More Work Needed to Achieve Telehealth Equity, NC Providers Say

Telehealth availability helped maintain continuity of care for Medicaid beneficiaries in North Carolina during the COVID-19 pandemic but did not overcome disparities in access to services, a recent study by physicians at Duke University’s Margolis Center for Health Policy found. At an event titled “Equitable Access to Care: Leveraging Telehealth for Medicaid Beneficiaries in North Carolina,” health care providers from the state discussed what impact the availability of telehealth has had on the state. The study found that people who...
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HHS To FCC: Let MCOs Text, Call Enrollees About Redeterminations

In preparation for the restart of the Medicaid redetermination process, HHS and CMS have asked the Federal Communications Commission to let federal, state and local workers and contractors, including Medicaid managed care plans, communicate with enrollees by text or through automated phone calls without running afoul of the Telephone Consumer Protection Act (TCPA). HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure stress in an April 28 letter to the FCC that allowing government employees and contractors to contact enrollees...
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FCC seeks public comments . . .
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CMS Issue: 
Inside CMS - 05/12/2022
CMS Volume: 
Vol. 25, No. 19
HEA Issue: 
Health Exchange Alert Weekly Report - 05/11/2022
HEA Volume: 
Vol. 10, No. 19
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FDA Limits Use Of J&J’s COVID-19 Shot Due To Risk Of Blood Clots

FDA on Thursday (May 5) announced it has limited use of Johnson & Johnson’s single-dose COVID-19 vaccine in certain people 18 and older because of the high risk of a rare and potentially life-threatening blood clot condition. People 18 and older should only take the shot when other authorized or approved coronavirus vaccines are unavailable or clinically inappropriate, and when they otherwise would not receive a COVID-19 vaccine, the agency says. The shot is only authorized for people 18 and...
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FDA Issue: 
FDA Week - 05/13/2022
FDA Volume: 
Vol. 28, No. 19
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Govt. Pays Moderna $308M For Pediatric Studies Of COVID-19 Vaccine

The government last month paid Moderna another $308 million for coronavirus vaccine development, which brings total taxpayer funding for the development of Moderna’s coronavirus vaccine to $1.7 billion, according to a securities filing, and that figure excludes contributions by the National Institutes of Health and what the government spent to buy the vaccine. The additional funding pays for testing the vaccine in children. “In March 2022, we entered into a further amendment to the BARDA agreement, increasing the amount of...
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IDP Issue: 
Inside Drug Pricing - 05/09/2022
IDP Volume: 
Vol. 5, No. 19
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E&C Draft User Fee Bill Limits Orphan Exclusivity To Indication

The House Energy & Commerce’s bipartisan draft user fee bill would limit orphan drug exclusivity to approved indications, instead of applying exclusivity to entire diseases or conditions. The measure would codify FDA’s interpretation of orphan exclusivity, which is the subject of a lawsuit that the U.S. Supreme Court has been asked to take up . The lawsuit is between Catalyst Pharmaceuticals and Jacobus Pharmaceuticals Company, both of which make drugs for the rare condition Lambert-Eaton Myasthenic Syndrome. FDA in 2018...
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FDA Issue: 
FDA Week - 05/13/2022
FDA Volume: 
Vol. 28, No. 19
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OMB Reviewing Drug Import Question-And-Answer Document

The White House budget office is reviewing an FDA question-and-answer document on drug importation. The title of the rule is Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide. The Trump administration wrote the rule to let states import drugs from Canada, but the Canadian government blocked the rule from having an effect by halting bulk exports of prescription drugs . Around the same time, the Pharmaceutical Research and Manufacturers of America sued over the rule...
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IDP Issue: 
Inside Drug Pricing - 05/09/2022
IDP Volume: 
Vol. 5, No. 19
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