Dems Pounce As Trump Revives ‘ACA Repeal, Replace’ Talk; Congress Returns To Year-End Uncertainty

Fresh from the pre-Thanksgiving news that more than 4.5 million Americans have already signed up for Obamacare, the White House, the Biden re-election campaign and other Democratic stakeholders pounced on former President Donald Trump’s aim to once again try repealing the Affordable Care Act if he returns to office. The Democrats are highlighting surveys that list the various impacts of a repeal and show the law has widespread support among both parties. In a post on Truth Social over the...
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CMS Issues Final Guidance On IRA’s Part D Discount Program

CMS posted final guidance on Medicare Part D’s new Manufacturer Discount Program, a feature of the Inflation Reduction Act’s (IRA) Part D benefit redesign, that clarifies how the agency will determine which drug companies qualify for multi-year phase-in periods to apply the discounts. The guidance also revises CMS’ definition of applicable Part D drugs to exclude drugs selected to undergo Medicare price negotiations for a new maximum fair price during the price applicability period for said drug, among other changes...
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Stakeholders Dispute OIG Claim That Recent Fraud Was Caused By RPM

HHS’ Office of the Inspector General issued an alert Nov. 22 notifying Medicare beneficiaries of a fraud scheme that improperly bills Medicare for the monitoring, set up and education codes of remote monitoring devices that are not medically necessary. But virtual care advocates say the scheme OIG points to is not actually RPM fraud, but rather durable medical equipment and pharmacy fraud. One virtual care advocate compared the RPM fraud alert with the HHS OIG and Justice Department’s telemarketing DME...
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Stakeholders Dispute OIG Claim That Recent Fraud Was Caused By RPM

HHS’ Office of the Inspector General issued an alert Nov. 22 notifying Medicare beneficiaries of a fraud scheme that improperly bills Medicare for the monitoring, set up and education codes of remote monitoring devices that are not medically necessary. But virtual care advocates say the scheme OIG points to is not actually RPM fraud, but rather durable medical equipment and pharmacy fraud. One virtual care advocate compared the RPM fraud alert with the HHS OIG and Justice Department’s telemarketing DME...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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Inside CMS - 11/30/2023
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Vol. 26, No. 48
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Compact Looks To Ease Interstate Licensing Process By Upping Tech Platform

The Interstate Medical Licensure Compact (IMLCC), one of the country’s largest medical practitioner licensure compacts, announced a partnership with software company Mocingbird to implement a provider-focused platform that will simplify the licensure process, certification compliance and continuing medical education for compact physicians. Licensure compacts already streamline and reduce costs for medical practitioners seeking licenses in other states. The implementation of an enhanced physician portal, which will centralize participating physicians’ data and create a user-friendly interface, is likely to further simplify...
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Hospitals Call For Team-Based Workforce Restructuring, Pipeline Updates

The American Hospital Association is calling for a team-based restructuring of the health care workforce, along with additional wellbeing and safety efforts that employers and policymakers should implement, as part of its 2024 health care workforce environmental scan released in mid-November. AHA’s solutions are part of a years-long effort to revitalize the workforce as pandemic-related pressure strained workers in the field, drove prospective providers out of the pipeline, and pushed others into retirement, all the while driving hospital margins into...
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CMS Issue: 
Inside CMS - 11/30/2023
CMS Volume: 
Vol. 26, No. 48
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CDER Biosimilar Research Pilot Focused On Reducing Human Trials

FDA is continuing to focus on reducing the use of human trials to support biosimilar product applications as it seeks feedback on research priorities in its BsUSA III Regulatory Science Pilot Program. The topic came up at a meeting FDA’s drug center held Oct. 16 to review the current status of the program and progress made since the authorization of the Biosimilar User Fee Amendments of 2022. It held holding a second meeting Oct. 26 in person at FDA’s White...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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Despite Quality Concerns, Califf Says FDA Won’t Publicize Form 483s

FDA Commissioner Robert Califf said the agency will not be sharing routine forms issued to drug makers about possible manufacturing issues despite some calls to publicize them, but will strive for more transparency in other ways as the agency works to address quality issues that have led to drug shortages. Califf broached the issue at the Healthcare Distribution Alliance’s board of directors meeting Nov. 15. According to his prepared remarks published by FDA, Califf said some stakeholders have asked FDA...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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Number Of FDA Remote Inspections Low Despite New Draft Guidance

FDA has conducted few remote inspections since April 2021, despite emphasizing in a recent draft guidance that the practice, established during the COVID-19 pandemic, was successful in meeting some inspection needs and is being continued. In a post on law firm Hyman, Phelps & McNamara’s FDA Law Blog , director Douglas Farquhar and senior regulatory device and biologics expert Richard Lewis wrote that FDA has performed less than 10 remote interactive inspections at drug facilities in the last 30 months...
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FDA Issue: 
FDA Week - 12/01/2023
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Vol. 29, No. 48
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