with Alexandra Ellerbeck

California Attorney General Xavier Becerra stepped in to defend Obamacare when the Trump administration refused to do so.

If he’s confirmed as Health and Human Services secretary, he’ll soon lead the agency that oversees it.

President-elect Joe Biden announced this morning he is nominating Becerra (D) — who has little health policy experience but has emerged as the nation’s defender of the Affordable Care Act — to helm the 80,000-employee agency that manages Healthcare.gov, regulates prescription drugs and oversees the government’s sweeping Medicare and Medicaid insurance programs.

Biden has also picked Rochelle Walensky, an infectious-disease specialist at Massachusetts General Hospital, to direct the Centers for Disease Control and Prevention within HHS. “A professor of medicine at Harvard Medical School, she is well-respected for her work, including on the comparative effectiveness of treatment for HIV and AIDs,” my colleagues report.

Biden also announced a number of other key health appointments which had been previously reported, including Vivek Murthy as surgeon general, Anthony S. Fauci as chief medical adviser to the president on covid-19, Jeff Zients as coordinator of the covid-19 response and Marcella Nunez-Smith, chair of a covid-19 equity task force.

“This trusted and accomplished team of leaders will bring the highest level of integrity, scientific rigor, and crisis-management experience to one of the toughest challenges America has ever faced — getting the pandemic under control so that the American people can get back to work, back to their lives, and back to their loved ones," Biden said in a statement from his transition team.

Becerra has never held a health policy specific role.

But health policy leaders and activists applauded his management experience and quarter-decade of legislative experience in the House.

“You need a leader, manager,” Andy Slavitt, who served as administrator of the Centers for Medicare and Medicaid Services, texted me. “He’s just a great fit. Right temperament.”

“Xavier Becerra is an exciting and experienced selection to be the next Secretary of Health and Human Services,” said Anthony Wright, executive director of Health Access California. "His track record shows he will work to not just undo the damage of the last four years, but to have a pro-active plan to deal with the pandemic and to pursue patient protections and needed reforms going forward."

Becerra’s background is unorthodox for an HHS secretary. The job has typically gone to governors, and public health officials had been urging Biden to select someone with medical expertise because of the coronavirus pandemic, Amy Goldstein notes.

But Biden had also been under pressure to select more Latinos in his Cabinet,” Amy writes. “Becerra becomes the second designated nominee who is Latino, after Alejandro Mayorkas, Biden’s pick for homeland security secretary.”

Becerra is in the ring on the latest legal tussle over the ACA.

Back in 2018, when Texas and other GOP-led states sued to overturn former Presidenty Barack Obama's health-care law, Trump’s Justice Department refused to defend it. So Becerra was granted permission by the courts to play the role of defender, joined in the effort by more than a dozen other Democratic attorneys general. 

Bloomberg News reporter Alex Ruoff:

The Supreme Court is expected to issue a ruling next spring, after hearing the case last month. The justices appeared skeptical of the case — which argues the entire law is unconstitutional without its penalty for lacking health insurance — and a decision to strike the law would strip millions of Americans of coverage and protections.

Becerra tweeted this after the Nov. 10 oral arguments:

Becerra has also gone after hospital consolidation.

His office sued Sutter Health, the largest hospital system in Northern California, over anti-competitive behavior. This behavior allegedly included “all or nothing” agreements in which insurers had to include all of Sutter's medical facilities within their networks if they wanted to contract with Sutter at all.

Last December the health system agreed to pay $575 million to settle the claims. It was also prohibited from engaging in several practices the AG office and others said the hospital system used to gain undue influence and hurt patients – including limiting what it can charge them for out-ot-network services.

“If we’re going to treat something that’s precious and lifesaving like a business, then the marketplace for health care must be vibrant and competitive so that the best in the business can rise to the top naturally," Becerra said at the time. “This first-in-the-nation settlement is one of the largest actions against anti-competitive conduct in the health care marketplace across the country.”

Larry Levitt, a senior vice president at the Kaiser Family Foundation:

Becerra was continually a thorn in the side of the Trump administration — but he didn’t always prevail.

He has led California in suing the administration more than 100 times over policies related to climate, energy, immigration — and health care.

When the administration issued rules in fall 2017 to broaden exemptions to the ACA’s requirement for employers to cover contraception, Becerra was one of several state officials and interest groups to swiftly file complaints in federal court. In July, the Supreme Court upheld the rules allowing private employers with moral or religious objections to deny women contraceptive coverage.

When the White House cut off extra Obamacare subsidy payments, Becerra led 17 other state AGs in challenging the move. But a federal district judge dismissed the lawsuit the following year. And opposition faded when it became clear President Trump’s decision had unexpectedly increased the subsidies that help low-income people afford monthly premiums.

Under Becerra, California lost a case involving the speech rights of crisis pregnancy centers.

In 2018 the Supreme Court struck down a requirement for these centers, which are run by antiabortion advocates, to tell their patients about the availability of state-offered services, including abortion. 

Becerra had argued the requirement was well within the bounds of what a state can require health providers to share (here’s the Health 202 interview with Becerra about the case). But the court ruled the law probably violated the First Amendment. Abortion-opposing groups noted the lawsuit yesterday in slamming Biden’s pick.

“He went all the way to the Supreme Court to try to force California’s pro-life pregnancy centers to advertise and refer for abortion a policy the court rejected as unconstitutional,” said Susan B. Anthony List President Marjorie Dannenfelser.

Picking an HHS secretary took Biden longer than in the last two presidential transitions.

Back in 2008, President Barack Obama announced Tom Daschle as his health secretary pick on Nov. 19 (although Kathleen Sebelius was ultimately confirmed as secretary after Daschle's nomination later fell apart) and in 2016, Trump nominated Tom Price on Nov. 29.

To be fair, Biden got a slow start because of Trump’s initial refusal to allow the transition process to be authorized. President George W. Bush — whose transition was delayed even longer than Biden’s because of the vote recounts in Florida — didn’t nominate Tommy Thompson for his health secretary until Dec. 29, 2000.

It’s not that he lacked options. Initial contenders included Murthy, Obama's surgeon general, New Mexico Gov. Michelle Lujan Grisham and Rhode Island Gov. Gina Raimondo.

But last week the transition team announced Murthy will again serve as surgeon general, as he did under Obama. Murthy is also being considered for an assistant secretary position at HHS, according to two sources. 

On Thursday, Grisham was confirmed as chairwoman of the Democratic Governors Association for 2021. The same day Raimondo, whose consideration had prompted pushback from progressive groups, said she was out of the running. The following day, Biden called Becerra and offered him the role, NBC News reports.

A number of reporters noted Becerra's late 2016 decision to leave Congress to become California AG. Daily Beast's Sam Stein:

The Hill's Scott Wong:

The Post's Dave Weigel:

Forbes reporter Andrew Solender:

Former congressman Jason Chaffez (R-Utah), with a slam:

Ahh, oof and ouch

AHH: Scientists’ gamble on experimental medical technology paid off with front-runner vaccines.

The vaccine candidates from Moderna and from Pfizer and BioNTech placed their bets on a still-experimental technology that harnesses the power of messenger RNA, genetic material that carries the instructions inscribed in DNA to the protein-making parts of the cell. The decision to rely on a technology that had never been used in an approved medical product was a risky bet that appears to have paid off, The Post’s Carolyn Y. Johnson reports.

“If, as expected in the next few weeks, regulators give those vaccines the green light, the technology and the precision approach to vaccine design could turn out to be the pandemic’s silver linings: scientific breakthroughs that could begin to change the trajectory of the virus this winter and also pave the way for highly effective vaccines and treatments for other diseases,” Carolyn writes.

But even though the messenger RNA technology is still experimental, it builds on decades of basic science research, including the work of scientists such as Katalin Karikó and Drew Weissman, who discovered a way to modify mRNA so it didn’t trigger an inflammatory response in the body. Karikó and Weissman’s groundbreaking work with mRNA went unappreciated for years.

Meanwhile, scientists were also working long before the pandemic to create a 3-D version of the spiky proteins typical of coronaviruses. When they did make the discovery, scientific journals rejected it, questioning its relevance.

“If all goes well with regulators, the coronavirus vaccines have the makings of a pharmaceutical industry fairy tale. The world faced an unparalleled threat, and companies leaped into the fight,” Carolyn writes. “But the world will also owe their existence to many scientists outside those companies, in government and academia who pursued ideas they thought were important even when the world doubted them.”

OOF: Companies will ship only 10 percent of the hundreds of millions of vaccine doses promised by the Trump administration.

“Instead of the delivery of 300 million or so doses of vaccine immediately after emergency-use approval and before the end of 2020 as the Trump administration had originally promised, current plans call for availability of around a tenth of that, or 35 to 40 million doses,” The Post’s Christopher Rowland, Lena H. Sun, Isaac Stanley-Becker and Carolyn Y. Johnson report.

Vaccine candidates from Moderna and Pfizer are considered on the verge of winning Food and Drug Administration approval, but the government and companies have begun lowering expectations about allocations of the vaccines. Moncef Slaoui, the head of Operation Warp Speed, the federal government’s vaccine initiative, said in May that he expected “several hundred million” doses of vaccine by the end of the year. Now, officials are planning to ship only enough vaccine for about 20 million people under a two-shot regimen.

After making a vaccine for coronavirus, you have to get it to the masses. But that’s not so easy for a so-called cold chain vaccine, requiring exact temps. (The Washington Post)

“The drop-off is a product of manufacturing problems, bottlenecks in the supply of raw materials and other hurdles in ramping up clinical-trial production of 5 liters of protein-based vaccine at a time to commercial-scale fermentation of 2,000-liter batches, the companies and the Trump administration said,” Christopher, Lena, Isaac and Carolyn write.

The decreased supply is leaving health officials with difficult decisions about how to allocate scarce doses. In Maine, health officials say that the proposed allotment will barely cover emergency department and front-line staff. 

Still, experts generally consider the government’s $9.3 billion investment in advanced purchases of vaccines a success. The reduced financial risk incentivized companies to ramp up production, even if it's coming slower than initially promised. 

OUCH: FDA officials and advisers are pushing back against allegations that the agency is moving too slowly. 

Weeks after Moderna and Pfizer claimed that their vaccines were highly effective, the FDA has come under criticism from the Trump administration and some outside health experts who allege that it has not moved quickly enough to authorize experimental vaccines for the coronavirus, Stat's Matthew Herper and Nicholas Florko report.

The White House has twice called in FDA Commissioner Stephen Hahn to explain why the agency is not moving faster to approve a vaccine, with the pressure only increasing after the United Kingdom's approval of the Pfizer and BioNTech vaccine last week.

Inside the agency, however, officials say that they are moving at breakneck speed. Meanwhile, four scientists who sit on the advisory panel that will review the vaccines this week and next told Stat that the process should not move any faster.

“A STAT review of the process of vaccine development reveals only three ways it could have been further sped up. The first, and biggest, revolves around an FDA decision to require two months of safety data for half the patients in a study before a company asked for authorization. Had it settled for less data, a vaccine likely would have been authorized quicker,” Matthew and Nicholas write.

The agency may have also saved time by reviewing data on a rolling basis, as U.K. regulators did, or by turning around the data for its advisory committee more quickly.

But all of these measures would have come with downsides. The move to require two months of safety data was strongly supported by scientists and FDA advisers at the time, many of whom worried that the Trump administration would push for even lower standards. Meanwhile, the FDA argues that it does not have a process to review data on a rolling basis and that its process, which involves reanalyzing raw data, is not comparable to that of other countries.

More in coronavirus

Elsewhere in health care

The Supreme Court agreed to hear a case on Trump’s plan to let states impose Medicaid work requirements.

Acting solicitor general Jeffrey B. Wall asked the Supreme Court to accept the case after a three-judge panel on a federal appeals court in February ruled that the Trump administration’s health officials had acted in an “arbitrary and capricious” manner when they allowed Arkansas to launch a Medicaid program with strict work requirements. More than 18,000 people were dropped from the state’s Medicaid rolls during the five months the rule was in effect before a judge blocked it.

“The goal of Trump’s Department of Health and Human Services was to allow states to experiment with job-training or work requirements on some of those whose access to Medicaid health benefits was facilitated by the Affordable Care Act,” The Post’s Robert Barnes reports

At the heart of the issue is whether work requirements can help achieve the goals of the Medicaid program. The Trump administration argues that the requirements can help beneficiaries transition to employer-sponsored or commercial coverage, but judges have ruled that the purpose of the program is to provide health benefits to the needy. 

“Arkansas and New Hampshire want to continue programs halted by lower courts, and more than a dozen other states say they want to impose similar requirements,” Robert reports

But despite the Supreme Court’s willingness to take up the case, it may be moot if the Biden administration restricts the requirements.

Drug industry trade groups are suing the Trump administration over a rule that ties drug payments to prices overseas.

“The suits were filed by PhRMA, the pharmaceutical industry trade group, and a group of biotechnology industry trade organizations, including Biotechnology Innovation Organization (BIO), in federal courts in Maryland and California, respectively,” Reuters’s Carl O’Donnell and Michael Erman report.

The Trump administration’s “most favored nation” rule says that the U.S. government won’t pay drugmakers more for certain drugs than the lowest rate that they charge other comparatively wealthy countries in Europe or elsewhere. The rule, which is slated to go into effect on Jan. 1, would affect the price of 50 drugs. 

Both lawsuits claim that the Trump administration did not follow proper procedures in passing the rule. PhRMA’s lawsuit also claims that the rule change is illegal because it goes beyond the administration’s authority to test out new drug pricing models.

The Association of Community Cancer Centers, a network of cancer treatment providers, joined PhRMA’s lawsuit over concerns that lower reimbursements for drugs could push some treatment centers out of business.

The House voted to decriminalize marijuana.

“The measure is not expected to pass into law, and, because of political skittishness, it was voted on only after the November election and more than a year after it emerged from committee,” The Post’s Mike DeBonis reports. “But the House took a stand at a moment of increasing momentum, with voters last month opting to liberalize marijuana laws in five states — including three that President Trump won handily.”

The bill would remove marijuana from the federal schedule of controlled substances and expunge federal convictions for nonviolent marijuana offenses. It also would put in place a 5 percent federal tax on marijuana sales aimed at funding programs for people “adversely impacted by the War on Drugs.”

The bill passed largely along party lines with opposition from all but five Republicans and is not expected to advance in the Republican-controlled Senate. Republicans denounced Democrats for spending time on what they portrayed as a frivolous political gesture amid negotiations over a coronavirus relief package.

House Minority Leader Kevin McCarthy (R-Calif.):

“Still, advocates of marijuana legalization say the passage of the bill in the House is a watershed moment in the long struggle to roll back marijuana prohibition, and many see it as only a matter of time before it becomes an issue of bipartisan concern.”

While support for eliminating marijuana restrictions is isolated to a small number of Republican lawmakers, about half of GOP voters support legalization. At least 15 states have legalized recreational cannabis to some degree, while 36 have approved medical marijuana programs.

Sugar rush