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Daily News

May 23, 2019

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A drug industry lawyer and a drug regulation expert applauded a recent FDA draft guidance on the use of real-world evidence (RWE) and real-world data (RWD) in drug and biologics applications as a major step forward, but said questions remain related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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The Senate health committee’s bipartisan draft bill on lowering health care costs does not expand the Trump administration’s point-of-sale rebate proposal to the commercial market, after Chair Lamar Alexander (R-TN) said the proposal was being considered for inclusion.

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Senate health committee leaders released a draft legislative package Thursday (May 23) that would set up an information exchange program for commercial insurers similar to CMS’ Blue Button initiative, strengthen incentives to improve cybersecurity practices, require a study of third-party health apps, and increase cost transparency, among other proposals to lower health care costs.

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May 22, 2019

FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.

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CMS Administrator Seema Verma on Wednesday (May 22) said the agency is taking its time with a national Medicare coverage policy for new expensive hospital-administered cancer drugs, which was due to be published May 17 but was delayed, because the policy will affect coverage of drugs other than the two chimeric antigen receptor (CAR) T-cell therapies already on the market.

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Senate Finance Committee Chair Chuck Grassley said Wednesday (May 17) that committee members are considering a rework of financial liability in the catastrophic phase of Medicare Part D to help curb rising drug prices.

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CMS Administrator Seema Verma on Wednesday (May 22) said court decisions that struck down 1115 Medicaid work requirement waivers in Kentucky and Arkansas, as well as concerns from the Government Accountability Office about waiver evaluations, won’t change the administration’s plans for Medicaid.

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After legislative talks between House Speaker Nancy Pelosi (D-CA) and President Donald Trump ground to a halt Wednesday morning, Senate Finance Chair Chuck Grassley (R-IA), who is helping lead negotiations on health care policy, said the Senate was always in the driver’s seat in the drug-pricing debate.

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Lawmakers stuck to partisan lines as they debated the tradeoffs of a single-payer health care system during a House Budget Committee hearing, with Republicans focusing on how a transition to the system could disrupt American health policy and Democrats highlighting the potential positive outcomes.

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President Donald Trump said Wednesday (May 22) that legislative negotiations on drug pricing are on hold until Democrats stop investigations into his potential role in his campaign’s ties to Russia and into other actions he has taken while in office.

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Milena Sullivan with Avalere expects a mandatory radiation oncology bundle that HHS signaled was in the works last year to be included in a proposed rule under review at the White House Office of Management and Budget, and others following the rule also said they wouldn’t be surprised to see the model included.

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A Georgetown University report released Wednesday (May 22) says expanding Medicaid is key to reducing maternal mortality and improving preventative care in women of childbearing age, a position shared by maternal health advocates who also say Medicaid coverage can be improved.

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The Center for Medicare and Medicaid Innovation (CMMI) pushed back by a week the deadline for stakeholders to respond to a request for information (RFI) on one payment option that is part of a new voluntary primary care model, though the reason for the delay has not been made clear.

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