MITRE Presidential Transition Report Discusses AI Regulatory Issues

The MITRE Corporation has developed policy recommendations on artificial intelligence for whichever party controls the White House after the November election, as part of the nonpartisan, nonprofit security consultancy’s 2024 presidential transition project. “With each new presidential term comes the opportunity to reassess and enhance our approach to rapidly advancing technologies. In the realm of AI, it will be essential for the administration to stay informed about the current state of AI, its potential impacts, and the importance of advancing...
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CMS May Issue Interim Final Rule If Congress Passes Telehealth Leg After Final PFS

The upcoming final 2025 physician fee schedule will be misaligned in its telehealth policies if Congress subsequently passes an extension of pandemic-era waivers at the end of the calendar year, creating what stakeholders say is unnecessary confusion among patients and providers. Under that scenario, CMS likely would rectify the schedule and telehealth legislation through an interim final rule that could take effect immediately after implementation, the stakeholders say. Although most telehealth stakeholders consider the permanent audio-only provisions included in the...
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Advocates Applaud Senate Passage Of Patent Thicket Reform Bill

The Senate on Thursday (July 11) unanimously passed a bill that would combat drug companies' use of patent thickets and other tactics to delay the entry of generic and biosimilar competition into the drug market, a long-awaited victory for drug pricing reform advocates and lawmakers who had been calling on Senate leadership for more than a year to move this and other drug patent reforms forward to aid in lowering prescription drug costs for patients and payers. The patent thicket...
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IDP Issue: 
Inside Drug Pricing - 07/15/2024
IDP Volume: 
Vol. 7, No. 29
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House GOP Leaders To HHS: Quickly Peg Regs, Court Cases Affected By Chevron’s Demise

Key House committee GOP chairs have given HHS and other agencies until the end of the month to identify all planned and current regs and guidance documents, as well as ongoing and prior court cases, dating back to Jan. 20, 2021, where agencies relied on the Chevron deference recently shot down by the Supreme Court. House Committee on Oversight & Accountability Chairman James Comer (KY) joined fellow House GOP committee leaders in sending leaders to dozens of agencies including...
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FDA Issue: 
FDA Week - 07/19/2024
FDA Volume: 
Vol. 30, No. 29
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CMS Proposes No-Cost Hep B Vaccinations, New Fee Schedule For Preventive Drugs Like PrEP

CMS proposes to offer free hepatitis B vaccinations, set up a fee schedule for drugs covered as additional preventative services like PrEP and expand coverage of colorectal cancer screening in its draft calendar year 2025 Medicare Physician Fee Schedule unveiled Wednesday (July 10). CMS says those who have not received the hepatitis vaccine and those who don’t know their status will be covered at no cost to the individual. CMS is also allowing for pharmacies to administer the vaccine, as...
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FDA Issue: 
FDA Week - 07/19/2024
FDA Volume: 
Vol. 30, No. 29
CMS Issue: 
Inside CMS - 07/18/2024
CMS Volume: 
Vol. 27, No. 29
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Coalition To Senate Finance: Mark Up SITE Act To Address Rising Health Care Costs, Hospital Consolidation

A coalition of 26 organizations is urging the Senate Finance Committee to mark up the bipartisan Site-based Invoicing and Transparency Enhancement (SITE) Act to combat rising health care costs driven by hospital consolidation, building on the groundwork laid by the site-neutral measure in the House-passed Lower Costs, More Transparency Act (H.R. 5378). The SITE Act (S.1869) -- introduced by Sens. Maggie Hassan (D-NH), Mike Braun (R-IN) and John Kennedy (R-LA) -- would ensure Medicare reimburses providers equally for the same...
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House And Senate Advance Starkly Different FDA Approps Bills

House and Senate appropriators have advanced fiscal 2025 spending bills for FDA that are $44 million apart on discretionary funding, coming as policy watchers anticipate another continuing resolution when the current fiscal year ends Sept. 30 and Republicans reportedly eye delaying final action on spending bills in hopes of assuming control of Congress in the November elections. The GOP-led House Appropriations Committee advanced on party lines late Wednesday (July 10) a bill that would cut FDA funding by $22 million,...
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FDA Issue: 
FDA Week - 07/12/2024
FDA Volume: 
Vol. 30, No. 28
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FDA Seeks Applications For Patient Engagement Collaborative

FDA and the Clinical Trials Transformation Initiative (CTTI) are requesting applications from patient advocates interested in participating in the agency’s Patient Engagement Collaborative, which aims to engage diverse patient representatives in conversations about medical product development and regulation. The Collaborative has 16 members and employs staggered membership terms. Eight members will be replaced in fall 2024, with new members selected by FDA and CTTI. Membership is open to patients who have a personal experience with a disease or medical condition,...
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FDA Issue: 
FDA Week - 07/19/2024
FDA Volume: 
Vol. 30, No. 29
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House Bills Take Aim At Marijuana Rescheduling, Synthetic Cannabinoids

Republicans on the House Appropriations Committee are aiming to prevent the Drug Enforcement Agency (DEA) from rescheduling marijuana, with a provision attached to the Department of Justice fiscal 2025 funding bill passed Tuesday (July 9) that restricts the agencies from using funds granted to them to reschedule or deschedule the drug. The House bill would also prohibit the Department of Justice from preventing states from implementing laws regarding medical marijuana. While the rider on marijuana rescheduling is unlike to pass...
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FDA Issue: 
FDA Week - 07/19/2024
FDA Volume: 
Vol. 30, No. 29
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FDA Finalizes Guidance On Trials Of Devices For Opioid Use Disorder

FDA hopes to boost development of medical devices to treat patients misusing opioids with a guidance finalized Thursday (July 11) offering recommendations for effectively conducting clinical trials. The recommendations are intended to inform the design of clinical studies for devices that seek to treat opioid use disorder (OUD), although FDA says the recommendations may change as more information becomes available and the research community gains experience with evaluating such devices. The finalized guidance is similar to the draft published last...
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FDA Issue: 
FDA Week - 07/19/2024
FDA Volume: 
Vol. 30, No. 29
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