Health Law Update

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<img class="alignright size-medium wp-image-4777" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2017/03/hlu-photo-300x200.jpg" alt="hlu photo" width="300" height="200" />House Passes ACA Repeal and Replace

Eight weeks after its introduction, legislation to “repeal and replace” the Affordable Care Act (ACA) won House approval today by a 217-213 vote. Vice President Mike Pence on Sunday said a vote in Congress to repeal the ACA was “just around the corner,” even as key House moderates continued to balk at changes they fear could undermine coverage for people with pre-existing conditions. In the end, the GOP leadership successfully kept up the pressure for a vote on the American Health Care Act (AHCA) before the House went on recess this week.

Now that the AHCA has passed the House, the Senate faces a similar ideological divide between conservatives and moderates – but with a narrower governing majority than the House. With only two votes to spare, Senate leaders could try to change the bill to cobble together at least 50 votes, sending the legislation back to the House. But House Majority Leader Kevin McCarthy, who spoke at BakerHostetler’s 28th Annual Legislative Seminar last week, said he believes Senate Republicans could approve the House-passed bill without any changes.

Spending Bill Includes Increased NIH Funding

Congress has agreed on a $1.8 trillion budget bill for the rest of fiscal 2017 that includes a $2 billion increase for National Institutes of Health (NIH). The boost comes after President Trump proposed cutting NIH funding by $1.2 billion and reflects the strong support on Capitol Hill for the research agency. The NIH funding is part of a government-wide budget bill that will cover spending through September 30. The White House is expected to release its fiscal 2018 budget proposal later this month.

Senate Panel to Hold CHIP Hearing

The Senate Finance Committee announced that it will hold a hearing May 9 on the Children’s Health Insurance Program (CHIP), which last year covered nearly nine million children nationally. Congress is likely to reauthorize CHIP – which enjoys wide bipartisan support – before it expires September 30. Governors had hoped Washington would renew CHIP before the summer, when most state budgets are being finalized.

Bipartisan Bill Targets Drug Prices

Republican and Democratic leaders of the House and Senate judiciary committees have introduced <a class="js-autopdflink" href="https://f.datasrvr.com/fr1/017/79785/CREATES_115th.withcosponsors.BOM17057.pdf" target="_blank" rel="noopener">legislation</a> designed to speed the development of generic drugs. Targeting what Sen. Patrick Leahy (D-Vt.) called “abusive delay tactics,” the legislation would create a private right of action allowing generic manufacturers to sue innovators to gain access to brand-name drugs protected by FDA safety programs. Including the private party lawsuit in the legislation allows the bill to be referred to the judiciary committees, which can hold hearings and vote to approve the bill. A Senate judiciary subcommittee last year held a hearing on similar legislation.

The legislation was introduced by Leahy and Sen. Chuck Grassley (R-Iowa), and Reps. Tom Marino (R-Pa.) and David Cicilline (D-R.I.). Grassley is chairman of the Senate Judiciary Committee, and Marino is chairman of the House Judiciary Subcommittee on Antitrust Law. It has also been reported that Marino will be tapped by President Trump to head the Office of National Drug Control Policy.

Brand-name manufacturers oppose the new legislation, saying it would ignore FDA-imposed safety requirements on high-risk drugs and cause unnecessary litigation. The bill follows <a class="js-autopdflink" href="https://www.congress.gov/115/bills/hr749/BILLS-115hr749ih.pdf" target="_blank" rel="noopener">similar legislation</a> introduced in the House last month that would compel brand-name companies to make their products available to generic drug makers for bioequivalence testing, but that bill doesn’t include a private right of action against the brand-name drug companies.

Both bills have been introduced in previous sessions of Congress and failed to gain significant traction. But both have picked up new bipartisan support as the issue of drug prices continues to swirl on Capitol Hill.

House Bill Would Update Rules for Device Accessories

Bipartisan <a href="https://www.congress.gov/bill/115th-congress/house-bill/2144/text">legislation</a> introduced in the House last week would streamline the FDA review process for medical device accessories. Medical accessories – everything from plastic trays to ultrasound probes – are classified and reviewed by the FDA along with their parent devices. Manufacturers say the process is burdensome and costly, and can delay approval of otherwise safe medical technology. Introduced by Reps. Mimi Walters (R-Calif.) and Ann Kuster (D-N.H.), the bill would classify accessories independently from their parent devices. The lawmakers said some accessories already approved shouldn’t require additional reviews when they are combined with other devices. Last year’s medical innovation law, the 21st Century Cures Act, directed the FDA to classify accessories independent of parent devices. The Walters-Kuster legislation would give the agency additional clarity and authority to decouple accessories from devices. The device industry trade association AdvaMed endorsed the bill.

Gottlieb Wins Committee Vote

President Trump’s nominee to lead the FDA, Dr. Scott Gottlieb, won approval last week in the Senate Health, Education, Labor and Pensions Committee on a largely party-line vote. The committee vote was 14-9. Only Sens. Michael Bennet (D-Colo.) and Sheldon Whitehouse (D-R.I.) broke ranks with panel Democrats and backed Gottlieb’s confirmation. The next step is a vote by the full Senate next week.

Meanwhile, Senate Democrats called on Gottlieb to overturn President Trump’s government-wide hiring freeze, which they say is particularly harming the FDA, and work to implement filling the new positions authorized in last year’s 21st Century Cures medical innovation legislation.

House Panel Examines Device Bills

The House Energy and Commerce Health Subcommittee held a <a href="https://energycommerce.house.gov/hearings-and-votes/hearings/examining-improvements-regulation-medical-technologies">hearing</a> this week on several medical device bills that could be included in the FDA user fee reauthorization. Congress is considering the five-year renewal of user fees negotiated by the FDA and the medical technology and pharmaceutical industries. The subcommittee may add other provisions, but likely only those that enjoy bipartisan support and wouldn’t jeopardize congressional passage of the underlying user fee bill.

BakerHostetler’s “Capitol Hill Healthcare Update” is distributed weekly when Congress is in session.