While Congress spends much of its time trying to reach a deal to repeal Obamacare, other must-pass healthcare issues are getting short shrift, and time is running out.
Funding for the Children’s Health Insurance Program expires at the end of the summer. So does an agreement for user fee programs for devices and drugs at the Food and Drug Administration.
Both measures need to be reauthorized before Congress’ month-long August recess, which starts at the end of July.
While that may seem like enough time, Congress is also pressing forward on other major legislation such as tax reform and overhauling the Dodd-Frank financial regulations, which promise to eat up a lot of time.
If the FDA and insurance programs are not reupped, more than 8 million low-income children could lose their insurance and FDA reviews of new drugs and devices may come to a grinding halt.
Some lawmakers admitted that they weren’t aware of the issues because of the emphasis on the Obamacare repeal.
“To tell you quite frankly, we have been so knee deep in everything else I hadn’t looked at it yet,” said Rep. Phil Roe, R-Tenn. But he said he remains confident that both pieces of legislation can be passed in time.
Under the FDA program, a drug or device maker pays the agency when it submits an application for a new drug or device, and the agency uses the money to speed up approval times. About 68 percent of the FDA’s approval budget for prescription drugs and 58 percent of generic drug approvals is paid with user fees, according to a 2016 report from research firm Avalere Health.
When the program was created in 1992, it was only for brand-name drugs. It has since expanded to include medical devices, generic drugs and tissue-based biologic drugs.
Reauthorization takes place every five years and is usually via a bipartisan vote. The same goes with CHIP, which was created in 1997 and provides insurance for low-income children whose parents make too much money to qualify for Medicaid.
Roe pointed to lawmakers’ desire to deal with the rising cost of prescription drugs as a proper motivator to approving the programs. He said a common refrain he hears at town halls is the staggering cost of prescription drugs.
“Now a $10 prescription is around $200,” he said.
Roe said the FDA user fee reauthorization program could act as a vehicle for handling drug prices, but it isn’t the only one.
Rep. Tim Murphy, R-Pa., who sits on the House Energy and Commerce Committee that will address both matters in the House, said he knows “we’ve gotta deal with that.”
“We always tend to be optimistic, and we have good leadership with the chairman, so we will work on that,” he said.
Lawmakers have started taking steps on reauthorizing the user fee program, as bipartisan legislation was announced a few weeks ago.
A markup of the user fee agreement is likely in early May, according to a representative for Sen. Lamar Alexander, R-Tenn., who is chairman of the Senate Health, Education, Labor and Pensions Committee, which will consider the user fees.
On the House side, Energy and Commerce is holding a hearing May 2 on some bills to include in the user fee reauthorization package. Lawmakers typically include FDA-related legislation in reauthorization.
The hearing will focus on four bills that introduce medical device reforms such as changes to the FDA’s device facility inspection process and a bill to let hearing aids be sold over-the-counter.
Meanwhile, the question on CHIP is how much funding will be given to the insurance program.
Obamacare boosted the federal matching rate for CHIP by 23 percentage points from 2016 to 2019.
Whether that bump would continue in the funding renewal appears to be a key question.
The Congressional Budget Office and other experts “believe the 23 percent match under Obamacare hasn’t increased coverage on net,” a House aide said. “So keeping the bump would literally spend billions of dollars without increasing coverage.”
