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Articles by Ryan Pate
Trying underground spots at Columbia
Columbia students have their tried and true favorite on-campus spots in Morningside Heights. From a Diana bowl to a Blue Java latte, students know what they like and tend to stay loyal to it. Beyond the classics, Columbia’s campus has so many options at our disposal that don’t get the same love—sometimes, for good reason. In order to shed light on some niche spots at Columbia, here are five underground spots that you might consider for your next on-campus adventure.
OIG Approves Free Companion Diagnostic Testing Program for Enzyme Inhibitor Drug
The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion 25-07) regarding a pharmaceutical manufacturer’s program to sponsor free companion diagnostic testing for certain oncology patients.
Building NPM packages for CommonJS with ESM dependencies
TLDR You have to use a bundler such as esbuild which will compile your project and bundle all of it's dependencies along with it so they aren't imported. This bypasses the ESM/CommonJS incompatibility issue. If you're impatient, you can go straight to the code with this example implementation. Context While preparing to release my new project Token.js over the weekend, I ran into a quite frustrating problem. I wanted my package to support CommonJS in addition to ESM, but I had pure ESM dependencies.
No Criminal Charges for Cooperative Medicare Advantage Organization
On October 26, 2023, the Department of Justice (“DOJ”) announced that a Miami federal grand jury returned an indictment charging a Medicare Advantage Organization’s (“MAO”) former director of Medicare risk adjustment analytics with six counts of criminal fraud. DOJ alleged that the MAO received more than $53 million in overpayments from the Centers for Medicare & Medicaid Services (“CMS”) due to false diagnoses submitted on reimbursement claims for beneficiaries enrolled in the MAO’s plans.
No Criminal Charges for Cooperative Medicare Advantage Organization
On October 26, 2023, the Department of Justice (“DOJ”) announced that a Miami federal grand jury returned an indictment charging a Medicare Advantage Organization’s (“MAO”) former director of Medicare risk adjustment analytics with six counts of criminal fraud. DOJ alleged that the MAO received more than $53 million in overpayments from the Centers for Medicare & Medicaid Services (“CMS”) due to false diagnoses submitted on reimbursement claims for beneficiaries enrolled in the MAO’s plans.
New Connecticut Law Targets Drug and Device Manufacturers who Employ Sales Representatives for Additional Scrutiny | JD Supra
Shortly after Connecticut’s 2023 legislative session kicked off, Governor Ned Lamont announced a series of policy initiatives aimed at reducing health care costs and undertaken in collaboration with the Connecticut Hospital Association. “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (“the Act”), which was passed by the Connecticut Legislature in early June and signed into law by Governor Lamont in late June, implements some of those initiatives.
New Connecticut Law Targets Drug And Device Manufacturers Who Employ Sales Representatives For Additional Scrutiny
Shortly after Connecticut's 2023 legislative session kicked off, Governor Ned Lamont announced a series of policy initiatives aimed at reducing health care costs and undertaken in collaboration with the Connecticut Hospital Association. "An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs" ("the Act"), which was passed by the Connecticut Legislature in early June and signed into law by Governor Lamont in late June, implements some of those initiatives.
New Connecticut Law Targets Drug and Device Manufacturers who Employ Sales Representatives for Additional Scrutiny
Shortly after Connecticut’s 2023 legislative session kicked off, Governor Ned Lamont announced a series of policy initiatives aimed at reducing health care costs and undertaken in collaboration with the Connecticut Hospital Association. “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (“the Act”), which was passed by the Connecticut Legislature in early June and signed into law by Governor Lamont in late June, implements some of those initiatives.
Eighth Circuit Finds “But-For” Causation Standard for AKS-Premised FCA Cases
The U.S. Court of Appeals for the Eighth Circuit recently weighed in on the causation standard for False Claims Act (“FCA”) cases premised on Anti-Kickback Statute (“AKS”) violations. United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828 (8th Cir. 2022).
CMS Issues Updated Open Payments FAQs
CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits. The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new FAQ is reproduced in full below.
Plausibility Pleading In The Digital Age: Federal Appellate Courts Take Fresh Look At Rule 8 In FCA Context
United States: Plausibility Pleading In The Digital Age: Federal Appellate Courts Take Fresh Look At Rule 8 In FCA Context 13 April 2021 Reed Smith Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. In recent years, the U.S. Department of Justice ("DOJ") has increasingly leveraged data analytics to combat fraud.
Plausibility Pleading in the Digital Age: Federal appellate courts take fresh look at Rule 8 in FCA context
In recent years, the U.S. Department of Justice (“DOJ”) has increasingly leveraged data analytics to combat fraud.
FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation | LexBlog
On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1] Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.
FDA Issues Draft Guidance Regarding Principles For Selecting, Developing, Modifying, And Adapting Patient-Reported Outcome Instruments For Use In Medical Device Evaluation - Food, Drugs, Healthcare, Life Sciences - United States
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FDA issues draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation | LexBlog
On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation. Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.
FDA Issued Guidance On Statistical Considerations For Clinical Trials During The COVID-19 Public Health Emergency
Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice): Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below. Mondaq has a "free to view" business model.
FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency
On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel restrictions, site closures, etc.—have impeded drug and device industry innovation.
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