Energy & Commerce Republicans Announce Sweeping Health Hearing

Lawmakers will consider a plethora of health care bills aimed at increasing patient access to care and reducing red tape for providers, House Energy & Commerce Republicans announced Thursday (Oct. 12). The hearing comes as the lower chamber continues to struggle with its speaker selection process, all amid the ticking clock of a dwindling continuing funding resolution set to expire in just one month and health care extenders to deal with. The hearing is set for the morning of Thursday...
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CMS Issue: 
Inside CMS - 10/19/2023
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Vol. 26, No. 42
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HHS Recommends Marijuana Scheduling Change Using FDA Data

HHS has recommended to the Drug Enforcement Agency (DEA) that marijuana be moved from a Schedule I to a Schedule III drug under the Controlled Substances Act (CSA), a move that would allow it to be made available via prescription and increase its availability in medical research, winning immediate praise from Democrats who favor decriminalization. Bloomberg reported Wednesday (Aug. 30) that the recommendation was based on an extensive review of evidence on the control status of marijuana by FDA,...
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FDA Issue: 
FDA Week - 09/01/2023
FDA Volume: 
Vol. 29, No. 35
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Labs Pleased CMS Opening Process For Revising Medicare Pay Rates

Laboratories are pleased that CMS is opening the process of setting reimbursement for laboratory services, just as it is doing for physician services, which will give labs more say over pay rates. The change, which is part of the annual Physician Fee Schedule rule unveiled late last week, adds to the run of positive developments for labs that started when Congress replaced CMS' plan to change clinical lab fees based on technological changes in the patch to the Sustainable Growth...
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Newsletter Volume: 
Vol. 17, No. 28
Newsletter Issue: 
Inside CMS - 07/10/2014
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Moran Report: Outpatient Chemo Costs Higher Than Clinics

Patients who receive chemotherapy in hospital outpatient departments cost Medicare more than those who receive the same care in cancer clinics, according to a Moran Company report for the US Oncology Network and Community Oncology Alliance. The oncologists are using the report to fight CMS' proposal to pay the same rates for cancer care in physician offices and outpatient departments. The Moran report finds that outpatient chemotherapy spending per beneficiary was 25 percent to 47 percent higher than physician clinic...
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Doc Pay Patch Could Emerge In Scaled-Back Health Package; Budget Talks Continue

As the stalemate over spending bills continues with the clock ticking to a partial government shutdown Friday (March 1), the prospects for substantial health reforms to advance before election season kicks into high gear have dimmed significantly, and stakeholders now expect lawmakers to craft a narrow health package that funds expiring programs and patches the Jan. 1 Medicare pay cut to doctors, but sets aside reforms to site-neutral pay, pharmacy benefit manager business practices and other, more controversial, policies to...
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Health Insider
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Grassley Slams FTC For Slow PBM Probe, Urges Senate Vote On PBM Bills

Sen. Chuck Grassley (R-IA) is calling on Majority Leader Chuck Schumer (D-NY) to immediately hold floor votes on pharmacy benefit manager reform bills passed by key committees throughout 2023, noting a lackluster update he just received from the Federal Trade Commission on its investigation into common PBM business practices and their effect on patient and payer drug costs. Grassley’s request comes as PBM reforms appear increasingly unlikely to be part of a potential scaled-back health care package in March. In...
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Silicon Valley Tycoon: Still ‘A Couple Of Years Out’ From An AI Doctor

Technology is a couple years away from the amount of reliability needed to create an artificial intelligence (AI) doctor, lawyer or tutor, the Silicon Valley businessman Marc Andreessen told governors during the National Governors Association conference Saturday (Feb. 24). Meanwhile, North Dakota Governor Doug Burgum (R), who moderated the conference session with Andreesen, warned his fellow statesmen about how AI will revolutionize drug development, leading to longer lifespans and hurting state pension funds. Andreessen, who co-founded Netscape and currently sits...
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Governors Stress State Leadership For Regulating AI

The absence of a federal law on regulating artificial intelligence has put states in a leadership role for establishing the safeguards for this emerging technology, says the National Governors Association in a summary of a portion of its annual winter meeting last week. “With no overarching federal regulations on AI, states are taking the lead to set policies to take advantage of the benefits of AI and put safeguards in place against its risks,” says the Feb. 24 NGA statement...
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Gene Therapy Group Seeks OIG ‘Safe Harbor’ For Patient Assistance

An industry group representing companies developing cell and gene therapies is pushing the HHS Office of Inspector General (OIG) to adopt safe harbor provisions under the Federal Anti-Kickback Statute (AKS) that would allow companies to provide more assistance to patients, while a bill before the House Energy & Commerce Committee would legally establish a similar policy. Alliance for Regenerative Medicine (ARM) sent a letter to OIG on Feb. 2 asking the office to establish safe harbor provisions that would give...
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E&C Considers Bill Requiring FDA Swiftly Allow Alternatives To Animal Testing

The House Energy & Commerce Committee will consider bipartisan legislation Thursday (Feb. 29) that would mandate FDA implement within 180 days a 2022 law that allows drug sponsors to use alternatives to animal testing, coming amid growing frustration by lawmakers that the agency hasn’t updated its guidance to reflect the 2022 law. The new bill, the FDA Modernization Act 3.0 (FDAMA 3.0) or H.R. 7248 , was introduced earlier this month in a bid to force the agency to...
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