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Daily News

February 01, 2019

The White House Office of Management and Budget on Jan. 30 started reviewing a final rule to revise the long-term care facilities’ Medicare requirement that prohibited binding pre-dispute arbitration, the proposed version of which was opposed by both industry and beneficiaries for different reasons.

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HHS Secretary Alex Azar on Friday (Feb. 1) challenged congressional Democrats, who are critical of the administration’s proposal to eliminate drug rebates, to suggest an alternative.

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FDA’s Leah Christl, head of the agency’s biologics and biosimilars staff in the Office of New Drugs (OND), will leave FDA on Feb. 22, after 16 years of working with the agency, drug center director Janet Woodcock announced in an email to center staff on Friday (Feb. 1).

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New Mexico is pushing to have a Medicaid buy-in bill that could reduce premiums as much as 29 percent in place by the end of next year -- a move that could put the state on the map as the first to implement such a program.

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A federal district court Friday (Feb. 1) dismissed Maryland Attorney General Brian Frosh’s lawsuit against the administration’s attacks on the Affordable Care Act due to lack of standing.

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Attorneys general from Colorado, Iowa, Michigan and Nevada on Thursday (Jan. 31) filed a motion to join 17 other Democratic attorneys general as defendants in the high-profile lawsuit that, if upheld, would invalidate the Affordable Care Act.

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CMS and the Centers for Disease Control and Prevention on Friday (Feb. 1) proposed updates to laboratory proficiency testing for analytes, or lab tests, added almost 30 tests to the list of those subject to proficiency testing and removed a handful of others.

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The HHS proposal to eliminate drug rebates would increase government spending up to $196 billion over a decade, CMS actuaries estimate.

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A bipartisan group of 10 first-term House lawmakers wrote a letter to FDA Commissioner Scott Gottlieb on Wednesday (Jan. 30), urging the agency to not allow plant-based products to use dairy terms in their labeling, an issue the agency hopes to resolve as a part of its multi-year nutrition innovation strategy.

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CMS Administrator Seema Verma called price transparency a “marketing opportunity” for hospitals as she continued to urge them to go beyond CMS’ requirements with their price transparency lists on Tuesday (Jan. 29).

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While stakeholders are mostly supportive of CMS’ expansion of the Value-Based Insurance Design demonstration, some are raising concerns with what the agency has dubbed an “aggressive” timeline for applications.

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January 31, 2019

HHS’ proposal to ban drug rebates, unless they’re shared directly with seniors at the pharmacy counter, would significantly lower out-of-pocket retail-drug spending for the minority of seniors on expensive drugs, but it would raise premiums for all Medicare beneficiaries.

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As House Progressive Caucus Co-Chair Rep. Pramila Jayapal (D-WA) gathers co-sponsors for an upcoming Medicare for All bill, which she says will be different than Sen. Bernie Sanders’ (I-VT) single-payer bill, Democrats signal they are open to a variety of approaches when it comes to single-payer or Medicare expansion.

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Kentucky is postponing the launch of its Medicaid work requirements for at least three months as a lawsuit challenging their legality is pending in federal court.

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The House Energy & Commerce Committee announced that for the first time it will hold a hearing on the controversial case to undo the Affordable Care Act.

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The Trump administration’s proposal to let exchange plans prohibit some manufacturer drug coupons from counting towards patients’ out-of-pocket cost caps is praised by insurers and generic drug makers as a way to lower consumers’ costs and promote generics, but patient advocates and brand-drug companies say it would increase patients’ costs.

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Former FDA Commissioner Robert Califf said accelerated approvals are causing medication access problems because the drugs often come with high price tags and a dearth of data on their value compared with lower-cost treatments.

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A pair of former FDA commissioners debated whether FDA should take the lead on using real-world data and real-world evidence to determine the actual value of drug therapies and in turn ensure the value translates to affordable prices.

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Experts in the antibiotic and medical device industries say FDA’s recent guidance for device and antibiotic makers on how to coordinate antibiotic susceptibility test (AST) development addresses a niche problem that should encourage more interest in antibiotic development.

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January 30, 2019

CMS wants Part D plans to expand access to naloxone, the opioid overdose reversal drug, through reduced cost-sharing and increased co-prescribing, and the agency is encouraging Medicare Advantage plans to offer pain management options like acupuncture and massage as supplemental benefits that the agency says can be opioid alternatives.

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