E&C Shows Bipartisan Backing To Reauthorize Alzheimer’s Support Bills

House Energy & Commerce Committee lawmakers Wednesday (Feb. 14) touted 19 bipartisan health bills, including four supporting Alzheimer’s disease patients and family caregivers, while on the same day FDA Commissioner Robert Califf hinted at an event the agency could soon approve another anti-amyloid drug to treat the disease. The bills considered for renewal at Wednesday’s legislative hearing include the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer's Act, which would authorize continuing a number of programs supporting states, local health...
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FDA Issue: 
FDA Week - 02/23/2024
FDA Volume: 
Vol. 30, No. 8
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NIST, HHS Update Cyber Guide On HIPAA Implementation

The National Institute of Standards and Technology has finalized an update to a resource guide for implementing the Health Insurance Portability and Accountability Act Security Rule, in partnership with HHS. The revised guide published on Wednesday (Feb. 14) provides practical guidance and resources that regulated entities of all sizes can use to ensure cybersecurity of electronic protected health information in accordance with the HIPAA Security Rule , according to NIST. The guide was initially published in 2005 and revised for...
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CMS Issue: 
Inside CMS - 02/22/2024
CMS Volume: 
Vol. 27, No. 8

FTC, HHS Probe GPO, Wholesaler Roles In Drug Shortages

The Federal Trade Commission and HHS have launched an investigation into whether the business practices of pharmaceutical chain middlemen like group purchasing organizations (GPOs) and wholesalers are contributing to drug shortages. The agencies are seeking stakeholder input on the issue as the Biden administration grapples with how to avert chronic generic drug shortages. The joint request for information (RFI) comes as the generic drug lobby and consumer advocacy groups raise concerns that three wholesalers are controlling 90% of the purchasing...
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FDA Issue: 
FDA Week - 02/16/2024
FDA Volume: 
Vol. 30, No. 7
CMS Issue: 
Inside CMS - 02/22/2024
CMS Volume: 
Vol. 27, No. 8
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Third Way Pushes For Charity Care Law Amid Hospital Extender Turmoil

Correction Appended Third Way is calling on Congress to pass a national charity care law that would rein in hospitals’ debt collection practices, establish minimum requirements for charity care, and simplify how charity care is provided as part of a new report released Tuesday (Feb. 13). The center-left think tank points to data showing non-profit hospitals’ tax breaks have outpaced their charity care, echoing findings by the Senate health committee in late 2023 that hospitals call misleading...
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CMS Issue: 
Inside CMS - 02/22/2024
CMS Volume: 
Vol. 27, No. 8
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HHS Announces New Maternal Health Collaboration With Six States

HHS is launching a new “Postpartum Maternal Health Collaborative” with leaders of six states, the department announced Wednesday (Feb. 14), which will aim to develop a better understanding of postpartum health challenges and work toward solutions. The collaborative will include “state experts, local providers, community partners, and federal experts,” according to HHS’ announcement . The states participating are Iowa, Massachusetts, Maryland, Michigan, Minnesota and New Mexico. At the same time, the National Governors Association is launching its new “Improving Maternal...
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CMS Issue: 
Inside CMS - 02/22/2024
CMS Volume: 
Vol. 27, No. 8
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NCOIL Advances Compromise Dental Loss Ratio Model

The association representing state insurance legislators last month advanced a model law that, if enacted, would require dental plans to report how much of their premium revenue is spent on claims and let regulators address outliers -- though the proposal does not require plans to meet an 85% loss ratio as initially proposed. The model law, sponsored by West Virginia Delegate Steve Westfall and Illinois Representative Rita Mayfield, emerged after more than a year of discussion among the National Council...
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CMS Issue: 
Inside CMS - 02/22/2024
CMS Volume: 
Vol. 27, No. 8
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Warner Pushes For Permanent Telehealth Leg Before End Of 2024

Sen. Mark Warner (D-VA) called for passage of permanent telehealth legislation to avoid telehealth becoming “just another extender” at the National Rural Health Association’s meeting in Washington Tuesday (Feb. 13). As telehealth lobbyists scramble to convince Congress to extend telehealth provisions beyond the end of 2024, lawmakers remain divided on whether to pass permanent telehealth legislation or issue another extension of the COVID-19 pandemic-era waivers before patients face a telehealth cliff at the end of the year. Warner urged attendees...
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FDA, Stakeholders Say Benefits Of CAR-T Treatment Outweigh Risks

As FDA investigates secondary cancers associated with chimeric antigen receptor T-cell (CAR-T) therapies, cell and gene therapy stakeholders say the benefits of the novel treatments continue to outweigh the risks and providers should keep offering them to the critically ill patient population. In January, FDA published safety labeling changes for six CAR-T products. The makers of the therapies will need to warn about the possibility of new blood cancers developing following a review of reports of the adverse events, known...
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FDA Issue: 
FDA Week - 02/16/2024
FDA Volume: 
Vol. 30, No. 7
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Geography Should Not Be A Red Flag On Telehealth Rx, Groups Say

A group of telehealth stakeholders wrote to the Drug Enforcement Administration Feb. 14 asking it to make clear that the geographical distance between a patient and a prescriber should not be a red flag when filling controlled substance prescriptions. Pharmacists are already hesitant to fill the prescriptions because of increased scrutiny resulting from the opioid epidemic, they say, which has limited access to telehealth prescriptions. The groups, which include virtual care lobbyists, telehealth opioid use disorder treatment companies and an...
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Bucshon: Expect Short-Term Doc Fix By March

Congress will likely mitigate pay cuts under the 2024 physician fee schedule by early March, but a long-term doc fix will probably take a few more years, Rep. Larry Bucshon (R-IN) said during the American Medical Association’s National Advocacy Conference on Tuesday (Feb. 13). The continuing resolution Congress settled on in January didn’t address the Medicare pay cuts -- much to providers’ disappointment -- but Bucshon has remained optimistic that lawmakers will be able to include at least temporary adjustments...
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CMS Issue: 
Inside CMS - 02/15/2024
CMS Volume: 
Vol. 27, No. 7

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