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Draft Senate Health Legislation

Senate Health Draft Offers Three Options To Address Surprise Billing

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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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.

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.

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.

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.

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.

A drug industry lawyer and a drug regulation expert applauded a recent FDA draft guidance on the use of real-world evidence (RWE) and real-world data (RWD) in drug and biologics applications as a major step forward, but said questions remain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

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.

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.

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.