HEALTH CARE BRIEFING: Holistic Drug Reform Eyed to Fix Inequity

Lawmakers seeking to lower drug costs should take a comprehensive approach rather than focus solely on manufacturers’ pricing practices—a strategy that’s only created disparities in the marketplace, policy analysts say.

Drug pricing will come back to the forefront of policy discussions in the coming months as Covid-19 vaccines become more readily available and lawmakers turn to other issues. But many of the roughly two dozen bills floating around Congress primarily address the prices drug companies set and ignore other aspects of the supply chain, including the pharmacy middlemen that control how insurance pays for medications.

It’s a warning sign that lawmakers might not have a full grasp of the bigger picture and what needs to change to make drugs cheaper. “We have often said let’s just get better rebates for Medicaid” or just do more drug discount programs, Antonio Ciaccia, CEO of the drug pricing research group 46brooklyn Research, said.

“The real problem is that creates a horrible system of inequity in the market,” Ciaccia said. “If Medicaid gets the best deal, who gets the worst deal? Small employers and patients who pay out of pocket are the ones who pay the price.”

Most Americans agree they pay too much for their drugs, but what each ends up paying can vary drastically depending on discounts or their insurance coverage. Medicare enrollees may pay just $35 for a 30-day supply of insulin. For those without Medicare or Medicaid coverage, out-of-pocket costs for insulin typically vary from 0% to 20% of the total cost of prescriptions, according to research by the Commonwealth Fund.

The variance exists because larger insurance groups have the financial leverage to demand better rebates for drugs. The government is the largest purchaser of drugs in the country, which is one reason Medicare and Medicaid plans can demand the best discounts.

To be effective and create an even playing field for all Americans, lawmakers must dismantle a system that allows one person to pay nothing for a drug, while someone else to pay hundreds of dollars, Ciaccia said. Read more from Jacquie Lee.

Happening on the Hill

House Floor: House lawmakers will consider a health-workplace violence bill under a structured rule that makes in order six amendments.

Under the bill (H.R. 1195) the Labor Department would have to issue a standard requiring health-care and social service employers to implement workplace violence prevention plans. The bill would define workplace violence as any act or threat of force against an employee that could result in a physical injury, psychological trauma, or stress. It also would include any act where a firearm or an improvised weapon was used. The White House “strongly supports” the measure, according to an April 13 statement of administration policy. For more, see the BGOV Bill Summary by Naoreen Chowdhury.

Biden Faces Questions on Research Agency Plan: President Joe Biden’s vision to create a new $8.5 billion biomedical research agency faces skeptical lawmakers who plan to question administration officials in the coming weeks about the idea. Biden is seeking funds to create what the White House calls the Advanced Research Projects Agency for Health, or ARPA-H, modeled after similar research initiatives at the departments of Defense and Energy. Once Biden releases a full fiscal 2022 budget plan in the coming weeks, House appropiators intend to ask officials from the National Institute of Health to detail the purpose of the new agency.

House Appropriations Chair Rosa DeLauro (D-Conn.) said such a division shouldn’t sap funding from the National Institutes of Health’s core mission of supporting basic science research efforts. “It’s critical we strike a balance between this new approach and investments in basic research and fundamental discovery at the NIH,” she said. Rep. Andy Harris (R-Md.) said the NIH already issues what’s called “transformative awards,” which go beyond basic science research. “My fear is it’s going to just duplicate what we have.”

Health and Human Services Secretary Xavier Becerra told lawmakers at a hearing yesterday the new division would take NIH research beyond fundamental research. “We’re trying to move beyond the basic research to be able to have transformational results,” said Becerra, Alex Ruoff reports.

Wyden Expresses Support for CMS, HHS Deputy Picks: Two Biden administration nominees for key positions at HHS received strong support from Senate Finance Chair Ron Wyden (D-Ore.) during a confirmation hearing yesterday. Andrea Palm is Biden’s nominee to become the deputy secretary at the Department of Health and Human Services, and Chiquita Brooks-LaSure is his choice to head the Centers for Medicare & Medicaid Services. “These are two individuals who are extraordinarily qualified for these essential positions,” Wyden said of both nominees. Read more from Tony Pugh.

VA Open to Health Care Accounting Shift: Secretary of Veterans Affairs Denis McDonough is open to an accounting switch that would put at least some veterans’ health care off-budget so that its growing expenditures don’t crowd out other spending priorities, he told lawmakers at a hearing yesterday. Biden administration officials have discussed an accounting change, but that decision is up to lawmakers, McDonough said. Such move could allow for increased VA health spending, a growing cost, without pressuring Congress to slash money elsewhere. Read more from Jack Fitzpatrick.

Lawmakers Ask CDC to Enforce Cruise Limits: Sen. Richard Blumenthal (D-Conn.) and Rep. Doris Matsui (D-Calif.) are asking CDC Director Walensky to keep current pandemic restrictions against cruise ship operations, USA Today reports. “Prematurely lifting restrictions on cruising—with thousands of people in close proximity and conditions ripe for spread of infections—threatens a serious setback,” the lawmakers said in a letter. The letter comes as Republican lawmakers from Alaska and Florida, two states hurt by the cruise limits, offered a bill to restart operations.

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The Coronavirus Pandemic

J&J’s Limbo Status Crimps U.S. Vaccine Drive at a Pivotal Moment: Communities across the U.S. are suddenly revamping their vaccination campaigns to adjust to an indefinite halt in Johnson & Johnson’s doses, which has required officials to reschedule tens of thousands of appointments as they seek to reassure people that Covid-19 vaccines are safe. Health professionals are split on whether the delay should continue. On the one hand, the blood-clotting syndrome that led to the pause in J&J vaccinations is serious and can be deadly. Conversely, with J&J doses out of circulation, that means fewer people are getting immunized even as fast-spreading Covid variants are tightening their grip, and concern about the J&J shots risks expanding vaccine hesitancy. Read more from Angelica LaVito and Fiona Rutherford.

CDC Advisers to Meet Next Week on J&J: U.S. public health advisers are tentatively set to reconvene late next week to resume their consideration of how to respond to a rare side effect of Johnson & Johnson’s Covid vaccine, the chairman of the panel said. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet Thursday or Friday of next week, chairman Jose Romero said in a telephone interview. Read more from John Lauerman.

Clot Risk Far Higher With Covid-19 Than Vaccine: The risk of blood clots among those who’ve been diagnosed with Covid-19 is higher than among those who’ve received vaccines against the disease, according to a new study from the University of Oxford. Covid-19 patients saw a clot risk of 39 in 1 million. That compared with four in 1 million in mRNA vaccines like Pfizer’s and Moderna’s, and five in 1 million after the AstraZeneca vaccine. Todd Gillespie has more.

Unused Shots Are Piling Up Across U.S.: Many U.S. states and cities have a growing surplus of Covid-19 vaccines, a sign that in some places demand is slowing before a large percentage of the population has been inoculated, a Bloomberg News analysis says. The data indicate as many as a third of doses are unused in some states. Vaccine appointments often go untaken, with few people signing up. And some states that are doing well are struggling with stubborn pockets where uptake is low. Read more from Anna Edney and Drew Armstrong.

Merck Pause Limits Study of Covid-19 Pill: Merck paused development of two experimental drugs for patients hospitalized with Covid-19 and started a final trial of one of them, its highly anticipated antiviral pill, for patients with milder disease after getting mixed results about the drug’s benefits. The pill, known as molnupiravir, reduced virus levels in patients during a mid-stage study but didn’t show meaningful benefits in preventing hospitalization and death, the company said. Read more from Riley Griffin and Cynthia Koons.

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What Else to Know Today

NIH Unveils Fetal Tissue Policy, Becerra Says: Restrictions on fetal tissue research imposed under the Trump administration may be rolled back as early as today, Becerra announced yesterday. If such restrictions are lifted, it would mark a win both for researchers and medical groups who argue the ban imposed in 2019 stifled a critical area of research that’s been going on for decades and that has contributed to studying infectious diseases such as HIV and Zika. Read more from Alex Ruoff and Jeannie Baumann.

Abortion Pill Case on Hold at Appeals Court: Litigation over a Food and Drug Administration restriction that kept women from using mail or a delivery service to get a drug used to induce abortion during the pandemic ended yesterday in the Fourth Circuit. The American College of Obstetricians and Gynecologists and the FDA asked the Fourth Circuit Wednesday to place the lawsuit in abeyance, as the agency suspended a rule forcing women to go to a doctor’s office or a hospital to obtain mifepristone prescribed for abortion. Mary Anne Pazanowski has more.

Lobby Firm Taps Two for Health Policy Office: Lobby shop Tiber Creek Group has added two to its health-care policy practice: Corey Malmgren and John Twomey. Malmgren served as executive director of U.S. policy and government relations at Merck. Before that, she served as health counsel and deputy legislative director under former Sen. Bill Nelson (D-Fla.). Twomey has previously served at HHS, including as chief of staff in the Office of the Assistant Secretary for Legislation, Megan R. Wilson reports.

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With assistance from Megan R. Wilson

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@bgov.com

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

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