Big Pay Rules On Deck As Election Nears

Stakeholders await key Medicare pay rules that could be out by the end of this week or early next week, including the final physician fee rule, which could solidify cuts of 2.8% or more that lawmakers from both parties have already said they hope to reverse in the lame duck; the final rules for outpatient hospitals is also on deck, as are those for home health and end-stage renal disease. Congress’ Medicaid advisors will also be convening a two-day meeting...
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Health Insider
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Generics Anticipate Difficulties As Likely BIOSECURE Passage Looms

The BIOSECURE Act is expected to be included in a legislative package before the end of the year, and legal experts on the generic drug industry are warning that the bill, which aims to cut off federal contracting with biotech companies tied to adversarial countries, will be costly, technically complex and likely lead to more drug shortages. Politico reported this week that, according to an aide, House Speaker Mike Johnson (R-LA) will push for inclusion of BIOSECURE in the...
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Generics Anticipate Difficulties As Likely BIOSECURE Passage Looms

The BIOSECURE Act is expected to be included in a legislative package before the end of the year, and legal experts on the generic drug industry are warning that the bill, which aims to cut off federal contracting with biotech companies tied to adversarial countries, will be costly, technically complex and likely lead to more drug shortages. Punchbowl recently reported that, according to an aide, House Speaker Mike Johnson (R-LA) will push for inclusion of BIOSECURE in the must-pass National...
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FDA Issue: 
FDA Week - 11/01/2024
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Vol. 30, No. 44
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Study Links Ozempic To Lower Alzheimer’s Risk, Expert Questions Method’s Validity

A new observational study found Novo Nordisk's diabetes and weight-loss drug Ozempic lowered the risk of Alzheimer’s in type-2 diabetes patients, coming as Novo Nordisk separately conducts its own Phase 3 clinical trial on oral semaglutide to treat early-stage Alzheimer’s disease. But a geriatrician alleges the observational research, published Oct. 24 in The Journal of the Alzheimer’s Association , is “significantly flawed” due to potential selection bias. Researchers at Case Western Reserve University analyzed medical records of over 1 million...
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Biden Admin Will Launch Pilot To Stem Pediatric Oncology Drug Shortages

The White House on Monday (Oct. 28) announced the Biden administration will launch a private sector pilot program aimed at ensuring uninterrupted access to seven pediatric cancer medications amid ongoing product shortages. The End Drug Shortages Alliance, first established in 2021 by the healthcare services company Vizient and chaired by Children’s Hospital Association Vice President of Pharmacy Terri Lyle Wilson, will coordinate with multiple children’s hospitals and drug industry experts at the US Pharmacopeia, and eventually issue a report on...
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Biden Admin Will Launch Pilot To Stem Pediatric Oncology Drug Shortages

The White House on Monday (Oct. 28) announced the Biden administration will launch a private sector pilot program aimed at ensuring uninterrupted access to seven pediatric cancer medications amid ongoing product shortages. The End Drug Shortages Alliance, first established in 2021 by the healthcare services company Vizient and chaired by Children’s Hospital Association Vice President of Pharmacy Terri Lyle Wilson, will coordinate with multiple children’s hospitals and drug industry experts at the US Pharmacopeia, and eventually issue a report on...
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FDA Issue: 
FDA Week - 11/01/2024
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Vol. 30, No. 44
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Baxter Ramps Up Production, FDA Extends IV Drug Expiration Dates

Baxter International will likely resume standard production on its highest-throughput manufacturing line for IV solutions, the company said in a statement Monday (Oct. 28), after its facility in North Carolina was flooded during Hurricane Helene, leading to shortages of several IV drug products. FDA is also allowing shelf-life extensions for several of Baxter’s IV drug products, and the company says it may soon be able to provide drugs to more peritoneal dialysis patients after limiting new patients to children only...
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Vaccine Advocates Emphasize Benefits As Trump Vows To Let RFK Jr. ‘Go Wild’

As former president Donald Trump vows to give a major purveyor of vaccine misinformation a role in a potential second administration, the organization Champions for Vaccine Education, Equity and Progress (CVEEP) is emphasizing the importance of vaccine access in preparing for future pandemics. CVEEP released results this month from its 2024 State of Infectious Disease Preparedness Survey showing large majorities of consumers (83%) and pharmacists (93%) believe vaccines protect them from future public health threats. Most consumers (93%) and pharmacists...
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FDA Issue: 
FDA Week - 11/01/2024
FDA Volume: 
Vol. 30, No. 44
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Trump Supports Tax Credits For Family Caregivers

Republican Presidential Candidate Donald Trump on Sunday (Oct. 27) said he would boost at-home care if elected president, but unlike his Democratic rival’s recently announced plan to do so via a new Medicare benefit, Trump would give a tax credit to family caregivers who take care of a parent or other family member. “It’s about time that they were recognized,” Trump said during a rally in New York City. A Trump campaign spokesperson, Karoline Leavitt, told USA Today Trump...
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CMS Issue: 
Inside CMS - 10/31/2024
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Vol. 27, No. 44
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Baxter Ramps Up Production, FDA Extends IV Drug Expiration Dates

Baxter International will likely resume standard production on its highest-throughput manufacturing line for IV solutions, the company said in a statement Monday (Oct. 28), after its facility in North Carolina was flooded during Hurricane Helene, leading to shortages of several IV drug products. FDA is also allowing shelf-life extensions for several of Baxter’s IV drug products, and the company says it may soon be able to provide drugs to more peritoneal dialysis patients after limiting new patients to children only...
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FDA Issue: 
FDA Week - 11/01/2024
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Vol. 30, No. 44
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