aggregate patients, but with a goal of minimizing (not just directing) facilities based care.) The two strategies are generally incompatible. If most hospitals use the same approach in a

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Optum opening new competitive terrain in Revenue Cycle Management

What is revenue cycle management? Revenue cycle management (RCM) is the process of converting care delivery into cash. At its most comprehensive, services include: patient intake (scheduling/registration, coverage verification and financial counseling) claim submission (charge capture, coding, documentation, submission), and payment capture (payment processing, denials, customer service and collections).   Effective RCM is challenging because of: The variety of plans and benefits designs (what’s covered, patient co-pays, rates, etc.), Ambiguities of payer approval of specific clinical services (prior authorization, etc.), Requirements and opportunities in characterizing the care and patient risk

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Profit engine swap-outs: How UPMC sustained itself after the Highmark decoupling

UPMC’s decoupling from Highmark exposed a critical vulnerability: economic dependence on its Allegheny County hospitals. In FY11-12,[1] these hospitals provided 70% of UPMC’s overall operating margin, an average of ~$270M annually.[2] A few years later, these operating margins had been cut in half and, by FY19, these same hospitals could contribute just $9M to the enterprise.[3] How did this happen? The Highmark dispute created severe economic headwinds for its western Pennsylvania (what we call “Core”)[4] hospitals: Decay in payer mix. As Highmark patients went elsewhere, the overall commercial share of

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Taking on tough indications: An opinionated take on NEJM highlights for October 2021

What makes an indication especially tough? The combination of a lack of understanding about the mechanism of disease and a lack of clarity on what endpoints would be sufficient for approval of a therapy in studies of reasonable duration. This month, two good examples in the NEJM.   A phase 2b success in NASH Non-alcoholic steatohepatitis (NASH) is a common slow-progressing disease and for most affected individuals the timescale to liver-related morbidity is at least 20 years, although some progress much faster. NASH is also a graveyard of clinical programs

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The Puzzling Future of Healthcare

This post is from a talk at the 2021 Link Ventures CEO summit. Original talk: Transcript: The practice of medicine has always been an information problem. Clinicians seek to diagnose an ailment and to prescribe a cure based on an incomplete understanding of what’s happening in a patient’s body as it relates to an incomplete set of knowledge about diagnoses and treatments.  This aspect of medicine has remained the same for centuries even as our collective understanding of medicine has gone through three major phases.  Until the 18th century, much

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From bleeding edge to basics: an opinionated take on NEJM highlights for August and September 2021

The weird world of synthetic biology In biology 101, one learns about the alphabet that translates DNA/RNA code into amino acids sequences ultimately resulting in proteins. Given that there are 64 possible triplet codons and 20 amino acids, multiple codons can map to the same amino acids. But this mapping can be reassigned including incorporating new amino acids – it has been done in E. coli with the promise of generating biologics with novel properties, although applications are not yet clear. A more practical application is to create strains of

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Summer catch-up: an opinionated take on NEJM highlights for May-July 2021

Cancer and mutational complexity Probably the biggest news in cancer treatment this year is the approval of sotorasib (Lumkras, Amgen) which received accelerated approval in lung cancer with mutated KRAS (G12C) and has potential for use in other cancers (see here). Mirati is hot on the trail with adagrasib, but unusually for a drug in the approval process, their paper in the NEJM is a deep dive into the mechanisms of resistance to KRAS G12C inhibition that lead to treatment failure. They present very detailed in vitro studies in which

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