Health Law Update

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<img class="alignright wp-image-4777 size-medium" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2017/03/hlu-photo-300x200.jpg" width="300" height="200">House approval last week of legislation repealing and replacing most of the Affordable Care Act (ACA) sets up a showdown in the Senate, where GOP leaders will confront a familiar web of political, policy and procedural obstacles that took House Republicans five months to navigate.

Majority Leader Mitch McConnell and key committee chairmen must reconcile differences between conservatives who say the House bill didn’t go far enough to end the ACA and moderates who want additional protections on pre-existing conditions and concessions to states that expanded Medicaid. Other senators also are demanding changes to the House bill’s provision ending federal funding for Planned Parenthood.

The coming weeks will feature both behind-the-scenes negotiating and public declarations as the competing factions jockey to shape the Senate legislation. Given the policy differences and procedural hurdles, a vote before Memorial Day isn’t likely. Instead, senators are sketching out a time line for a potential vote in June – but even that could slip to later in the summer.

GOP leaders are hamstrung by the policy changes they can make to the underlying legislation. The House-approved American Health Care Act (AHCA) is a budget reconciliation bill, which needs only 51 Senate votes to pass, not the usual 60 votes to approve legislation. But only certain provisions are eligible to be included in a reconciliation bill – for example, ending the ACA’s individual mandate isn’t eligible, but repealing the tax on individuals who don’t buy insurance is.

The Congressional Budget Office later this month will release its economic analysis of the House-approved bill. The Senate parliamentarian, Elizabeth MacDonough will also require a CBO score of any fresh Senate language to determine whether it’s eligible to be included in the reconciliation bill. MacDonough’s procedural rulings will be effectively binding because Republicans lack the votes to override them.

Republicans have 52 senators – Vice President Pence could vote to break any 50-50 tie – leaving GOP leaders with a narrow pathway to resolve competing intra-party political and policy demands while navigating the Senate’s complex rules.

McConnell convened a group of senators – conservatives, moderates and committee chairmen – to try to forge consensus on next steps. The Senate bill won’t be developed by committees with jurisdiction over healthcare policy. Instead, Republicans will bring their modifications directly to the Senate floor as an amendment to the House bill. Any changes to the House bill would require a new House vote before final legislation could be sent to the White House.

The Senate largely sat on the sidelines while the House took months to develop an ACA repeal bill it could pass. To avoid the pitfalls that bedeviled House leaders, Senate Finance Committee Chairman Orrin Hatch said last week that the Senate “must manage expectations and remain focused on the art of the doable.”

Senate to Vote on Gottlieb This Week

Senate Majority Leader Mitch McConnell scheduled a preliminary vote Monday on President Trump’s nominee to head the FDA, paving the way for a final Senate vote later this week. Dr. Scott Gottlieb is expected to win Senate confirmation although most Democrats on the Senate HELP Committee opposed his nomination last month, saying he was too close to the pharmaceutical industry he would be in charge of overseeing. During President George W. Bush’s administration, Gottlieb served as deputy FDA commissioner and also worked at CMS. He is a cancer survivor, having previously been diagnosed with Hodgkin’s lymphoma.

Senate Panel to Vote on User Fee Bill

The Senate HELP Committee on Wednesday is expected to vote on legislation reauthorizing FDA user fees for brand and generic drugs, biosimilars and medical technology. The committee is also expected today to release a manager’s amendment of narrow bipartisan provisions that would be included in the user fee bill, like changes to medical inspections, diagnostics, accessories, post-market pilots and contrast agents used in imaging. Other changes could include legislation introduced last week that expanded eligibility to participate in clinical trials in an effort bridge differences between patient groups lobbying for right-to-try legislation and drug companies opposed to easier access to unapproved medicines.

It’s possible Sens. Bernie Sanders (I-Vt.) or Elizabeth Warren (D-Mass.) could force votes on amendments related to drug pricing or Bayh-Dole march-in rights. But committee leaders are working to ensure only amendments pre-vetted and with bipartisan support are added to the package.

The House Energy and Commerce Committee last week held a hearing on potential amendments to the user fee agreements, but that committee’s schedule for voting on the broader user fee bill isn’t clear. Current user fees expire Sept. 30, and Congress is expected to approve new user fees by this summer.

House Bill Would Allow Suits Against Device Makers

Legislation introduced last week in the House would nullify a 2008 Supreme Court decision and allow state lawsuits against medical technology manufacturers. The court’s 8-1 ruling held that federal law prohibits claims challenging safety or effectiveness of Class III medical devices that undergo the FDA’s most stringent review and approval process. Introduced by Rep. Rosa DeLauro (D-Conn.), the bill has been introduced in each congressional session since the Supreme Court’s ruling. Although supported by liberal Democrats and pushed externally by trial lawyers, the bill has failed to gain traction in Congress.

Only about 2 percent of all medical devices are approved under FDA’s premarket approval pathway referenced in the court ruling. Patients can still sue if a medical device is manufactured improperly or if a company misleads the FDA about the device’s safety or effectiveness.

Senate Committee Delays CHIP Hearing

As expected, the Senate Finance Committee delayed a hearing scheduled for this week on reauthorizing the Children’s Health Insurance Program (CHIP). House passage last week of the AHCA forced the delay, as key senators on the committee will begin focusing on drafting the Senate GOP version of the health overhaul. The CHIP hearing hasn’t been rescheduled. Still, Congress is likely to reauthorize the program – which enjoys wide bipartisan support – before it expires Sept. 30.

Capitol Hill Healthcare Update