A device and diagnostics lawyer says FDA’s formal recognition of a public database of information about genes, genetic variants and their relationship to disease could help new genetic tests reach market.
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Daily News
December 05, 2018
The American Hospital Association and a wide range of health care stakeholders urged congressional leaders to pass a key health security bill before the end of the lame-duck session, arguing that, without reauthorization from lawmakers, essential HHS emergency preparedness authorities will expire and gaps in federal response programs will remain unfilled.
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The incoming Senate Finance Committee chair and ranking Democrat introduced Tuesday (Dec. 4) a bill to recoup Medicaid rebates from drug companies that misclassify drugs.
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The incoming Senate Finance Committee chair and ranking Democrat introduced Tuesday (Dec. 4) a bill to recoup Medicaid rebates from drug companies that misclassify drugs.
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The Institute for Clinical Economic Review (ICER) on Monday (Dec. 3) issued a final report featuring recommendations for how to develop policy on and increase access to extended-release medications for addiction treatment.
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December 04, 2018
The American Hospital Association and Association of American Medical Colleges sued CMS Tuesday (Nov. 4) over deep reimbursement cuts for clinic visits at hospital off-campus facilities that were included in a site-neutral policy in the final 2019 hospital outpatient pay rule.
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The Idaho Supreme Court agreed on Monday (Dec. 3) to quickly hear a case seeking to block the implementation of the state’s Nov. 6 ballot initiative in which 61 percent of the state’s voters chose to expand Medicaid.
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HHS Secretary Alex Azar on Tuesday (Dec. 4) said that Medicare Advantage may account for a larger share of Medicare than fee-for-service in the next five to 10 years, and if that happens HHS may have to rethink the system so that innovation occurs first in the MA space and the rest of the program follows suit.
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HHS Secretary Alex Azar on Tuesday (Dec. 4) said that Medicare Advantage may account for a larger share of Medicare than fee-for-service in the next five to 10 years, and if that happens HHS may have to rethink the system so that innovation occurs first in the MA space and the rest of the program follows suit.
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A medical device industry expert told Inside Health Policy he expects a new proposed rule published by FDA on the de novo pathway will go a long way towards clarifying the process for device manufacturers, helping FDA reach the performance goals laid out by Congress and helping the agency achieve its goals of modernizing the 510(k) premarket notification process.
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CMS on Tuesday (Nov. 4) again extended the prior authorization program for non-emergency, repetitive ambulance trips.
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Arkansas told a federal judge evaluating the legality of the state’s Medicaid work requirements to ignore early data showing substantial coverage losses in the early months of the program.
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Technology firm HealthSherpa on Tuesday (Dec. 4) announced it is the first private sector partner approved by CMS to use the new enhanced direct enrollment pathway to sign up consumers for exchange plans, confirming news first reported by Inside Health Policy last week.
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Technology firm HealthSherpa on Tuesday (Dec. 4) announced it is the first private sector partner approved by CMS to use the new enhanced direct enrollment pathway to sign up consumers for exchange plans, confirming news first reported by Inside Health Policy last week.
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Technology firm HealthSherpa on Tuesday (Dec. 4) announced it is the first private sector partner approved by CMS to use the new enhanced direct enrollment pathway to sign up consumers for exchange plans, confirming news first reported by Inside Health Policy last week.
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December 03, 2018
HHS is pushing Congress to consider more site-neutral pay policies in Medicare, repeal the Affordable Care Act’s limit on physician-owned hospitals, relax telehealth restrictions and give Medicare beneficiaries more access to health savings accounts, as part of a new Trump administration report on ways to increase health care choice and competition.
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The Trump administration released a series of health policy recommendations Monday (Dec. 3) that officials say would reduce barriers to competition in the individual and other markets, including loosening network adequacy restrictions, expanding access to health savings accounts, eliminating the employer mandate and altering the Affordable Care Act’s non-discrimination provisions.
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The Trump administration released a series of health policy recommendations Monday (Dec. 3) that officials say would reduce barriers to competition in the individual and other markets, including loosening network adequacy restrictions, expanding access to health savings accounts, eliminating the employer mandate and altering the Affordable Care Act’s non-discrimination provisions.
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The administration criticized state laws that open up restricted pharmacy networks, because administration officials believe those laws make it difficult for plans and pharmacy benefit managers to negotiate discounts from providers, which increases costs to consumers.
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In a further bid to streamline generic drug development, FDA on Monday (Dec. 3) clarified the procedures for generic drug makers to request meetings with the agency after receiving complete response letters (CRL) indicating deficiencies in their applications.
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