Mangesh Mahalle’s Post

BEHIND-THE-SCENES AUDITS OFTEN HIDE CAUSE OF TEST CLAIM DENIALS PRIVATE PAYER AUDITS OF LAB TEST CLAIMS ARE HAPPENING MORE FRE­QUENTLY. This is particularly true for molecular and genetic test claims. It is one reason why your lab may see the regular flow of reimbursement payments from a specific health plan suddenly stop without warning. But there is another reason why a private payer may abruptly stop paying a lab company’s test claims. It’s because the payer believes the lab is on a federal gov­ernment watch list. I know of several lab companies that – after payments for their test claims had ceased – discovered that one of their important payers believed they were on a federal government watch list. (See sidebar below for details.) Payers conduct claims audits behind the scenes and labs are unaware that their test claims are being audited. In the most common scenario, either the pay­er’s auditing department or an outside auditing service takes a small sampling of claims and runs them through an algo­rithm. Thepayer then extrapolates the data into a prediction of all claims filed by that lab. If the audit turns up something amiss, the payer will... Read The Dark Report article at https://hubs.ly/Q02GNsSJ0 Not already a subscriber? Sign up for a FREE 14-Day Trial at https://hubs.ly/Q02GNtfY0 Need A Group Membership? Company Discounts are Available! Get more information now at https://hubs.ly/Q02GNsP30

BEHIND-THE-SCENES AUDITS OFTEN HIDE CAUSE OF TEST CLAIM DENIALS PRIVATE PAYER AUDITS OF LAB TEST CLAIMS ARE HAPPENING MORE FRE­QUENTLY. This is particularly true for molecular and genetic test claims. It is one reason why your lab may see the regular flow of reimbursement payments from a specific health plan suddenly stop without warning. But there is another reason why a private payer may abruptly stop paying a lab company’s test claims. It’s because the payer believes the lab is on a federal gov­ernment watch list. I know of several lab companies that – after payments for their test claims had ceased – discovered that one of their important payers believed they were on a federal government watch list. (See sidebar below for details.) Payers conduct claims audits behind the scenes and labs are unaware that their test claims are being audited. In the most common scenario, either the pay­er’s auditing department or an outside auditing service takes a small sampling of claims and runs them through an algo­rithm. Thepayer then extrapolates the data into a prediction of all claims filed by that lab. If the audit turns up something amiss, the payer will... Read The Dark Report article at https://hubs.ly/Q02GNzmj0 Not already a subscriber? Sign up for a FREE 14-Day Trial at https://hubs.ly/Q02GNFSM0 Need A Group Membership? Company Discounts are Available! Get more information now at https://hubs.ly/Q02GNzCc0

An interesting deficiency case where how indications statement is written affected the required clinical evidence. Read the document below for the insight! #mdr #indications #clinicalevidence

What factors should clinicians consider when deciding to use a drug off-label? Yesterday I sat down with master repurposing clinician Dr. Luke Chen to discuss this. Here are several factors that come to mind: 1. Safety Profile: How safe is the drug? The patient’s overall health and potential risks are crucial considerations. 2. Severity of the Disease: How severe is the disease? The urgency of the situation often influences the willingness to try new treatments. 3. Mechanism of the Drug: Is there a plausible connection between the drug’s mechanism and the disease? Understanding this connection is crucial. 4. Clinical Data: Is there clinical data suggesting the drug has been effective in similar cases? Prior usage can provide valuable insights. 5. Cost of the Drug: The drug’s cost can be a significant factor. If it's exorbitantly expensive, it might change the decision-making process. 6. Patient’s Current Condition: Consideration of the patient’s current state in their disease course is essential. The decision might differ based on their immediate health status. What other factors do you think are important when considering off-label drug use? I’d love to hear your thoughts! #DrugRepurposing #PatientCare #ClinicalPractice #OffLabel

What does a KRI Stands for in clinical trials?🤔 In clinical trials, KRI stands for Key Risk Indicator. KRIs are metrics used to identify and monitor potential risks that could impact the success or integrity of the trial. These indicators help in proactively managing and mitigating risks to ensure the trial is conducted according to protocol, regulatory requirements, and Good Clinical Practice (GCP) standards. Key Risk Indicators typically include: 1. Protocol Deviations. 2. Patient Enrollment. 3. Data Quality. 4. Adverse Events. 5. Site Performance By regularly analyzing these KRIs, sponsors and investigators can identify potential issues early, implement corrective actions, and ensure the trial's success and integrity. #clinicaltrials #KRI #Keyriskindicator #CAPA #clinicalresearch

One of the key highlights from the latest report from Milken Institute is that #clinicaltrials are not always close to high-prevalence populations. There are “high-prevalence remote counties” that contain populations in the top quarter of disease prevalence and are over 60 miles from the nearest trial county. These locations are high-priority places for expansion of clinical trials. #Pharma and #CROs should take note when they are selecting #sites and leverage #digitaltechnologies to reach those patients in their #community/#rural settings. This is key for your #DiversityActionPlans which are now required as per the FDA final regulatory guidance released this week. “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert Califf M.D. Access the full report and a wonderful interactive map here: https://lnkd.in/gidVzQW9

As healthcare professionals, we face the ongoing challenge of combating the opioid epidemic. Fentanyl testing is a crucial tool in our arsenal, aiding in accurate diagnosis and patient care. The Fentanyl Test Cartridge stands out with its reliability and ease of use, making it an indispensable asset for any medical practice. Here's why: ✔ FDA and CLIA Waived: This test meets rigorous standards, providing peace of mind with every result. ✔ Affordable Pricing: At just $1.09 per cartridge, it offers an economical solution without compromising accuracy. ✔ Ease of Use: Designed with straightforward instructions and minimal required materials, this test is accessible for all healthcare providers. Utilizing the Fentanyl Test Cartridge allows for better management of patients who may be at risk of opioid misuse. Quick, accurate results mean timely and effective intervention, significantly improving patient outcomes.  By incorporating fentanyl testing into your practice, you're taking a significant step toward addressing a critical issue in today's healthcare landscape. Visit 12PanelNow.com Today! Learn more: https://lnkd.in/e2icNXWS  . . . #12paneldrugtest #12paneldrugtestnearme #whatisa12paneldrugtest #12paneldrugscreentest #12PanelNow #12panelurinedrugtest #12paneldrugtesting

Want to learn more about estimators of absolute and relative AE risk? And which (biased or unbiased) estimators are recommended in pertinent clinical trial guidelines? I have posted about the SAVVY project here before, see links in comments. We have now summarized key methods and results from SAVVY in a short (open-access!) overview paper that was posted online today by "Trials". Our conclusions, reiterating messages from the summarized papers, are: - The choice of the estimator of the cumulative AE probability and the definition of competing events are crucial. - Whenever varying follow-up times and/or CEs are present in the assessment of AEs, we recommend using the Aalen-Johansen estimator (AJE) with an appropriate definition of CEs to quantify AE risk. - There is an urgent need to improve pertinent clinical trial reporting guidelines for reporting AEs so that incidence proportions or one minus Kaplan-Meier estimators are finally replaced by the AJE with appropriate definition of CEs. #biostatistics #safety #benefitrisk Jan Beyersmann Tim Friede Claudia Schmoor Regina Stegherr

Regulatory aspects of Clinical Development and Analyzing Clinical endpoints. One of the critical parts of assembling a product’s is the researching and planning of clinical endpoints. Endpoints are measures intended to reflect the effects (efficacy endpoints) or safety (safety endpoints) of a drug or device. They include assessments of clinical events (e.g., stroke, pulmonary exacerbation, venous thromboembolism), outcomes (e.g., final result of treatment long term, mortality, tumor resolution, cure of disease, remission), patient symptoms (e.g., pain, dyspnea, depression), measures of function (e.g., ability to walk or exercise), adverse events or surrogates of these effects or symptoms; clinical outcomes are considered the most reliable endpoint.1 One of the critical parts of assembling either a product’s “Strategy Playbook” or “Clinical Development Plan” is the researching and planning of endpoints from Phase 1 through 3, including navigating through FDA’s understanding and interpretation of the laws and definitions. #pharmaindustry #regulatoryaffairs #clinicaltrials #endpoints #assessments