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Submission: On March 18 via manual from US — Scanned from DE
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Jump to Navigation LOGIN Username * Password * Remember me * Home * News * Daily News * Documents * Health Insider * Abortion Roundup * Special Opioid Report * Topics * Biden Health Agenda * Election 2024 * AI * Coronavirus * Abortion * Health Equity * Health Reform Debate * Opioids * Medicaid * Medicare * Rx Drugs * Medical Devices * Congress * ACOs * Emergency Response * The Courts * 21st Century Cures * Budget * Cybersecurity * Food Safety * Tobacco * User Fees * Waste and Fraud * FDA Week * Inside CMS * Inside Drug Pricing * Latest News * Documents * Health Exchange Alert * Latest News * Documents * Inside TeleHealth * About Us * About Us * Privacy Policy * Terms and Conditions * Login Help Monday, March 18, 2024 FREE TRIAL Receive 30 days of no-obligation access. SIGN UP HOME TOP STORY SENATE FINANCE LEADERS SEEK QUICK PASSAGE OF PBM REFORMS Senate Finance Chair Ron Wyden (D-OR) and ranking Republican Mike Crapo (ID) said Thursday they hope to get a key pharmacy benefit manager reform bill over the finish line in the next few days, signaling it potentially could be included in upcoming spending legislation that must be passed by March 22 to avoid a partial government shutdown. CBO SCORES E&C PBM BILL AFTER SUGGESTING DELINKING COULD SAVE LESS THAN ANTICIPATED CHANGE HEATHCARE NEWS WYDEN BACKS PENALTIES FOR PROVIDERS THAT LACK CYBERSECURITY Senate Finance Committee Chair Ron Wyden (D-OR) is backing HHS’ plan to slap penalties on hospitals and providers starting in fiscal 2029 that do not have cybersecurity procedures in place as a step to prevent future large-scale cyberattacks -- like the Change Healthcare attack -- from crippling the health care system. OCR PROBES UHG FOR HIPAA COMPLIANCE, BUT REMINDS OTHERS TO FOLLOW RULES AHIP BALKS AS HHS URGES PLANS TO PAUSE PRIOR AUTH DUE TO CHANGE ATTACK AHA SEEKS LEGISLATIVE HELP WITH CHANGE ATTACK FALLOUT LATEST NEWS Docs Say MedPAC Rec Tying Pay to Half of MEI Still Insufficient Doctors' lobbies say the congressional Medicare payment advisers’ recommendation that lawmakers tie physician pay updates to half of the Medical Economic Index fails to ensure that reimbursements will keep pace with costs and Congress must enact legislation that links pay to the full MEI. Patient Advocates Ask States To Enforce Co-Pay Accumulator Ruling Patient advocates are calling for state insurance commissioners to enforce a recent ruling by the U.S. District Court for the District of Columbia that copay assistance for prescription drugs must be counted towards insurance cost sharing. Despite Concerns, Ad Comm Members Favor Expanded CAR-T Availability Members of FDA’s Oncologic Drugs Advisory Committee (ODAC) voted Friday (March 15) to recommend the agency allow patients with multiple myeloma to access two chimeric antigen receptor T-cell (CAR-T) therapies earlier in the course of disease progression, despite FDA scientists’ concerns about the treatments potentially contributing to early deaths and members’ ambivalence about some of the data provided. BIDEN'S BUDGET REQUEST Biden Admin Rehashes Major Medicare Requests In 2025 Budget The Biden administration requests $838.8 billion in Medicare mandatory outlays for fiscal 2025 and also includes numerous nursing home, home and community-based services (HCBS) and maternal health priorities from previous budgets. Lengthy Medicaid Wishlist Laid Out In Biden’s Budget Request Biden’s Budget Hikes FDA Funding, But Becerra Says FDA Needs More More news → HOT TOPICS HEALTH REFORM Pallone, Wyden To CMS: Demand States Comply With Medicaid Eligibility & Enrollment Law Medicaid CMS: Expect Guidance On MCOs Collecting Beneficiary Signatures Health Equity Biden Kicks Off SOTU Defending Abortion Rights, IVF Medical Devices Cassidy Joins House GOP In Seeking Alternatives To LDT Rule Medicare W&M Excited About Home-Based Care, But Lacks Urgency On Telehealth INSIDE DRUG PRICING NJ Judge Shows Skepticism Of Claims Against IRA Implementation Sanders Asks Other Inhaler Makers To Follow Suit On BI’s OOP Cap INSIDE TELEHEALTH Group Counters Telehealth ‘Myths’ Spread At W&M Hearing Telehealth Privacy Act Scored At Zero Cost To Government INSIDE CMS CMS Releases Best Practices For Money Follows The Person Demo OCAN: Medicare Obesity Drug Coverage Would Have Ripple Effect FDA WEEK Califf Seeks Insurers’ Help On Gene Therapy Trials Amidst Funding Challenges FDA Seeks Input On New Section In Medical Device Cybersecurity Guidance HEALTH EXCHANGE ALERT W&M Bipartisan Duo Introduce HDHP Telehealth Coverage Bill Advocates Allege More States Violating ADA In Medicaid Renewal Processes MORE TOP STORIES FDA Launches New Plan To Regulate AI In Medical Devices FDA laid out a near-term plan to wrangle its purview to regulate artificial intelligence in medical devices by issuing new draft guidances on AI lifecycle management and marketing submission recommendations, clarifying industry best practices and launching efforts to fill gaps in AI knowledge and regulatory science. E&C GOP To Air Gripes With LDT Rule At Hearing Thursday House Republicans will air their concerns with a controversial FDA plan to assert jurisdiction over laboratory developed tests at a hearing next week, coming as FDA seeks White House approval to quickly get the rule out to avoid it becoming ensnared by GOP Congressional Review Act tactics. EPA’s Final EtO Rule Adds Longer Time Frame, Predicts Limited Medical Device Impact The Environmental Protection Agency’s long-awaited final rule on ethylene oxide sterilizers attempts to address some concerns raised by the medical device industry by instituting a slightly less stringent emissions standard than originally planned, a three-year period to come into compliance, and the possibility of temporary exemptions for devices without sterilization alternatives. BIO Cuts Ties With Member Company After Congressional Scrutiny The Biotechnology Innovation Organization announced Wednesday (March 13) that it is cutting ties with the Chinese-owned biologics company Wuxi Apptec and committing to backing a bill that would bar federal contracting with some foreign-owned companies after facing political pressure from lawmakers who say the company’s members was a cause for national security concern. MORE NEWS New FDA-Approved Indication For Wegovy ‘Good News’ For TROA Recall Authority, Notification Requirements In FDA Legislative Asks FDA Seeks More Authority To Regulate Supplements, Food FDA Pushes Legislative Proposals To Boost Generic Competition Jim Jones: FY 2024 Flat-Funding Imperils FDA’s Food Chemical Efforts More news → DOCUMENTS Wyden, Crapo Call For Swift Passage Of Bipartisan PBM Reforms FDA Releases Budget Justification, Legislative Proposals House To Take Up Burgess’ Bill On CBO Scoring Of Health Prevention Under Suspension Of The Rules New Healthsperien Report Finds 340B Drug Discounts Are Small Share Of Drug Companies’ Revenue President's 2025 Budget Request More documents → FEATURES * Daily News * Documents * Insider NEWSLETTERS * FDA Week * Inside CMS * Health Exchange Alert * Inside Drug Pricing * Inside TeleHealth TOPICS * Biden Health Agenda * Coronavirus * Abortion * Health Equity * Health Reform Debate * Budget * Congress * Cybersecurity * Emergency Response * Food Safety * Medicaid * Medical Devices * Medicare * Opioids * Rx Drugs * Spotlight on ACOs * The Courts * Tobacco * User Fees * Waste and Fraud * 21st Century Cures INSIDE HEALTH POLICY * Home * About * Terms and Conditions * Privacy Policy * Advertising on Inside Health Policy * About Inside Washington Publishers STAY CONNECTED © 2002-2024. 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