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HEALTH CARE BRIEFING: Fall Hurdles on Drug Price, Surprise Bills
September 8, 2020 6:09 AM	 By Zachary Sherwood
Lawmakers return to Washington this week with a few outstanding health-care issues to wrap up before the November elections. The House and Senate will look for a path forward on drug pricing and surprise billing measures, while negotiations continue over the next round of coronavirus stimulus legislation and the annual spending bills ahead of the end of the fiscal year on Sept. 30.
Bloomberg Government's Fall 2020 Hill Watch offers comprehensive coverage of all the issues and legislation on lawmakers' agenda the rest of this year. Read the report here.
Negotiations over the next round of aid to stimulate the economy during the coronavirus pandemic will take up much of lawmakers time.
Democrats have pushed for Senate passage of most of the $3.4 trillion Heroes Act (H.R. 6800) passed in May. In more recent talks with the administration, Democrats said they were willing to drop demands to the $2.2 trillion level. The administration argued for the $1 trillion contained in the HEALS Act, proposed by Republicans in August, but recently said they might go beyond that figure. The Senate this week could also vote on a $500 billion "skinny" stimulus measure. Read more Nancy Ognanovich.
Drug Prices: Lowering the cost of prescription drugs was supposed to be one of the few areas where lawmakers could find bipartisan common ground.
But with time running out on the 116th Congress, Senate Finance Chairman Chuck Grassley (R-Iowa) has yet to find a path forward for his package of drug-pricing measures that would, among other things, cap out-of-pocket costs for the elderly in Medicare Part D at $3,100 and limit how much drugmakers can raise their prices in Medicare. Finance Committee ranking member Ron Wyden (D-Ore.), Grassley's one-time co-author for the drug pricing bill, has withdrawn support for S. 2543, raising doubts about the extent of support among Senate Democrats.
Surprise Billing: Surprise medical billing proposals are aimed at ending balance billing, where a doctor or facility can't agree with an insurer on the cost of services and charges the patient more than the insurer will pay. Despite bipartisan agreement on the issue, a fix hasn't advanced.
The chairmen of the House Energy and Commerce and Education and Labor committees have together called for including a compromise agreement in the next coronavirus related legislative package. House Ways and Means Chairman Richard Neal (D-Mass.), however, has not signed off on that compromise, leaving Democratic leaders split on the issue.
Senate Health, Education, Labor and Pensions Chairman Lamar Alexander (R-Tenn.) was part of the agreement with House committee leaders to add a surprise medical billing fix to the next coronavirus related package of bills.
The Week's Hearings on the Hill:
Energy & Commerce Markup: The House Energy and Commerce Committee will consider 38 measures at a markup tomorrow. The panel will consider a slate of health care, mental health, and drug measures. See the full list of measures here.
Vaccines & Virus: National institutes of Health Director Francis Collins and U.S. Surgeon General Jerome Adams are scheduled to testify before the Senate Health, Education, Labor and Pensions Committee tomorrow on vaccines and public health, according to a statement from the committee.
Virus & Research: The House Science, Space and Technology Subcommittee on Research and Technology holds a hearing tomorrow on the effect of Covid-19 on university research.
Energy Research & Virus: The House Science, Space and Technology Subcommittee on Energy scheduled a hearing Friday on Energy Department biological research and responding to Covid-19.
Veterans' Mental Health Bill: The Senate Veterans' Affairs Committee meets tomorrow to discussS. 785, a bill aimed at improving mental health care provided by the Department of Veterans Affairs.
The Coronavirus Pandemic
Trump Says Vaccine Could Be Ready in October: President Donald Trump, speaking at the White House yesterday, hinted that the U.S. could approve a coronavirus vaccine in October, ahead of the November election, as Joe Biden demanded transparency from the government as it studies the shots.
Many public health officials and scientists have expressed concerns that the FDA is under pressure from the White House to approve a vaccine before Trump faces re-election on Nov. 3. Americans may be unwilling to receive a shot if they believe it was rushed to market based on the campaign timetable.
Before Trump's news conference, Biden said he would heed the advice of scientists about whether to get a coronavirus vaccine if one were to become available before November's presidential election. Read more from Jennifer Epstein.
Meanwhile, vice presidential nominee Sen. Kamala Harris (D-Calif.) told CNN that she wouldn't take Trump's word alone on the efficacy of a coronavirus vaccine, Sydney Maki reports.
Drugmakers are planning a public pledge to not send any Covid-19 vaccine to the FDA for review without extensive safety and efficacy data, according to people familiar with the effort. The joint stance is seen as a bulwark against political pressure being applied on the Food and Drug Administration to get a vaccine out as soon as possible. It is likely to be announced in a multi-company statement as soon as this week. The plans, which could still change, were described by people involved in the effort on condition of anonymity. Read more from Robert Langreth.
An unsubstantiated claim two weeks ago by Trump — that the "deep state" was slowing approval of a Covid-19 vaccine — has set off an effort by government officials and private industry to ensure the White House doesn't interfere with a methodical, careful scientific process. FDA leaders are insulating the agency's vaccine reviewers from outside political pressure by sticking by June guidelines that set the standard for what it will take for a vaccine to pass through the agency, said one official familiar with the planning, who asked for anonymity discussing private deliberations. They're also making clear to FDA staff that the political noise shouldn't influence the agency's decisions. FDA Commissioner Stephen Hahn last week sent an email to all 17,000 staff, promising that the agency would adhere to the science in a vaccine review. He has also met with leaders of the health agency's various departments, including the one that reviews vaccines, to reassure them. Read more from Anna Edney, Drew Armstrong and Robert Langreth.
State health officials also pushed back on the administration's suggestion that a vaccine could be cleared for use before clinical trials are complete. The group representing state public-health leaders said last week that any vaccine approval must be insulated from political motives and driven by science. "We want the safety and efficacy to be demonstrated," Rachel Levine, president of the Association of State and Territorial Health Officials, said in an interview. Read more from John Tozzi.
Virus Fatigue Is Risk, Ex-FDA Head Says: "Pandemic fatigue" is an additional risk as the U.S. heads into the fall and winter, when infectious diseases traditionally spread more readily, former FDA head Scott Gottlieb said. A coronavirus vaccine is unlikely to be available for widespread use this year, and more than 20% of the U.S. population could be infected with Covid-19 by year-end based on current spread rates, Gottlieb said on CBS's "Face the Nation" on Sunday. "People are exhausted," he said. "People have been social distancing and wearing masks and staying home for a long period of time right now. Small businesses are hurting." Read more from Tony Czuczka and Yueqi Yang.
More than 400,000 Covid-19 Deaths Predicted by New Year: A long-term forecast predicts a significant increase in Covid-19 deaths in the U.S. by the new year. Under the latest projections from the Institute for Health Metrics and Evaluation at the University of Washington's School of Medicine, Covid-19 deaths could rise to 410,451 by the end of 2020. In a worst-case scenario, there could be 620,029 fatalities, according to the estimates. The difference between the projected and worst-case scenarios comes down to how diligent authorities are in mandating masks and social distancing, according to the report. Read more from Reg Gale.
Saliva Sample Tests Show Promise: Two studies made the case recently for an alternative to the invasive Covid-19 tests that require collecting a sample from deep in the nose. Saliva samples, both studies found, were nearly as reliable and far less of a hassle. Read more from Kristen V Brown.
Related: DNA Firm With History of Errors Botched Nursing-Home Covid Tests
U.S. Cases Tick Up Amid Specter of Labor Day Surge
Skyrocketing Indian Virus Cases Could Eclipse U.S. Outbreak
China Says U.S. Visitors Will Need Negative Virus-Test Results
Covid-19 Patients May Have Prolonged Gut Infection, Study Finds
What Else to Know
Hospitals Trail Rebound in Hiring: Hospitals are lagging the rest of the health-care industry in hiring workers as executives navigate a changing landscape for insurance coverage. The health-care industry gained 75,000 jobs in August, buoyed largely by the 49,000 jobs added by physician and dental offices, according to the latest Bureau of Labor Statistics data. By contrast, hospitals, which account for almost a third of all U.S. health-care jobs, employed 60,000 fewer Americans than they did during the same month in 2019.
This slower rebound in rehiring comes as hospitals expect lower profits as a result of fewer Americans having private, employer-sponsored health insurance, which pays higher rates than publicly funded coverage. Read more from Alex Ruoff.
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AbbVie Inks $2.9 Billion Cancer Deal With China's I-Mab
Insurer Gets New Trial on Reasonableness of Hospital's Bill
To contact the reporter on this story: Zachary Sherwood in Washington at zsherwood@bgov.com
To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com
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