HealthCare Roundtable e-News – February 13, 2020

McConnell Casts Doubt that Senate Drug Pricing Bill Agreement will be Achieved

Tuesday, Senate Majority Leader Mitch McConnell (R-KY) expressed doubt that the Senate, and especially members of his own party, will come to agreement on drug pricing legislation just as Senate Finance Committee Chairman Chuck Grassley (R-IA) claimed GOP support is growing.

“We have internal divisions within my party in the Senate on both the Grassley bill and the bill that came out of the HELP committee on surprise billing,” McConnell said.

Since its bipartisan passage out of committee in July, Chairman Grassley has been lobbying colleagues to support his bill, S. 2543, while Senator Minority Leader Chuck Schumer (D-NY) has been working toward a vote on the House Democrats’ bill, HR 3.

Legislation to control drug prices and curb surprise billing are supposed to help pay for renewing a group of popular health care programs called the “extenders,” which expire in May. McConnell indicated that the Memorial Day deadline for funding those programs will “generate another discussion” on both policies. However, he said the division within the Republican party and between the two parties makes it difficult to get a deal on drug pricing. (InsideHealthPolicy)

The FDA and FTC Team Up to Speed Biosimilar Application Review Process

The FTC and FDA are teaming up to support marketplace growth for biologic medicines, according to a recent press announcement. The alliance will support efforts to crack down on misleading promotions and comparisons of biosimilars, support market competition and strengthen consumer confidence in cheaper medicines as part of the administration’s efforts to lower drug costs.

“Competition is key for helping American patients have access to affordable medicines. While these therapies are critical for patients, biological products contribute significantly to drug costs, as they are often far more complex to develop than other drugs,” said FDA Commissioner Stephen M. Hahn, M.D.

According to the announcement, the agencies will also collaborate on future public outreach efforts and bring together participants from industry, academia and government agencies to collectively discuss and review competition in the biologics market.

The FDA also proposed a draft guidance on quicker reviews of biosimilars last week, which will aim to shorten application reviews from 10 months to 6 months. Michael Cottler, a partner at Goodwin Procter, noted that the FDA “has talked for a long time about streamlining regulatory process for biosimilars and this appears to be one step in that direction.”

House Ways & Means Committee Unveils Legislation Tackling Surprise Billing

Leaders of the House Ways & Means Committee unveiled new legislation last week aiming to protect hospital patients from surprise medical bills. The committee’s proposal opens the door for negotiation between doctors and insurers on payment particulars, a turn from previous discussions that call for a benchmark on what insurers would pay for a surprise out-of-network bill. The proposal also notes that doctors and insurers can only call in an independent arbiter if there’s no agreement within 30 days.

“Our priority throughout the painstaking process of crafting our legislation has been to get the policy right for patients, and we firmly believe that we have done that,” said Committee Chairman Rep. Richard Neal (D-Mass.) and Minority Leader Rep. Kevin Brady (R-Texas).

The Trump administration has supported efforts to tackle surprise billing but expressed concerns regarding the W&M proposal Tuesday. CBO has said it will save the federal government over $17 billion over ten years.

The bill competes with the House Energy & Commerce Committee’s bill that was passed last year, and both committees will need to come to an agreement before one or the other will move forward. The W&M leaders said on Friday that their bill differs from the E&C Committee’s in that their bill includes a more “balanced negotiation process,” but despite the differences the two are not far apart from one another.

Trump’s 2021 Budget Blueprint Request Includes Funding Cuts to Non-Defense Spending, Pushes for Drug Pricing Deal

The Trump administration announced that the president’s budget request for the upcoming fiscal year that includes cuts to non-defense spending, in addition to seeking major savings by targeting the federal safety net, as reported by POLITICO. Totally nearly $4.8 trillion, funding cuts to aid the administration’s budget blueprint will come from the Departments of Commerce, Interior, Energy, Housing and Urban Development, and Health and Human Services, among others.

The request will include spending boosts for the Department of Veteran’s Affairs, the Department of Homeland Security, the National Nuclear Security Administration and NASA. The Trump administration will also likely ask Congress for a spending increase to support the Pentagon, in addition to the requested $2 billion for border wall construction and immigration enforcement.

Among other initiatives the budget blueprint aims to support is a bipartisan drug pricing effort, as President Trump continues to subtly encourage the Senate’s drug pricing bill and the recruitment of more Republican support, which has been lacking since the bill was unveiled. The budget request assumes savings in the neighborhood of $135 billion over ten years from drug pricing legislation and leaves room for negotiation with Congress’ on their drug pricing proposal.

The president’s budget blueprint claims anticipated economic growth of 3 percent over the next decade, driven by the implementation of his policies, and aims to reduce the country’s deficit by $4.4 trillion over a decade.