HEALTH CARE BRIEFING: Drug Pricing Efforts on Post-Crisis Agenda

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The global coronavirus outbreak has upended major agenda items on Congress’ priority list for health-care issues. But the crisis may also offer lawmakers a new perspective as they aim to tackle drug pricing, surprise medical billing, and drug supply chains when the nation recovers.

Bloomberg Government’s Spring 2020 Hill Watch offers comprehensive coverage of all the issues and legislation on lawmakers’ agenda in the next several months. Read the report here.

Senators, as they return to Capitol Hill today, will be focused on negotiations on a fourth major stimulus package that may include more relief for hospitals and state and local government responses to the fight the virus, and health-focused members are seeking to use the measure to include health-care priorities that were sidelined by the pandemic.

In an effort to rein in surprise medical bills, Senate Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-Tenn.) and House Energy and Commerce Chairman Frank Pallone (D-N.J.), have been promoting bills to prohibit balance billing, in which a health-care provider might bill a patient for charges that their insurer won’t cover, and require doctors in some instances to accept a rate similar to what insurers pay other providers for the same service.

Alexander and House Energy and Commerce ranking member Greg Walden (R-Ore.) have also been pushing to include surprise medical billing measures in one of the coronavirus relief bills, but have so far been unsuccessful. Alex Ruoff has more on that effort.

Prior to the crisis, House Democrats rallied around a bill (H.R. 3), endorsed by House Speaker Nancy Pelosi (D-Calif.) to empower the U.S. government to demand lower prices from drugmakers for many medicines. Likewise, House Democrats since the pandemic have been pushing for price controls on drugs and any vaccines developed for Covid-19.

That bill faces competition from a bipartisan Senate package (S. 2543) by Senate Finance Chairman Chuck Grassley (R-Iowa) and top Democrat Ron Wyden (Ore.)—tepidly endorsed by the White House—to require drugmakers to offer customers Medicare inflation rebates while capping out-of-pocket drug costs for Medicare beneficiaries. Grassley has been pressing fellow Republicans to back the legislation to convince Majority Leader Mitch McConnell (R-Ky.) to allow a vote.

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Grassley has sought to use “must-pass” extensions for health programs that were set to expire this month to push through his drug pricing legislation, but Congress included those extensions in a coronavirus stimulus package signed into law in March. Those programs, including Temporary Assistance for Needy Families, now expire Nov. 30. Danielle Parnass delves into the funding figures for the health programs.

Meanwhile, the spread of the coronavirus has reignited the push in Congress to expand domestic manufacturing of drugs, and renewed concerns the U.S. relies too much on foreign medicine makers. The need for medications can be urgent during a pandemic and lawmakers on both sides of the aisle have raised alarms about possible shortages.

Rep. Anna Eshoo (D-Calif.), the chairwoman of the House Energy and Commerce Health Subcommittee, has been pushing for a bill to boost domestic manufacturing of pharmaceutical products. Reps. Eshoo and Susan Brooks (R-Ind.) unveiled a measure that would require the National Academies of Sciences, Engineering, and Medicine to “convene a committee of experts to analyze the impact of U.S. dependence” on foreign medicines and to make recommendations to Congress. They cited Covid-19 as a critical example for the need to reassess the nation’s drug supply chain.

Reps. John Garamendi (D-Calif.) and Vicky Hartzler (R-Mo.) want to use the fiscal 2021 defense authorization bill to strengthen U.S.-based pharmaceutical manufacturing and advance “make it in America” policies that favor domestic drug-production plants. Garamendi introduced a bill (H.R. 4710) that would direct the secretary of defense to include drug supply chains in the Pentagon’s national security strategy.

Follow these issues and more with BGOV’s Spring 2020 Hill Watch

Trump Wants Payroll Tax Cut, Revises Death Estimate

President Donald Trump revised upward the number of Americans he expects to die from the virus to as many as 100,000 and promised more assistance for those put out of work in a televised town hall event at the Lincoln Memorial last night. “We’re going to lose anywhere between 75, 80 to 100,000,” he said. He had said at the beginning of April he hoped deaths would total less than 60,000. The number of U.S. dead so far is more than 67,000. Read more.

Trump also said yesterday he won’t agree to pass further stimulus measures to combat the economic fallout of the coronavirus outbreak without payroll tax cut. Trump has been advocating for a payroll tax cut for weeks but it’s opposed by most congressional Democrats and it’s not clear the idea has much support in Trump’s own party. A payroll tax cut would have no benefit for Americans put out of work in the wake of the outbreak until they return to employment. Read more from Jordan Fabian and Jennifer Jacobs.

Congress Squaring Off Over Priorities for Next Virus Aid Measure: Congress turns its attention this week to negotiations over another round of economic stimulus, with battle lines drawn over more than $1 trillion in additional spending floated by Democrats amid objections from Republicans and demands from Trump.

Republicans are chafing at the prospect of adding to the $2.9 trillion already allocated to pandemic relief, yet the two sides are open to some funding for the most contentious piece: aid to state and local governments. GOP lawmakers have eased their opposition to the Democratic-backed proposal, expressing openness to offering some relief in exchange for business liability protections.

Related: GOP, Hospital Groups Eye New Liability Shields

And Pelosi has indicated at least partial agreement with McConnell that state and local aid should be focused on the losses caused by the coronavirus pandemic. But the biggest potential obstacle may be Trump, who said Democrats’ willingness to wait until now to push for up to $1 trillion sought by states and localities creates an advantage for the GOP. “If they do it, they’re going to have to give us a lot,” he said Friday on host Dan Bongino’s podcast. On Sunday, he set down one marker.

“We’re not doing anything without a payroll tax cut,” Trump said in a “virtual town hall” event hosted by Fox News at the Lincoln Memorial in Washington. Read more from Erik Wasson and Laura Litvan.

Pelosi, McConnell Reject Rapid Test Offer: Pelosi and McConnell declined a White House offer of rapid Covid-19 testing for lawmakers until “these speedier technologies become more widely available.” In a joint statement, the pair said they were “grateful” for the offer but would “respectfully decline.” The country’s testing capacities “are continuing to scale up nationwide and Congress wants to keep directing resources to the front-line facilities where they can do the most good the most quickly,” Pelosi and McConnell said.

Health and Human Services Secretary Alex Azar and Trump earlier said that all senators would be able to be tested for the coronavirus as lawmakers prepare to return to Washington. Azar tweeted the “good news” Friday night: “we have now received an initial request and are sending 3 Abbott point of care testing machines and 1,000 tests for their use.” Read more from Ros Krasny.

  • Meanwhile, the new reality confronting the Senate when it convenes today after a recess of nearly six weeks will be one of filing in past door-keepers wearing face masks and having nowhere to go for a gourmet jolt of coffee. There will be less uniformity in how individual lawmakers and both parties will conduct duties. While Pelosi has declined to second-guess McConnell’s decision, saying that “they’re 100, we’re four times that,” some Democratic said not only that it’s unsafe to return now but also senseless with no new virus relief package on the agenda, James Rowley and Emily Wilkins report.

Also on Congress’ Coronavirus Radar

This Week’s Hearings:

  • The Senate Health, Education, Labor, and Pensions Committee convenes on Thursday to discuss new testing to diagnose Covid-19. National institutes of Health Director Francis Collins and Biomedical Advanced Research And Development Authority acting Director Gary Disbrow will testify.
  • The Trump administration has barred Anthony Fauci, the scientist who’s leading the country’s response tothe pandemic, from testifying before a congressional hearing on Wednesday. Fauci had been sought as a witness for a House Appropriations subcommittee that’d been looking into the U.S. response to the coronavirus crisis, according to Evan Hollander, a panel spokesman. Read more from Erik Wasson and Jennifer Jacobs.

Legislation & Letters:

Treatment, Testing & Research Efforts

Hurdles to Getting Vaccine to Whole World: Coming up with a vaccine to stop Covid-19 in a matter of months isn’t the only colossal challenge. The next major test: getting billions of doses to all corners of the world at a time when countries increasingly are putting their own interests first. A variety of financing tools are under consideration to spur production of large quantities of potential vaccines and ensure they’re distributed equitably. In one arrangement, developers would agree to provide shots at affordable prices in return for funding commitments from governments or other donors.

The stakes are immense with coronavirus sickening more than 3 million people, even as billions hide from the pathogen indoors. Health advocates are worried about wealthier nations monopolizing the global supply of coronavirus vaccines should companies succeed, a scenario that played out during the 2009 swine flu pandemic. Distributing shots widely, they say, isn’t just the right thing to do—it’s also crucial in curbing the spread of the virus. Read more from James Paton.

Meanwhile, researchers continue to debate how fast a coronavirus vaccine may be available as states and nations look for a fast track to recovery from the pandemic’s economic toll, with January or even the fall now on the timetable. British scientists hope to see a “signal” on whether their vaccine candidate is working by June, John Bell, professor of medicine at Oxford University, said yesterday, reports Ros Krasny.

Trump in an interview with Fox News last night said he was confident a vaccine would be developed by the end of the year.

  • FDA Approves Gilead Drug for Emergencies: Gilead’s antiviral drug remdesivir was cleared by federal regulators for emergency use in Covid-19 patients, becoming the first medication supported by early clinical data to be made available to fight the novel coronavirus. Remdesivir reduced the time it took hospitalized Covid-19 patients to recover in an interim analysis of a study that is ongoing. The FDA granted an emergency-use authorization, Trump said Friday, a move in which the agency can let products be used without a complete review of their safety and efficacy. Read more from Drew Armstrong.
  • Gilead is also seeking ways to make its experimental medicine more broadly available, potentially treating Covid-19 patients in the outpatient setting, the company’s CEO Daniel O’Day said on Friday. Read more here.
  • O’Day also Friday said he promises to make remdesivir affordable. Gilead has gone from 5,000 remdesivir treatment courses to 100,000, and the drugmaker expects to have millions available by the end of the year, he said. Read more here.

FDA Approves Roche Test for Emergencies: Roche Holding became the latest company to win emergency federal clearance for a coronavirus antibody test and promised a fast scale-up of the tool that the White House hopes will smooth the reopening of economies. The Swiss giant expects production of the test to reach the high double-digit millions by next month, and pass the 100 million monthly threshold later this year. The test seeks out antibodies in blood that have been raised to fight off the virus that causes Covid-19.

Roche’s test version runs on a high-volume instrument that can produce a single result in 18 minutes and as many as 300 results in an hour, the company said in a statement Sunday after receiving emergency authorization from the FDA. Tim Loh and Catherine Bosely have more.

Doctors Push for ‘Czar’ to Coordinate Tests, Supplies: U.S. doctors and other health-care workers dealing with the pandemic are urging a coordinated federal effort to make sure medical equipment, protective gear, and tests get to where they are needed, urging the administration in a letter for a “medical equipment czar” and a task force to specifically oversee supply and distribution of the gear. Senate Democrats last week introduced a bill that would federalize the medical supply chain. Read more from Susan Decker.

Maryland Test Kits Under Guard: Maryland Gov. Larry Hogan (R) said 500,000 of novel coronavirus test kits acquired from South Korea, so far unused, are at an undisclosed location protected by the National Guard and police to prevent the U.S. government from commandeering them. “There had been several reports of shipments being intercepted or diverted by the federal government from a couple of my colleague governors from around the country,” Hogan told CNN’s “State of the Union.” Read more.

Hospitals in Hot Spots to Get Aid Based on Admissions: Hospitals in Covid-19 “hot spots” will get funding from the Trump administration based on how many patients they admitted, HHS announced on Friday. HHS detailed how it will distribute $22 billion in additional funding to health-care providers in Covid-19 hot spots and rural areas after criticisms over how the first round of funding was released. Congress has appropriated a total of $175 billion for the provider relief fund. But the first $30 billion released has been plagued by complaints from lawmakers and health-care providers that it didn’t go where it was most needed because it was allocated based on previous Medicare payments. Read more from Shira Stein.

More Headlines:

What Else to Know

Trump Promises ‘Conclusive’ U.S. Report on Virus’s China Origins: Trump promised a “conclusive” report on the Chinese origins of the coronavirus outbreak, showing relations between the world’s biggest economies are set to remain rocky at least until the next election six months from now.

Trump pledged the report Sunday in a “virtual town hall” with Fox News, in which he added that he had little doubt that Beijing misled the world about the scale and risk of the disease. Earlier, Secretary of State Michael Pompeo said “enormous evidence” shows the Covid-19 outbreak began in a laboratory in the central Chinese city of Wuhan, without providing evidence to support his claims.

“We’re going to be giving a very strong report as to exactly what we think happened. And I think it will be very conclusive,” Trump said in response to a question about the lab. “My opinion is they made a mistake. They tried to cover it. They tried to put it out, just like a fire.” Read more from Jordan Fabian, Jennifer Jacobs and Iain Marlow.

Assistant U.S. Attorney Tapped for HHS IG: Trump will nominate Jason Weida to be inspector general for the Department of Health and Human Services, the White House announced late Friday. The announcement comes after Trump criticized Principal Deputy Inspector General Christi Grimm during a White House press conference on April 6 after she released a report on severe hospital shortages of Covid-19 tests and equipment. Read more from Shira Stein.

Generic Drug Decisions Stall Amid Pandemic: Patients with cancer, kidney disease, and other illnesses could have to pay higher drug prices for months longer than they otherwise would have thanks to court delays caused by the coronavirus pandemic. At least six patent infringement lawsuits over brand-name drugs are at risk of surpassing, or are already set to exceed, Food and Drug Administration timelines for approving generic versions, according to a Bloomberg Law review of court dockets. Depending on how long the Covid-19 crisis goes on, that list could grow. Read more from Valerie Bauman.

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To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Zachary Sherwood at zsherwood@bgov.com; Michaela Ross at mross@bgov.com

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