November 1, 2024
Races to watch on Election Day/Night: Senate and House are up for grabs, but divided government still likely
While the race between former President Donald Trump and Vice President Kamala Harris will likely hinge on seven swing states (Wisconsin, Nevada, Arizona, Pennsylvania, Michigan, North Carolina and Georgia—where all the polls remain extremely tight), there are a handful of other important races that will likely determine if we have one-party control in Washington, D.C. for the next two years or if divided government will prevail. On the House of Representatives side, Democrats appear poised to regain control, but polls remain very tight with a variety of unknowns. Observers routinely cite only 27 House seats as true “toss ups”, and which way this group of 27 lands will likely determine who controls the House. Of the 27 seats, 12 are currently held by Democrats, while 15 are currently represented by Republicans. Republicans will need to perform extremely well in California and New York districts (where they won several with razor-thin margins in 2022) in order to keep control the House. On the Senate side, Democrats are defending more seats than Republicans, prompting many observers to predict that Republicans are likely to gain control. Key races: 1) Montana, where Republican challenger Tim Sheehy is leading incumbent Sen. John Tester (D) in the polls; 2) Pennsylvania, where Republican challenger Dan McCormick is polling almost even with incumbent Sen. Bob Casey (D); 3) Wisconsin, where Republican challenger Eric Hovde is just 1-2 percentage points behind Sen. Tammy Baldwin (D); and 4) Michigan, with Congresswoman Elissa Slotkin slightly leading Republican Congressman Mike Rogers in that state’s open senate seat. Regardless of which party wins control of each body, it’s very unlikely that either party will have sizeable majorities in the next Congress.
Lame Duck session priorities begin to become clearer: BIOSECURE Act appears teed up for action
When the final weeks of the congressional session commence on November 12, it’ll spark a race to the finish line for the 118th Congress. Congress has several “must pass” bills on its to-do list before the end of the year, including a five-year extension of the pediatric rare disease Priority Review Voucher (PRV) program, extension of telehealth benefits in Medicare, physician payment fixes and the BIOSECURE Act. House Speaker Mike Johnson (R-LA) reportedly plans to add the BIOSECURE language (which, as a reminder, aims to cut off federal funding to biotech “companies of concern” with ties to the Chinese government) to the National Defense Authorization Act (NDAA), which must pass before the end of the year. While BIOSECURE has already passed the House, it has not cleared the Senate, where some members are allegedly considering alternative language. If the House and Senate cannot agree on language during the lame duck session, the legislation will be difficult to pass. On telehealth extension, there is no disagreement on whether coverage for telehealth services should be continued, but how it’s paid for remains an issue. It’s likely that a telehealth extension will be limited to one year due to its hefty price tag (around $2 billion per year). The size of any end-of-year health care package will likely be determined by a variety of factors, including overall cost, political will power and the general climate in Washington, D.C. and the nation following the November 5 elections.
Advocates push for new rare disease therapy approval processes, but can’t coalesce on one solution
As progress continues to bring new therapies to the estimated 1 in 10 Americans who have been diagnosed with one of the more than 7,000 rare diseases, debate is raging over how the U.S. Food & Drug Administration can approve drugs faster, without sacrificing patient safety. In the U.S. Senate, a bipartisan bill, The Promising Pathway Act, is receiving a last-minute push for passage before the end of the congressional session. The bill would establish a limited provisional approval pathway for certain drugs and biologic products intended to treat rare, progressive, and terminal diseases. Sen. Mike Braun (R-IN), the bill’s champion, says he considers the pathway to be like a “passing lane” for drugs that have shown safety and early evidence of effectiveness for patients who don’t have time to wait for formal FDA approval. The bill is unlikely to pass before Congress adjourns. While rare disease organizations aren’t supporting Braun’s bill, some are reportedly working with key Senate and House committees to develop new legislation to allow alternatives to randomized controlled trials (RCTs) for rare disease products. One of the groups, the Haystack Project, says it does not back Braun’s legislation that would create a limited-term conditional approval pathway. They’re arguing that FDA’s overarching “substantial evidence” standard should remain intact, but that action from Congress is needed to ensure alternative evidence can be used instead of RCTs. At an event hosted by the Haystack Project on October 23, former FDA Deputy Commissioner Janet Woodcock endorsed the idea of shifting FDA metrics for evidence in the case of rare diseases, saying, “We can’t generate the evidence with traditional methods. We simply can’t. You’re not going to get evidence within RCT and placebo control of RCT in many of these rare diseases.” Suffice it to say, the broader topic of rare disease drug development and potential policy solutions to bring new therapies to patients will continue to garner substantial attention on Capitol Hill next session.
Trump reportedly ditches support of “Most Favored Nation” drug pricing program
Former President Donald Trump has allegedly backed off support for a controversial program he pushed during his first term to link U.S. prescription drug prices to those in foreign countries. In 2020, then-President Trump signed an executive order to ensure Medicare didn’t pay more for prescription drugs than other developed countries, often referred to as international reference pricing. The order was eventually rescinded by the Biden Administration as it successfully sought to pass legislation to allow price controls in Medicare through government negotiation. Last year, the Trump campaign spotlighted the “Most Favored Nation” prescription drug pricing program as one of candidate Trump’s policy proposals to “end global freeloading on American consumers”. Earlier this month, the campaign removed any reference to the program from its website and deleted a video promoting the policy. A campaign spokesperson confirmed that Trump now has no plans to revive the program if he is elected again.
Health Policy Snippets
- It’s Open Enrollment Season for Medicare & the Health Insurance Marketplace. Millions of Americans are in the midst of selecting their 2025 health care plans, but a new study by the Kaiser Family Foundation found the vast majority of consumers don’t utilize the tools available to compare plans. In Medicare, it’s estimated that about 70% of enrollees do not compare plans before selecting a Medicare Advantage plan or a stand-alone Medicare Part D prescription plan. Why? Some may be heavily influenced by the barrage of advertising appearing this time of year, while others may be satisfied with their existing plan and don’t want to make a change. The one thing on which everyone can agree? The number of scammers is on the rise, and it’s important for everyone to remain vigilant with their health care information.
- RFK Jr. in the Trump Administration? Republican presidential candidate Donald Trump confirmed that he would consider Robert F. Kennedy Jr. for key positions in his new administration if elected, including positions “focusing on health and food policy”. Some observers believe Trump could tap Kennedy to lead the U.S. Department of Agriculture (USDA), citing social media posts by Kennedy outlining what how he would change current U.S. farm policy.
