Search This Blog

Saturday, November 7, 2020

As ObamaCare heads to Supreme Court, potential outcomes are many

With the presidential election still hanging in the balance, all eyes are on the U.S. Supreme Court and whether the justices will overturn the landmark Affordable Care Act. Still, legal experts say there are a number of possible outcomes for the final ruling and it's not a choice between simply two results. 

"I think about it as a spectrum," Katie Keith, a lawyer and health policy expert at Georgetown University​, said. 

The individual plaintiffs challenging the legality of the ACA argue that the individual mandate is unconstitutional and so intertwined and inextricably linked to the rest of the law that the entire piece of legislation must fall.

From a common sense point of view, the case may seem absurd: The plaintiffs are asking for relief from a law that requires they purchase individual coverage or face a penalty. Except there is no longer any financial penalty, Congress eliminated it in 2017. 

"This whole line of argument is preposterous," Nicholas Bagley, a health law expert and professor at the University of Michigan said in a recent New York Times op-ed with former CMS Administrator Andy Slavitt.

That is the crux of this case. The challengers are directly targeting the linchpin that saved the law when it was last before the Supreme Court. The court in 2012 ruled that the individual mandate could be considered a tax, and therefore was constitutional. Take that penalty away, and the plaintiffs argue it is no longer constitutional.    

The key question is whether the individual mandate can be "severed" from the remainder of President Barack Obama's monumental health law, which transformed the nation's healthcare system. 

If the justices find that the mandate is severable, how exactly will they pluck that unlawful piece from the rest of the law and what will come with it? 

"The court is going to draw the line," Keith said, and that's where it may get complicated. 

Range of possible outcomes

The justices are set to hear oral arguments Tuesday in the highly anticipated case that has wound its way to the nation's highest court. A final decision that could determine the fate of the law is expected to be delivered next year and the stakes are high. Millions rely on the law for coverage and its basic consumer protections that have significantly reshaped the healthcare sector.  

The key question in the case centers on the question of severability. Ultimately, what ACA proponents fear most is a decision in which the justices are deciding what pieces of the law may be severed and taking a bigger chunk out of the law than supporters deem necessary.

In the spectrum of possible outcomes, on one end, the justices could decide that the individual mandate is constitutional and they never have to answer the question of severability. On the opposite end of the spectrum, they could rule the mandate is unconstitutional and not severable, which would end the entire law, jeopardizing coverage for millions and potentially a slew of ancillary programs, some of which enjoy popular support.

Avalere illustrates the possible outcomes in the ACA case.
Permission granted by Chris Sloan, Avalere
 

Or, the justices find the individual mandate is unconstitutional and severable and that is where the cutting begins, and what elicits the most concern.

If it's severable the question is: What gets extracted from the law? 

The fear among proponents is that instead of using a scalpel, the justices will use blunt instruments and take a whack at the core protections. 

The individual mandate is included in Title I of the ACA, which has numerous titles and spans hundreds of pages. Some of the law's more well-known protections are codified in Title I, including protections for those with pre-existing conditions, coverage for preventive health services, and allowing dependents to stay on their parents' plan until age 26, just to name a few. 

So, if the individual mandate is unconstitutional, does that throw all of Title I into jeopardy? 

The individual mandate was a mechanism to spur healthy people to enroll in coverage instead of waiting until they're sick. It was thought to be important to drive healthy consumers to coverage, especially if insurers were going to be required to cover everyone regardless of pre-existing conditions or health status.    

Although the Trump administration's Department of Justice has since changed its position, it originally argued the individual mandate is unconstitutional and severable — but the mandate was so essential to guaranteed-issue and community-rating provisions, they would have to be cut from the law as well. Those hallmark provisions guarantee insurance coverage to people regardless of their health status and prevents insurers from charging people more due to their status. 

Some advocacy groups, worried about how the justices may rule on the severability question, submitted friend of the court briefs laying out their arguments on what should be kept intact. 

In its 41-page brief, the National Health Law Program argues Medicaid expansion and other provisions bolstering the program should remain untouched if the justices start slicing and dicing the law. The brief also points out a handful of times that the Medicaid provisions are included in Title II of the law, a possible nod to the concern around the potential vulnerability of Title I.

"We think that there's numerous hurdles that the court would need to jump over — and would be surprised if they jumped all over all of them — to get to this question. But when something as important as the Affordable Care Act in its entirety, or in part, is in front of the Supreme Court, I think it's important to provide what we think is important information to the court as it's considering the issues," Jane Perkins, legal director of NHeLP, said.

Or, the justices could maintain the status quo by deciding the mandate is unconstitutional but fully severable.

Using a scalpel

After the passing of Justice Ruth Bader Ginsburg this summer, backers of the law feared the case was in grave peril with the loss of the liberal lion who had voted to uphold the law in previous challenges. 

Trump nominee Judge Amy Coney Barrett, who in record time has already replaced Ginsburg on the bench, moved the court a notch further to the right — marking a total of six justices now appointed by Republican presidents and just three picked by Democrats. 

Recent rulings from the court suggest some of the Republican-appointed members on the bench prefer to use a sharp edge when it comes to severability. 

"We think it clear that Congress would prefer that we use a scalpel rather than a bulldozer," Chief Justice John Roberts wrote in a 5-4 decision from this latest term regarding a challenge to the Consumer Financial Protection Bureau.

In a different case, Justice Brett Kavanaugh seemed emphatic about his belief that the court should "salvage rather than destroy" a law that contains an unconstitutional piece.

"The Court’s precedents reflect a decisive preference for surgical severance rather than wholesale destruction, even in the absence of a severability clause," Kavanaugh wrote in his opinion in the case, Barr v. Association of Political Consultants. 

Tim Jost, professor Washington and Lee University School of Law, said these earlier rulings give him hope that the ACA will be upheld.

"If they stick to that position, then there should be five votes to uphold the ACA whether or not Trump gets a confirmation," Jost, a supporter of the law, said.

But there are no sure bets. Barrett has been critical of the ACA, though she did acknowledge in the less than substantive hearings that, "The presumption is always in favor of severability."

https://www.healthcaredive.com/news/as-pivotal-aca-case-heads-to-supreme-court-potential-outcomes-are-many/587662/

Biden faces a divided Congress, stifling chance for more progressive health policies

Former Vice President Joe Biden has won the presidency, the Associated Press and major networks said, after Pennsylvania went for the former Senator.

With the 2020 election results still in flux, even if former Vice President Joe Biden squeaks out a win, the chances of him achieving his more ambitious health policy objectives are slim given a Congress even more fractured than before.

The former Delaware senator said Wednesday afternoon he believes he will be the victor when all the votes are counted — which could be days or weeks away. 

And President Donald Trump's campaign has said it will begin legal challenges in states with close outcomes.

As of Thursday morning, four Senate seats are also still undecided making a switch in control not impossible for Democrats. The path, however, is narrow. Democrats did maintain control over the House, but lost their margin.

If the current projections play out and Biden presides with a divided Congress, a few key insights can be gleaned.

COVID-19 drives agenda

The United States hit a record-high number of COVID-19 cases recorded in a single day Wednesday at more than 103,000, according to the COVID Tracking Project

With a third spike of coronavirus infections in the U.S. underway, the pandemic will take center stage in a potential Biden administration.

The former VP has reportedly started putting together a transition team to implement the plan for tackling the virus he released previously.

"They're going to really try to get ahold of this virus. To me, that's what this election was about," said Lyndean Brick, CEO of consultancy Advis. She added later: "You're not going to see a lot of rash activity. He's got to deal with this pandemic."

The pandemic was top of mind for voters this year and Biden has pledged to tackle it head on if elected. 

That would be starkly different from Trump's approach of emphasizing a desire to keep the economy running and pinning most of the country's hopes on a vaccine.

Biden could install mandates for testing, hospital staffing or domestic production of personal protective equipment, for example.

He could also work with Congress to tweak the Coronavirus Aid, Relief, and Economic Security Act in providers favor by forgiving Medicare loans and changing reporting requirements for receiving funding. Another relief package would also be a priority.

Before Election Day, the two parties couldn't agree on legislation, with the issue of how much funding to include forming as a key sticking point. Senate Majority Leader Mitch McConnell and House Speaker Nancy Pelosi have both been on the record recently as interested in pursuing agreement, possibly in a lame duck session.

If Biden wins the presidency and no relief bill has been passed, he would likely put that at the top of the list for his first 100 days in office.

"So to the extent that the federal government can step in and take some of the burden of the industry, the industry is going to be able to take a breath and figure out how it needs to respond," Brick said. "Honestly, it hasn't had time to do that."

Public option, lower Medicare age all but off the table

Biden's healthcare platform had two key policies that would have brought about substantial change — although far short of the single-payer plans espoused by his primary opponents.

He supports a public option, which would allow anyone to buy Medicare-like coverage that would be cheaper than many alternatives. He also would like to lower the Medicare age to 60, which could open access to an additional 20 million Americans.

But neither of those are possible without cooperation from Congress. The Democrats held on to the House of Representatives this year, but unless they wrangle away the Senate as well, such policies are essentially dead in the water.

That unlikelihood of progressive policies would be good overall for commercial insurers, especially those heavily SVB Leerink analysts said in a note Thursday morning, noting one index of payer stocks was up 9% Wednesday.

The scenario is also a positive for providers, the analysts said, as Medicare rates are lower than what commercial payers pay, the analysts said. "The weakness in [healthcare] provider stocks yesterday seems to reflect the return of the overhang from the SCOTUS review of the ACA."

With a GOP-controlled Senate, Biden would be left with the most options via administrative actions, experts said. He could roll back restrictive Medicaid expansion waivers with work requirements and encourage more states to expand to bigger populations.

Lindsay Bealor Greenleaf, vice president of policy at health policy consulting firm Advi, said Biden could also turn to executive orders, which can be used to explicitly pull back a previous president's executive orders.

ACA case before Supreme Court gets weightier

The scenario of a trifecta in D.C., with Democrats nabbing the White House and Senate, would have been a great relief to supporters of the Affordable Care Act. The landmark law faces an existential challenge from a lawsuit brought by Republican attorneys general and backed by Trump's Department of Justice.

The U.S. Supreme Court, which now has a clear majority of justices appointed by Republican presidents, is set to hear arguments next Tuesday. An opinion is expected next year, and a range of options is possible. If the high court throws out the law entirely, the country's healthcare infrastructure would be upended.

Biden, who pushed the law to passage during his vice presidency and remains a staunch supporter, would be able to take legislative action to secure the ACA if he has the votes in Congress. A GOP Senate isn't likely to give that to him.

Biden could take a few steps in executive actions, like restoring funding for ACA navigators who help people select plans and relaxing rules on enrollment during the pandemic public health emergency.

Bipartisan paths most plausible

One key possibility for movement is a fix for surprise medical billing, which both candidates discussed on the campaign trail. Democrats and Republicans have put forward plans for legislation banning the practice, but payers and providers have thrown a lot of lobbying dollars to oppose certain bills.

Providers favor using arbitration to settle surprise bills while payers back a set rate for out-of-network clinicians. If enough support in Congress builds behind one approach, or a mix of the two, there is a chance of passing a fix.

Alternative payment models, such as from Center for Medicare and Medicaid Innovation, also enjoys some bipartisan backing.

That agency could become key for Biden if he's working with a divided Congress, as it has broad authority to waive the entire Medicare statute when implementing a demonstration project, Bealor Greenleaf said. "There aren't really many restrictions on what and how CMMI could implement such a demo," she said. "It's really really broad wording."

Brick said she's optimistic Biden could find a way to reach across the aisle. "The thing about Biden is he's a dealmaker," she said. "He's a senator first and foremost. To me the big question is going to be: What's the left wing of the Democratic party going to allow him to cut deals about?"

Other possibilities

If Trump continues to challenge results in favor of Biden, the final outcome of the election could be dragged out for months. The fate of the Senate could also be delayed, potentially until January if the determination falls to two runoff elections in Georgia.

That scenario adds uncertainty, but it's hard for the landscape to get more volatile for the industry considering the still raging pandemic. Heading into winter and the height of flu season is once again pushing hospitals to the brink.

"Living in an uncertain world is something we're all getting a little used to," Bealor Greenleaf said.

If Trump does pull out a win, his assault on the ACA would likely continue if the high court does not invalidate the law on its own. He would also be likely to continue to support more restrictions on Medicaid enrollment in his second term.

He could also continue to propose cuts to Medicare as well as Medicaid, which could threaten the programs' solvency.

https://www.healthcaredive.com/news/even-if-biden-wins-divided-congress-stifles-chance-for-more-progressive-he/588291/

Humanized COVID‐19 decoy antibody effectively blocks viral entry, prevents SARS‐CoV‐2 infection

EMBO Mol Med (2020)0:e12828https://doi.org/10.15252/emmm.202012828

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi:10.15252/emmm.202012828

PDF: https://www.embopress.org/doi/epdf/10.15252/emmm.202012828


To circumvent the devastating pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection, a humanized decoy antibody (ACE2‐Fc fusion protein) was designed to target the interaction between viral spike protein and its cellular receptor, angiotensin‐converting enzyme 2 (ACE2). First, we demonstrated that ACE2‐Fc could specifically abrogate virus replication by blocking the entry of SARS‐CoV‐2 spike‐expressing pseudotyped virus into both ACE2‐expressing lung cells and lung organoids. The impairment of viral entry was not affected by virus variants, since efficient inhibition was also observed in six SARS‐CoV‐2 clinical strains, including the D614G variants which have been shown to exhibit increased infectivity. The preservation of peptidase activity also enables ACE2‐Fc to reduce the angiotensin II‐mediated cytokine cascade. Furthermore, this Fc domain of ACE2‐Fc was shown to activate NK cell degranulation after coincubation with Spike‐expressing H1975 cells. These promising characteristics potentiate the therapeutic prospects of ACE2‐Fc as an effective treatment for COVID‐19.