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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 * Midterm Elections 2022 * Biden Health Agenda * 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 Wednesday, November 9, 2022 GET 30 DAYS FREE Sign up for 30 days of no-obligation access for all the essential news during this critical time -- you'll be able to choose one of our online services as part of your trial: Inside CMS, FDA Week, Health Exchange Alert, Inside Drug Pricing or Inside TeleHealth. HOME ELECTION NEWS GOP TEES UP HEALTH CARE OVERSIGHT FOR NEXT CONGRESS House Republicans, who could take control of the House though many of Tuesday’s races have yet to be called, are laying plans to step up oversight of Democrats’ policies on Medicare, Medicaid, the COVID-19 public health emergency and the Affordable Care Act in lieu of pushing a major health care legislative agenda that could be blocked by presidential vetoes, lobbyists say, with the possible exceptions being Medicare pay system and telehealth reforms that could draw bipartisan support. MEDICAID EXPANSION NEARS 40 STATES AFTER SOUTH DAKOTA APPROVAL SENATE APPROPS PREPARES FOR LEADERSHIP SHIFT NEXT YEAR LATEST PANDEMIC NEWS FAMILIES USA CALLS FOR ONE MORE PUBLIC HEALTH EMERGENCY EXTENSION Consumer advocacy group Families USA Tuesday (Nov. 8) called on the Biden administration to extend the public health emergency (PPHE) beyond Jan. 11 to give states more time to prepare to reverify about 90 million Medicaid beneficiaries once the emergency ends. PFIZER, BIONTECH SAY OMICRON SHOT OFFERS MORE PROTECTION THAN ORIGINAL VAX TRIPS CHAIR LAMENTS LACK OF PROGRESS IN COVID-19 DEAL EXPANSION TALKS More Coverage → LATEST NEWS GOP E&C Leaders Criticize CDC After Monkeypox Test Returns False Negatives Republican leaders of the House Energy & Commerce Committee are linking the Centers for Disease Control and Prevention’s flawed testing rollout for monkeypox to a lack of public confidence in the agency in a letter to director Rochelle Walensky requesting more information on testing difficulties and previewing a likely piece of the GOP’s health oversight agenda should Republicans regain control of the lower chamber in Tuesday’s elections. Dialysis Stakeholders Say CMS Pay Bump Not Enough, Turn To Congress Kidney care experts are concerned CMS’ unprecedented increase in pay rates for renal dialysis services still isn’t enough to account for ongoing workforce shortages that have hamstrung the sector, and with less than 60 days remaining until the rule kicks in, stakeholders would like to see Congress undo the Supreme Court’s July dialysis ruling as a substitute fix. MedPAC Weighs Options For Standardizing MA Supplemental Benefits Medicare Payment Advisory Commission members on Friday (Nov. 4) discussed how to standardize a set of three or four benefits -- potentially hearing, vision and dental services -- in Medicare Advantage for a future recommendation to Congress after MedPAC staff found that people have a more challenging time comparing plans when they have a variety of options. MedPAC Mulls Future Medicare Coverage Of Social Determinants Congress’ Medicare pay advisors are weighing how Medicare should tackle social determinants of health, including how big of a role the program should have, with some commissioners saying at a meeting Thursday (Nov. 4) that the program’s finite resources need to be focused on health services while others said they don’t want Medicare to close the door to services not directly related to health. Warner Floats Requiring Cyber Controls To Participate In Medicare Senate Intelligence Chairman Mark Warner (D-VA) says the health care sector is uniquely vulnerable to cybersecurity attacks, and Thursday (Nov. 3) floated potential solutions including making cybersecurity requirements a condition for providers to participate in Medicare, setting up a health care cyber framework, reforming HIPAA, tightening software security, and improving coordination among federal health and cyber officials. Panel Backs FDA Plan To Expand KASA Platform To New Drugs, Biologics A panel of FDA advisers unanimously supported the agency’s plan to expand its generic drug quality review platform to also include new drugs, biologics and post-approval changes over the next five years. FDA: Lilly’s COVID Drug Not Expected To Work Against BQ.1, BQ.1.1 FDA on Friday (Nov. 4) cautioned health care providers that Eli Lilly’s COVID-19 monoclonal antibody bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1, which comprise about 17% and 19% of coronavirus cases in the United States, respectively. Carter Hopes To Unify GOP On Medicare, Dems’ Seize Issue In Campaign Rep. Buddy Carter (R-GA), who wants to lead the Budget Committee if the GOP takes House control, hopes to unify his party under one set of Medicare reform proposals, his office told Inside Health Policy, while Democrats campaign on a message that Republicans would cut back Medicare even though some GOP leaders have distanced themselves from Sen. Rick Scott’s (R-FL) controversial call to re-up most legislation every five years and the Republican Study Committee’s blueprint to raise the program’s minimum age among other big reforms. Pfizer, BioNTech Launch Phase 1 Study Of Combo COVID And Flu Vax Pfizer and BioNTech are the latest companies to begin studying a combination COVID-19-flu vaccine, BioNTech announced Thursday (Nov. 3) as public health officials warn of a potential “tripledemic” -- a combination of severe flu, respiratory syncytial virus (RSV) and continued COVID-19 cases -- this fall. Remanufacturing Guide Tops FDA’s 2023 Device Guidance Agenda FDA’s remanufacturing draft guidance is at the top of the device center’s guidance agenda for fiscal 2023, indicating the agency could publish the highly-anticipated final version of the document this fiscal year. More News → CORONAVIRUS Our complete coverage of COVID-19 INSIDE DRUG PRICING PORTER CRITICIZES RISING CANCER DRUG PRICES AHEAD OF ELECTIONS In a tight race days before the election, Rep. Katie Porter (D-CA) published a report on rising cancer drug prices and touted Democrats’ new drug pricing law. SCOTUS ACCEPTS ONE OF TWO CASES WITH SIMILAR DRUG PATENT DISPUTES Full Coverage → Not a subscriber? Contact customer service at ihp@iwpnews.com or 703-416-8505. For a free trial, contact Steve Reilly. HEALTH REFORM DEBATE Analyst: Bright Health’s Exit Creates Opportunity For Other Big Exchange Players Key exchange insurers, including Centene, United, CVS Health and Cigna, are a well-positioned to glean new consumers due to Bright Health Group’s recent decision to drop out of the exchange market, which has left about a million consumers having to find new coverage, a health care analyst says in a recent memo. Becerra: Regs Will Push Culturally, Linguistically Competent Health Care KFF: Employer Plan Costs To Jump; Mental Health Demand Grows Insurers, Advocates At Odds On Standardized Plan Policy More Health Reform News → DOCUMENTS Health Experts Urge Congress To Exclude PASTEUR From NDAA Vermonters Approve Constitutional Amendment To Protect Abortion In Landslide Vote The John A. Hartford Foundation: “Americans Want MORE Caregiver Support!” NIH: E-Cigarettes Linked With Blood Vessel Damage FDA Alerts Health Care Professionals Of Risks To Patients Exposed To Xylazine In Illicit Drugs Administrative Simplification: Proposed Modifications To The National Council For Prescription Drug Programs Retail Pharmacy Standards And Adoption Of A New Pharmacy Subrogation Standard Medicaid Managed Care Your Plans Working To Improve Health Equity New Certified Independent Dispute Resolution Entities Announced FDA Publishes Draft Guidance On Sameness Evaluations In ANDAs HHS Lists Services And Supports For Those With Long COVID Vaxxas Announces Initiation Of Phase I Clinical Study Of First Needle-Free COVID-19 Vaccine (HexaPro) Delivered Using High-Density Microarray Patch (HD-MAP) CMMI Unveils New Strategic Vision More Documents → ABORTION POLICY ROUNDUP CMS PROBES EMTALA ABORTION VIOLATION; OBGYNS SUE IN AG FOR PRIVACY VIOLATIONS; MATERNAL HEALTH OUTCOMES DETERIORATE POST-DOBBS While Americans on Tuesday (Nov. 8) define the next iteration of the abortion landscape by heading to the polls over abortion rights and other hot health care topics, litigation over patient privacy and emergency care are in full swing. Full Coverage → Stakeholders Mixed On VA Plan To Let Trainees Conduct Telehealth Find out how to subscribe › FINAL PHYSICIAN FEE AND OUTPATIENT RULES CMS INCREASES 2023 CUTS IN FINAL PHYSICIAN FEE RULE Doctors are upset that CMS slightly increased pay cuts Tuesday (Nov. 1) in the final 2023 Medicare physician fee schedule, to about 4.5% for next year, and they are turning to Congress to mitigate the impact of the regulation. HOSPITAL OUTPATIENT SERVICES GET 3.8% BUMP; AHA SAYS IT’S NOT ENOUGH CMS FINALIZES MEDICARE BEHAVIORAL HEALTH REIMBURSEMENT REFORMS MEDICARE CUTS PAY 3.09% FOR NON-DRUG OUTPATIENT SERVICES TO COVER 340B COSTS CMS CREATES PATCHWORK OF TELEHEALTH COVERAGE IN 2023 PFS FINAL HOME HEALTH AND ESRD RULES CMS INCREASES PDGM HOME HEALTH CUTS, BUT WILL PHASE THEM IN CMS finalized a 0.7% pay bump for home health providers in 2023 on Monday (Oct. 31) after the agency opted to phase in cuts based on what the agency sees as changes in behavior tied to the 2020 pay system for the sector – but although agency will only incorporate half of the behavioral adjustment cuts into providers’ 2023 pay, the agency doubled down with a slight increase to the total cuts it plans to implement across multiple rules. HEALTH EQUITY Covering the hottest new health policy debate in Washington -- in-depth reporting on the surging efforts to tackle social, racial and economic barriers to equitable health care. MedPAC Mulls Future Medicare Coverage Of Social Determinants More Coverage → Inside CMS CMS Delays Finalizing MA Risk Adjustment Rule Amid Coding Controversy CMS Increases 2023 Cuts In Final Physician Fee Rule CMS Lays Plan To Move Those Losing Medicaid To Marketplace States Tee Up Medicaid Expansion, Dialysis, Abortion Midterm Referendums Inside CMS → Health Exchange Alert Insurers, Advocates At Odds On Standardized Plan Policy Analyst: Bright Health’s Exit Creates Opportunity For Other Big Exchange Players Families USA Calls For One More Public Health Emergency Extension Becerra: Regs Will Push Culturally, Linguistically Competent Health Care Health Exchange Alert → FDA Week FDA Lacks Authority To Overhaul LDT Regs, Diagnostic Experts Say FDA Panel Backs Proposed Drug Quality Rating System To Curb Shortages Califf, Walensky Defend Use Of Paxlovid For COVID Amid Rebound Cases FDA: Increased Demand For Amoxicillin Caused Reported Shortages FDA Week → Inside Drug Pricing Health Centers Request Meeting With HHS On 340B Restrictions Pharmacies Hit By Restrictions On 340B Drug Discounts Court Refuses To Dismiss Patent Infringement Suit Over Moderna COVID-19 Vaccine Rubio Backs Importing Canadian Price Controls; Opposes US Price Controls Inside Drug Pricing → Medicare GOP Tees Up Health Care Oversight For Next Congress Dialysis Stakeholders Say CMS Pay Bump Not Enough, Turn To Congress MedPAC Weighs Options For Standardizing MA Supplemental Benefits Congress GOP Tees Up Health Care Oversight For Next Congress Medicaid Expansion Nears 40 States After South Dakota Approval Senate Approps Prepares For Leadership Shift Next Year Rx Drugs Pfizer, BioNTech Say Omicron Shot Offers More Protection Than Original Vax Panel Backs FDA Plan To Expand KASA Platform To New Drugs, Biologics FDA: Lilly’s COVID Drug Not Expected To Work Against BQ.1, BQ.1.1 Medical Devices Remanufacturing Guide Tops FDA’s 2023 Device Guidance Agenda FDA Lacks Authority To Overhaul LDT Regs, Diagnostic Experts Say Lawyer Warns Continual User Fee Hikes Could Discourage Device Innovation Budget House Passes Fiscal 2023 Minibus That Gives FDA $341M Funding Hike No Appropriations Bill Without Hyde Amendment, Republicans Say FDA Funding Bill Clears Committee With GE Meat, Russia Measures Food Safety Senate Approps Prepares For Leadership Shift Next Year Grassley: GAO To Investigate Impact Of Sole-Source Infant Formula Contracts FDA Warns Of Repercussions If Foreign Food Facilities Shun Inspectors 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 * About Inside Washington Publishers STAY CONNECTED © 2002-2022. Inside Washington Publishers | Contact Us ABOUT THIS SITE InsideHealthPolicy.com is a subscription-based news service. Access requires a subscription to one or more of our three areas of coverage (listed below), each of which includes both online and print components. New: Health Exchange Alert - Daily news and analysis on the hottest issue in health care reform – federal and state requirements for the creation of health insurance exchanges. Inside CMS - Covering Medicare and Medicaid from the inside out. FDA Week - Exclusive reporting on the Food and Drug Administration's regulation of drugs, devices, food safety and related areas. Sign up for one month of free, no-obligation access to InsideHealthPolicy.com. EXCLUSIVE, RELIABLE HEALTH POLICY REPORTING, JUST WHEN IT MATTERS MOST. NOW IS THE TIME TO TRY INSIDE HEALTH POLICY. FREE TRIAL SIGN UP FOR 30 DAYS OF FREE ACCESS.