Taking executive action to bolster the Affordable Care Act

https://mailchi.mp/2c6956b2ac0d/the-weekly-gist-january-29-2021?e=d1e747d2d8

Thursday was healthcare day at the Biden White House, the latest in a series of themed days during which the President has issued executive orders on topics ranging from COVID response to climate change to racial equity.

Facing a closely divided Congress, the new administration has focused so far on actions it can take unilaterally to advance its agenda, and as President Biden described it at a signing ceremony yesterday, his healthcare agenda is centered on “restoring the Affordable Care Act and restoring Medicaid to the way it was” prior to the Trump administration.

The new executive order reopens the HealthCare.gov insurance marketplace for a “special enrollment period”, lasting from mid-February to mid-May, allowing approximately 15M uninsured Americans in 36 states (including 3M who lost employer-based insurance due to COVID) to sign up for coverage, many subsidized by the federal government.

The order also instructs agencies to review many of the regulatory changes made by the Trump administration, including loosening restrictions on short-term insurance plans, and allowing states to use waivers to implement Medicaid work requirements. (Also included in Thursday’s action was a measure to immediately rescind the ban on taxpayer funding for abortion-related counseling by international nonprofits, the so-called “Mexico City rule”.)

Actually unwinding those Trump-era changes will take months (or possibly years) of regulatory work to accomplish, but Biden’s executive order puts that work in motion. Attention now turns to Congress, which the Biden team hopes will provide funding for increased subsidies for coverage on the Obamacare exchanges, along with allocating money for the administration’s aggressive COVID response plan. 

Yesterday’s executive order is best understood as the starting gun for the lengthy legislative and regulatory process that lies ahead, as the Biden administration tries to bolster the 2010 health reform law, and stamp its mark on American healthcare.

3 healthcare executive actions expected from Biden this week

Biden sets agenda on Day One with executive actions | kare11.com

President Joe Biden is expected to sign executive actions this week related to immigration, healthcare and climate, according to a memo obtained by The Hill.

The executive actions would follow 10 he signed Jan. 21 to combat COVID-19 spread.

Here are the three healthcare executive actions to expect Jan. 28, according to The Hill

1. President Biden is set to rescind a policy banning foreign aid for abortion, known as the Mexico City policy. It prohibits the use of U.S. funds for foreign and national health organizations that perform or actively promote abortion, according to NBC News. The policy was announced by former President Ronald Reagan in 1984. According to The Hill, it has been rescinded by Democratic presidents and reinstated by Republican presidents, including former President Donald Trump, since then.

2. President Biden will also call for a review of the Title X family planning program, according to a memo obtained by The Hill. The federal program provides family planning and related preventive health services for low-income or uninsured people and others. In 2019, the Trump administration issued a final rule prohibiting providers that receive federal family planning money under the program from providing or promoting abortions. NBC News reported that the Biden administration is expected to back off this rule and “restore federal funding for Planned Parenthood,” which left the program in 2019.

3. President Biden plans to sign an executive action on Medicaid and initiate an open enrollment period under the ACA, according to a memo obtained by The Hill. The annual open enrollment period for 2021 closed in December. However, President Biden could initiate a special enrollment period. 

Biden to reopen ACA insurance marketplaces as pandemic has cost millions of Americans their coverage

President Biden is scheduled to take executive actions as early as Thursday to reopen federal marketplaces selling Affordable Care Act health plans and to lower recent barriers to joining Medicaid.

The orders will be Biden’s first steps since taking office to help Americans gain health insurance, a prominent campaign goal that has assumed escalating significance as the pandemic has dramatized the need for affordable health care — and deprived millions of Americans coverage as they have lost jobs in the economic fallout.

Under one order, HealthCare.gov, the online insurance marketplace for Americans who cannot get affordable coverage through their jobs, will swiftly reopen for at least a few months, according to several individuals inside and outside the administration familiar with the plans. Ordinarily, signing up for such coverage is tightly restricted outside a six-week period late each year.

Another part of Biden’s scheduled actions, the individuals said, is intended to reverse Trump-era changes to Medicaid that critics say damaged Americans’ access to the safety-net insurance. It is unclear whether Biden’s order will undo a Trump-era rule allowing states to impose work requirements, or simply direct federal health officials to review rules to make sure they expand coverage to the program that insures about 70 million low-income people in the United States.

The actions are part of a series of rapid executive orders the president is issuing in his initial days in office to demonstrate he intends to steer the machinery of government in a direction far different from that of his predecessor.

Biden has been saying for many months that helping people get insurance is a crucial federal responsibility. Yet until the actions planned for this week, he has not yet focused on this broader objective, shining a spotlight instead on trying to expand vaccinations and other federal responses to the pandemic.

The most ambitious parts of Biden’s campaign health-care platform would require Congress to provide consent and money. Those include creating a government insurance option alongside the ACA health plans sold by private insurers, and helping poor residents afford ACA coverage if they live in about a dozen states that have not expanded their Medicaid programs under the decade-old health law.

A White House spokesman declined to discuss the plans. Two HHS officials, speaking on the condition of anonymity about an event the White House has not announced, said Monday they were anticipating that the event would be held on Thursday.

According to a document obtained by The Washington Post, the president also intends to sign an order rescinding the so-called Mexico City rule, which compels nonprofits in other countries that receive federal family planning aid to promise not to perform or encourage abortions. Biden advisers last week previewed an end to this rule, which for decades has reappeared when Republicans occupied the White House and vanished under Democratic presidents.

The document also says Biden will disavow a multinational antiabortion declaration that the Trump administration signed three months ago.

The actions to expand insurance through the ACA and Medicaid come as the Supreme Court is considering two cases that could shape the outcome. One case is an effort to overturn rulings by lower federal courts, which have held that state rules, requiring some residents to work or prepare for jobs to qualify for Medicaid, are illegal. The other case involves an attempt to overturn the entire ACA.

According to the individuals inside and outside the administration, the order to reopen the federal insurance marketplaces will be framed in the context of the pandemic, essentially saying that anyone eligible for ACA coverage who has been harmed by the coronavirus will be allowed to sign up.

“This is absolutely in the covid age and the recession caused by covid,” said a health-care policy leader who has been in discussions with the administration. “There is financial displacement we need to address,” said this person, who spoke on the condition of anonymity to describe plans the White House has not announced.

The reopening of HealthCare.gov will be accompanied by an infusion of federal support to draw attention to the opportunity through advertising and other outreach efforts. This, too, reverses the Trump administration’s stance that supporting such outreach was wasteful. During its first two years, it slashed money for advertising and for community groups known as navigators that helped people enroll.

It is not clear whether restoring outreach will be part of Biden’s order or will be done more quietly within federal health-care agencies.

Federal rules already allow people to qualify for a special enrollment period to buy ACA health plans if their circumstances change in important ways, including losing a job. But such exceptions require people to seek permission individually, and many are unaware they can do so. Trump health officials also tightened the rules for qualifying for special enrollment.

In contrast, Biden is expected to open enrollment without anyone needing to seek permission, said Eliot Fishman, senior director of health policy for Families USA, a consumer health-advocacy group.

In the early days of the pandemic, the health insurance industry and congressional Democrats urged the Trump administration to reopen HealthCare.gov, the online federal ACA enrollment system on which three dozen states rely, to give more people the opportunity to sign up. At the end of March, Trump health officials decided against that.

During the most recent enrollment period, ending the middle of last month, nearly 8.3 million people signed up for health plans in the states using HealthCare.gov. The figure is about the same as the previous year, even though it includes two fewer states, which began operating their own marketplaces.

Leaders of groups helping with enrollment around the country said they were approached for help this last time by many people who had lost jobs or income because of the pandemic.

The order involving Medicaid is designed to alter course on experiments — known as “waivers” — that allow states to get federal permission to run their Medicaid programs in nontraditional ways. The work requirements, blocked so far by federal courts, are one of those experiments. Another was an announcement a year ago by Seema Verma, the Trump administration’s administrator of the Centers for Medicare and Medicaid Services, that states could apply for a fundamental change to the program, favored by conservatives, that would cap its funding, rather than operating as an entitlement program with federal money rising and falling with the number of people covered.

“You could think about it as announcing a war against the war on Medicaid,” said Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation.

Dan Mendelson, founder of Avalere Health, a consulting firm, said Biden’s initial steps to broaden insurance match his campaign position that the United States does not need to switch to a system of single-payer insurance favored by more liberal Democrats.

The orders the president will sign “are going to do it through the existing programs,” Mendelson said.

Trump moves to lift coronavirus travel restrictions on Europe, Brazil

https://thehill.com/homenews/administration/534718-trump-moves-to-lift-travel-restrictions-on-europe-brazil?rnd=1611014258

Trump moves to lift coronavirus travel restrictions on Europe, Brazil |  TheHill


President Trump on Monday moved to lift restrictions imposed on travelers to the U.S. from much of Europe and Brazil that were implemented last year to slow the spread of the novel coronavirus, though the action is expected to be stopped by the incoming Biden administration.

Trump issued an executive order terminating the travel restrictions on the United Kingdom, Ireland, Brazil and the countries in Europe that compose the Schengen Area effective Jan. 26. The order came two days before Trump leaves office. President-elect Joe Biden’s team immediately signaled they would move to reverse the order.

“With the pandemic worsening, and more contagious variants emerging around the world, this is not the time to be lifting restrictions on international travel,” tweeted incoming White House press secretary Jen Psaki.

“On the advice of our medical team, the Administration does not intend to lift these restrictions on 1/26. In fact, we plan to strengthen public health measures around international travel in order to further mitigate the spread of COVID-19,” Psaki continued.

The order states that Trump’s action came at the recommendation of outgoing Health and Human Services Secretary Alex Azar. The memo cites the new order from the Centers for Disease Control and Prevention (CDC) that requires passengers traveling by air to the U.S. to receive a negative COVID-19 test within three days before their flight departs, saying it will help prevent travelers from spreading the virus.

The Trump administration’s travel restrictions on China and Iran will remain in place, however, because, the order states, the countries “repeatedly have failed to cooperate with the United States public health authorities and to share timely, accurate information about the spread of the virus” and therefore cannot be trusted to implement the CDC’s order.

“Accordingly, the Secretary has advised me to remove the restrictions applicable to the Schengen Area, the United Kingdom, the Republic of Ireland, and the Federative Republic of Brazil, while leaving in place the restrictions applicable to the People’s Republic of China and the Islamic Republic of Iran,” Trump’s order states. “I agree with the Secretary that this action is the best way to continue protecting Americans from COVID-19 while enabling travel to resume safely.”

Though Trump signed the order on Monday, the action does not take effect until six days after he leaves office and Biden is inaugurated. 

The order comes as coronavirus cases and deaths continue to hit worrisome, record-high levels on a daily basis. Nearly 400,000 people in the U.S. and more than 2 million people globally have died from COVID-19. While two vaccines have been approved for emergency use in the U.S., the Trump administration has fallen far short of early targets in distributing and administering the vaccine.

The order will be one of the final actions that Trump takes with respect to the pandemic, after being widely criticized for regularly minimizing the threat posed by the virus.

Trump announced in mid-March of last year that he would impose travel restrictions on individuals entering the United States from the 26 countries that compose the Schengen Area, weeks after the first case was reported in the U.S. The move initially attracted scrutiny because it did not include the U.K. or Ireland, and the Trump administration later moved to restrict travel from those countries as well.

Trump later placed travel restrictions on Brazil at the end of May.

The executive order lifting the travel restrictions was one of several released by the White House on Monday as the final hours of Trump’s presidency wind down. Trump is also expected to grant a final slew of pardons before he leaves office on Wednesday. 

Here are six key ways Biden is promising to fight the coronavirus pandemic

By the time President-elect Joe Biden takes the oath of office on Wednesday, more than 400,000 Americans will have died of covid-19 — a dismal milestone in the deadly pandemic.

Yet the crucial task he faces  rapidly distributing coronavirus vaccines to the American public  is one that most experts one year ago didn’t think would even be an option by this point. Few expected multiple vaccines to be approved within a year — a record for vaccine development, by any measure. And although the rollout has been criticized, Israel and Great Britain are the only major nations the United States lags in vaccinations per capita and its daily rate of immunizations has more than doubled in the past two weeks.

“You have my word: We will manage the hell out of this operation,” Biden said in a speech on Friday, announcing his own vaccination plan. 

Regardless of whether one views the vaccine effort up to this point as a failure or success, this much is true: Biden and his new administration will face an enormous task, not only in getting the vaccines distributed but also in ramping up testing, convincing Americans to follow public health recommendations and responding to the economic fallout from the pandemic. 

Here are six key promises Biden is making about his pandemic response:

1. Administer 100 million doses of coronavirus vaccine during the first 100 days of his administration.

Biden previously cited this as a goal. He reiterated it Friday while rolling out a broader plan for coronavirus vaccinations

The plan would require a rate of 1 million immunizations per day — and the United States isn’t too far away from that goal right now. Nearly 800,000 Americans are getting shots every day on average. That’s a considerable improvement from two weeks ago, when the daily rate was closer to 350,000.

The 100-shot goal is “absolutely a doable thing,” Anthony S. Fauci, direct of the National Institute for Allergy and Infectious Disease, told NBC’s Chuck Todd yesterday.

“The feasibility of his goal is absolutely clear; there’s no doubt about it,” Fauci said. “That can be done.”

But top Biden advisers are also cautioning ramping up immunizations will be gradual and will require lots of coordination.

“The first days of that 100 days may be substantially slower than it will be towards the end,” Michael Osterholm, a member of Biden’s covid-19 task force, told Stat News. “It’s not going to occur quickly … you’re going to see the ramp-up occurring only when the resources really begin to flow.”

2. Set up mass vaccination clinics.

By the end of his first month in office, Biden has promised to open 100 federally managed clinics to administer shots. According to his vaccination plan, these sites would be set up by the Federal Emergency Management Agency. The federal government would reimburse states for sending National Guard members to help run them.

Biden says he also wants to deploy mobile units to rural and underserved areas, along with boosting the role already being played by pharmacies in distributing shots. 

This approach would diverge significantly from how things are being done now, with the Trump administration leaving it up to hospitals, doctors, pharmacies and state public health departments to administer the shots. Some cities and states have set up large vaccination sites, but many haven’t.

“Overall, the president-elect’s plan lays out a more muscular federal role than the Trump administration’s approach, which has relied heavily on each state to administer vaccines once the federal government ships them out,” Anne Gearan, Amy Goldstein and Laurie McGinley report.

“Many of the elements — such as seeking to expand the number of vaccination sites and setting up mobile vaccination clinics — were foreshadowed in a radio interview Biden gave last week and in an economic and health ‘relief plan’ he issued Thursday, which contains a $20 billion request of Congress to pay for a stepped-up campaign of mass vaccination,” our colleagues add.

3. Allow federally qualified health centers to directly access vaccines.

These community health centers — which receive higher government reimbursements but are required to accept all patients regardless of their ability to pay — are a core part of the nation’s safety net for low-income Americans.

Biden’s plan proposes a new program “to ensure [federally qualified health centers] can directly access vaccine supply where needed,” although here, too, it’s unclear exactly how that might work.

Under the Trump administration’s plan, these centers have been asked to enroll with state health departments as vaccine providers. States were then supposed to communicate to the federal government how many doses were needed and where they should go.

How well this is actually working is “all over the map,” said Amy Simmons Farber of the National Association of Community Health Centers. She said supplies vary from county to county and many health centers have received their supplies with little notice, making it challenging to prioritize and plan.

Farber declined to comment on the Biden plan, saying she doesn’t have a lot of details about it. But she’s “very encouraged by the recognition of the important role health centers have played in fighting the pandemic and the need to adequately resource them.”

4. Use the Defense Production Act to ensure plenty of vaccine supplies.

Several times over the course of the pandemic, President Trump has invoked the Defense Production Act, which allows the president to require companies to prioritize contracts deemed essential for national security.

Ventilator tubes are attached to a covid-19 patient at Providence Holy Cross Medical Center in Los Angeles. 

He has used the DPA to speed the production of coronavirus tests and ventilators, and to keep meatpacking plants open. But he hasn’t invoked the authority to compel faster production of the supplies needed for packaging and administering the vaccine.

Biden says he will invoke DPA to ensure a steady stream of these supplies, which include glass vials, stoppers, syringes, needles and the capacity for companies to rapidly fill vaccine vials and finish packaging them.

5. Sign executive actions to combat the virus.

Biden has promised a raft of executive actions in his first ten days as president, laid out over the weekend in a memo from incoming White House Chief of Staff Ron Klain. They’ll include a number of pandemic-related orders.

On Inauguration Day, Biden intends to issue a mask mandate on federal property and for interstate travel, while encouraging all Americans to wear masks for what he’s calling a “100 Day Masking Challenge.”

The following day, Thursday, he’ll sign executive orders aimed at helping schools and businesses reopen safely, expanding testing, protecting workers and establishing clearer public health standards. And on Friday, Biden will direct his Cabinet secretaries to take immediate action to deliver economic relief to families.

“President-elect Biden will take action — not just to reverse the gravest damages of the Trump administration — but also to start moving our country forward,” Klain wrote.

6. Launch a vaccine education campaign.

The memo says Biden will run a “federally-run, locally-focused public education campaign.”

“The campaign will work to elevate trusted local voices and outline the historic efforts to deliver a safe and effective vaccine as part of a national strategy for beating covid-19,” it says.

But the transition team hasn’t detailed how the education campaign might differ from one launched by the Trump administration last month. 

The Department of Health and Human Services said it plans to spend $250 million on efforts to promote vaccine awareness. It kicked off the effort with a $150,000 buy on YouTube for ads that feature Fauci and Food and Drug Administration Commissioner Stephen Hahn. 

The norms around science and politics are cracking

https://www.axios.com/science-politics-norms-cracking-f67bcff2-b399-44f4-8827-085573f5ae52.html

Illustration of a hand holding a cracked microscope slide containing the U.S. flag.

Crafting successful public health measures depends on the ability of top scientists to gather data and report their findings unrestricted to policymakers.

State of play: But concern has spiked among health experts and physicians over what they see as an assault on key science protections, particularly during a raging pandemic. And a move last week by President Trump, via an executive order, is triggering even more worries.

What’s happening: If implemented, the order creates a “Schedule F” class of federal employees who are policymakers from certain agencies who would no longer have protection against being easily fired— and would likely include some veteran civil service scientists who offer key guidance to Congress and the White House.

  • Those agencies might handle the order differently, and it is unclear how many positions could fall under Schedule F — but some say possibly thousands.
  • “This much-needed reform will increase accountability in essential policymaking positions within the government,” OMB director Russ Vought tells Axios in a statement.

What they’re saying: Several medical associations, including the Infectious Diseases Society of America, strongly condemned the action, and Democrats on the House oversight panel demanded the administration “immediately cease” implementation.

  • “If you take how it’s written at face value, it has the potential to turn every government employee into a political appointee, who can be hired and fired at the whim of a political appointee or even the president,” says University of Colorado Boulder’s Roger Pielke Jr.
  • Protections for members of civil service allow them to argue for evidence-based decision-making and enable them to provide the best advice, says CRDF Global’s Julie Fischer, adding that “federal decision-makers really need access to that expertise — quickly and ideally in house.”

Between the lines: Politics plays some role in science, via funding, policymaking and national security issues.

  • The public health system is a mix of agency leaders who are political appointees, like HHS Secretary Alex Azar, and career civil servants not dependent on the president’s approval, like NIAID director Anthony Fauci.
  • “Public health is inherently political because it has to do with controlling the way human beings move around,” says University of Pennsylvania’s Jonathan Moreno.

Yes, but: The norm is to have a robust discussion — and what has been happening under the Trump administration is not the norm, some say.

  • “Schedule F is just remarkable,” Pielke says. “It’s not like political appointees editing a report, [who are] working within the system to kind of subvert the system. This is an effort to completely redefine the system.”
  • The Center for Strategic and International Studies’ Stephen Morrison says that the administration has been defying normative practices, including statements denigrating scientists, the CDC and FDA.

The big picture: Public trust in scientists,which tends to be high, is taking a hit, not only due to messaging from the administration but also from public confusion over changes in guidance, which vacillated over masks and other suggestions.

  • Public health institutions “need to have the trust of the American people. In order to have the trust of the American people, they can’t have their autonomy and their credibility compromised, and they have to have a voice,” Morrison says.
  • “If you deny CDC the ability to have briefings for the public, and you take away control over authoring their guidance, and you attack them and discredit them so public perceptions of them are negative, you are taking them out of the game and leaving the stage completely open for falsehoods,” he adds.
  • “All scientists don’t agree on all the evidence, every time. But what we do agree on is that there’s a process. We look at what we know, we decide what we can clearly recommend based on what we know, sometimes when we learn more, we change our recommendations, and that’s the scientific process,” Fischer says.

What’s next: The scientific community is going to need to be proactive on rebuilding public trust in how the scientific process works and being clear when guidance changes and why it has changed, Fischer says.

Election 2020: Trump and Biden’s starkly diverging views on healthcare

https://www.healthcaredive.com/news/presidential-election-2020-trump-biden-different-healthcare-policies-ACA-coronavirus/585184/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-10-01%20Healthcare%20Dive%20%5Bissue:29992%5D&utm_term=Healthcare%20Dive

Spoiler: the 2 nominees differ on almost everything.

President Donald Trump and Democrat nominee Joe Biden’s starkly contrasting views on healthcare were laid bare during this week’s chaotic debate. But some major industry executives noted at a recent conference they’ve done relatively well under Trump and could likely weather a Biden presidency, given his moderate stance and rejection of liberal dreams of “Medicare for All.”

The former vice president stresses incremental measures to shore up President Barack Obama’s landmark Affordable Care Act. Trump’s campaign website has no list of healthcare priorities, making his record even more relevant to attempts to forecast his future policies.

“I think a lot of the president’s second term agenda will be extensions of things he’s done in his first term,” Lanhee Chen, domestic policy director at Stanford University’s Public Policy program, said at AHIP in September.

Either way, the impact of whoever lands in the White House next year still matters for the industry’s future.

And 33 seats in the Senate are also up for grabs in November, complicating the outlook. Two scenarios would likely lead to health policy gridlock, according to analysts and DC experts: Trump wins regardless of Senate outcome, or Biden wins and Republicans maintain control of the Senate. A third scenario, where Biden wins and Democrats retake the Senate, would be the most negative for healthcare stocks, Jefferies analysts say, while the other two outcomes would be a net positive or mostly neutral.

Here’s a look at where the candidates stand on the biggest healthcare issues: the coronavirus pandemic, the Affordable Care Act, changes to Medicare and Medicaid and lowering skyrocketing healthcare costs.

COVID-19 response

Trump

Of all wealthy nations, the U.S. has been particularly unsuccessful in mitigating the pandemic. The U.S. makes up 4% of the global population, but accounted for 23% of all COVID-19 cases and 21% of all deaths as of early September.

Public health experts assign the majority of the blame to an uncoordinated federal response, with the president electing to take a largely hands-off approach to the virus that’s killed nearly 207,000 people in the U.S. to date. That backseat stance is unlikely to change if Trump is elected to a second term.

In March, Trump said a final COVID-19 death toll in the range of 100,000 to 200,000 Americans would mean he’s “done a very good job.”

Critics blame shortages of supplies like test materials, personal protective equipment and ventilators, especially in the crucial early days of the pandemic, on Trump’s approach. States and healthcare companies have also reported challenges with shifting federal guidelines on topics from risk of infection to hospital requirements for reporting COVID-19 caseloads.

Trump has also pushed unproven treatments for COVID-19, giving rise to concerns about political influence on traditionally nonpartisan agencies like the Food and Drug Administration and the Centers for Disease Control and Prevention.

These concerns have colored Operation Warp Speed, the administration’s public-private partnership to fast-track viable vaccines. The operation received $10 billion in funds from Congress, but administration officials have also pulled $700 million from the CDC, even as top health officials face accusations of trying to manipulate CDC scientific research publications.

Fears that political motivations, not clinical rigor, are driving the historically speedy timeline could lower public trust in a vaccine once it’s eventually approved.

Trump has also repeatedly refused to endorse basic protections like widespread mask wearing, often eschewing the face covering himself in public appearances. He’s consistently downplayed the severity of the pandemic, saying it’ll go away on its own while suggesting falsely that rising COVID-19 cases were solely due to increased testing.

While Trump’s list of priorities for his second term include “eradicating COVID-19,” the plan is short on details. His most aggressive promise has been approval of a vaccine by the end of this year and creating all “critical medicines and supplies for healthcare workers” for a planned return to normal in 2021, along with refilling stockpiles to prepare for future pandemics.

Biden

Biden, for his part, would likely work to enact COVID-19 legislation and dramatically change the role of the federal government in pandemic response first thing if elected.

The Democratic candidate says he would re-assume primary responsibility for the pandemic. He plans to “dramatically scale up testing” and “giving states and local governments the resources they need to open schools and businesses safely,” per an August speech in Wilmington, Delaware.

Biden says he’d take a backseat to scientists and allow FDA to unilaterally make decisions on emergency authorizations and approvals.

The candidate supports reopening an ACA enrollment period for the uninsured, eliminating out-of-pocket costs for COVID-19 treatment, enacting additional pay and protective equipment for essential workers, increasing the federal match rate for Medicaid by at least 10%, covering COBRA with 100% premium subsidies during the emergency, expanding unemployment insurance and sick leave, reimbursing employers for sick leave and giving them tax credits for COVID-19 healthcare costs.

Trump opposes most of these measures, though he did sign COVID-19 relief legislation that upped the Medicaid match rate by 6.2% and extended the COBRA election period, though without subsidies.

Biden has said he’d be willing to use executive power for a national mask mandate, though ensuring compliance would be difficult. He’d also rejoin the World Health Organization, which Trump pulled the U.S. out of in May.

Affordable Care Act

Trump

On his first day in office, Trump issued an executive order saying: “It is the policy of my Administration to seek the prompt repeal of the Patient Protection and Affordable Care Act.” But after the Republican repeal-and-replace effort floundered in 2017, the administration began steadily chipping away at key tenets of the decade-old law through regulatory avenues.

Trump has maintained he’ll protect the 150 million people with preexisting conditions in the U.S. But despite publicly promising a comprehensive replacement plan on the 2015 campaign trail (and at least five times this year alone), Trump has yet to make one public. The president did in September sign a largely symbolic executive order that it’s the stance of his administration to protect patients with preexisting conditions.

The president doesn’t mention the ACA in his list of second term priorities. The omission could have been intentional, as Trump is backing a Republican state-led lawsuit seeking to overturn the sweeping law, now pending in front of the U.S. Supreme Court and scheduled for oral arguments one week after the election.

The death of liberal justice Ruth Bader Ginsburg puts the law in an even more precarious position.

And Trump’s health agencies have enacted myriad policies keeping the law from functioning as designed.

The president signed legislation zeroing out the individual mandate penalty requiring people to be insured in 2017. The same year, he ended cost-sharing reduction payments to insurers, suggesting that would cause the ACA to become “dead.” But the marketplace generally stabilized.

The administration has also increased access to skimpier but cheaper coverage that doesn’t have to comply with the 10 essential health benefits under the ACA. The short-term insurance plans widely discriminate against people with pre-existing health conditions, even as a growing number of Americans, facing rising healthcare costs, enrolled, according to a probe conducted by House Democrats this year.

Trump has also encouraged state waivers that promote non-ACA plans, cut funding for consumer enrollment assistance and outreach, shortened the open enrollment period and limited mid-year special enrollments.

​Despite his efforts, the ACA has grown in popularity among voters on both sides of the aisle, mostly due to provisions like shoring up pre-existing conditions and allowing young adults to stay on their parent’s insurance until age 26.

Biden

If elected, Biden would likely roll back Trump-era policies that allowed short-term insurance to proliferate, and restore funding for consumer outreach and assistance, political consultants say.

Building on the law is the linchpin of Biden’s healthcare plan. The nominee has pledged to increase marketplace subsidies to help more people afford ACA plans through a number of policy tweaks, including lowering the share of income subsidized households pay for their coverage; determining subsidies by setting the benchmark plan at the pricier “gold” level; and removing the current cap limiting subsidies to people making 400% of the federal poverty level or below.

Biden maintains as a result of these changes, no Americans would have to pay more than 8.5% of their annual income toward premiums. They could save millions of people hundreds of dollars a month, according to a Kaiser Family Foundation analysis. Commercial payers mostly support these efforts, hoping they’ll stabilize the exchanges.

But a second prong of Biden’s health strategy is deeply unpopular with private insurers: the public option. Biden’s called for a Medicare-like alternative to commercial coverage, available to anyone, including people who can’t afford private coverage or those living in a state that hasn’t expanded Medicaid.

The rationale of the public plan is that it can directly negotiate prices with hospitals and other providers, lowering costs across the board. However, market clout will depend on enrollment, which is still to-be-determined.

Critics see the plan, which by Biden’s estimate would cost $750 billion over 10 years, as a down payment on Medicare for All. And the private sector worries it could threaten the very profitable healthcare industry, which makes up about a fifth of the U.S. economy.

Medicare

Trump

Neither Trump nor Biden supports Medicare for All, dashing the hopes of supporters of the sweeping insurance scheme for at least another four years.

“It has a pulse — it’s not dead — I just don’t see it happening in any near term,” John Cipriani, vice president at public affairs firm Global Strategy Group, said at AHIP.

Trump has promised to protect Medicare if elected to a second term, and it’s unlikely he’d make any major changes to the program’s structure or eligibility requirements, experts say.

But Medicare is quickly running out of money, and neither Trump nor Biden has issued a complete plan to ensure it survives beyond 2024. Political consultants think it’ll teeter right up to the edge of insolvency before lawmakers feel compelled to act.

The president’s administration has allowed Medicare to pay for telehealth and expanding supplemental benefits in privately run Medicare Advantage programs, efforts that would likely bleed into his second term — or Biden’s first, given general bipartisan support on both, experts say.

Under Trump, HHS did pass a site-neutral payment policy, cutting Medicare payments for hospital outpatient visits in a bid to save money. But Democratic lawmakers have argued Trump’s calls to get rid of the federal payroll tax, which partially funds Medicare, could throw the future of the cash-strapped program in jeopardy.

The president has also signed legislation experts say accelerated insolvency, including the Tax Cuts and Jobs Act of 2017, the Bipartisan Budget Act of 2018 and the Further Consolidated Appropriations Act of 2020, which repealed the ACA’s Cadillac tax — a tax on job-based insurance premiums above a certain level.

Nixing that tax lowered payroll tax revenue, also dinging Medicare’s shrinking trust fund.

Trump’s proposed budget for the 2021 fiscal year floated culling about $450 billion in Medicare spending over a decade. And repealing the ACA would also nix provisions that closed the Medicare prescription drug “donut hole,” that added free coverage of preventive services and reduced spending to strengthen Medicare’s winnowing Hospital Insurance Trust Fund.

Biden

Biden has proposed lowering the Medicare age of eligibility to 60 years, with the option for people aged 60-64 to keep their coverage if they like it. The idea is popular politically, though providers oppose it, fearful of losing more lucrative commercial revenue.

It would make about 20 million more people eligible for the insurance, but could also add even more stress onto the program, experts say. Biden’s campaign says it would be financed separately from the current Medicare program, with dollars from regular tax revenues, and will reduce hospital costs.

Biden also says he’d add hearing, vision and dental benefits to Medicare.

Medicaid

Trump

Trump’s tenure has also been defined by repeated efforts to prune Medicaid. The president has consistently backed major cuts to the safety net insurance program, along with stricter rules for who can receive coverage. That’s likely to continue.

Republican lawmakers maintain the program costs too much and discourages low-income Americans from getting job-based coverage, and have enacted policies trying to privatize Medicaid. The Trump administration took a step toward a long-held conservative dream earlier this year, when CMS invited state waivers that would allow states to deviate from federal standards in program design and oversight, in exchange for capped funding.

So far, no states have enacted the block grants.

The administration also aggressively encouraged states to adopt work requirements, programs tying Medicaid coverage to work or volunteering hours. A handful of states followed suit, but all halted implementation or rolled back the idea following fierce public backlash and legal ramifications.

And repealing the ACA would ax Medicaid expansion, which saved some 20,000 lives between 2014 and 2017, according to the Center on Budget and Policy Priorities.

Biden

Biden, however, wants to preserve expansion, and would take a number of other steps to bolster the program, including increasing federal Medicaid funding for home- and community-based services. The roughly 4.8 million adults in states that elected not to expand Medicaid would be automatically enrolled into his public option, with no premium and full Medicaid benefits.

Additionally, states that have expanded Medicaid could elect to move their enrollees into the public option, with a maintenance-of-effort payment.

Lowering costs of drugs and services

Trump

Efforts to lower prescription drug costs have defined Trump’s healthcare agenda in his first term, and been a major talking point for the president. That’s more than likely to continue into a second term, experts say, despite a lack of results.

Trump did cap insulin costs for some Medicare enrollees, effective 2021. He also signed legislation in 2018 banning gag clauses preventing pharmacists from telling customers about cheaper options.

But despite fiery rhetoric and a litany of executive orders, Trump has made little if any concrete progress on actually lowering prices. One week into 2020, drugmakers had announced price hikes for almost 450 drugs, despite small price drops earlier in Trump’s tenure.

Trump has proposed several ideas either dropped later or challenged successfully by drugmakers in court, including allowing patients to import drugs from countries like Canada, banning rebates paid to pharmacy benefit manufacturers in Medicare and forcing drugmakers to disclose the list prices of drugs in TV ads.

The president has signed recent executive orders to lower costs largely viewed as pre-election gambits, including one tying drug prices in Medicare to other developed nations and another directing his agencies to end surprise billing. Implementation on both is months away. Trump has also promised to send Medicare beneficiaries $200 in drug discount cards before the election, an effort slammed as vote-buying that would cost Medicare at least $6.6 billion.

Both Trump and Biden support eliminating surprise bills but haven’t provided any details how. That “how” is important, as hospitals and payers support wildly different solutions.

Biden

Biden also has a long list​ of proposals to curb drug costs, including allowing the federal government to negotiate directly with drug manufacturers on behalf of Medicare and some other public and private purchasers, with prices capped at the level paid by other wealthy countries. Trump actually supported this proposal in his 2016 campaign, but quickly dropped it amid fierce opposition from drugmakers and free market Republican allies.

Biden would also cap out-of-pocket drug costs in Medicare Part D — but wouldn’t ban rebates, as of his current plan, allow consumers to import drugs (subject to safeguards) and eliminate tax breaks for drug advertising expenses.

He would also prohibit prices for all brand-name and some generic drugs from rising faster than inflation under Medicare and his novel public option. Biden would create a board to assess the value of new drugs and recommend a market-based price, in a model that’s shown some efficacy in other wealthy countries like Germany.

Both Biden and Trump say they support developing alternative payment models to lower costs. But they diverge on the role of competition versus transparency in making healthcare more affordable. In a rule currently being challenged in court, Trump’s HHS required hospitals to disclose private negotiated prices between hospitals and insurers, with the hope price transparency will allow consumers to shop between different care sites and shame companies into lowering their prices.

Biden, by comparison, says he would enforce antitrust laws to prevent anti-competitive healthcare consolidations, and other business practices that jack up spending. Trump has been mum on the role of M&A in driving healthcare costs, and inherited a complacent Federal Trade Commission that’s done little to reduce provider consolidation. Until a contentious hospital merger in February this year, the FTC hadn’t opposed a hospital merger since 2016.

 

 

 

 

The first presidential debate: 7 healthcare takeaways

https://www.beckershospitalreview.com/hospital-management-administration/the-first-presidential-debate-7-healthcare-takeaways.html?origin=CFOE&utm_source=CFOE&utm_medium=email&oly_enc_id=2893H2397267F7G

5 key takeaways from Joe Biden and Donald Trump's 1st presidential debate -  ABC News

President Donald Trump and former Vice President and Democratic presidential nominee Joe Biden sparred over the future of the ACA, the COVID-19 pandemic and health insurance during a 90-minute debate in Cleveland Sept. 29.

Seven takeaways for healthcare leaders:

The ACA

1. Moderator and Fox News host Chris Wallace opened the debate with the topic of President Trump’s nomination of Judge Amy Coney Barrett of the U.S. Court of Appeals for the 7th Circuit to the U.S. Supreme Court. In the first few minutes of the debate, the discussion turned to the future of the ACA should Ms. Coney Barrett join the Supreme Court. A week after the November presidential election, the Supreme Court is set to hear a lawsuit, supported by the Trump administration, that seeks to overturn the ACA. 

2. If the Supreme Court overturns the ACA, Mr. Biden said 22 million Americans would lose insurance and 100 million would lose protections for preexisting conditions. HHS said in 2017 as many as 133 million Americans have preexisting conditions, and a KFF analysis estimates 54 million Americans have conditions serious enough to lead to coverage denials if the ACA is overturned.

3. Mr. Wallace questioned the president about his promise to repeal and replace the ACA, adding that President Trump hadn’t released a comprehensive plan to replace the health law despite pledges to do so. The president disagreed with that, saying he had gotten rid of the individual mandate. Mr. Wallace said eliminating the mandate was not a comprehensive plan. Mr. Wallace called President Trump’s recent executive orders on preexisting conditions and surprise billing “largely symbolic.” President Trump disagreed, but did not tell how the executive orders would be implemented.

Drug prices 

4. The president said drug prices would be coming down “80 or 90 percent.” The president highlighted insulin, which he said he’s getting so inexpensively, “it’s like water.” Insulin continues to retail for about $300 per vial, according to STAT, but cheaper insulin prices could be coming for some seniors. CMS recently said it is expanding the number of Medicare Advantage plans that provide insulin for a $35 or less monthly copay.

Public option

5. In an exchange with Mr. Biden, President Trump accused the Democratic Party of wanting “socialist medicine,” and claimed Mr. Biden wants to end private insurance. Mr. Biden denied those claims and said his health plan, which includes expanded ACA subsidies and a public option, would allow employees to keep their private health insurance. He has not supported Medicare-for-All proposals.

COVID-19

6. On the topic of the pandemic, Mr. Wallace asked President Trump about differing timelines for a vaccine that have been presented by him versus federal scientists like CDC Director Robert Redfield, MD. The president said he has spoken with Pfizer, Moderna and Johnson & Johnson, who’ve said “they can go faster” on a vaccine, but “it’s a very political thing.” He added that the military is already set up to distribute vaccines. Mr. Biden questioned Americans’ trust in the process. A Sept. 29 poll from the Axios/Ipsos Coronavirus Index found 8 in 10 Americans wouldn’t likely get a first generation COVID-19 vaccine if the president said it was safe.

7. President Trump and Mr. Biden took different stances on masks. Mr. Biden cited Dr. Redfield’s renewed call to wear masks, and said masking up and social distancing would save 100,000 lives between now and January. President Trump responded by saying, “They’ve said the opposite.” He alluded to early in the pandemic when public health experts, including Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, were slow to recommend widespread mask-wearing before scientists better understood how the virus spreads. The CDC currently recommends that every American wear a mask.

 

 

 

Administration Sketches Healthcare Plan, Signs Executive Order

https://www.medpagetoday.com/washington-watch/electioncoverage/88810?xid=fb_o&trw=no&fbclid=IwAR1OTD2FHXYsDzbKZ_H3MdTUNnvlxhe7kqEMtaZMXjRBpkHFksvvY-lHVGc

New Executive Order Applies to Foreign Third-Party Code | The Media Trust

Critics question value of provision addressing preexisting condition coverage.

President Trump presented his “America First Healthcare Plan” during a speech to healthcare professionals in Charlotte, North Carolina, on Thursday — a plan that mentioned preexisting condition coverage protections and surprise billing but did not seem to include comprehensive changes to the healthcare system.

“Under the America First Healthcare Plan, we will ensure the highest standard of care anywhere in the world, cutting-edge treatments, state-of-the-art medicine, groundbreaking cures, and true health security for you and your loved ones,” Trump said. “And we will do it rapidly, and it’s in very good order, and some of it has already been implemented.”

Executive Order Provisions

The president signed an executive order outlining the plan, but the order contained initiatives in only a few areas, including:

  • Preexisting condition coverage. The order says simply: “It has been and will continue to be the policy of the United States to ensure that Americans with preexisting conditions can obtain the insurance of their choice at affordable rates.” The order does not direct any government agency to enact a regulation nor request Congress to pass legislation. In August 2018, the Trump administration allowed the sale of “short-term, limited duration” insurance plans that could last for up to 3 years; these often exclude coverage for preexisting conditions but also typically cost less than comprehensive coverage.
  • Surprise billing. “Recognizing that both chambers of the Congress have made substantial progress towards a solution to end surprise billing, the Secretary of Health and Human Services (HHS) shall work with the Congress to reach a legislative solution by December 31, 2020,” the order says. “In the event a legislative solution is not reached by December 31, 2020, the Secretary of Health and Human Services shall take administrative action to prevent a patient from receiving a bill for out-of-pocket expenses that the patient could not have reasonably foreseen.”
  • Price transparency. “Within 180 days of the date of this order, the Secretary of Health and Human Services shall update the Medicare.gov Hospital Compare website to inform beneficiaries of hospital billing quality, including whether the hospital is in compliance with the Hospital Price Transparency Final Rule whether, upon discharge, the hospital provides patients with a receipt that includes a list of itemized services received during a hospital stay; and how often the hospital pursues legal action against patients, including to garnish wages, to place a lien on a patient’s home, or to withdraw money from a patient’s income tax refund,” the order reads.

Trump also announced another initiative, this one aimed at seniors. “Under my plan, 33 million Medicare beneficiaries will soon receive a card in the mail containing $200 that they can use to help pay for prescription drugs … The cards will be mailed out in coming weeks,” Trump said. The $6.6 billion cost of the cards will be paid for under the auspices of a Medicare demonstration program. These funds are ostensibly available via savings generated through Trump’s “most favored nation” executive order allowing Medicare to pay no more for certain prescription drugs than the price paid by other developed countries, a White House official said. That executive order has not yet been implemented, however, and court challenges are expected.

Final Rule Issued on Drug Importation

Trump also noted that the FDA issued a final rule on Thursday implementing the president’s July executive order earlier this month to allow for importation of certain less expensive prescription drugs from Canada. “This means a state or whatever — can go to Canada and buy drugs for a fraction of the price that they’re charging right now,” he said.

He also highlighted individual actions his administration had taken that mostly affected particular groups, including lowering insulin prices for certain Medicare beneficiaries, investing in childhood cancer research, and expanding health reimbursement accounts that employers can use to reimburse employees for medical expenses. The COVID-19 pandemic received scant mention other than a reference to slashing red tape to accelerate development of treatments for the disease, and a sentence about how the pandemic had greatly increased the use of telehealth.

During a telephone briefing with reporters Thursday afternoon, HHS Secretary Alex Azar highlighted the surprise billing provision. “The President is saying that all the relevant players — hospitals, doctors, insurance companies — had better get their act together and get legislation passed through Congress that protects patients against surprise medical bills from anybody — hospitals or doctors, doesn’t matter,” he said.

“Those special interest groups need to sort it out and figure out how that would work,” he continued. “There have been legislative packages that have come quite close on the Hill that are bipartisan, but…. the president is saying the time is now. And if they do not get legislation passed by January 1st, he is instructing me to use the full regulatory power of the U.S. government to protect patients against surprise medical bills.”

Sen. Lamar Alexander (R-Tenn.), outgoing chairman of the Senate Health, Education, Labor, & Pensions (HELP) Committee, praised the surprise billing announcement. “The president is right to call on Congress to pass legislation this year to end surprise medical billing,” Alexander said in a statement, adding that a bill currently going through the House and Senate addresses the issue effectively. “Ending surprise medical bills is a problem that requires a permanent solution passed by Congress this year. The American people can’t afford to wait any longer.”

Preexisting Condition Provision Panned

The preexisting condition provision drew scorn from Democratic legislators. The provision “offers no protection not already available through the existing Affordable Care Act (ACA) and no protection for millions of Americans with preexisting conditions if Trump is successful in packing the Supreme Court to destroy the ACA,” Rep. Lloyd Doggett (D-Texas), chairman of the House Ways & Means Health Subcommittee, said in a statement.

But Azar said during the briefing that the ACA’s clause requiring insurers to cover preexisting conditions does no good if people aren’t able to afford insurance in the first place. “If you’re a couple, aged 55, living in Missouri, making $70,000 a year, Obamacare is going to cost you $30,000 in premiums and a $12,000 deductible,” he said.

Azar promised that the administration “will work with Congress or otherwise to ensure” that people with pre-existing conditions are protected, but he did not indicate how that would be made affordable to individuals without government subsidies of the sort Republicans have long opposed.

Bob Laszewski, president of Health Policy and Strategy Associates in Alexandria, Virginia, questioned how much good the executive order’s preexisting condition provision would do. “Trump and the Republicans couldn’t pass an alternative to Obamacare in 2017 when they controlled the White House and both houses of Congress,” he wrote in a blog post. “But, now he can just sign an executive order and everything is fixed? He has signed a number of healthcare-related executive orders and just about all of them are tied up in the byzantine federal regulatory process, or have faded away. This is just an election-year gimmick in an attempt to persuade voters that Trump has healthcare policy under control. There are a lot of governments in the world that operate by executive fiat. Ours is not one of them.”

 

 

 

 

Drug pricing politics aren’t dead

https://www.axios.com/newsletters/axios-vitals-319d5198-f7a8-401f-9b00-26118ca0b966.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Ending The Cycle Of Drug Price Hikes, Death And Outrage | Cognoscenti

President Trump released an executive order yesterday ordering the Department of Health and Human Services to begin the process of limiting what Medicare pays for prescription drugs relative to other countries.

Why it matters: It’s September of an election year. That means that this executive order is, at best, a statement of Trump’s intention to keep trying to achieve something big on drug prices should he get a second term.

  • But given that he’s had four years already to act on what was also a big issue in 2016, there’s plenty of reason to be skeptical of this ever translating into official policy.
  • “President Trump’s executive order on drug pricing does not by itself do anything. It has to be followed up by regulations, which will take time. Trump has a history of bold talk on drug prices, only to pull back when it comes to putting actual regulations in place,” the Kaiser Family Foundation’s Larry Levitt tweeted.

Details: The order calls for Medicare to receive the “most-favored-nation” price for certain drugs.

  • This price is defined as “the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a member country of the [OECD] that has a comparable per-capita gross domestic product.”

The bottom line: Trump and Joe Biden have both pitched aggressive drug pricing policies — a good reminder that once we get the pandemic under control, the issue is bound to become front-and-center again.