May 25, 2017

President Signals Intent To Work With Lawmakers On 340B Changes

Inside Health Policy posted an article titled, “President Signals Intent To Work With Lawmakers On 340B Changes.” The article reads as follows;

“The Trump administration wants to work with lawmakers on legislation to improve program integrity in the 340B drug discount program and provide the Health Resources and Services Administration more regulatory authority. HHS’ intentions are laid out in HRSA’s fiscal 2018 budget justification, though the budget includes few details on what such a package would include.

The budget requests $10 million for the 340B drug discount program, the same as level of funding as in the fiscal 2017 continuing resolution. HHS’ budget in brief says the president’s fiscal 2018 request proposes to update HRSA’s regulatory authority in 340B to increase transparency and improve program integrity, but HRSA’s budget justification says HHS has yet to come up with such a proposal.

‘HHS will work with Congress to develop a legislative proposal to improve 340B Program integrity and ensure that the benefits derived from participation in the program are used to benefit patients, especially low-income and uninsured populations. This proposal would provide regulatory authority’, HRSA’s budget justification says.

A court ruling in 2014 left HRSA with the ability to craft regulations in only three areas — ceiling prices, dispute resolution and civil monetary penalties. Prior to the House Energy & Commerce Committee’s attempt to make legislative changes to 340B by including reforms in the 21st Century Cures Act — which were pulled before the bill passed the committee — some committee members said that Congress could give HRSA rulemaking authority over patient eligibility for the 340B program if the agency asked for it.

A spokesperson for Pharmaceutical Research and Manufacturers of America said drug makers are pleased Trump’s budget ‘recognizes the need for improving transparency and program integrity in the 340B Drug Discount Program’.

340B Health, which represents 340B hospitals, says it ‘supports program integrity and transparency but believes legislation is unnecessary to accomplish those goals’.

Drug makers have long pushed the notion that more transparency is needed for hospitals in the 340B program to track how those providers use savings from the program, and PhRMA has previously pushed the idea that hospitals should have to report how they use 340B savings in a similar manner to 340B grantees.

Rep. Chris Collins (R-NY) recently said he is working on 340B legislation that would likely require such reporting from 340B hospitals, as well as a statutory patient definition for 340B. The bill is also expected to limit contract pharmacy arrangements, eliminate duplicate discounts, revise hospital eligibility determinations, and improve HRSA’s resources. Sen. Bill Cassidy (R-LA) also said he is working on a drug pricing bill and expects 340B changes to be part of his legislation as well.”

Click here to view the article.

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