Ravi B. Parikh

My Spidey Sense Is Tingling Cordavis, Quallent Pharmaceuticals Health, LLC, and #NUVILA, the “private label” subs/sisters of CVS Health, Express Scripts by Evernorth, and Optum, are making quite the splash. Although the opagueness of these PL arrangements makes definitive analysis impossible right now, my fraud and abuse spidey sense is tingling. Of course, the term “private label” itself has a fraud and abuse connotation. Drug makers, back in the day, took False Claims Act hits because of PL arrangements, many of which involved Kaiser Permanente. The kernel of these “arrangements” was the observation that Best Price for #Medicaid price reporting purposes is reported based on the 9 digit National Drug Code, which includes a segment for the “labeler” entity. The bright idea was to transfer the product at a low price to a purchaser, where a new NDC associated with the purchaser would be affixed to the product. This supposedly meant the drug maker did not have to report the low transfer price to the purchaser in the drug maker’s own Best Price reporting, avoiding higher Medicaid rebates and lower #340B prices. These “lick and stick” label arrangements were rejected by the Centers for Medicare & Medicaid Services, HHS Office of Inspector General, and the U.S. Department of Justice, leading to the False Claims Act cases. But the fraud and abuse line of guidance that seems perhaps even more relevant to the PBM PL arrangements is the “contract joint venture” guidance. There, OIG has warned, for many years, that “joint ventures” are suspect where: 1. the contract joint venture partner “is expanding into a related business” that is “dependent on patient referrals” it generates; 2. the owner “neither operates nor commits substantial resources” to the “new” business; 3. absent the contractual arrangement, the “contracting entity” (the original owner of the business) would be “a competitor” to the JV; and 4. payments to the “partner” are based on its “referrals to the new business”. As OIG cautioned in its original 2003 Special Fraud Bulletin, stakeholders “are warned that the presence of ANY of these or similar elements in a contractual joint venture potentially indicates a prohibited arrangement”. Here, drug makers which seem fully capable of offering drug products without the JV “help” of PBMs enter into JVs with entities that appear to control access to their products in a substantial manner. Hmmmm. I can’t say based on the publicly available information that there is a problem, but I do feel a tingle. #fraud #fraudandabuse #healthcarefraud #healthcarecompliance #healthcareenforcement #FCA #AKS #antikickback #kickback #JV #jointventures #OIG #HHS #DOJ #PBM #PharmacyBenefitManagers #drugpricing #managedcare

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The intersection of artificial intelligence (AI) and biotechnology holds immense promise for advancing healthcare, from drug discovery and personalized medicine to improving diagnostics and patient care. AI can analyze vast amounts of biological data more quickly and accurately than humans, leading to insights that can accelerate medical breakthroughs. Biotech, on the other hand, provides the tools and techniques to manipulate biological systems, such as gene editing and synthetic biology, which AI can enhance through predictive modeling and optimization. Together, AI and biotech can revolutionize drug development by streamlining the identification of potential drug candidates, predicting their efficacy and safety profiles, and optimizing treatment regimens for individual patients. In diagnostics, AI algorithms can analyze medical images, genetic data, and other biomarkers to improve disease detection and diagnosis accuracy. Additionally, AI-powered wearable devices and remote monitoring systems can provide real-time health insights, enabling early intervention and preventive care. However, this convergence also raises ethical, regulatory, and privacy concerns, particularly regarding the responsible use of patient data, the potential for algorithmic biases, and the implications of gene editing technologies. It's essential for stakeholders in both fields to collaborate closely to ensure that AI-driven biotech innovations prioritize patient safety, equity, and ethical considerations while maximizing their transformative potential in healthcare. #AI #Biotech #drugdevelopment #Data #HIT #predictivemodeling #machinelearning #healthcare #Informatics #ecosystems

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A fascinating article authored by esteemed Girard College alumni, Henry Grabowski examing the potential impact of the Inflation Reduction Act on oncology drug innovation. #Healthaffairs #IRA #Healthpolicy #Oncology #Pharmaceuticals #Duke #GirardCollege #STEM

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Last week’s bipartisan action by 15 senators in support of Medicare beneficiary access to Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) scans could have a potentially positive impact for accessibility of therapies for neurodegenerative disease, including Alzheimer’s. These technologies are critical for precision diagnosis, preventing patients who don’t qualify based on biology from being exposed to treatment unnecessarily, and ensuring patients who do qualify have access to treatment. This is a very encouraging development an estimated 6.9 million Americans 65+ were living with Alzheimer's in 2024, which is about 1 in 9 in that age group, according to Alzheimer's Association®. https://lnkd.in/e3tQb6es

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For those actively thinking about how to evolve their own patient-reported outcome measures (PROMs), I would encourage you to read this paper just published in NEJM Catalyst. Fantastic summary of Mass General Brigham's evolution in PROMs over the last decade. A few highlights: 1. Our traditional outcomes are insufficient to assess whether or not we as clinicians have met the patient's goals. Rather than just address conformance quality, patient-reported measures address performance quality (ie achieve the patient's goals in seeking care). 2. Displaying PROM scores can highlight or predict adverse trends (e.g., when a patient has become depressed after a procedure). Novel methods such as using #LLM and #NLP are on the horizon here. 3. The team details how they have incorporated #healthequity measures, increasing inclusivity for patients, built dashboards (love their heat map by zipcode!), and allowed patients to view their own trends over time. 4. PROMs can be actively used, allowing clinicians to focus on a patient's biggest concerns and even reduce unnecessary visits. The Centers for Medicare & Medicaid Services recently issued a rule on a patient-reported outcome-based performance measure (PRO-PM) with public reporting and financial implications beginning 2028. Though the CMS rule specifically focuses on orthopedic procedures, I'd venture to say we'll see more of these coming over the next few years. I would not be surprised if #cardiology was one of the next. So much of what we do is focused on symptomatic improvement-- we're going to need PROMs to truly understand our impact. Thank you Jason Liu Robert Kaplan David Bates Maria Orlando Edelen Rachel Sisodia Andrea Pusic for sharing your amazing work. https://lnkd.in/evjRw8ZU #clinicalquality #innovation #digitalhealth #valuebasedcare

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Value-based care, anyone? If shared quality and outcomes are the foundation of VBC networks, MSSPs, and ACOs, why are hospital-owned physicians and groups still compensated based on volume (relative value units)? This RVU-based compensation system can only last until legislation appears on the horizon. Quantity will never equal quality. #ValueBasedCare #HealthcareReform

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Our second session covers: Addressing the Gap Between Clinical Trials and Implementation into Clinical Practice and Population Health. Nandini Raghuraman from WashU OBGYN presented "De-Implementation of Low-Value Care". The panel was moderated by Bill Powderly, MD, the Associate Dean for Clinical and Translational Science. Learn more about how the ICTS can support your clinical and translational research> www.icts.wustl.edu

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Dr Eric J. Feldman, director at Montefiore Einstein Comprehensive Cancer Center, explains how they are bringing early phase clinical trials to their community. Learn more about this process and how he is addressing these challenges in our interview below. Read the article here: https://lnkd.in/eT8yJNTB #ClinicalResearch #ClinicalTrials #Trials

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✨ So happy health equity getting the attention it deserves in the latest Journal of Clinical Oncology-CCI issue featuring our publication! ✨ In "Future of Cancer Treatment Guidelines: Integrating Real-World Insights for Equitable Cancer Care," Gregory Calip, PharmD, MPH, PhD and I explore how real-world data (RWD) can bridge critical gaps in cancer treatment guidelines, especially for underrepresented populations. 🩺📊 Key Takeaways: 1️⃣ Bridging Gaps: RWD holds promise for making guidelines more inclusive and applicable, but it requires rigorous methodology. 2️⃣ Guideline Evolution: Integrating real-world evidence can drive more personalized, equitable care in oncology. 🔗 https://lnkd.in/eDkakbhE #HealthEquity #Oncology #RealWorldData

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Circulatory ECMO is the way to bridge to definite therapy for difficult cases of high-risk acute PE's. Read our published review article in #Journal_CHESTCritCare.

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Physicians and other health care professionals must be engaged about the use of AI. We can't have a "wait and see" approach. Please check out the recent position paper by American College of Physicians (ACP) on how we should use AI in clinical practice. Honored to be part of the committee putting out this report. https://lnkd.in/eUKWY6xm #artificalintelligence #aihealth #ai #augmentedintelligence

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Important read highlighting need for stronger consequences for digital health companies misusing patient information. Jonathan JK Stoltman, Ph.D. of Opioid Policy Institute writes in STAT, "Digital health approaches to addiction treatment and recovery are thought to increase connections between people seeking treatment or in long-term recovery to prescribers, psychological services, or recovery supports through websites or apps. The goal is to reduce barriers like travel time, difficulty accessing providers, and isolation. But as with all technology, this digital approach comes with readily anticipated, potentially severe, and completely preventable privacy risks. Among the 23 opioid addiction treatment and recovery companies the Opioid Policy Institute monitors, 22 engaged in activity similar to that found to be illegal in the FTC’s recent cases. Twelve of the 23 received NIDA funding. These companies conspicuously claimed to be “private,” “confidential,” or “HIPAA compliant” while surreptitiously sharing personal and health data with outside firms that can then use this information to target advertising. This means information like drug use history, health insurance, and detailed personal information can be used to determine what ads are served — or not served — to people who browse these services, contributing to silent and illegal discrimination based on their health condition. It’s not clear how things got to this point. NIDA knows that privacy is a core part of addiction treatment, harm reduction, recovery, and research. These 23 companies, including those funded by NIDA, also appear to know privacy is important to people seeking addiction support because they frequently mention they offer private, secure, confidential treatment and recovery support on their websites, apps, and advertisements. It’s a standard — and deceptive — part of their sales pitches. People who use drugs rank privacy as an essential aspect of addiction support because they have historically been marginalized, overpoliced, and exploited. Knowledge about an individual’s drug use — past or present — has led to substantial harm across employment, housing, and other human rights violations. These are not hypothetical harms: people who use drugs face these barriers daily. Yet no one appears to be protecting the privacy of vulnerable people using these services. It appears that these NIDA-funded digital health companies said they were private, secure, and confidential, and both the funder and people seeking care took their word on it. This is unacceptable. Addiction treatment and recovery support can certainly benefit from digital approaches. But accessing addiction treatment and recovery support cannot come at the expense of individual’s federally protected privacy rights. NIDA cannot afford to be naïve about these risks. The costs to people using these services are too great." https://lnkd.in/e-MSKY-Z

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Is the increased cardiovascular risk in #SouthAsians genetically driven? My patients and family tell me so. DNA is not destiny. I agree, however, that there are genetic pathways implicated in baseline cardiovascular risk factors such as diabetes and lipid abnormalities, for example. Great to collaborate with the team at OurHealth (Pradeep Natarajan and Romit Bhattacharya, MD, FACC) to prepare this nice review of genomic studies, pharmacogenetics, and integration of genetic information as it pertains to #SouthAsians into polygenic risk scores to improve cardiovascular risk prediction led by Johns Hopkins Medicine Osler Residency star, Abhi Gami. Ciccarone Center for the Prevention of Heart Disease Anandita Agarwala Kulkarni MD, FACC Payal Kohli, MD, FACC Ankur Kalra Ami Bhatt, MD Martha Gulati Roger Blumenthal Natasha Chida Garima Sharma MD, FACC, FAHA

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With election season in full swing, here is a good summary of some of the most impactful issues to healthcare that are lingering in the legislative space. https://lnkd.in/gNaG94dE

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#PatientsUseAI Here is a great simple example of how LLMs can help laypersons understand a fundamental, and yet poorly understood concept in medicine and statistics (sensitivity vs specificity): Me: "Explain: Snoring has a sensitivity of 80 to 90 percent for diagnosing OSA, but its specificity is below 50 percent." ChatGPT: **Sensitivity and Specificity in Diagnosing OSA with Snoring** 𝐒𝐞𝐧𝐬𝐢𝐭𝐢𝐯𝐢𝐭𝐲: - 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻: Sensitivity measures how often a test correctly identifies a condition. In this case, it refers to the percentage of people with obstructive sleep apnea (OSA) who snore. - 𝗛𝗶𝗴𝗵 𝗦𝗲𝗻𝘀𝗶𝘁𝗶𝘃𝗶𝘁𝘆 (𝟴𝟬-𝟵𝟬%): Snoring is highly sensitive for diagnosing OSA because 80-90% of people who have OSA also snore. This means if someone has OSA, there's an 80-90% chance they will snore. Hence, snoring is a common symptom among those with OSA. 𝐒𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐢𝐭𝐲: - 𝗗𝗲𝗳𝗶𝗻𝗶𝘁𝗶𝗼𝗻: Specificity measures how often a test correctly identifies people who do not have a condition. Here, it indicates the percentage of people without OSA who do not snore. - 𝗟𝗼𝘄 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗶𝘁𝘆 (𝗯𝗲𝗹𝗼𝘄 𝟱𝟬%): Snoring has low specificity for diagnosing OSA because less than 50% of people who snore actually have OSA. This means many people who snore do not have OSA, and thus, snoring alone is not a reliable indicator of the condition. 𝐈𝐦𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬: - 𝗛𝗶𝗴𝗵 𝗦𝗲𝗻𝘀𝗶𝘁𝗶𝘃𝗶𝘁𝘆: Snoring is a good initial indicator to suggest further testing for OSA. If a patient snores, there's a high chance they could have OSA, warranting additional diagnostic tests. - 𝗟𝗼𝘄 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗶𝘁𝘆: Snoring alone should not be used to diagnose OSA. Many people snore without having OSA, so other symptoms and tests must be considered to confirm the diagnosis. In summary, while snoring is common in individuals with OSA (𝐡𝐢𝐠𝐡 𝐬𝐞𝐧𝐬𝐢𝐭𝐢𝐯𝐢𝐭𝐲), not everyone who snores has OSA (𝐥𝐨𝐰 𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜𝐢𝐭𝐲). Therefore, snoring is a useful sign for identifying potential OSA but not definitive without further testing.

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AI is truly making a difference in patient care. At last month's PERT Symposium, Dr. Farnaz Dadrass shared insights that highlight its power. One critical insight from Mount Sinai's study was how AI expedited data analysis - what used to take days or weeks, AI did instantly. In critical cases like pulmonary embolism, this speed can be life-saving. The study also revealed that 27% of PEs were found incidentally, diagnoses that might have been missed without AI. It’s a clear reminder that AI isn’t just about efficiency - it’s about transforming patient outcomes. https://okt.to/V9bOYd

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📢New article alert from the Journal of Comparative Effectiveness Research:   Title: Evaluation of inpatient and emergency department healthcare resource utilization and costs pre- and post-nusinersen for the treatment of spinal muscular atrophy using United States claims   A new study from Johnson et al. evaluates the impact of nusinersen on healthcare resource utilization and costs for #SpinalMuscularAtrophy patients using US claims data, finding significant reductions in inpatient admissions and costs for both pediatric and adult patients post-treatment compared with pre-treatment.   Authors: Cong Zhu, Craig Zaidman, Bora Youn, Angela Paradis, ScD, Stéphanie Raynaud Delcroix, Bridget A Neville & Nicole Benjamin Johnson Biogen, Washington University School of Medicine in St. Louis   #SMA #Nusinersen #Healthcare #ClinicalOutcomes #HealthEconomics #Pharma 🔗 https://lnkd.in/ePcXF_B2

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