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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FDA’s LDT Rule Puts Pressure On Congress To Act, Cassidy Alleges Rule Is Illegal

FDA on Friday (Sept. 29) unveiled its long-anticipated proposal to assert regulatory jurisdiction over laboratory developed tests, and the move immediately sparked protests from the Senate health committee’s ranking Republican that the agency is overstepping its statutory authority. “The FDA does not have the authority to unilaterally expand its regulatory jurisdiction. We saw during the pandemic how too much government interference and red tape could do more to delay lifesaving care,” said health committee ranking Republican Bill Cassidy (LA) ...
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CMS Eyes Coverage For OTC Preventive Services Without Prescription, Seeks Input

The Biden administration said Friday (Sept. 29) it intends to require individual and group health plan issuers, including employer plans, to cover over-the-counter preventive services without cost-sharing or a prescription, including birth control, tobacco cessation products and breastfeeding supplies, and seeks stakeholder input on potential challenges. The policy shift comes months after FDA approved the first OTC birth control product, at which time CMS affirmed that plans were not required to cover those products without a prescription under the Affordable...
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AI Can Solve The Health Care Workforce Crisis, But Tech Isn’t Ready

Panelists at a Duke AI and Connected Health Initiative event this week touted the ability of artificial intelligence to “super charge” clinicians, reduce clinician burnout and slow down the workforce shortage. However, artificial intelligence may not be clinician-centric enough to effectively achieve those aims now, American Medical Association President Jesse Ehrenfeld said. Myriad panelists, including Bakul Patel of Google and AMA’s Ehrenfeld, stressed that, for now, AI should be thought of as augmented intelligence rather than artificial intelligence, and that...
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House FDA Funding Bill Fails As Shutdown Standoff Continues

Updated Story A House vote on FDA funding legislation failed Thursday night (Sept. 28) as a government shutdown draws nearer, with the bill’s controversial measure to roll back telehealth availability of the abortion drug mifepristone leading some moderate Republicans to vote with Democrats against the measure. While three other appropriations bills were approved by the House’s Republican majority, the bill to fund FDA and the Department of Agriculture failed by a vote of 191-237. Twenty-seven Republicans joined...
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CBO: CMS Innovation Center’s First 10 Years Cost $5.4 Billion

The Congressional Budget Office says CMS’ innovation center increased spending by $5.4 billion in its first decade, despite initial estimates that it would save $2.8 billion during that time frame, and the office projects the center’s work will cost another $1.3 billion from 2021-2030, though it could begin to see net annual savings during that time. Joe Antos, health care fellow at the American Enterprise Institute and former assistant director for health and human resources at CBO, said the report...
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CMS To Enforce Transparency Rule’s Drug Disclosure Mandate

House Energy & Commerce leaders from both parties are cheering the Biden administration’s decision to start enforcing a Trump administration rule finalized in 2020 requiring health insurers to report data on prescription drug cost-sharing, and the lawmakers say they will continue seeking to codify the Transparency in Coverage rules through legislation. The Lower Costs, More Transparency Act, which would have done that, was on track to swiftly pass the House this week but was pulled from the suspension calendar. Under...
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