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Daily News

January 03, 2020

Beneficiary advocates are pleased that House Speaker Nancy Pelosi’s (D-CA) drug pricing bill passed the lower chamber with a number of Medicare improvements, including protections aimed at expanding the number of beneficiaries who can access a Medigap plan. Even though Pelosi’s bill is expected to stall in the Senate, some following the issue say the package’s inclusion of the Medigap policies has spurred dialogue on the issue and the policies could be on the table for future health care legislation.

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Dialysis stakeholders are cheering a California federal judge’s Monday decision blocking the state from implementing a controversial new law that bars patient steering and limits reimbursements for patients who receive charitable help with premiums, and at least one analyst says the move could calm fears that similar legislation might take hold in other states.

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More than 200 Republican lawmakers on Thursday asked the Supreme Court to reconsider the 1973 Roe v. Wade decision in an amicus brief filed in support of a controversial Louisiana abortion law that the Supreme Court will review March 4.

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January 02, 2020

FDA said it will soon start enforcing, on a case-by-case, its ban on unapproved flavored cartridge-based electronic nicotine delivery system (ENDS) products, except those that contain tobacco or menthol flavors.

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Stakeholders will have an additional 15 days to weigh in on a controversial proposed rule that seeks to prevent states from manipulating Medicaid supplemental payments in order to receive extra federal funding.

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CMS approved a waiver allowing Indiana to use Medicaid to fund inpatient treatment for serious mental illness in late December. The state joins Vermont and the District of Columbia in using Medicaid to fund inpatient treatment in certain large facilities for both serious mental illness and substance use disorder.

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The new year ushers in continued uncertainty over proposals to lower prescription drug prices, and President Donald Trump is viewed as the wildcard on whether Congress will pass major drug pricing legislation.

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The industry-lauded repeal of the health insurance tax may lead to Medicare Advantage plans offering more supplemental benefits tied to investment in social determinants of health, according to industry advocacy organizations.

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Beneficiary advocates are calling on HHS, Congress and the administration to adopt policies to bridge racial disparities in health care, as proposed in a recent report by the Medicare Advantage advocacy organization Better Medicare Alliance in collaboration with other advocates.

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The White House budget office is reviewing a final FDA guidance that allows 510(k) applications for low-to-moderate risk devices to be reviewed by a third party for review and only involve FDA for the final decision on the submission.

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Colorado Governor Jared Polis (D) recently released wide-ranging recommendations for stemming drug costs that include price controls, patent reforms and an expansion of the state’s plan to import Canadian drugs.

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Generic drug and biosimilars companies that make and sell FDA-approved versions of their products overseas would not be allowed to import them into the United States under one prong of HHS’ drug importation plan, which was issued through draft guidance on Wednesday (Dec. 18).

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December 31, 2019

Providers and health IT groups urge Congress to look into privacy and security implications of third-party health apps in response to calls from lawmakers on what they should include in a follow-on to the 21st Century Cures Act.

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The White House budget office is again reviewing a draft FDA electronic nicotine delivery systems compliance guidance that is expected to lay out enforcement priorities for deemed tobacco products, including e-cigarettes, that are on the market without premarket authorization.

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December 30, 2019

The nursing home industry says an expected recommendation from Congress’ Medicare advisors for fiscal 2021 would hurt long-term and post-acute care providers, as the recommendation would come amid other CMS Medicaid proposals about which the industry is also concerned.

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A major cancer research advocacy organization wants key House lawmakers to include in their upcoming Cures 2.0 package a policy that would give FDA authority to require generic drug labels be updated to reflect new information about the drug and its use.

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When Inbrija was close to market, Acorda Therapeutics wanted to set the price of Parkinson’s therapy below the specialty tier monthly threshold of $670, but consultants and pharmacy benefit managers made the company set the list price at $950 per box, according to Ron Cohen, who founded Acorda and is the president and CEO of the company.

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December 26, 2019

FDA recently released data showing there was a slight increase in the sales and distribution of antimicrobials for food-producing animals in 2018, when compared with data from 2017.

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FDA on Friday (Dec. 20) finalized a guidance that details how manufacturers can develop dried plasma products and gain approval of devices used to manufacture dried plasma for application beyond the battlefield.

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December 24, 2019

FDA and the European Medicines Agency (EMA) are working with officials in India and China to fight antimicrobial resistance (AMR), an EMA official and others involved told Inside Health Policy.

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