THE PROGNOSIS

The Affordable Care Act finally seemed in for a smoother ride after years of court challenges, repeal attempts and marketplace turbulence. But now the 2010 law that expanded health-care coverage to millions of Americans might be heading to the Supreme Court for a high-stakes hearing — again.

U.S. District Judge Reed O’Connor sided on Friday with GOP-led states trying to dismantle the ACA, writing in a sweeping and surprising ruling that the entire law must fall because the basis for its constitutionality — the mandate to buy health coverage — is essentially defunct. The ruling came on the eve of the final day of 2019 enrollment on Healthcare.gov, reigniting partisan battles over protections for Americans with preexisting conditions and sending insurers and advocates scrambling to urge people to continue signing up.

The ruling opens up a whole new chapter in Obamacare’s life story, which by now reads like a legal thriller. Every time the political debate over Obamacare appears to be over, something else happens to revive it (Exhibit No. 1: President Trump’s 2016 victory, which enabled Republicans to try to repeal the law, again). Should this latest story line play out according to Democrats' and ACA advocates’ worst fears, the law’s insurance expansions and its protections for people with preexisting conditions could be wiped out.

Of course, we’re not even close to that point yet. The ACA will stay put for now as the case winds its way through the courts. Its next stop is most likely the U.S. Court of Appeals for the Fifth Circuit, where the Democratic state attorneys general who are defending the ACA (because the Trump administration is refusing to do so) would have to appeal the ruling.

“We are working as expeditiously as possible to challenge the decision in court,” a spokeswoman for California Attorney General Xavier Becerra, who is leading the defense, told me yesterday.

But here’s a reason for Becerra and Co. to be nervous: The fifth circuit is known as one of the country’s most conservative appellate courts, so court-watchers say it very well could uphold the lower court’s decision. And if that happens, the Supreme Court might find it necessary to step in. The high court upheld the law in 2012, but since then it has only become more conservative.

It’s actually the court’s reasoning in that 2012 case that makes Texas and 19 other Republican-led states believe they’ve got another shot at getting the law struck down. In his opinion at the time, Chief Justice John Roberts said the penalty for lacking coverage is basically a tax. It’s constitutional for the government to require people to buy coverage because it has the authority to tax, Roberts argued at the time.

The ruling puts many Republicans in an uncomfortable place. They just spent the midterm election season dodging attacks from Democrats over this lawsuit and its potential to strike the ACA’s protections for people with preexisting conditions. And they spent 2017 trying and failing to repeal and replace Obamacare.

So they’re trying this spin on for size: Now, they say, it will be possible to unify with Democrats in passing a bipartisan health-care law that fixes the U.S. health-care system once and for all. President Trump made several boasts along these lines, over the weekend.

“I believe we're going to get really good health care,” Trump said at the White House on Saturday night. “Exciting things happened over the last 24 hours.”

“And if the Republicans and the Democrats get together, we are going to end up with incredible health care, which is the way it should have been from Day One,” the president added. “And it's going to happen. It now has a chance to happen.”

Trump made the argument in a Monday morning tweet:

And after the ruling Friday:

"We have a rare opportunity for truly bipartisan health care reform that protects those with pre-existing conditions, increases transparency and choice, and lowers costs," Rep. Greg Walden (R-Ore.), chairman of the Energy and Commerce Committee, said in a statement responding to the ruling. "I urge my Democratic colleagues to work with Republicans to finally enact patient-centered reforms to our nation's health care system."

But O’Connor’s ruling is hardly prompting a moment of cross-aisle unity, especially as Democrats prepare to take the House gavel in January. “Friday Night Lights meets Texas Chainsaw Massacre!,” is how Thomas Miller, a health-policy expert at the conservative American Enterprise Institute, dubbed it.

Democrats are relishing an “I told you so” moment. They’d spent much of the midterm elections hyping the court challenge and warning voters that Republican attorneys general were trying to get rid of protections for people with preexisting conditions.

“In the midterms, the threat to health-care was theoretical, and now it’s a clear and present danger,” said Jesse Ferguson, a former Democratic Congressional Campaign Committee official.

“While many congressional Democrats spoke out in the hours after the judge’s ruling, Republicans on Capitol Hill were much quieter Saturday,” my colleague Sean Sullivan writes, in a look at how the ruling put Republicans on defensive. “The dynamic resembled this year’s midterm elections, in which Democrats were eager to run on health care and Republicans sought to direct voters’ focus to other topics.”

Fast-forward to December 2017. When Congress passed its tax overhaul, it included a repeal of the penalty for being uninsured. The Republican-led states are arguing that without that penalty, the individual mandate no longer counts as a tax – and is therefore now unconstitutional. Not only do the GOP attorneys general want the mandate struck down, but also the rest of the law  along with it: including the ACA's Medicaid expansion, its insurance subsidies, its consumer protections and many other components that have bearing on the entire health-care system.

O’Connor agreed with this argument, writing in his 55-page opinion that the mandate “can no longer be fairly read as an exercise of Congress’ tax power.” He also concurred that the rest of the law can’t exist without the mandate, calling it “essential to and inseverable from the remainder of the ACA.”

Here’s the problem with O’Connor’s argument, according to many legal scholars who disagree with him. By repealing the penalty, Congress basically said the rest of the ACA can exist just fine without it. So even if the mandate is now unconstitutional, it doesn’t mean the rest of the law must be suspended, according to the legislative branch of government.

“Congress’s own act of 2017 makes clear Congress thinks the law works without an operational mandate,” Jonathan Adler, a law professor at Case Western Reserve University, wrote with Yale law professor Abbe Gluck, in an op-ed published Saturday by the New York Times.

Adler has received wide attention for his position in this lawsuit, as he had supported previous legal challenges to the ACA. He and Gluck, who have often stood on opposite sides of these court cases, now both have sharp words for Justice O’Connor.

“A ruling of this consequence had better be based on rock-solid legal argument,” they wrote. “Instead, the opinion by Judge Reed O’Connor is an exercise of raw judicial power, unmoored from the relevant doctrines concerning when judges may strike down a whole law because of a single alleged legal infirmity buried within.”

Democrats are contemplating how they’ll respond next year. Top Senate Democrat Chuck Schumer (N.Y.) and top House Democrat Nancy Pelosi (Calif.), who is expected to be the next speaker of the House, promised yesterday to make Democrats part of an appeal.  "The first thing we’re going to do when we get back there in the Senate is . . . put a vote on the floor, urging an intervention in the case," Schumer said in NBC's "Meet the Press."

Why are Democrats so much happier to talk about the ruling than Republicans? "Barring a dramatic change, such as one or more liberals on the Supreme Court being replaced by the president, they don't think O'Connor's decision will survive in higher courts," my colleague Dave Weigel writes. "While it works its way over, the decision refocuses voters on an issue that, according to public and private polling, breaks overwhelmingly for Democrats."

Beyond the politics, however, the lawsuit is creating even more uncertainty for insurers. They’re trying to sound positive, but some acknowledge the potentially huge disruption should the courts ultimately strike down the ACA — a law that has allowed about 20 million more Americans to gain health coverage.

Insurers have already weathered years of uncertainty around the ACA, as congressional Republicans erased its individual mandate penalty after trying to repeal much more of it and as the Trump administration rewrote some of the marketplace rules.

More uncertainty is the last thing insurers are looking for. Blue Cross plans, which occupy a sizable presence in the individual marketplaces, are especially vulnerable.

“This will be a lengthy legal process, so I don’t think it will have an impact on 2019,” Justine Handelman, senior vice president of the office of policy and representation at Blue Cross Blue Shield Association, told me yesterday. “But certainly, as you do look to the future, it does bring in uncertainty.”

And it’s not just plans purchased by individuals that would be affected, Handelman noted. The ACA also extended broad new requirements to group insurance plans as well, including mandates to cover children up to age 26 on their parents' plans and bans on lifetime and annual coverage limits.

“When you look at how much it has been embedded in our health-care system, it just can’t be undone without disruption to our entire health-care system,” Handelman said.

There was an immediate impact because of the decision: Confusion on Saturday for the tens of thousands of people who typically sign up for marketplace plans at the last minute.

"That timing created a maximal shudder across the health-care industry," my colleague Amy Goldstein writes, noting that even attorneys for the Justice Department, which had refused to defend the ACA, had asked O’Connor to hold off issuing any injunction until after open enrollment. Former CMS administrator Andy Slavitt, who has presided over several enrollment periods, called for an extended deadline but the agency did not do so.

"Federal figures due out in a few days will show whether the latest legal peril to the law prompted consumers to shy away on what is typically the biggest enrollment day of the season — or remember to sign up as news of the ruling prompted heightened attention to the deadline," Amy writes.

Seema Verma, administrator of the Centers for Medicare and Medicaid Services, tweeted a reassurance but also expressed support for the ruling:

AHH, OOF and OUCH

AHH: Former president Barack Obama sought over the weekend to quell fears over the outcome of the ruling, telling people it won’t lead to any immediate changes. He urged people to sign up for health-care plans on Saturday, reiterating that his landmark law will remain in place as the ruling goes through months or years of legal maneuvering.

“There are two things you need to know today about health care,” Obama wrote on Facebook on Saturday. “First today’s the last day of open enrollment… Second, you might have heard about a federal court decision on a Republican lawsuit trying to strike down the Affordable Care Act in its entirety. That can be a scary thing to hear, particularly if you or someone you care about has a pre-existing condition.”

OOF: Trump’s predecessor also took a jab at Republicans following the ruling, saying the GOP will “never stop trying to undo” his namesake law. “If they can’t get it done in Congress, they’ll keep trying in the courts, even when it puts people’s pre-existing conditions coverage at risk," Obama wrote.

Such protections were a critical part of the law. “No talking point... got more attention from Obama than the ACA’s protections for people with preexisting conditions,” our Post colleague Timothy Bella writes. “Without the ACA, 52 million Americans under 65 could see their insurance at risk due to a preexisting condition, according to a 2016 analysis from the Kaiser Family Foundation.”

OUCH: Industry and medical groups lined up in opposition to O’Connor’s ruling, expressing concern that suspending the ACA would lead to reduced insurance options and instability for patients. Here are a few of the responses:

  • President of the American Medical Association, Barbara L. McAneny called the ruling an “unfortunate step backward for our health system that is contrary to overwhelming public sentiment to preserve pre-existing condition protections and other policies that have extended health insurance coverage to millions of Americans.”
  • The American Cancer Society Cancer Action Network, American Diabetes Association, American Heart Association, American Lung Association and National Multiple Sclerosis Society issued a joint statement saying if the ruling stands, it “threatens to resurrect barriers to health care for people with serious illnesses including cancer, heart disease, stroke, lung disease, diabetes and those with neurological conditions.”
  • America’s Health Insurance Plans called the ruling “misguided and wrong.” “We argued in an amicus brief before the court that provisions of the Affordable Care Act (ACA) affecting patients with pre-existing conditions, and those covered by Medicaid and Medicare should remain law regardless of what the court ruled on the individual mandate. Unfortunately, this ruling harms all of these Americans.”
  • Blue Cross Blue Shield called it the “first step in what we expect will be a lengthy legal process...While we are extremely disappointed in the court’s ruling, we will continue to work with lawmakers on a bipartisan basis to ensure that all Americans can access the consistent, quality health coverage they need and deserve.”
  • The American Hospital Association said the “ruling puts health coverage at risk for tens of millions of Americans, including those with chronic and pre-existing conditions, while also making it more difficult for hospitals and health systems to provide access to high-quality care.”
INDUSTRY RX

— Medical-products giant Johnson & Johnson denied a report by Reuters that said the company was aware for decades that raw ingredients used in its talcum powder sometimes contained traces of cancer-causing asbestos, our Post colleague Christopher Rowland reports.

The report sent the company's stock price down 10 percent on Friday. The company called the Reuters report “one-sided, false and inflammatory” and a “conspiracy theory.”

“Reuters said that from at least 1971 until the 2000s, Johnson & Johnson’s raw talc and finishing powders tested positive for asbestos, although the majority of test documents Reuters reviewed showed no asbestos,” Christopher writes.

Johnson & Johnson has been plagued with lawsuits by plaintiffs who say the company’s baby powder and Shower to Shower powder caused mesothelioma, a form of cancer that results from asbestos exposure, as well as other lawsuits from plaintiffs who say their products caused ovarian cancer.

The Reuters report highlights internal documents by executives in the company who debated the presence of small amounts of asbestos in talc, and looked to convince regulators that such amounts would not be harmful. “But the evidence appears to show that Johnson & Johnson turned over favorable test results to the Food and Drug Administration but withheld test results that showed the talc contained asbestos, a point cited by a New Jersey judge this year affirming a verdict against the company,” Christopher reports.

REPRODUCTIVE WARS

— Family-planning clinics that oppose abortions have been increasingly competing to receive the same federal funding granted to Planned Parenthood, Politico’s Victoria Colliver reports. A proposal by the administration that could be finalized soon would allow such faith-based clinics to vie for Title X family planning money.

“This new front in the abortion wars comes as conservatives have largely given up on completely defunding Planned Parenthood, so they’re trying to use the rules to their advantage, pushing for faith-driven women’s clinics to apply for those same federal funds to push an anti-abortion agenda,” Victoria writes.

These clinics have long offered services such as pregnancy testing, ultrasounds and certain support for women with unplanned pregnancies -- but advise them against obtaining abortions. “Now, some are trying to become anti-abortion, abstinence-promoting alternatives to Planned Parenthood clinics,” Victoria reports. “Scrapping the quotes from Scripture displayed on their walls, some pregnancy crisis centers are becoming licensed clinics by adding health services like prenatal care, sexually transmitted disease testing or treatment, and 'natural family planning' or fertility awareness — though not FDA-approved contraceptives like birth control pills or condoms, and certainly not abortions or abortion counseling.”

But at least one such clinic has been rejected for Title X family planning grants because the administration still requires clinics to offer hormonal birth control, Victoria writes.

OPIOID OPTICS

— An Kentucky appeals court has ruled sealed documents related to Purdue Pharma’s marketing of OxyContin should be released, upholding a lower court decision.

The sealed records include a deposition of former Purdue president Richard Sackler, Stat’s David Armstrong and Andrew Joseph report. The records also include marketing strategies, internal emails, internal analysis of clinical trials, settlement communications from a previous criminal case and other marketing information.

“Despite Friday’s ruling, the company records will not be made public immediately,” David and Andrew write. “Purdue has the opportunity to decide whether it wants to request another hearing before the appeals court or ask the Supreme Court of Kentucky to overturn the decision. The company has 30 days to appeal the decision to the state Supreme Court.”

“We’re disappointed with the Court of Appeals’ decision today,” Purdue said in a statement. “The documents in question were never entered into evidence and did not play a role in any judicial decision. Under Kentucky law, such documents should remain private as outlined in the Protective Order with the Commonwealth of Kentucky.”

MEDICAL MISSIVES

— A human heart was left in the cargo compartment of a Southwest Airlines flight from Sacramento to Seattle last weekend.

Our Post colleagues Kimberly Kindy and Lenny Bernstein report there are conflicting stories and an investigation underway into what went wrong during the transport – the heart was meant to be picked up in Seattle but it stayed on the plane as it left for Dallas. They write the incident “provides a glimpse into the nation’s transplant system, which relies on an obscure network of nonprofit organizations to collect and transport human organs and tissue.”

The heart was headed to a “’tissue processor’ in Renton, Wash., a suburb of Seattle, where the valves could be removed for transplant, according to an official with LifeNet Health, a nonprofit organization in Virginia Beach that runs the facility,” they write.

LifeNet Health is one of 58 organ procurement organizations, OPOs, which are meant to transport organs and tissue, a process that “involves a number of crucial steps that often rely on airlines and couriers. All of them are potentially subject to human error."

“At the moment, it’s unclear who was responsible for Sunday’s incident and why it wasn’t discovered until the plane was in the air to Dallas,” they add. “Sierra Donor Services, the OPO that provided the heart, said a courier did not show up in time to collect the heart….[a] LifeNet spokesman, said that Southwest failed to take the heart off the plane and that the error was discovered by its courier. Southwest acknowledged that its crew did not remove the heart from the cargo compartment but is not sure how the error was discovered.”

— A newborn baby girl is the youngest survivor of the latest Ebola outbreak in the Democratic Republic of Congo.

The newborn was admitted for treatment at an Ebola treatment center less than a week after she was born, but has since recovered from the virus, the Associated Press reports, and was discharged last week. The baby’s mother, who also had Ebola, died in childbirth.

There are now 467 confirmed cases of Ebola in Congo, including high numbers of children who have contracted the virus and who now make up more than a third of all cases in the outbreak. There have been 255 confirmed deaths. This outbreak is currently the second deadliest. 

“Few cases of Ebola in babies have been reported, but experts suspect transmission may occur through breast milk or close contact with infected parents,” per the AP. “So far, more than 400 children have been left orphaned or unaccompanied in the outbreak as patients can spend weeks in treatment centers, Unicef said.”

— And here are a few more good reads: 

The increase in early vaccination may be due to fresh memories of how bad last winter was, but other factors may also be at play.
Stat
National
CDC scientists armed with GPS devices hope that spying on the nightly escapades of tiny fruit bats in Uganda will help them understand how Marburg, which is as deadly as Ebola, is spreading to humans.
Lena H. Sun, Bonnie Jo Mount, Karly Domb Sadof and Mia Torres
CVS Health Corp (CVS.N) defended on Friday an agreement with the U.S. Justice Department which allowed it to purchase health insurer Aetna for $69 billion, a settlement that a federal judge is still assessing.
Reuters
Universities are installing vending machines where students can purchase emergency contraception, an effort to remove barriers to and anxiety surrounding products like Plan B.
Wall Street Journal
As hospitals face greater competition amid broader shifts to value-based care, some New York facilities are putting a little hotel experience into the health-care setting.
Wall Street Journal
STATE SCAN
Politics
The outgoing GOP governor said the impact of the measures has been overstated, accusing the national media of “hysteria.”
Mark Berman and John Wagner
A higher percentage of California marijuana products are passing strict safety tests, but the sudden closing of a lab that state authorities found wasn’t correctly checking for pesticides has raised new questions about the system intended to protect the purity and potency of legal cannabis.
Associated Press
TRUMP TEMPERATURE
National
Guatemalan girl’s family is calling for an “objective and thorough” investigation into her death, a representative for the family said Saturday.
Michael Brice-Saddler
DAYBOOK

Coming Up

  • The Senate and House Veterans Affairs committees hold a joint hearing on "Tracking Transformation: VA MISSION Act Implementation” on Wednesday.
  • The House Veterans Affairs Subcommittee on Oversight and Investigations holds a hearing on "The Veterans First Program after Kingdomware" on Thursday.
SUGAR RUSH

Deputy White House press secretary Hogan Gidley called the death of a 7-year-old girl in Border Patrol custody a “horrific, tragic situation" and "100 percent preventable":

Stephen Miller: Trump will 'absolutely' shut down government over wall funding