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Alston & Bird Health Care Week in Review - March 2021 #1 | Alston & Bird

Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS announced additional funding to support the 2021 Special Enrollment Period (SEP) for Marketplace health coverage. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On March 4, 2021, the Food and Drug Agency (FDA) issued guidance entitled,
COVID-19 Container Closure System and Component Changes. FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), ....

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Washington Healthcare Update - March 2021 #2 | McGuireWoods Consulting

340B: 266 House Legislators Want Fines for Drug Companies
Two hundred sixty-six members of the House of Representatives have told the Department of Health and Human Services that HHS should fine drug companies that deny 340B discounts to hospitals for drugs dispensed by contract pharmacies and to make drug companies pay hospitals back for discounts that were withheld. The letter says it’s the long-held position of the Health Resources and Services Administration that drug companies must provide 340B discounts to hospitals and clinics that qualify, regardless of whether hospitals dispense the drugs themselves. The letter states there are no provisions in the statute that allow manufacturers to set conditions or impede access to 340B discounts. ....

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Permanent Telehealth Expansion Gains Bipartisan Support

email article
Making the pandemic s emergency suspension of Medicare s telehealth rules permanent got overwhelming support at a virtual hearing of the House Committee on Energy and Commerce s health subcommittee on Tuesday.
Members touted their bipartisan appreciation for what the technology has done and can yet do for healthcare.
It s time to make Medicare reimbursement for telehealth permanent, said subcommittee chairwoman Anna G. Eshoo (D-Calif.) in opening the hearing. Telehealth isn t the silver bullet for the deeper problems that exist in our healthcare system, but it s demonstrated great promise for high quality, innovative care if we intentionally create legislation that fits our nation s needs. ....

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Support for telehealth Medicare reimbursement gains steam in Congress

Healthcare ....

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