What happens next with J&J — First in PULSE: Pair of maternal health bills return — Hospital lobby plans in-person conference

From: POLITICO Pulse - Wednesday Apr 14,2021 02:03 pm

Apr 14, 2021

Presented by

With Carmen Paun and Susannah Luthi

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Quick Fix

— Experts convene today to discuss next steps for Johnson & Johnson’s shot after reports of rare but severe blood clots post-vaccination.

— A bipartisan pair of senators is pitching legislation designed to boost maternal flu shot rates and ensure the government covers the shots.

— A major hospital association will hold its upcoming annual conference in person, with no requirement that attendees be vaccinated against the coronavirus.

WELCOME TO WEDNESDAY PULSE. For some of us, just getting out of bed this past year was an accomplishment. Patrick Radden Keefe, meanwhile, was writing a book on the family that fueled the opioid crisis while sitting in bed the whole time.

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Driving the Day

WHAT HAPPENS NEXT WITH J&J — An expert panel enlisted by the CDC meets this afternoon to discuss whether Johnson & Johnson’s vaccine should be limited to certain populations amid news that six women developed a severe type of blood clot after receiving the shot, and one died.

On the table today: Doctors, public health experts, scientists and statisticians will gather to discuss what is known so far about how those patients became ill and whether they shared any risk factors, such as underlying conditions, age or medications. CDC and FDA officials said Tuesday that it was too early to tell, but members of CDC’s Advisory Committee on Immunization Practices will hear from J&J itself during the meeting today.

Besides those details, the committee will have to discuss “the relative risk of this particular complication versus the relative risk of dying or having an adverse event from Covid,” ACIP Chair José Romero told POLITICO.

Romero, who is also Arkansas’ Secretary of Health, expects the committee to have questions — if not today, then in the future — about the implications these blood clot reports have for similar vaccines such as AstraZeneca’s shot, which uses the same technology. Several European countries have already limited use of that vaccine over blood clot concerns.

"The public is going to come away, I hope, with a sense that we are taking this very seriously and we want people to have the safest vaccines possible,” Romero added.

But in the meantime: Biden officials are bracing for the possibility that the pause on J&J’s vaccine could last for weeks. Its distribution could even be halted permanently for certain populations, such as women aged 18 to 48, according to two administration officials.

J&J said late Tuesday that it will delay its European rollout of the vaccine and pause all its clinical trials while it updates guidance.

Biden officials say they are still on track to vaccinate most U.S. adults by the end of May because Moderna and Pfizer are churning out hundreds of millions of shots. That still doesn’t account for everyone; millions of children will be in line next, and no vaccine has been authorized yet for children under 16.

But there is a bright spot: Pfizer CEO Albert Bourla announced late Tuesday that the company is surging ahead of production goals and can increase supply by an additional 10 percent in May. It will also hit 300 million doses by the end of July, two weeks early.

E&C WANTS TRUMP's HOSPITAL TRANSPARENCY RULE ENFORCED — The leaders of the House Energy and Commerce Committee are urging HHS Secretary Xavier Becerra to consider harsher penalties for hospitals that refuse to post their privately negotiated prices as required by a new rule.

The request comes amid "widespread non-compliance by hospitals," committee Chair Frank Pallone (D-N.J.) and ranking member Cathy McMorris Rodgers (R-Wash.) wrote in a letter, which also asked HHS to brief them on implementation of the rule.

— The Trump-era regulation, which went into effect in January, requires providers to post their prices for 300 common “shoppable” procedures and services, like joint replacements, MRIs and CT scans. But a POLITICO analysis in early January found many big health systems hadn’t yet compiled, hid their prices or made them difficult to understand.

Reviews conducted in the weeks since found that hospitals are still dragging their feet on the rule, even deploying special code to block the information from appearing in search engines, The Wall Street Journal reported.

— The E&C letter bodes well for the policy's future. Though the Biden administration has yet to indicate whether it will keep the rule in place, support from a senior congressional Democrat means it could be one of the few Trump health reforms that end up enjoying broad support.

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On the Hill

FIRST IN PULSE: MATERNAL HEALTH BILLS RETURN — Sens. Maggie Hassan (D-N.H.) and Bill Cassidy (R-La.) today will reintroduce two bills aimed at increasing the number of pregnant people who get the annual flu shot and the tetanus, diphtheria, and pertussis vaccine.

Many people covered under Medicaid don’t receive their recommended vaccinations, including expectant mothers: Just 31.4 percent of pregnant Medicaid enrollees got the Tdap vaccine in 2017, while 17.5 percent got a flu shot.

One bill would direct CMS to issue guidance on how to improve these rates and bolster data collection on pregnant people. The other measure would require state Medicaid programs to cover ACIP-recommended shots.

FIRST IN PULSE: HOUSE PROPOSAL TAKES AIM AT HEALTH DISPARITIES — A bipartisan bill to be reintroduced today would create a grant program dedicated to initiatives that address social factors that determine health.

The legislation led by Reps. Cheri Bustos (D-Ill.), Tom Cole (R-Okla.), Jim McGovern (D-Mass.) and Markwayne Mullin (R-Okla.) would set aside funding for states and local governments to solve economic and social issues that contribute to poorer health outcomes.

Industry Intel

HOSPITAL LOBBY PLANS IN-PERSON ANNUAL CONFERENCE — The Federation of American Hospitals will hold its annual expo in Nashville this June, becoming one of the first health care organizations to resume in-person events since the coronavirus pandemic began.

The for-profit hospital association will host between 700 and 800 people at the Gaylord Opryland convention center, spokesperson Sean Brown said. That’s about half the conference’s normal attendance, with FAH planning to impose a series of Covid precautions, including mandatory physical distancing, masks, and a requirement that attendees and required masks wearing.

— But vaccinations won’t be required. While attendees will need to get their temperature checked and answer some health-related questions to enter the conference each day, they won’t have to show proof of vaccination — a decision that sidesteps the politically thorny debate over vaccine passports.

Public Health

CDC: STDs HIT ALL-TIME HIGH — The agency recorded 2.5 million cases of chlamydia, gonorrhea and syphilis in 2019, as the total number of reported cases of sexually-transmitted diseases hit a new high for the sixth consecutive year.

Cases of the three diseases have now risen nearly 30 percent since 2015, with the sharpest increase coming in cases of syphilis among newborns. The CDC warned that early indications show the trends continued in 2020, amid Covid-prompted disruptions to STD testing and treatment services.

— Racial and ethnic minorities were disproportionately affected, a disparity that CDC researchers chalked up to "social, cultural, and economic conditions that make it more difficult for some populations to stay healthy."

STD rates for Black people were as much as eight times higher than for white people in 2019. People of American Indian descent and Latinos were also more likely than whites to contract STDs. Gay and bisexual men, meanwhile, made up nearly half of all primary and secondary syphilis cases.

TUNE IN TODAY — Join POLITICO and the Harvard Chan School of Public Health at noon for a virtual conversation on “Health and Social Policy Moving Forward: The Partisan Divide.”

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Featuring: Georgetown’s Sabrina Corlette, Duke Law’s Guy-Uriel Charles, a member of President Joe Biden’s new commission on the future of the Supreme Court, the Kennedy School’s David King and Harvard’s Robert Blendon.

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Around the World

AFRICA LOOKS TO PUNCH UP VACCINE PRODUCTION WITH NEW DEAL — The African Union plans to boost its capacity to research and manufacture vaccines against infectious diseases affecting the continent with a new partnership with the Coalition for Epidemic Preparedness Innovations, the bloc announced Tuesday.

The plan is to invest in vaccine R&D innovation that would make it easier and faster to produce shots in Africa, invest in local labs and research hubs and train people to work in them, Carmen Paun writes.

Only 2 percent of all clinical trials now take place in Africa, and the continent produces only 1 percent of the vaccines it needs. African leaders met virtually this week to discuss how to improve vaccine development and production on the continent, so it doesn’t have to depend on supplies from the rest of the world when the next health emergency hits.

What We're Reading

Sandra Elizabeth Ford, the director of the DeKalb County health department, is joining the White House Domestic Policy Council as a special assistant for public health and science, The Atlanta Journal-Constitution's Tyler Estep reports.

After a year of his "do-nothing” approach to the pandemic, Brazilian President Jair Bolsonaro's political future may finally be in danger, The New Yorker's Jon Lee Anderson writes.

Two separate efforts to develop therapies for Huntington’s disease suffered setbacks in March, shocking patients and others dedicated to finding a treatment, STAT’s Andrew Joseph reports.

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