E&C Clears Animal Drug User Fee Bill, Without Animal Feed Proposal

The House Energy & Commerce Committee on Wednesday (May 24) unanimously passed legislation that would reauthorize FDA’s animal drug user fee program, give HHS authority to remove animals from the “major species” list and require FDA to update Congress on agency efforts to ensure proper prescribing of antibiotics in veterinary medicine. The legislation, The Animal Drug User Fee Amendments of 2023 (H.R. 1418), must be passed by Sept. 30 for the fifth iteration of FDA’s animal drug user fee and...
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FDA Issue: 
FDA Week - 05/26/2023
FDA Volume: 
Vol. 29, No. 21
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Democrats Split Over E&C Bill To Codify Medicaid Value-Based Purchasing

House Energy & Commerce Democratic leadership on Wednesday split over legislation to codify permission for state Medicaid programs to use value-based purchasing arrangements with drug makers for high-costs cell and gene therapies, as health subcommittee ranking Democrat Anna Eshoo (CA) backed the bill while full committee ranking Democrat Frank Pallone (NJ) said the bill is unnecessary and could have unintended consequences. The bill, which passed the committee 31-19, contains a provision that would codify a Trump-era regulation and change the...
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IDP Issue: 
Inside Drug Pricing - 05/29/2023
IDP Volume: 
Vol. 6, No. 22
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House Pursues National Broadband Strategy; Senate Eyes Effective Broadband Programs

House Republicans are pushing for a national, coordinated plan for expanding broadband to unserved and underserved areas using the billions of dollars already allocated across more than 100 federal and state agency programs, and senators are sifting through the overwhelming number of broadband programs and legislation to target which programs would be most effective in expanding internet access for telehealth use. Lawmakers in both the Senate and House are committed to pursuing broadband legislation to prevent deployment errors that have...
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Broadband May Impact NTIA Reauthorization, Lawmakers Say

As a group of bipartisan lawmakers on the House Energy & Commerce Committee push for a reauthorization of National Telecommunications and Information Administration’s statutory tools for the first time since 1993, the diverse number of broadband expansion programs under the agency’s purview could influence reauthorization costs and specifics. As lawmakers become more hesitant about continuing audio-only provisions permanently beyond the omnibus extension, rural patients need broadband over the next couple of years to furnish audio-video appointments. E&C oversight subcommittee on...
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ATI, Arnold Ventures Tout Person-Centered Recs To Improve Duals Plans

ATI Advisory laid out a set of changes policymakers could explore to improve the enrollment experience, benefits and coverage for those dually eligible for Medicare and Medicaid services while the Senate health committee ranking Republican Bill Cassidy (R-LA) solicits of feedback on draft legislation to improve those beneficiaries’ care. “Central to what we heard is that individuals who are dual eligible and their caregivers seek a person-centered and seamless consumer experience,” the report says. ATI’s May 17 report, which was...
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CMS Issue: 
Inside CMS - 05/25/2023
CMS Volume: 
Vol. 26, No. 21
Author: 

Advocates Press Against HHS’ Defense Of Copay Accumulators As Suit Heats Up

Patient advocacy groups suing over a 2021 rule that allows insurers to use copay accumulators urged a federal district court earlier this month to reject HHS’ claim that now isn’t the right time for a lawsuit because the department hasn’t made an overarching decision on copay accumulators but simply removed a prohibition. In a May 1 brief in the case -– HIV and Hepatitis Policy Institute et al v. United States Department of Health and Human Services et al...
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CMS Unveils Medicaid Prescription Price Transparency Proposals

CMS wants to provide state Medicaid programs with a new drug price verification survey tool, require the inclusion of drug payment information in contracts between Medicaid-managed care plans and pharmacy benefit managers (PBMs), and get ahead of potential misclassifications of brand name and generic drugs so states can receive the appropriate rebate amounts they’re owed, according to CMS’ notice of proposed rulemaking (NPRM) released Tuesday (May 23). The proposed rule aims to improve the Medicaid Drug Rebate Program (MDRP) and...
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CMS Issue: 
Inside CMS - 05/25/2023
CMS Volume: 
Vol. 26, No. 21
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Bertagnolli’s Push For Trial Reforms, Data Sharing Aligns With FDA

National Institutes of Health Director-nominee Monica Bertagnolli’s decades-long work to help reform the U.S. clinical trial enterprise, including in the cancer space, and enhance data-sharing across the research community likely will be a boon to the Biden administration, and especially FDA, according to HHS and advocates, as the agency works to increase diversity in clinical trials, streamline trial designs, break down currently existing data silos and meet the goals of the Cancer Moonshot program. Bertagnolli, who has served as director...
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FDA Issue: 
FDA Week - 05/26/2023
FDA Volume: 
Vol. 29, No. 21
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Advocates Press Against HHS’ Defense Of Copay Accumulators As Suit Heats Up

Patient advocacy groups suing over a 2021 rule that allows insurers to use copay accumulators urged a federal district court earlier this month to reject HHS’ claim that now isn’t the right time for a lawsuit because the department hasn’t made an overarching decision on copay accumulators but simply removed a prohibition. In a May 1 brief in the case -– HIV and Hepatitis Policy Institute et al v. United States Department of Health and Human Services et al...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 05/29/2023
IDP Volume: 
Vol. 6, No. 22
Author: 

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