Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: shutdown risk increases as talks stall; Gottlieb’s Hill testimony postponed; more bills targeting drug prices introduced; hearing focuses on bolstering ACA; and more.
SHUTDOWN UPDATE: TALKS STALL AHEAD OF FRIDAY DEADLINE
Bipartisan negotiations to avert a new partial government shutdown – which would include the FDA – broke down over the weekend amid continuing disagreements over funding for border security, immigrant detention policies and interior enforcement.
Congress and the White House face a Friday deadline to reach a budget agreement before funding expires for multiple government departments and agencies. Leaders in both parties said last week they were adamant in wanting to avoid another shutdown.
If negotiations remain bogged down, one alternative is for Congress to approve a stopgap funding bill to keep the government open while discussions continue. Other options are less appealing: a partial government shutdown or President Donald Trump declaring a national emergency, under which the White House would redirect existing funding to build a wall along the U.S.-Mexico border. Such a declaration – opposed by Democrats and many Republicans on Capitol Hill – would likely be challenged in court.
During the 35-day closure in December and January – the longest shutdown in history – all but essential functions were shuttered at the departments of Agriculture, Commerce, Justice, Homeland Security, Interior, State, Transportation, and Housing and Urban Development, as well as several smaller agencies. Nearly 800,000 workers were furloughed, including nearly 7,000 at the FDA.
If there’s another shutdown, the FDA would be prevented from accepting new drug and medical device applications. The agency could continue working on applications where user fees were paid before a shutdown begins.
PELOSI PANS TRUMP’S CALL TO BOOST CHILDHOOD CANCER RESEARCH
President Donald Trump last week urged Congress to approve $500 million to study childhood cancer, but the top Democrat on Capitol Hill criticized the proposal as inadequate.
During his State of the Union address, Trump recognized Grace Eline, a 10-year-old girl diagnosed with brain cancer. He said many childhood cancers have not seen new therapies in decades, and he called on Congress to approve $500 million over 10 years to fund childhood cancer research.
“$500 million over 10 years – are you kidding me?” Pelosi reportedly later told Democrats in a closed-door meeting. “We’re talking about a moonshot. He’s talking about a trolley ride.”
Of the National Cancer Institute’s $6.1 billion annual budget, only about 5 percent is targeted to childhood cancer research, according to the Coalition Against Childhood Cancer.
LAWMAKERS URGE CMS NOT TO CHANGE PART D PROTECTED CLASSES
Nearly 40 House lawmakers called on CMS to withdraw a proposed regulation that aims to lower prescription drug costs by allowing Medicare Part D and Medicare Advantage plans to exclude from formularies coverage of certain medicines – including cancer drugs.
CMS says its proposal would give plans flexibility not to cover drugs in the so-called six protected classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals and cancer drugs.
The move sparked concern among patient groups, which fear newly approved treatments could lack Medicare coverage.
Rep. Grace Napolitano, D-Calif., organized a letter to HHS Secretary Alex Azar, writing that upending the protected classes would jeopardize the health of patients living with mental illnesses, AIDS, cancer, epilepsy and organ transplants. Napolitano, who is founder of the Congressional Mental Health Caucus, said the policy change could cause patients to drop their current medication in favor of new drugs subject to prior authorization or step therapy.
SENATE BILL REINTRODUCED ON COORDINATING KIDS CARE
Senate Finance Committee Chairman Chuck Grassley, R-Iowa, reintroduced bipartisan legislation last week that aims to coordinate care under Medicaid for children with complex medical conditions.
The ACE Kids Act would allow states to participate in national children’s hospital networks, effectively allowing kids living in one state to be treated by pediatric providers in other states. The bill wouldn’t mandate that states participate, but would allow them to opt in to the networks, which could coordinate services among home, primary, ambulatory, acute and post-acute care providers.
Sen. Michael Bennet, D-Colo., is co-sponsoring the legislation, and companion legislation is expected to be introduced in the House.
Medicaid covers about two million children with complex medical conditions, including cancer, congenital heart disease, cystic fibrosis, Down syndrome and chronic health challenges from premature birth. On average, children with complex medical needs require five to six specialists, with as many as 30 health and allied health professionals involved in their care.
Grassley said many children require travel to another state to find appropriate treatment, and the legislation would streamline that process under Medicaid.
The measure nearly passed Congress last year but was tripped up by the lame-duck session and the partial government shutdown that began in December.
GOTTLIEB HILL TESTIMONY POSTPONED
FDA Commissioner Scott Gottlieb was scheduled to testify Tuesday before the House panel that approves his agency’s congressional appropriations, but the hearing has been postponed to allow lawmakers to attend the funeral of Rep. John Dingell, D-Mich.
Dingell, 92, served in the House for 59 years – the longest tenure in history – and was chairman of the Energy and Commerce Committee, which has jurisdiction over the FDA and several Medicare Part D plans.
Gottlieb was the only witness to testify before the House Appropriations Agriculture Subcommittee, just three days before funding is scheduled to expire. The commissioner was expected to outline how the most recent shutdown affected operations with drug and medical device approvals.
PANEL HOLDS DRUG PRICE HEARING AS MORE BILLS INTRODUCED
The House Ways and Means Committee on Tuesday will hold its first hearing on prescription drug prices, as lawmakers in both chambers continue to introduce legislation targeting drug prices.
Witnesses include Mark Miller of Arnold Ventures; Rachel Sachs of Washington University; Alan Ruether of the United Autoworkers; Dr. Odunola Ojewumi, a patient from Maryland; and Joseph Antos of the American Enterprise Institute.
Rep. Lloyd Doggett, D-Texas, last week reintroduced legislation that would allow Medicare to negotiate prices directly with manufacturers – and if the companies refuse to negotiate, HHS could invalidate patents and grant competitive licenses to other manufacturers.
Doggett, the chairman of the panel’s Health Subcommittee, introduced similar legislation last summer.
Separately, top executives from AbbVie, Johnson & Johnson, Sanofi and other pharmaceutical companies agreed to participate in a Senate Finance Committee meeting on Feb. 26. The hearing on drug prices is expected to be explosive, as it’s the first time this many pharmaceutical CEOs have testified before Congress since the Affordable Care Act was debated in 2009 and 2010.
SENATE HEARING TO FOCUS ON OPIOIDS AND PAIN MANAGEMENT
The Senate HELP Committee will hold a hearing Tuesday focusing on treating pain amid the opioids crisis.
The committee is expected to discuss pain management techniques and the development of new medicines and nondrug alternatives.
HOUSE PANEL TO HOLD HEARING ON HEALTH LAW BILLS
The House Energy and Commerce Health Subcommittee will hold a hearing Wednesday on a series of bills designed to bolster the Affordable Care Act (ACA) and the nation’s insurance markets.
The panel will consider legislation by Rep. Ann Kuster, D-N.H., that would nullify Trump administration approval of states linking work requirements to expanded Medicaid coverage. The committee will review legislation by Rep. Lisa Blunt Rochester, D-Del., that would restore ACA outreach and enrollment funding to assist consumers in signing up for healthcare coverage.
HOUSE REPUBLICAN INTRODUCES BILLS TARGETING PBMs
The top Republican on the House Judiciary Committee introduced two bipartisan bills last week that would overhaul the role of pharmacy benefit managers, with the aim of increasing transparency and lowering prescription drug costs.
A second Collins bill aims to increase transparency about PBM operations in Medicare Part D, Medicare Advantage and Federal Employees Health Benefits Program plans.
Collins introduced both bills in the 115th Congress.