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Daily News

May 28, 2019

A group of more than 30 House lawmakers, most of whom are Republicans and who are led by Rep. Michael Burgess (R-TX), asked CMS earlier this month to consider using the innovation center to run a demonstration expanding the use of physician-owned hospitals.

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Despite lingering questions surrounding FDA’s authority to implement its software precertification program, the agency is moving forward with a pre-cert test program in which it hopes to test out its pre-cert model with a range of software companies.

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May 24, 2019

HHS’ Office of Civil Rights (OCR) on Friday (May 24) proposed to replace the Obama-era rule on the ACA’s non-discrimination section 1557 with a significantly altered rule that rolls back protections for transgender individuals and woman who have had an abortion, repeals several language access requirements, and narrows the scope of the provision.

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The Oklahoma Supreme Court is preparing to weigh in on the validity of a proposed ballot measure that seeks to expand Medicaid in Oklahoma, and the legal fight turns on a question raised by a well-known bit of mathematical minutia in the Affordable Care Act: whether the Medicaid expansion eligibility ceiling is best understood as 133% of the federal poverty level or 138% of the federal poverty level.

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Maryland on Friday (May 24) became the first state to create a board that will study drug costs, and could be given the power to set drug pay rates. Maryland Gov. Larry Hogan (R) allowed the state legislature’s banner drug-pricing bill to become law without his signature.

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The dietary supplement industry says FDA should use existing master files to protect the intellectual property of supplement makers, with several industry officials saying such a move would incentivize legitimate companies to continue investing in research.

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The Federal Trade Commission said on Thursday (May 23) that while brand and generic drug makers settled patent disputes more often in fiscal year 2016 than prior years, only one of the agreements met the Supreme Court’s criteria of potentially being anticompetitive.

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FDA’s drug center would receive an approximate $50 million increase in budget authority over fiscal 2019 levels under the 2020 funding bill passed by the House Appropriations agriculture subcommittee on Thursday (May 23), according to a preliminary analysis by the Alliance for a Stronger FDA.

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The Campaign for Tobacco-Free Kids on Thursday (May 23) urged Senate Majority Leader Mitch McConnell (R-KY) to remove from his bill, which raises the minimum purchase age of tobacco from 18 to 21, a provision that would require each state to individually pass laws raising the minimum age.

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A draft legislative package released by Senate health committee leaders Thursday (May 23) would require plans to have up-to-date provider directories, available online or within 24 hours of an inquiry, but Medicare Advantage (MA) plans would not be included in that policy, according to the office of Chair Lamar Alexander (R-TN).

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May 23, 2019

CMS on Thursday (May 23) announced it will again provide $10 million a year in grants to fund the Affordable Care Act’s navigator program for the 34 states that fully rely on the federal government for their exchange functions, releasing a $20 million funding opportunity through 2021 since the agency has extended the performance period for two years.

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In a quick turn of events, the focus of drug-pricing legislation in the House shifted from Medicare negotiation to Part D reinsurance reform, which also is the approach that is being considered in the Senate.

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A bipartisan group of House lawmakers, led by emergency room physician Rep. Raul Ruiz (D-CA), unveiled Thursday (May 23) an outline of legislation that would hold patients harmless from surprise bills and allow providers and issuers to resolve payment disputes through arbitration.

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The Kentucky Hospital Association is siding with Kentucky and CMS in the lawsuit challenging the state’s proposed Medicaid work requirements--a rare example of the hospital industry endorsing work requirements as a condition for maintaining health coverage.

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The House Appropriations agriculture subcommittee on Thursday (May 23) voted to send a fiscal 2020 funding bill that would give FDA a $184 million increase over its fiscal 2019 levels to the full committee.

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The Fifth Circuit Court of Appeals announced Wednesday that it will hear oral arguments in the high-prolife lawsuit over the Affordable Care Act, Texas v. Azar, on July 9.

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The Senate health committee’s bipartisan legislative proposal would hold patients harmless for surprise bills and lays out three possible reimbursement options for those situations: benchmark rates that are similar to the House Energy & Commerce Committee’s solution; an “in-network guarantee” that is supported by employers; and an arbitration option, which hospitals and providers have backed.

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FDA has once again officially delayed its planned release of a highly anticipated nonprescription drug proposed rule, although an FDA official said this week the agency hopes to get the rule out as soon as possible.

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The Democratic sponsors of bipartisan Tobacco to 21 legislation in the Senate are urging Majority Leader Mitch McConnell (R-KY) to sign on as a co-sponsor rather than move forward with his recently introduced bill that also would raise the minimum age to purchase tobacco from 18 to 21.

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A drug industry lawyer and a drug regulation expert applauded a recent FDA draft guidance on the use of real-world evidence (RWE) and real-world data (RWD) in drug and biologics applications as a major step forward, but said questions remain related to data quality and informed consent.

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