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Daily News

July 19, 2018

House Majority Leader Kevin McCarthy (R-CA) on Thursday revealed plans to bring a permanent repeal of the medical device tax, a two-year delay of the health insurance tax, a reversal of the ACA's ban on using tax-preferred accounts for over-the-counter medicine and tweaks to health savings accounts (HSAs) to the floor next week, but sources say he doesn't plan a vote on legislation that would delay the 40 percent tax on high-cost plans (known as the Cadillac tax) or mitigate the employer mandate at this time.

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Senate Democrats are urging their GOP colleagues to back a resolution calling for the Senate to intervene and defend the Affordable Care Act's preexisting conditions protections in the lawsuit brought by 20 GOP-led states challenging the constitutionality of the ACA, but Republicans, who have consistently said they support the consumer protections, have yet to agree to the resolution.

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An interim final rule clarifying the Affordable Care Act's risk adjustment payment methodology, pending at the White House Office of Management and Budget as of Wednesday night (July 18), may not be finalized and is one of several options being considered as the courts sort out conflicting rulings, CMS told Inside Health Policy on Thursday.

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The final version of the Trump administration’s long-awaited, controversial rule expanding short-term plans landed at the White House Office of Management and Budget for review on Wednesday (July 18) and could be released shortly.

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FDA sent shock waves through the pharmaceutical industry Thursday (July 19) by announcing it will study how to import drugs as a response to price spikes.

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The White House Office of Management and Budget is reviewing an HHS Inspector General proposal to both remove safe harbor protections and create new ones for drug rebates, according to the title of the proposed rule.

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July 18, 2018

FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives.

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The House Energy & Commerce health subcommittee on July 25 will hear from FDA Commissioner Scott Gottlieb and National Institutes of Health Director Francis Collins about the work being done to implement provisions of the 21st Century Cures Act, the subcommittee announced Wednesday (July 18).

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Maryland Insurance Commissioner Al Redmer, Jr. announced Wednesday he will hold a public hearing July 30 on issuers' proposed rate increases in the small and large group market.

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Justices of the Maine Supreme Judicial Court on Wednesday (July 18) were uncertain whether the court should -- or could -- intervene in a political impasse between the state's governor and the legislature over funding for the voter-approved Medicaid expansion.

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A federal court in California on Wednesday dismissed a case brought by 18 Democratic attorneys general challenging the Trump administration's decision last year to end the ACA's cost-sharing reduction payments to insurers, but the court leaves the door open for the attorneys general to refile their case if HHS moves to block the silver-loading workaround that has made up for the lack of CSRs.

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HHS Secretary Alex Azar announced Wednesday (July 18) that Center for Medicare and Medicaid Innovation (CMMI) Director Adam Boehler will also begin serving as senior advisor for Value-Based Transformation and Innovation.

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FDA approved new uses of a cancer drug using two new pilot review programs that aim to streamline the review of cancer drugs and improve the standards for evaluating safety and efficacy, the agency announced Wednesday (July 18).

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CMS Administrator Seema Verma sent a letter to doctors touting a proposed overhaul of evaluation and management documentation and coding, as well as changes to electronic health records, as reforms that will make doctors' lives easier, though oncologists argue the E/M coding proposal “defies all logic.”

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FDA commissioner Scott Gottlieb said his agency will soon open a docket to receive public comment on whether non-dairy products can be marketed as milk, stepping into a heated debate between the dairy industry and those marketing non-dairy milk.

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July 17, 2018

FDA, in a bid to expand use of nonprescription drugs, issued a draft guidance Tuesday (July 17) that proposes two new ways sponsors could demonstrate the safety and effectiveness of nonprescription drugs: providing supplemental information about a drug beyond what is included on the drug facts label (DFL) and requiring consumers meet certain criteria before being allowed to purchase the product.

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House Ways & Means Chairman Kevin Brady (R-TX) said Tuesday (July 17) that he has been talking with HHS Secretary Alex Azar about possible ways to resume risk adjustment payments, but he has not yet decided by what means, and that he plans to bring a package of Affordable Care Act-related bills to the floor next week.

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The group of 18 Democratic attorneys general who filed suit after the administration ended cost-sharing reduction (CSR) payments last October are now asking the federal court in Northern California to put the case, California v. Trump, on hold so long as a silver-loading work-around continues.

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FDA, through its Drug Shortages Task Force, will work with CMS to revamp reimbursement policies for critical access drugs, especially sterile injectables, to incentivize manufacturers to invest in and modernize their manufacturing processes and spur development of critical access drugs, FDA Commissioner Scott Gottlieb said during a policy summit on Tuesday (July 17).

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CMS is more inclined to approve Medicaid work requirements in states that have expanded Medicaid eligibility under the Affordable Care Act, the Kansas Medicaid director said Monday (July 16), and as such, the outlook for Kansas’ work requirement waiver that is under review by CMS may depend on whether the state expands Medicaid after the midterm elections.

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