FDA sent warning letters to four e-cigarette and hookah companies Thursday (Aug. 8) telling them to remove 44 flavored e-cigarette and hookah tobacco products from the market, as none of the products have received marketing authorization.
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Daily News
August 09, 2019
Nevada is on track to transition from reliance on healthcare.gov to a state-based health exchange with a soft launch of the platform set for September, Nevada Health Link Executive Director Heather Korbulic says.
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August 08, 2019
Some generic drug stakeholders told Congress’ oversight arm that brand-drug makers are strategically timing labeling changes as a ploy to stall generic drug competition.
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Proposals with bipartisan support have been left out of the trifecta of Senate drug-pricing bills, including legislation to require that drug makers disclose list prices in television ads and to ban agreements between generic and brand drug makers that delay generic competition.
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CMS is asking what chronic conditions should be eligible for Chronic Condition Special Needs Plans before the agency convenes a panel this fall to update the list so it complies with changes in the Bipartisan Budget Act of 2018.
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Senate Finance Committee Chair Chuck Grassley (R-IA) is pressing FDA to resume surprise inspections of foreign drug manufacturing facilities as part of the administration’s newly unveiled plan to allow prescription drug imports.
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NEW YORK -- Randy Pate, director of CMS’ Center for Consumer Information and Insurance Oversight, told regulators at the National Association of Insurance Commissioners summer meeting that the exchange environment is steady, new information on rates suggest the marketplace is moving in the right direction and the administration’s policy changes will be beneficial -- even though other HHS officials have blasted the Affordable Care Act as unworkable.
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State Medicaid programs soon will be required to implement stricter controls around opioid prescriptions and will also gain the option to more easily access federal money to care for beneficiaries with substance use disorders in large inpatient treatment centers.
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An expected proposal from the Substance Abuse and Mental Health Services Administration to change 42 CFR Part 2 could be released this month, according to stakeholders who want to see the stringent privacy scheme aligned with Health Insurance Portability and Accountability Act (HIPAA).
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Patient advocates and a panel of experts on Wednesday (Aug. 7) laid out a host of concerns with drug maker Gilead’s proposal to allow its already-approved HIV drug Descovy to be used for pre-exposure prophylaxis (PrEP).
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August 07, 2019
Hospitals that administer the expensive new CAR-T gene therapy are not required to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the cancer drugs approved, according to the national coverage determination CMS published Wednesday (Aug. 7).
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Novartis CEO Vasant Narasimhan said his company did the right thing by not informing FDA of data manipulation in the development process of its drug Zolgensma until after the company had completed an investigation of the issue.
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HHS recently withdrew rules proposed decades ago that would have codified the HHS Office of Inspector General’s ability to penalize hospitals that offer doctors incentives to reduce care for Medicare and Medicaid beneficiaries and would have expanded an existing safe harbor to include waivers of beneficiary cost sharing for those with certain Medigap plans.
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The majority of postmarketing requirements and postmarketing commitment studies for fiscal 2018 were successfully completed by industry or are on their way to being completed on time, with few studies delayed, Acting FDA Commissioner Ned Sharpless said Tuesday (Aug. 6).
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August 06, 2019
The National Association of Attorneys General called on House and Senate leaders to vote on bills that would loosen the strict privacy scheme known as 42 CFR Part 2, pass legislation to remove barriers to accessing buprenorphine, and fully eliminate the Institutions for Mental Diseases (IMD) exclusion in order to expand access to medication-assisted treatment (MAT).
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FDA on Tuesday (Aug. 6) announced that it was investigating a report from drug-maker AveXis Inc. in late June of data manipulation regarding the manufacturing process of the recently approved gene replacement therapy Zolgensma.
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CMS will increase the add-on payments hospitals receive for CAR-T cancer treatments, but the agency didn’t make what industry sources say are easy changes to the reimbursement system that would have allowed CMS to know the true price of chimeric antigen receptor T-cells.
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DaVita officials said in a recent earnings call that the economic impact of President Donald Trump’s kidney care executive order is uncertain, and the dialysis company wants to work with CMS to ensure the new mandatory model included in the broader kidney care plan has a sustainable pay rate over the long term.
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FDA issued its first-ever draft guidance focused on development of drugs for newborn babies, particularly for those born prematurely, to help address gaps in pediatric labeling information.
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August 05, 2019
NEW YORK -- Insurance commissioners from 18 states are calling on the Trump administration to scrap its plan to eliminate health care protections for the transgender population via a proposal that would roll back the scope of the Obama-era 1557 antidiscrimination rule.
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