Mississippi, Alabama Set Permanent Telehealth Laws

Two Southern states, Mississippi and Alabama, recently enacted laws governing how telehealth will be treated going forward after the end of state public health emergencies. The Mississippi law requires payment parity between telehealth an in-person care, but doesn’t initially include audio-only virtual care, and the Alabama law sets practice standards for a broadly defined set of telehealth services but ends a pandemic allowance that let physicians licensed outside the state practice telemedicine with Alabama patients. In Mississippi, Senate Bill 2738...
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CDC Thinks Hepatitis Cases Due To Adenovirus, But Still Probes COVID-19

Evidence is increasing that cases of acute hepatitis of unknown origin in young children are linked to adenovirus, Centers for Disease Control and Prevention officials told reporters in a briefing on Friday (May 20). But the agency also continues to investigate other factors that potentially could be linked to the cases, including COVID-19 infection and multisystem inflammatory syndrome, which the coronavirus can cause in children. Jay Butler, deputy director for infectious diseases at the CDC, said adenovirus and particularly the...
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FDA Issue: 
FDA Week - 05/27/2022
FDA Volume: 
Vol. 28, No. 21
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Inside CMS - 05/26/2022
CMS Volume: 
Vol. 25, No. 21
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FDA Approves IV Version Of Smallpox Drug As Monkeypox Emerges

FDA on Thursday (May 19) approved an intravenous version of SIGA Technologies’ smallpox drug TPOXX (tecovirimat), coming as cases of monkeypox -- which is in the same viral family as smallpox -- emerge around the world and in the United States. TPOXX is not FDA-approved to treat monkeypox, but a company official told Inside Health Policy it has been shown to work against the disease. There is no FDA-approved treatment for monkeypox, but there are currently two FDA-approved drugs...
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Monkeypox News
FDA Issue: 
FDA Week - 05/27/2022
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Vol. 28, No. 21
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FDA Rolls Out Next Stage Of Its IT, Data Modernization Efforts

FDA on Friday (May 20) announced its Enterprise Modernization Action Plan (EMAP) through which the agency hopes to develop a more standard, agency-wide -- rather than siloed and fragmented -- approach to data management and business processes. Aligning the objectives of the different centers and offices at FDA will improve efficiency and allow the agency to better manage its funding, the agency says in a Friday press release . “Successful enterprise transformation will ensure that the FDA functions not as...
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FDA Week - 05/27/2022
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Vol. 28, No. 21
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Wyden, Neal: Glitch Fix Aligns With Congressional Intent

The Democratic chairs of Congress’ tax writing committees Thursday told Treasury and IRS that they fully support the administration’s proposal to fix the so-called “family’s glitch” by basing the Affordable Care Act’s affordability test on family instead of self-only coverage, which they say is consistent with congressional intent. The letter from Senate Finance Chair Ron Wyden (D-OR) and House Ways & Means Chair Richard Neal (D-MA) comes just weeks after the GOP ranking members of both committees told Treasury and...
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CMS Issue: 
Inside CMS - 05/26/2022
CMS Volume: 
Vol. 25, No. 21
HEA Issue: 
Health Exchange Alert Weekly Report - 05/25/2022
HEA Volume: 
Vol. 10, No. 21
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CMS Approves Virginia Reinsurance Program

CMS Thursday (May 20) approved Virginia’s request to establish a state-level reinsurance program under an Affordable Care Act 1332 waiver starting in 2023. The five-year waiver is expected to lower premiums by 15.6 % and increase enrollment by 2.9% in the first year, according to Virginia’s projections, which CMS notes were verified by independent actuaries. With the addition of Virginia, CMS has now approved reinsurance programs in 17 states. Virginia’s traditional reinsurance program will reimburse 70% of claims from a...
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CMS Issue: 
Inside CMS - 05/26/2022
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Vol. 25, No. 21
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Health Exchange Alert Weekly Report - 05/25/2022
HEA Volume: 
Vol. 10, No. 21
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Stakeholders Doubtful HHS Will Let PHE Expire Sooner Than October

Most stakeholders expect HHS will renew the public health emergency declaration in mid-July for 90 days with some speculating about the possibility of another extension to carry pass the midterm elections, but experts say the administration could renew the declaration for fewer days if it wanted to and still fulfill its promise to provide stakeholders with 60-days advance notice. HHS Secretary Xavier Becerra extended HHS’ public health emergency on April 12 for the maximum amount of time he can renew...
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FDA Issue: 
FDA Week - 05/27/2022
FDA Volume: 
Vol. 28, No. 21
CMS Issue: 
Inside CMS - 05/26/2022
CMS Volume: 
Vol. 25, No. 21
HEA Issue: 
Health Exchange Alert Weekly Report - 05/25/2022
HEA Volume: 
Vol. 10, No. 21

Murray Plans To Add Accelerated Approval Reforms To User Fee Bill

Senate health committee Chair Patty Murray plans to add accelerated approval reforms to the FDA user fee legislation her committee is working on, an aide to the Washington Democrat said. The House Energy & Commerce Committee on Wednesday unanimously voted for a user fee bill that includes accelerated approval reforms, including some requested by FDA. “Senator Murray is still looking at ideas on accelerated approvals reform and would like to get something done in a bipartisan way in the final...
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IDP Issue: 
Inside Drug Pricing - 05/23/2022
IDP Volume: 
Vol. 5, No. 21
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