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The clock is ticking. President Trump has until midnight tonight to sign a Food and Drug Administration funding package into law. The bill would reauthorize the FDA’s user fee program in which drug and device makers pay the FDA a fee for every new application and the agency uses that money to hire more staff and speed up approvals. The user fee program expires at the end of September. Trump has 10 calendar days if Congress is in session to sign or veto it. While Congress is technically in recess, it has been holding pro forma sessions since it adjourned earlier this month. When the Senate passed the bill this month, a White House aide told the Washington Examiner he was expected to sign it. The White House has complained that it wants all of the agency’s funding to be from user fees. But that request has not been possible as the user fee agreement between the FDA and the industry was negotiated more than a year ago. The bill also includes measures to speed up approval of generic drugs to foster more competition and lower drug prices.
California tries to stabilize its Obamacare market. California’s state-run Obamacare exchange has approved a hefty surcharge on health insurance plans and has taken other steps to help stabilize insurance companies in light of fears that certain funding from the federal government might soon dry up. The exchange’s board approved a measure that will give health insurers until Sept. 30 to add a surcharge to silver Obamacare plans. The surcharge of about 12.4 percent would help insurers if Congress or President Trump decides to not make cost-sharing reduction payments to insurers. A major source of uncertainty for insurers is the fate of the payments, which reimburse insurers for lowering out-of-pocket costs. The Trump administration has not clarified whether these payments would continue after August.
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Democrats demand answers on Obamacare outreach. Top congressional Democrats want to meet with the Trump administration to see how preparations are going for Obamacare’s open enrollment, which starts in a few months. The request for a meeting comes after reports of the administration possibly limiting outreach and after President Trump has repeatedly said he wants to let Obamacare “implode.” “Rather than encouraging enrollment in the marketplaces, the administration appears intent on depressing it, which we fear will contribute to destabilizing insurance markets and drive up costs for consumers,” they wrote in a letter Friday to Health and Human Services Secretary Tom Price and Centers for Medicare and Medicaid Services Administrator Seema Verma.
Hispanic Caucus ‘alarmed’ HHS isn’t reaching out to Latinos. The group also is demanding a meeting with Price to discuss the lack of outreach to key advocacy groups tasked with enrolling Latinos in Obamacare. It says it is “alarmed” by a report from Talking Points Memo that the administration has abandoned Latino outreach for Obamacare’s open enrollment set to start Nov. 1. “Preparation efforts and resources for Latino outreach are even more critical this upcoming open enrollment period, given the very limited timeframe people have to enroll,” they wrote. Open enrollment is scheduled to end Dec. 15. The lawmakers added that Obamacare remains the law and that HHS is tasked with a “successful 2018 enrollment period.”
Major health organizations cancel fundraisers at Mar-a-Lago. Thursday saw the Cleveland Clinic, American Cancer Society and Israeli Red Cross all cancel planned events at Trump’s Palm Beach, Fla., resort. The Cleveland Clinic’s Florida campus canceled a fundraiser it has held at the club for eight consecutive years and that typically raises about $1 million for the hospital’s equipment and programs. The fundraiser had been scheduled for Feb. 24, 2018, and a new location and date hasn’t been selected. The American Cancer Society’s event, “Rock Palm Beach,” was supposed to take place at the club in February. The group had held events at Mar-a-Lago for the past decade. “When we chose to hold our 2018 event and related dinner at Mar-a-Lago, we selected the venue based on a variety of factors, including costs and venue requirements,” the cancer society said. “Our values and commitment to diversity are critical as we work to address the impact of cancer in every community. It has become increasingly clear that the challenge to those values is outweighing other business considerations.” The American Friends of Magen David Adom, known as the Israeli Red Cross, became the third organization on Thursday to announce it had canceled an event. “After considerable deliberation, AFMDA — an apolitical and humanitarian aid organization will not hold its 2018 Palm Beach Celebration of Life Gala at Mar-a-Lago,” the group said. Businesses have been under pressure to distance themselves from Trump after he said Tuesday that “both sides” bore some responsibility for the violence that erupted in Charlottesville, Va. involving white supremacist and nationalist protesters and their counter-protesters last weekend. Eileen Sheil, a spokeswoman for the Cleveland Clinic, would not say whether Trump’s comments influenced the hospital’s decision, saying only that they “considered a number of factors.” The hospital already was under pressure to move its event by healthcare providers who oppose Trump’s aim to repeal and replace portions of Obamacare and other groups who protest his budget proposal to cut research funding from the National Institutes of Health. An open letter signed by nearly 1,700 doctors, medical students and patients says that holding such a fundraiser at Mar-a-Lago is “unacceptable,” saying it “symbolically and financially supports a politician” with those goals.
Sen. Ron Johnson demands OPM records on Obamacare carve-out for Congress. The Wisconsin Republican this week demanded more information about how the Office of Personnel Management decided to allow members of Congress and their staffs to buy health insurance plans on the small business exchange in Washington, D.C., and to let the federal government subsidize those plans. He sent a letter Wednesday asking OPM to preserve all records, including some as far back as 2010, related to how the agency created the rule. Johnson’s letter noted that OPM allowed lawmakers to use the city government’s Small Business Health Options Plan, or the SHOP exchange, to buy insurance under Obamacare, even though the exchange was meant for employers with fewer than 50 people. That decision allowed the government to subsidize those plans. “Without this classification, members of Congress and their staff would be required to purchase health insurance on the individual exchange, where no employer contributions are permitted,” he wrote. Trump has raised the issue of congressional health plans and has appeared to threaten lawmakers with the idea of getting rid of the government’s contribution. “If ObamaCare is hurting people, & it is, why shouldn’t it hurt the insurance companies & why should Congress not be paying what public pays?” Trump asked in a late July tweet. Johnson asked OPM for “all documents and communications” related to the decision, and a description of the process OPM follows to meet that request. He demanded that information by Aug. 31.
Mylan agrees to pay back government $465 million for EpiPen overbilling. The settlement comes at the end of an investigation that found Mylan avoided paying state Medicaid programs higher rebates for the EpiPen by improperly naming it as a generic medication. The Centers for Medicare and Medicaid Services said the company was reclassifying its EpiPen retroactively, beginning April 1. The move, they said, would save hundreds of millions of dollars for the Medicaid program. “Mylan’s agreement with CMS to correctly classify EpiPen is a huge win for Medicaid beneficiaries and American taxpayers,” said CMS Administrator Seema Verma. Mylan announced the settlement amount in October, and it does not contain an admission of fault or wrongdoing. Mylan said in a statement that the drug was classified under its previous owner, before it acquired it in 2007. The overbilling tip was sent to federal investigators in 2014 by Sanofi, a company that previously produced a rival allergy medication while paying the higher Medicaid rebates. Sanofi filed a False Claims Act and will receive $38.7 million from the settlement.
Lawmakers dismayed over the Mylan agreement. Sen. Chuck Grassley, R-Iowa, who had been investigating the price increases, said the settlement was “a disappointment,” noting that the Office of the Inspector General at the Department of Health and Human Services found overbilling had amounted to $1.27 billion from 2006 to 2016, and that Mylan didn’t correct the false classification for a few years after it was pointed out to them. “There are serious problems here,” he said. “It looks like the settlement amount shortchanges taxpayers.” Rep. Lloyd Doggett, D-Texas, chairman of the Prescription Drug Task Force, echoed similar sentiments and lamented that the Trump administration had not revisited the settlement agreed to under the Obama administration. “This sorry settlement amounts to a shocking $800 million gift to a leading price gouger at taxpayer expense,” he said. “It insults families who have been crying out for relief from Mylan and is an affront to taxpayers. Once again, the Trump administration adds another brick to the wall of broken promises, letting one of the companies that Trump said are ‘getting away with murder’ keep so much of its ill-gotten gains.”
National HHS spokeswoman Alleigh Marre leaves her post. Marre has held her position since March. Questions from journalists should go to Caitlin Oakley at HHS’s office of communications.
RUNDOWN
STAT News Most hospices fare well in first public release of Medicare quality scores
Bloomberg There’s a sugar shock ahead, in a world that’s eating smarter
Axios Bernie Sanders’ first draft of ‘Medicare for all’
Morning Consult Time crunch amid hurdles for bipartisan Senate push to bolster ACA
New York Times Guns play oversize role in rural suicides
NPR Inside the lab where scientists are editing DNA in human embryos
LA Times column: It shouldn’t take generous strangers to help patients cope with drug prices
Calendar
FRIDAY | Aug. 18
Noon CDT/1 p.m. EST. American Legion Post. Sen. Jerry Moran, R-Kan., to hold a listening tour. Details.
2 p.m. CDT/ 3 p.m. EST. Cass County Justice Center. Sen. Claire McCaskill, D-Mo., to hold a town hall. Details.
3 p.m. MDT/5 p.m. EST. Bean Broker. Sen. Deb Fisher, R-Neb., to hold a listening session. Details.
MONDAY | Aug. 21
9 p.m. House Speaker Paul Ryan to appear in CNN town hall. Details.
