Category Archives: Health Policy

ACA Section 1332 State Innovation Waivers Update

Posted on by • Posted in ACA, ACA Section 1332 State Innovation Waivers, Center for Medicare and Medicaid Services (CMS), Health Policy, Medicaid, Medicaid Expansion, Reinsurance • Leave a comment

https://www.healthaffairs.org/do/10.1377/hblog20200729.217545/full/

Tracking Section 1332 State Innovation Waivers | KFF

On July 24, 2020, the Centers for Medicare and Medicaid Services (CMS) and the Treasury Department approved Pennsylvania’s waiver application to operate a state-based reinsurance program under Section 1332 of the Affordable Care Act (ACA). This makes Pennsylvania the thirteenth state to be approved for a state-based reinsurance program. This post also summarizes the newest waiver proposal in Georgia.

Pennsylvania’s Waiver And More On Section 1332 Waivers

In late June, Pennsylvania received federal approval for a five-year reinsurance program beginning with the 2021 plan year. The state’s $139.3 million reinsurance program is expected to reduce premiums by about 4.6 percent (relative to what premiums would have been in the absence of the waiver) and increase enrollment in the individual market by about 0.5 percent in 2021. The federal government will contribute $95.1 million while state funds would account for about $44.2 million.

Implementation of the reinsurance program will coincide with a transition away from the federal marketplace to the new state-based marketplace, the Pennsylvania Health Insurance Exchange (Exchange). Both the reinsurance program and the Exchange were created in the same piece of 2019 legislation, which requires the Exchange to assess and collect fees—up to 3.5 percent of total monthly premiums—to support the reinsurance program. Pennsylvania expects to set the initial user fee at 3 percent of total monthly premiums. Each year, the Exchange will collect the user fee from insurers, deduct its operating expenses, and transfer the remaining funds to a reinsurance fund. In making reinsurance payments to insurers, Pennsylvania intends to first exhaust federal pass-through funding and then user fee revenue.

Based on CMS data, Pennsylvania insurers paid HealthCare.gov user fees of about $98.1 million for 2018 and about $83.1 million for 2019. (CMS has released 2018 and 2019 user fee data for each state that uses HealthCare.gov.) User fees in 2018 and 2019 were set at 3.5 percent of premiums, although the federal user fee was reduced to 3 percent for 2020.

Like nearly all states with reinsurance programs, Pennsylvania will use an overall attachment point model with parameters set annually by the insurance department. For 2021, the program is expected to reimburse insurers for 60 percent of claims between $60,000 and $100,000. To ensure program flexibility, the insurance department can make payments on a pro rata basis if funding is insufficient. Pennsylvania also intends to leverage the EDGE server maintained by CMS to determine how much each insurer is due. (This issue—whether and how states could leverage EDGE server infrastructure for reinsurance—has come up in at least one other state as well.)

Pennsylvania’s waiver application was submitted on February 11 and deemed complete on March 12. Federal regulators received and considered two supportive comments on the state’s application. In an approval letter to Commissioner Jessica Altman on July 24, the Departments laid out specific terms and conditions that the state must accept within 30 days for the waiver to go into effect. Once the waiver is accepted, the Departments will notify Pennsylvania of its amount of pass-through funding for 2021.

With Pennsylvania, 14 states have approved Section 1332 waivers. All but one approved waiver has been for a state-based reinsurance program, and CMS released a report on the effect of the 12 already-established state-based reinsurance programs. The report identifies the funding source for each state, program parameters, the impact on premiums by state and year, insurer participation, and enrollment. The average premium reduction for 2020 across all states was 17.7 percent. New Hampshire may be soon added to this list for 2021: the state’s waiver application was submitted in late April.

Latest On Georgia’s Waiver Application

Georgia submitted a waiver application in late December 2019. As discussed more here, Georgia’s application had two phases: phase one is for a reinsurance program and phase two involves much broader changes to the state’s individual market known as the “Georgia Access” model. Phase one was deemed complete on February 6, and review of phase two was “paused” to Georgia leaders could submit additional information.

Under the original Georgia Access Model, Georgia would have eliminated the use of HealthCare.gov, transitioned consumers to decentralized enrollment through private web-brokers and insurers, established its own subsidy structure, enabled the subsidization of plans that do not comply with all the ACA’s requirements, and capped enrollment if subsidy costs exceed federal and state funds. The proposal was criticized for jeopardizing access to comprehensive coverage and failing to satisfy Section 1332’s statutory guardrails.

About five months after review was “paused,” Georgia modified its waiver application, requesting that its reinsurance program be approved for 2022 (rather than 2021) and abandoning some initial components of phase two. The new waiver application was posted in early July and exposed for public comment until July 23.

The main change for phase two is that Georgia would no longer develop its own state-specific subsidy structure. Georgia would validate a consumer’s eligibility for premium tax credits and then send this information to the federal government. The federal government would then issue the subsidies to insurers and reconcile subsidies during tax season. Subsidies would only be available for qualified health plans under the ACA, as they are now. But Georgia wants to conduct its own eligibility determinations because it believes doing so will be more accurate: the state can leverage existing infrastructure, use more recent employment data, and integrate Medicaid eligibility determinations.

The waiver would, however, still eliminate the use of HealthCare.gov, which would make Georgia the only state to do so. Marketplace consumers would be forced to transition to a highly decentralized enrollment system that uses web-brokers and insurers. As a summary of the revised application puts it, Georgia will “transition responsibility for front-end functions of consumer outreach, customer service, plan shopping, selection, and enrollment from the [federal marketplace] to the commercial market.”

While federal subsidies could not be used towards non-ACA plans, Georgia continues to note that a benefit of moving away from HealthCare.gov to web-brokers and insurers is that residents could “view the full range of health plans” offered in the state. Georgia would leverage enhanced direct enrollment (EDE) standards which, as discussed more below, can lead to significant consumer confusion.

From here, Georgia will presumably respond to the latest round of public comment on its new proposal and then submit its revised application.

 

A large racial divide exists in the concern over ability to pay for COVID-19 treatment

Posted on by • Posted in 2020 Election Issues, ACA, Chronic Care Management, Chronic Conditions, Chronic Diseases, Coronavirus, Deferred Healthcare, Employer-Based Health Insurance, Essential Health Benefits, Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Out of Pocket Expenses, Preexisting Conditions, Prescription Drugs, Short Term Health Insurance, Skinny Health Plans, Social Determinants of Health, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Vaccine • Leave a comment

https://www.healthcarefinancenews.com/news/large-racial-divide-exists-concern-over-ability-pay-covid-19-treatment

Nonwhite adults say they’re either “extremely concerned” or “concerned” about the potential cost of care.

People of color are far more likely to worry about their ability to pay for healthcare if they are diagnosed with COVID-19 than their white counterparts, according to a new survey from nonprofit West Health and Gallup.

By a margin of almost two to one (58% vs. 32%), nonwhite adults report that they are either “extremely concerned” or “concerned” about the potential cost of care. That concern is three times higher among lower-income than higher-income households (60% vs. 20%).

The data come from an ongoing survey about Americans’ experiences with and attitudes about the healthcare system. The latest findings are based on a nationally representative sample of 1,017 U.S. adults interviewed between June 8 and June 30.

There’s also a disturbing trend when it comes to medication insecurity. Overall, 24% of U.S. adults say they lacked money to pay for at least one prescribed medicine in the past 12 months, an increase from 19% in early 2019. Among nonwhite Americans, the burden is growing even more quickly. Medication insecurity jumped 10 percentage points, from 21% to 31%, compared with a statistically insignificant three-point increase among white Americans (17% to 20%).

WHAT’S THE IMPACT?

All of this results in what Tim Lash, chief strategy officer for West Health, called a “significant and increasing racial and socioeconomic divide” in Americans’ views on the cost of healthcare and the impact it has on their lives. When polling started in 2019, one in five Americans were unable to pay for prescription medications within the past 12 months. That number now stands at one in four. The bottom line is that the situation is getting worse.

Amid broad concern about paying for the cost of COVID-19 or other medical expenses, health insurance benefits are likely more important than ever to U.S. workers. The survey found that 12% of workers are staying in a job they want to leave because they are afraid of losing healthcare benefits, a sentiment that is about twice as likely to be held by nonwhite workers as white workers (17% vs. 9%).

However, Americans step across racial lines in their overwhelming support for disallowing political contributions by pharmaceutical companies, and for government intervention in setting price limits for government-sponsored research and a COVID vaccine.

Nearly 9 in 10 U.S. adults (89%) think the federal government should be able to negotiate the cost of a COVID-19 vaccine, while only 10% say the drug company itself should set the price. Similarly, 86% of U.S. adults say there should be limits on the price of drugs that government-funded research helped develop.

Regarding the influence of pharmaceutical companies on the political process, 78% of adults say political campaigns should not be allowed to accept donations from pharmaceutical companies during the coronavirus pandemic.

THE LARGER TREND

Concerns over payment aren’t the only race-related disparities found in healthcare. Dr. Garth Graham, the vice president of community health at CVS Health, said during AHIP’s Institute and Expo in June that although African Americans make up 13% of the U.S. population, they account for about 24% of COVID-19 deaths.

He attributed some of the driving factors for these particular COVID-19-related disparities to the social determinants of health, the over-predominance of African American and Latino frontline workers, and the higher incidence-rates of chronic illness such as diabetes and hypertension in minority groups.

On June 19 – Juneteenth, as it’s known for many Black Americans – 36 Chicago hospitals penned an open letter declaring that systemic racism is a “public health crisis.”

“Systemic racism is a real threat to the health of our patients, families and communities,” the letter reads. “We stand with all of those who have raised their voices to capture the attention of Chicago and the nation with a clear call for action.”

 

 

 

 

Some providers face daunting repayment deadline for Medicare advance loans

Posted on by • Posted in Cash, Cash Reserves, Center for Medicare and Medicaid Services (CMS), Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Stimulus, Health Policy, Health System, Hospital, Hospital Industry, Liquidity, Medicare, Medicare Advance Payments • Leave a comment

https://www.fiercehealthcare.com/hospitals/some-providers-face-daunting-aug-1-repayment-deadline-for-medicare-advance-loans?mkt_tok=eyJpIjoiWkRReFlqRmpaamRtWVdabSIsInQiOiJFTEp3SjQ3NG01NXcwRTg3Z0hCZkdTRlwvOURSeEVlblwvRlFUWlZcL09ONjZGNVEybzl3ekl3VFd2ZEgxSjY2NGQ0TkFIRFdtQ0ZDWUx0ak96NU15d09qMWcrdm9BMFUxOSszcVI0T21rak5raEN0aE5Kb0VUUGFcL254QnBjMjdCbzkifQ%3D%3D&mrkid=959610

Starting this month, some providers are facing the prospect of their Medicare payments garnished to repay COVID-19 loans.

The pressing Aug. 1 deadline has sparked concerns from some experts and hospital groups that worry providers couldn’t afford to lose out on Medicare revenue as they combat revenue losses caused by the pandemic. While the program was intended to be a short-term solution, COVID-19 surges are proving that is not the case for some hospitals.

At the onset of the pandemic in March, the Centers for Medicare & Medicaid Services (CMS) extended the advance payment program, which has been used previously to help providers beset by disasters such as hurricanes. Providers and suppliers could apply for advance Medicare payments to offset massive losses sparked by declines in patient volumes due to COVID-19.

Most providers could get up to 100% of their Medicare payments for a three-month period, and inpatient acute care hospitals, children’s hospitals and some cancer hospitals can request up to 100% for a six-month period. Critical access hospitals could have gotten up to 125% over six months.

CMS had given out $100 billion of loans before suspending the program.

“It was very effective because the process was already in place,” said Denise Burke, a partner with the healthcare compliance and operations group for law firm Waller Lansden Dortch & Davis.

The goal behind the program is to help providers stay afloat and was meant to be a short-term solution, as repayment starts 120 days after a provider gets the first payment. But that is the problem, experts say.

“It was intended as a short-term bridge so they could get through the summer before everything returned to normal, only problem is nothing has returned to normal,” said Dan Mendelson, founder and former president of consulting firm Avalere Health.

Now, repayment for the first loans are due on Aug. 1 as more and more states are seeing massive surges of COVID-19. Some major hospital systems, such as HCA and CHS, have been able to offset massive declines in revenue thanks to the loans and money from a $175 billion provider relief fund passed by Congress.

Hospitals have one year from the date of the accelerated payment to repay the balance of the loan, but Medicare Part A providers and Part B suppliers have 210 days from the accelerated payment to repay.

“CMS should think about relative to financial position of the provider,” Mendelson said. “Some providers are doing just fine and can repay loans just like everybody else.”

After the 120-day period is up, CMS will take 100% of Medicare claims payments that would have gone to the provider to offset the balance of the loan.

But it remains unclear whether CMS can change the terms of the repayment to give providers and suppliers more time, especially if they are struggling.

“CMS moves deadlines all the time,” Mendelson said. “The question is whether they can or are willing to exercise this discretion in this case.”

It also is unlikely that CMS will resume the program, which some provider groups have also called for.

“It seems unlikely CMS will continue to allocate money through the advance payment program that has fewer terms and conditions than allocating through provider relief fund,” Burke said, referring to the $175 billion fund that Health and Human Services is still allocating.

CMS did not return a request for comment as of press time.

A major problem for some hospitals is they may not have the liquidity available to repay the loans.

“There are a lot of hospitals struggling right now because volumes are off,” Mendelson said. “This comes down to the fact that people are staying away from the hospital to the extent they possibly can.”

Provider groups such as the American Hospital Association are imploring Congress to forgive the loans, or at the very least change the repayment terms.

For instance, some groups want to lower the interest rates to 50 or 25% of a Medicare payment as opposed to 100%.

But talks on a new COVID-19 relief package have stalled so far no deal has emerged.

Senate Republicans released their own package earlier this week that includes another $25 billion for providers and gives liability protections for hospitals and other businesses. But the package doesn’t include changes to the loans.

 

 

 

Appeals court upholds nearly 30% payment cut to 340B hospitals

Posted on by • Posted in 2020 Election Issues, Dept of Health and Human Services (HHS), District Court of Appeals, Health Policy, Health System, Hospital, Hospital Industry, Medicare, Medicare 340B Drug Discount Program, Medicare Site Neutral Payment, Pandemic, Safety Net Hospitals, Safety-Net Providers • Leave a comment

https://www.fiercehealthcare.com/hospitals/appeals-court-upholds-nearly-30-payment-cut-to-340b-hospitals?mkt_tok=eyJpIjoiWkRReFlqRmpaamRtWVdabSIsInQiOiJFTEp3SjQ3NG01NXcwRTg3Z0hCZkdTRlwvOURSeEVlblwvRlFUWlZcL09ONjZGNVEybzl3ekl3VFd2ZEgxSjY2NGQ0TkFIRFdtQ0ZDWUx0ak96NU15d09qMWcrdm9BMFUxOSszcVI0T21rak5raEN0aE5Kb0VUUGFcL254QnBjMjdCbzkifQ%3D%3D&mrkid=959610

In court filing, AHA says HHS should make 340B hospitals 'whole ...

A federal appeals court has ruled the Trump administration can install nearly 30% cuts to the 340B drug discount program.

The ruling Friday is the latest legal setback for hospitals that have been vociferously fighting cuts the Department of Health and Human Services (HHS) announced back in 2017.

340B requires pharmaceutical manufacturers to deliver discounts to safety net hospitals in exchange for participation in Medicaid. A hospital will pay typically between 20% and 50% below the average sales price for the covered drugs.

HHS sought to address a payment gap between 340B and Medicare Part B, which reimburses providers for drugs administered in a physician’s office such as chemotherapy. There was a 25% and 55% gap between the price for a 340B drug and on Medicare Part B.

So HHS administered a 28.5% cut in the 2018 hospital payment rule. The agency also included the cuts in the 2019 payment rule.

Three hospital groups sued to stop the cut, arguing that HHS exceeded its federal authority to adjust the rates to the program.

A lower court agreed with the hospitals and called for the agency to come up with a remedy for the cuts that already went into effect.

But HHS argued that when it sets 340B payment amounts, it has the authority to adjust the amounts to ensure they don’t reimburse hospitals at higher levels than the actual costs to acquire the drugs.

If the hospital acquisition cost data are not available, HHS could determine the amount of payment equal to the average drug price. HHS argued that hospital cost acquisition data was not available and so HHS needed to determine the payment rates based on the average drug price.

The court agreed with the agency’s interpretation.

“At a minimum, the statute does not clearly preclude HHS from adjusting the [340B] rate in a focused manner to address problems with reimbursement rates applicable only to certain types of hospitals,” the ruling said.

The court added that the $1.6 billion gleaned from the cuts would go to all providers as additional reimbursements for other services.

340B groups were disappointed with the decision.

“These cuts of nearly 30% have caused real and lasting pain to safety-net hospitals and the patients they serve,” said Maureen Testoni, president and CEO of advocacy group 340B Health, which represents more than 1,400 hospitals that participate in the program. “Keeping these cuts in place will only deepen the damage of forced cutbacks in patient services and cancellations of planned care expansions.”

This is the latest legal defeat for the hospital industry. A few weeks ago, the same appeals court ruled that HHS had the legal authority to institute cuts to off-campus clinics to bring Medicare payments in line with physician offices, reversing a lower court’s ruling.

The groups behind the lawsuit — American Hospital Association, American Association of Medical Colleges and America’s Essential Hospitals — slammed the decision as hurtful to hospitals fighting the COVID-19 pandemic. But the groups didn’t say if it would appeal the decision.

“Hospitals that rely on the savings from the 340B drug pricing program are also on the front-lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time,” the groups said in a statement Friday.

 

 

 

How Many People in the U.S. Are Hospitalized With COVID-19? Who Knows?

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Data, Data Analytics, Data Control, Data Governance, Data Interpretation, Data Management, Data Ownership, Data Sharing, Dept of Health and Human Services (HHS), Health Policy, Health System, Hospital, Hospital Industry, Pandemic, Public Health, Public Safety, Transparency • Leave a comment

https://www.propublica.org/article/how-many-people-in-the-us-are-hospitalized-with-covid-19-who-knows?utm_source=sailthru&utm_medium=email&utm_campaign=dailynewsletter&utm_content=feature

 

The Trump administration told hospitals to stop reporting data to the CDC, and report it to HHS instead. Vice President Mike Pence said the information would continue to be released publicly. It hasn’t worked out as promised.

In mid-July, the Trump administration instructed hospitals to change the way they reported data on their coronavirus patients, promising the new approach would provide better, more up-to-the-minute information about the virus’s toll and allow resources and supplies to be quickly dispatched across the country.

Instead, the move has created widespread confusion, leaving some states in the dark about their hospitals’ remaining bed and intensive care capacity and, at least temporarily, removing this information from public view. As a result, it has been unclear how many people are in hospitals being treated for COVID-19 at a time when the number of infected patients nationally has been soaring.

Hospitalizations for COVID-19 have been seen as a key metric of both the coronavirus’s toll and the health care system’s ability to deal with it.

Since early in the pandemic, hospitals had been reporting data on COVID-19 patients to the U.S. Centers for Disease Control and Prevention through its National Healthcare Safety Network, which traditionally tracks hospital-acquired infections.

In a memo dated July 10, the U.S. Department of Health and Human Services told hospitals to abruptly change course — to stop reporting their data to the CDC and instead to submit it to HHS through a new portal run by a company called TeleTracking. The change took effect within days. Vice President Mike Pence said the administration would continue releasing the data publicly, as the CDC had done.

Almost immediately, the CDC pulled its historical data offline, only to repost it under pressure a couple days later. Meanwhile the website for the administration’s new portal promised to update numbers on a daily basis, but, as of Friday morning, the site hadn’t been updated since July 23. (HHS is posting some data daily on a different federal website but not representative estimates for each state.)

“The most pernicious portion of it is that at the state level and at the regional level we lost our situational awareness,” said Dave Dillon, spokesman for the Missouri Hospital Association. “At the end of this, we may have a fantastic data product out of HHS. I will not beat them up for trying to do something positive about the data, but the rollout of this has been absolutely a catastrophe.”

The Missouri Hospital Association had taken the daily data submitted by its hospitals to the CDC and created a state dashboard. The transition knocked that offline. The dashboard came back online this week, but Dillon said in a follow-up email, “the data is only as good as our ability to know that everyone is reporting the same data, in the correct way, for tracking and comparison purposes at the state level.”

Other states, including Idaho and South Carolina, also experienced temporary information blackouts. And The COVID Tracking Project, which has been following the pandemic’s toll across the country based on state data, noted issues with its figures. “These problems mean that our hospitalization data — a crucial metric of the COVID-19 pandemic — is, for now, unreliable, and likely an undercount. We do not think that either the state-level hospitalization data or the new federal data is reliable in isolation,” according to a blog post Tuesday on the group’s website.

Making matters more complicated, the administration has changed the information that it is requiring hospitals to report, adding many elements, such as the age range of admitted COVID-19 patients, and removing others. As of this week, for instance, HHS told hospitals to stop reporting the total number of deaths they’ve had since Jan. 1, the total number of COVID-19 deaths and the total number of COVID-19 admissions. (Hospitals still report daily figures, just not historical ones.)

“Massachusetts hospitals are continuing to navigate the dramatic increase of daily data requirements,” the Massachusetts Health and Hospital Association said in a newsletter on Monday. “MHA and other state health officials continue to raise concerns about the administrative burden and questionable usefulness of some of the data.”

“Hospitals across the country were given little time to adjust to the unnecessary and seismic changes put forth by the U.S. Department of Health and Human Services, which fundamentally shift both the volume of data and the platforms through which data is submitted,” the association’s CEO, Steve Walsh, said in the newsletter.

A number of state websites also noted problems with hospital data. For days, the Texas Department of State Health Services included a note on its dashboard that it was “reporting incomplete hospitalization numbers … due to a transition in reporting to comply with new federal requirements.” That came just as the state was experiencing a peak in COVID-19 hospitalizations.

California likewise noted problems.

A spokesperson for HHS acknowledged some bumps in the transition but said in an email: “We are pleased with the progress we have made during this transition and the actionable data it is providing. We have had some states and hospital associations report difficulty with the new collection system. When HHS identifies errors in the data submissions, we work directly with the state or hospital association to quickly resolve them.

“Our objective with this new approach is to collaborate with the states and the healthcare system. The goal of full transparency is to acknowledge when we find discrepancies in the data and correct them.”

Last week, HHS noted, 93% of its prioritized list of hospitals, excluding psychiatric, rehabilitation and religious nonmedical facilities, reported data at least once during the week. (The guidance to hospitals asks them to report every day.)

Asked about the lack of timely data on its public website, HHS said it will update the site to “make it clear that the estimates are only updated weekly.” HHS is now posting a date file each day on healthdata.gov with aggregate information on hospitalizations by state.

But unlike the prior releases from CDC, which provided estimates on hospital capacity based on the responses, this file only gives totals for the hospitals that reported data. It’s unclear which hospitals did not report, how large they are, or whether the reported data is representative.

It’s also unclear if it’s accurate. New York state, for instance, reported that fewer than 600 people were currently hospitalized with COVID-19, as of Friday. Federal data released the same day pegged the number of suspected and confirmed COVID-19 hospitalizations at around 1,800.

Louisiana says more than 1,500 people are currently hospitalized with COVID-19. The federal data puts the figure at fewer than 700.

Nationally, The COVID Tracking Project reports that more than 56,000 people were hospitalized around the country with the virus, as of Thursday.

The data released by HHS on Friday puts the figure at more than 70,000.

NPR reported this week that it had found irregularities in the process used by the Trump administration to award the contract to manage the hospital data. Among other things, HHS directly contacted TeleTracking about the contract and the agency used a process that is more often used for innovative scientific research, NPR reported.

An HHS spokesperson told NPR that the contract process it used is a “common mechanism … for areas of research interest,” and said that the system used by the CDC was “fraught with challenges.”

Ryan Panchadsaram, co-founder of the tracking website CovidExitStrategy.org, has been critical of the problems created by the hospital data changeover.

“Without real-time accurate monitoring, you can’t make quick and fast and accurate decisions in a crisis,” he said in an interview. “This is just so important. This indicator that’s gone shows how the health system in a state is doing.”

Dillon of the Missouri Hospital Association said the administration could have handled this differently. For big technology projects, he noted, there is often a well-publicized transition with information sessions, an educational program and, perhaps, running the old system and the new one in parallel.

This “was extremely abrupt,” he said. “That is not akin to anything you would expect from HHS about how you would implement a program.”

 

Administration keeps promising an overhaul of the nation’s health-care system that never arrives

Posted on by • Posted in 2020 Election Issues, ACA, Campaign, Consumer Protection, Election, Essential Health Benefits, Executive Orders, Health Insurance Coverage Adequacy, Health Policy, Individual Mandate, Mixed Message, Out of Pocket Expenses, Preexisting Conditions, Short Term Health Insurance, Skinny Health Plans, Supreme Court, Underinsured, Uninsured, Wishful Thinking • Leave a comment

https://www.washingtonpost.com/politics/trump-obamacare-promise/2020/08/01/856ce250-d348-11ea-8d32-1ebf4e9d8e0d_story.html

Conversations About Health Reform - Dr. Susan Mazer Blog

It was a bold claim when President Trump said that he was about to produce an overhaul of the nation’s health-care system, at last doing away with the Affordable Care Act, which he has long promised to abolish.

“We’re signing a health-care plan within two weeks, a full and complete health-care plan,” Trump pledged in a July 19 interview with “Fox News Sunday” anchor Chris Wallace.

Now, with the two weeks expiring Sunday, there is no evidence that the administration has designed a replacement for the 2010 health-care law. Instead, there is a sense of familiarity.

Repeatedly and starting before he took office, Trump has vowed that he is on the cusp of delivering a full-fledged plan to reshape the health-care system along conservative lines and replace the central domestic achievement of Barack Obama’s presidency.

No total revamp has ever emerged.

Trump’s latest promise comes amid the outbreak of the novel coronavirus, which has infected millions, caused more than 150,000 deaths and cost Americans their work and the health benefits that often come with jobs. His vow comes three months before the presidential election and at a time when Trump’s Republican allies in Congress may least want to revisit an issue that was a political loser for the party in the 2018 midterm elections.

Yet Trump has returned to the theme in recent days.

“We’re going to be doing a health-care plan. We’re going to be doing a very inclusive health-care plan. I’ll be signing it sometime very soon,” Trump said during an exchange with reporters at an event in Belleair, Fla., on Friday. When a reporter noted that he told Fox’s Wallace that he would sign it in two weeks, Trump added: “Might be Sunday. But it’s going to be very soon.”

Trump’s decision to revive a health-care promise that he has failed to deliver on — this time with less than 100 days before Election Day — carries political risks. Although it may appeal to voters who don’t like the ACA, it also highlights his party’s inability to come up with an alternative, despite spending almost a decade promising one.

It also raises questions about what exactly his plan would look like and whether it would cover fewer Americans than the current system as the pandemic ravages the country.

Nonetheless, some of Trump’s allies said floating health-care ideas is a smart move by the president.

Sen. Lindsey O. Graham (R-S.C.), who regularly meets and golfs with the president, said the health-care plan that Trump has referred to would come in the form of an executive order that Graham called “fairly comprehensive.” However broad, an executive order would fall short of a full legislative overhaul.

Graham said what Trump has in mind now would ensure that consumers do not risk losing their health plans if they get sick, but he did not give details.

“He’s pretty excited about it,” Graham said of the president. The ACA’s consumer protections for people with preexisting medical conditions is one its most popular facets with the public, and it is the one part of the law Trump consistently says he would preserve if he could get rid of the rest. How he could do that while containing costs after he and congressional Republicans remove the law’s requirement that everyone has to purchase health insurance remains the question.

Graham said it is politically astute for the White House to present an alternative to Democratic proposals close to the election, including the idea of Joe Biden, the party’s presumptive nominee, to build on the ACA so that more people could get coverage.

Still, senior Republican aides on Capitol Hill who are steeped in health care said they had little knowledge of any White House planning for a comprehensive replacement of the ACA.

The White House did not offer details or parse the president’s terminology, which has included saying that the forthcoming plan would be a bill. That implied legislation rather than an executive order.

“President Trump continues to act in delivering better and cheaper health care, protecting Americans with preexisting conditions, lowering prescription drug costs, and defending the right of Americans to keep their doctors and plans of their choice,” White House press secretary Kayleigh McEnany said in a statement to The Washington Post.

McEnany pointed out that Trump issued four executive orders in late July intended to lower prescription drug prices. “There will be more action to come in the coming weeks,” she said without identifying any.

On Capitol Hill, the president’s promises of health plans and legal efforts by the administration to scrap the ACA have created dilemmas for some Republicans. Of the GOP senators facing competitive races this fall, only Susan Collins (Maine) has said that she opposes the Justice Department’s decision to back an effort to gut the law in the courts. Other Republicans have struggled to answer directly, walking a tightrope between embracing a position that would go against popular provisions in the health-care law and risking the wrath of conservatives who want Obamacare repealed.

And the pandemic has also only sharpened the relevance of health care in the eyes of voters — increasing Republican anxiety about doing anything that could limit coverage ahead of the election. Republican Sens. John Cornyn (Tex.), Dan Sullivan (Alaska), Steve Daines (Mont.) and Martha McSally (Ariz.) — all on the ballot this November — this past week drafted legislation that would provide assistance through COBRA for people who lose their employer-sponsored health care as jobs continue to vanish during the pandemic.

“I think there’s definitely things we need to do,” Cornyn said. “But I think our focus ought to be on giving people more choices.”

The ACA — politically polarizing throughout the decade it has existed — is favored by a slim majority of Americans. A Kaiser Family Foundation survey in July found that 51 percent support the law while 36 percent oppose it. A Fox News survey in June showed 56 percent support and 38 percent opposition.

For Trump, saying that he is about to produce a health-care plan to replace the ACA has become a recurrent mantra of his presidency.

During his 2016 campaign, condemning the law was central to Trump’s candidacy. During that campaign’s final days, Trump said he was so eager to repeal and replace the 2010 law that he might ask Congress to convene a special session to do it.

“It will be such an honor for me, for you and for everybody in this country,” the then-Republican nominee said, “because Obamacare has to be replaced. And we will do it, and we will do it very, very quickly.”

The ACA was a significant theme of the president’s joint address to Congress just over a month into his tenure. “Tonight I am calling on this Congress to repeal and replace Obamacare,” he said, calling for measures that would “expand choice, increase access, lower costs and, at the same time, provide better health care.”

With GOP majorities in both the House and the Senate, Congress devoted much of 2017 to trying to get rid of substantial parts of the law. But a succession of repeal bills ultimately faltered in the Senate. When the last one did, Trump said nothing.

Near the end of the year, Congress took one big whack at the health law. As part of a major change in tax law, it eliminated the penalty the ACA levied on most Americans if they failed to carry health insurance. The penalty’s end neutralized the law’s insurance mandate.

With little appetite after that among Senate Republicans to continue trying to gut the law, and a Democratic House majority a year later, the momentum for replacing the ACA fell back to the Trump administration. Cabinet departments have, by turns, undercut specific parts of the law and tried to have it invalidated in the courts, while emphasizing that their concern for the nation’s health-care system and America’s patients reaches beyond the ACA.

And the president? He has continued to periodically vow that he would come up with a better health plan.

In the fall of 2017, Trump took a major swipe at the law by ending payments to insurance companies that had helped them afford to offer lower-income customers discounts on their deductibles and other out-of-pocket costs, as the ACA requires.

During 2018, health officials sought to shrink the law in several other ways. They wrote rules that gave states greater latitude in defining a set of 10 “essential health benefits” that the ACA requires many health plans to cover. They widened the availability of short-term health plans — originally intended as bridge coverage when someone was, say, between jobs — that do not meet consumer protections or benefits that the law otherwise requires.

The administration has joined with a group of Republican attorneys general who are pursuing a lawsuit, now before the Supreme Court, that contends the entire ACA is unconstitutional. At first, the Justice Department argued that only part of the law is invalid, but the administration hardened its position to argue that the entire law should be thrown out.

As these and other administration health-care actions have played out, the drumbeat has continued that the president was about to reveal an ACA replacement plan.

In June 2019, Trump said in an interview with ABC News that he would announce a “phenomenal” new health-care plan “in about two months, maybe less.”

Two months later, White House counselor Kellyanne Conway told reporters that the president was preparing to introduce an elaborate plan to redesign the nation’s health-care system in a speech the following month. “We’re working every single day here,” Conway said last August. “I’ve already been in meetings this morning on the president’s health-care plan. It’s pretty impressive.”

No speech or plan came.

In June, Health and Human Services Secretary Alex Azar suggested that the administration would develop a health-care plan only if the nation’s highest court, which has upheld the law in two earlier cases over the past eight years, overturns it this time. “We’ll work with Congress on a plan if the ACA is struck down,” Azar said on NBC’s “Meet the Press.” “We’ll see what the Supreme Court rules.”

That was three weeks before the president told Fox that he was about to issue a plan.

The administration’s antipathy toward the law has not produced much real-world change for the approximately 20 million people who have coverage through the insurance marketplaces the ACA created for those who cannot get affordable health benefits through a job and those insured through Medicaid expansions.

Early on, HHS slashed federal funding for advertising and other outreach efforts to encourage people to buy ACA health plans during the annual enrollment period. Critics of the administration predicted that sign-ups would ebb. They have not.

The most recent enrollment figures document the number of people choosing an ACA health plan who had followed up by paying insurance premiums last winter so their coverage was in place as of February. The figures, released last week, show that 10.7 million consumers have such plans, slightly more than the 10.6 million a year earlier.

Despite the administration’s steps to undercut parts of the law, and the elimination of the penalty for not having insurance, some of the ACA’s main features remain in place. They include federal subsidies for more than 8 in 10 people who buy health plans in the marketplaces created under the law, the expansion of Medicaid in most states, many consumer insurance protections, and a rule that young adults can stay on their parents’ insurance until they turn 26.

Against existing evidence, Trump says that will soon change.

“We’re getting rid of it because we’re going to replace it with something much better,” Trump told Wallace two weeks ago.

 

 

 

 

Can we ‘TRUST’ the ‘CARES ACT’ to ‘HEAL’ our nation?

Posted on by • Posted in 2020 Election Issues, Coronavirus, Economic Crisis, Economic Stimulus, Election, Health Policy, Medicare, Medicare Hospital Fund, Pandemic, Partisanship, Social Security, The CARES Act, Transparency, Vote, Voting, Voting by Mail • Leave a comment

https://www.washingtonpost.com/business/2020/08/01/cares-trust-heals-heroes-congress-stimulus/?utm_campaign=wp_post_most&utm_medium=email&utm_source=newsletter&wpisrc=nl_most

Social Security Error Leads to Unpaid Medicare Coverage

A groan-up look at Congress’s aspirational acronyms for its various stimulus bills.

Two of the things missing from the increasingly bitter debate about how to handle covid-19’s effect on our people, our businesses and our economy are a sense of humor and bipartisanship.

So as a public service, let me try to bring both of those to bear by doing a deep dive into the various pieces of stimulus legislation currently running around in Our Nation’s Capital.

No, I’m not going to give you a detailed, sleep-inducing analysis featuring numbers and experts opining about various provisions. Instead, I’m going to look at the names — which I find hilariously tortured — of the various pieces of legislation.

Possibly because I’m both a recovering English major and a non-Washingtonian, I like to know the full names of the legislation — like the Cares Act — that I’m writing about. And these names are just great. Let’s start with the Cares (or as I prefer to call it, CARES) Act.

Do you know what the full name of that legislation is? Probably not. Okay, I’ll tell you. It’s the Coronavirus Aid, Relief and Economic Security Act. A name clearly invented to produce a seemingly empathetic acronym.

Now, let’s move on to two total groaners — the Democrats’ and Republicans’ proposals for more stimulus legislation. Remember, I’m not talking about the proposals’ provisions — I’m talking about their names. The Democrats’ candidate in the current stimulus battle is the Heroes (or rather HEROES) Act. The full name of this piece of work, which has been passed by the House, is the Health and Economic Recovery Omnibus Emergency Solutions Act. My favorite part is “Omnibus,” which clearly is in the title because an acronym meister needed an O, and Omnibus was better than Outsized or Over-the-top.

Showing that they would not be out-acronymed, the Republicans named their legislation, which is currently kicking around (and being kicked around) in the Senate, the Heals (or HEALS) Act. That stands for Health, Economic Assistance, Liability protection and Schools Act. The lowercase p in “protection” let the acronym mavens call the legislation HEALS rather than HEALPS.

And finally, there’s legislation that’s been around for several years but that I discovered only recently when Mitch McConnell and his crew stuck it into the HEALS Act. It’s a proposal that would let a congressional committee, operating outside of public sight, propose cuts and changes to Social Security, Medicare and some other federal programs that use trust funds. It’s called the Time to Rescue United States Trusts (or TRUST) Act. I’ve looked at it only superficially — but from what I’ve seen, I don’t think there’s any reason to trust it.

I hope you’ve noticed that I’m doing equal-opportunity name mocking: the Cares and Trust acts, which are bipartisan; the Heroes Act, which is Democratic; and the Heals (or HEALPS) Act, which is Republican.

What do I propose to do about these contorted names? I’m glad you asked. My answer, naturally, is to propose a piece of legislation of my own: The Get Rid Of Acronyms Now Act. That, my friends, would be a true GROAN-er.

 

A Viral Epidemic Splintering into Deadly Pieces

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Clinical Research, Clinical Research Funding, Clinical Testing, Contact Tracing, Coronavirus, Coronavirus Treatment, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Economy Reopening, Employer-Based Health Insurance, False Hope, False Narrative, Food and Drug Administration (FDA), Health Insurance Coverage Adequacy, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership Culture, Leadership Decentralized, Leadership Integrity, Leadership Trust, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Out of Control, Out of Pocket Expenses, Pandemic, Personal Protective Equipment (PPE), Preexisting Conditions, Public Good, Public Health, Public Safety, Public Trust, Quarantine, Scientists, Social Determinants of Health, Social Distancing, Transparency, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Vaccine • Leave a comment

Once again, the coronavirus is ascendant. As infections mount across the country, it is dawning on Americans that the epidemic is now unstoppable, and that no corner of the nation will be left untouched.

As of Wednesday, the pathogen had infected at least 4.3 million Americans, killing more than 150,000. Many experts fear the virus could kill 200,000 or even 300,000 by year’s end. Even President Trump has donned a mask, after resisting for months, and has canceled the Republican National Convention celebrations in Florida.

Each state, each city has its own crisis driven by its own risk factors: vacation crowds in one, bars reopened too soon in another, a revolt against masks in a third.

“We are in a worse place than we were in March,” when the virus coursed through New York, said Dr. Leana S. Wen, a former Baltimore health commissioner. “Back then we had one epicenter. Now we have lots.”

To assess where the country is heading now, The New York Times interviewed 20 public health experts — not just clinicians and epidemiologists, but also historians and sociologists, because the spread of the virus is now influenced as much by human behavior as it is by the pathogen itself.

Not only are American cities in the South and West facing deadly outbreaks like those that struck Northeastern cities in the spring, but rural areas are being hurt, too. In every region, people of color will continue to suffer disproportionately, experts said.

While there may be no appetite for a national lockdown, local restrictions must be tightened when required, the researchers said, and governors and mayors must have identical goals. Testing must become more targeted.

In most states, contact tracing is now moot — there are simply too many cases to track. And while progress has been made on vaccines, none is expected to arrive this winter in time to stave off what many fear will be a new wave of deaths.

Overall, the scientists conveyed a pervasive sense of sadness and exhaustion. Where once there was defiance, and then a growing sense of dread, now there seems to be sorrow and frustration, a feeling that so many funerals never had to happen and that nothing is going well. The United States is a wounded giant, while much of Europe, which was hit first, is recovering and reopening — although not to us.

“We’re all incredibly depressed and in shock at how out of control the virus is in the U.S.,” said Dr. Michele Barry, the director of the Center for Innovation in Global Health at Stanford University.

With so much wealth and medical talent, they asked, how could we have done so poorly? How did we fare not just worse than autocratic China and isolated New Zealand, but also worse than tiny, much poorer nations like Vietnam and Rwanda?

“National hubris and belief in American exceptionalism have served us badly,” said Martha L. Lincoln, a medical anthropologist and historian at San Francisco State University. “We were not prepared to see the risk of failure.”

Since the coronavirus was first found to be the cause of lethal pneumonias in Wuhan, China, in late 2019, scientists have gained a better understanding of the enemy.

It is extremely transmissible, through not just coughed droplets but also a fine aerosol mist that is expelled when people talk loudly, laugh or sing and that can linger in indoor air. As a result, masks are far more effective than scientists once believed.

Virus carriers with mild or no symptoms can be infectious, and there may be 10 times as many people spreading the illness as have tested positive for it.

The infection may start in the lungs, but it is very different from influenza, a respiratory virus. In severely ill patients, the coronavirus may attach to receptors inside the veins and arteries, and move on to attack the kidneys, the heart, the gut and even the brain, choking off these organs with hundreds of tiny blood clots.

Most of the virus’s victims are elderly, but it has not spared young adults, especially those with obesity, high blood pressure or diabetes. Adults aged 18 to 49 now account for more hospitalized cases than people aged 50 to 64 or those 65 and older.

Children are usually not harmed by the virus, although clinicians were dismayed to discover a few who were struck by a rare but dangerous inflammatory version. Young children appear to transmit the virus less often than teenagers, which may affect how schools can be opened.

Among adults, a very different picture has emerged. Growing evidence suggests that perhaps 10 percent of the infected account for 80 percent of new transmissions. Unpredictable superspreading events in nursing homes, meatpacking plants, churches, prisons and bars are major drivers of the epidemic.

Thus far, none of the medicines for which hopes were once high — repurposed malaria drugs, AIDS drugs and antivirals — have proved to be rapid cures. One antiviral, remdesivir, has been shown to shorten hospital stays, while a common steroid, dexamethasone, has helped save some severely ill patients.

One or even several vaccines may be available by year’s end, which would be a spectacular achievement. But by then the virus may have in its grip virtually every village and city on the globe.

Some experts, like Michael T. Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy, argue that only a nationwide lockdown can completely contain the virus now. Other researchers think that is politically impossible, but emphasize that localities must be free to act quickly and enforce strong measures with support from their state legislators.

Danielle Allen, the director of Harvard University’s Edmond J. Safra Center for Ethics, which has issued pandemic response plans, said that finding less than one case per 100,000 people means a community should continue testing, contact tracing and isolating cases — with financial support for those who need it.

Up to 25 cases per 100,000 requires greater restrictions, like closing bars and limiting gatherings. Above that number, authorities should issue stay-at-home orders, she said.

Testing must be focused, not just offered at convenient parking lots, experts said, and it should be most intense in institutions like nursing homes, prisons, factories or other places at risk of superspreading events.

Testing must be free in places where people are poor or uninsured, such as public housing projects, Native American reservations and churches and grocery stores in impoverished neighborhoods.

None of this will be possible unless the nation’s capacity for testing, a continuing disaster, is greatly expanded. By the end of summer, the administration hopes to start using “pooling,” in which tests are combined in batches to speed up the process.

But the method only works in communities with lower infection rates, where large numbers of pooled tests turn up relatively few positive results. It fails where the virus has spread everywhere, because too many batches turn up positive results that require retesting.

At the moment, the United States tests roughly 800,000 people per day, about 38 percent of the number some experts think is needed.

Above all, researchers said, mask use should be universal indoors — including airplanes, subway cars and every other enclosed space — and outdoors anywhere people are less than six feet apart.

Dr. Emily Landon, an infection control specialist at the University of Chicago Pritzker School of Medicine, said it was “sad that something as simple as a mask got politicized.”

“It’s not a statement, it’s a piece of clothing,” she added. “You get used to it the way you got used to wearing pants.”

Arguments that masks infringe on personal rights must be countered both by legal orders and by persuasion. “We need more credible messengers endorsing masks,” Dr. Wen said — just before the president himself became a messenger.

“They could include C.E.O.s or celebrities or religious leaders. Different people are influencers to different demographics.”

Although this feels like a new debate, it is actually an old one. Masks were common in some Western cities during the 1918 flu pandemic and mandatory in San Francisco. There was even a jingle: “Obey the laws, wear the gauze. Protect your jaws from septic paws.”

“A libertarian movement, the Anti-Mask League, emerged,” Dr. Lincoln of San Francisco State said. “There were fistfights with police officers over it.” Ultimately, city officials “waffled” and compliance faded.

“I wonder what this issue would be like today,” she mused, “if that hadn’t happened.”

Images of Americans disregarding social distancing requirements have become a daily news staple. But the pictures are deceptive: Americans are more accepting of social distancing than the media sometimes portrays, said Beth Redbird, a Northwestern University sociologist who since March has conducted regular surveys of 8,000 adults about the impact of the virus.

“About 70 percent of Americans report using all forms of it,” she said. “And when we give them adjective choices, they describe people who won’t distance as mean, selfish or unintelligent, not as generous, open-minded or patriotic.”

The key predictor, she said in early July, was whether or not the poll respondent trusted Mr. Trump. Those who trusted him were less likely to practice social distancing. That was true of Republicans and independents, “and there’s no such thing as a Democrat who trusts Donald Trump,” she added.

Whether or not people support coercive measures like stay-at-home orders or bar closures depended on how scared the respondent was.

“When rising case numbers make people more afraid, they have more taste for liberty-constraining actions,” Dr. Redbird said. And no economic recovery will occur, she added, “until people aren’t afraid. If they are, they won’t go out and spend money even if they’re allowed to.”

As of Wednesday, new infections were rising in 33 states, and in Puerto Rico and the District of Columbia, according to a database maintained by The Times.

Weeks ago, experts like Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases, were advising states where the virus was surging to pull back from reopening by closing down bars, forbidding large gatherings and requiring mask usage.

Many of those states are finally taking that advice, but it is not yet clear whether this national change of heart has happened in time to stop the newest wave of deaths from ultimately exceeding the 2,750-a-day peak of mid-April. Now, the daily average is 1,106 virus deaths nationwide.

Deaths may surge even higher, experts warned, when cold weather, rain and snow force Americans to meet indoors, eat indoors and crowd into public transit.

Oddly, states that are now hard-hit might become safer, some experts suggested. In the South and Southwest, summers are so hot that diners seek air-conditioning indoors, but eating outdoors in December can be pleasant.

Several studies have confirmed transmission in air-conditioned rooms. In one well-known case cluster in a restaurant in Guangzhou, China, researchers concluded that air-conditioners blew around a viral cloud, infecting patrons as far as 10 feet from a sick diner.

Rural areas face another risk. Almost 80 percent of the country’s counties lack even one infectious disease specialist, according to a study led by Dr. Rochelle Walensky, the chief of infectious diseases at Massachusetts General Hospital in Boston.

At the moment, the crisis is most acute in Southern and Southwestern states. But websites that track transmission rates show that hot spots can turn up anywhere. For three weeks, for example, Alaska’s small outbreak has been one of the country’s fastest-spreading, while transmission in Texas and Arizona has dramatically slowed.

Deaths now may rise more slowly than they did in spring, because hospitalized patients are, on average, younger this time. But overwhelmed hospitals can lead to excess deaths from many causes all over a community, as ambulances are delayed and people having health crises avoid hospitals out of fear.

The experts were divided as to what role influenza will play in the fall. A harsh flu season could flood hospitals with pneumonia patients needing ventilators. But some said the flu season could be mild or almost nonexistent this year.

Normally, the flu virus migrates from the Northern Hemisphere to the Southern Hemisphere in the spring — presumably in air travelers — and then returns in the fall, with new mutations that may make it a poor match for the annual vaccine.

But this year, the national lockdown abruptly ended flu transmission in late April, according to weekly Fluview reports from the Centers for Disease Control and Prevention. International air travel has been sharply curtailed, and there has been almost no flu activity in the whole southern hemisphere this year.

Assuming there is still little air travel to the United States this fall, there may be little “reseeding” of the flu virus here. But in case that prediction turns out be wrong, all the researchers advised getting flu shots anyway.

“There’s no reason to be caught unprepared for two respiratory viruses,” said Tara C. Smith, an epidemiologist at Kent State University’s School of Public Health.

Experts familiar with vaccine and drug manufacturing were disappointed that, thus far, only dexamethasone and remdesivir have proved to be effective treatments, and then only partially.

Most felt that monoclonal antibodies — cloned human proteins that can be grown in cell culture — represented the best hope until vaccines arrive. Regeneron, Eli Lilly and other drugmakers are working on candidates.

“They’re promising both for treatment and for prophylaxis, and there are companies with track records and manufacturing platforms,” said Dr. Luciana Borio, a former director of medical and biodefense preparedness at the National Security Council. “But manufacturing capacity is limited.”

According to a database compiled by The Times, researchers worldwide are developing more than 165 vaccine candidates, and 27 are in human trials.

New announcements are pouring in, and the pressure to hurry is intense: The Trump administration just awarded nearly $2 billion to a Pfizer-led consortium that promised 100 million doses by December, assuming trials succeed.

Because the virus is still spreading rapidly, most experts said “challenge trials,” in which a small number of volunteers are vaccinated and then deliberately infected, would probably not be needed.

Absent a known cure, “challenges” can be ethically fraught, and some doctors oppose doing them for this virus. “They don’t tell you anything about safety,” Dr. Borio said.

And when a virus is circulating unchecked, a typical placebo-controlled trial with up to 30,000 participants can be done efficiently, she added. Moderna and Pfizer have already begun such trials.

The Food and Drug Administration has said a vaccine will pass muster even if it is only 50 percent effective. Experts said they could accept that, at least initially, because the first vaccine approved could save lives while testing continued on better alternatives.

“A vaccine doesn’t have to work perfectly to be useful,” Dr. Walensky said. “Even with measles vaccine, you can sometimes still get measles — but it’s mild, and you aren’t infectious.”

“We don’t know if a vaccine will work in older folks. We don’t know exactly what level of herd immunity we’ll need to stop the epidemic. But anything safe and fairly effective should help.”

Still, haste is risky, experts warned, especially when opponents of vaccines are spreading fear. If a vaccine is rushed to market without thorough safety testing and recipients are hurt by it, all vaccines could be set back for years.

No matter what state the virus reaches, one risk remains constant. Even in states with few Black and Hispanic residents, they are usually hit hardest, experts said.

People of color are more likely to have jobs that require physical presence and sometimes close contact, such as construction work, store clerking and nursing. They are more likely to rely on public transit and to live in neighborhoods where grocery stores are scarce and crowded.

They are more likely to live in crowded housing and multigenerational homes, some with only one bathroom, making safe home isolation impossible when sickness strikes. They have higher rates of obesity, high blood pressure, diabetes and asthma.

Federal data gathered through May 28 shows that Black and Hispanic Americans were three times as likely to get infected as their white neighbors, and twice as likely to die, even if they lived in remote rural counties with few Black or Hispanic residents.

“By the time that minority patient sets foot in a hospital, he is already on an unequal footing,” said Elaine Hernandez, a sociologist at Indiana University.

The differences persist even though Black and Hispanic adults drastically altered their behavior. One study found that through the beginning of May, the average Black American practiced more social distancing than the average white American.

Officials in Chicago, Baltimore and other communities faced another threat: rumors flying about social media that Black people were somehow immune.

The top factor making people adopt self-protective behavior is personally knowing someone who fell ill, said Dr. Redbird. By the end of spring, Black and Hispanic Americans were 50 percent more likely than white Americans to know someone who had been sickened by the virus, her surveys found.

Dr. Hernandez, whose parents live in Arizona, said their neighbors who had not been scared in June had since changed their attitudes.

Her father, a physician, had set an example. Early on, he wore a mask with a silly mustache when he and his wife took walks, and they would decline friends’ invitations, saying, “No, we’re staying in our bubble.”

Now, she said, their neighbors are wearing masks, “and people are telling my father, ‘You were right,’” Dr. Hernandez said.

There was no widespread agreement among experts about what is likely to happen in the years after the pandemic. Some scientists expected a quick economic recovery; others thought the damage could persist for years.

Working at home will become more common, some predicted, while crowded, open-plan offices may be changed. The just-in-time supply chains on which many businesses depend will need fixing because the processes failed to deliver adequate protective gear, ventilators and test materials.

A disease-modeling system like that used by the National Weather Service to predict storms is needed, said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. Right now, the country has surveillance for seasonal flu but no national map tracking all disease outbreaks. As Dr. Thomas R. Frieden, a former C.D.C. director, recently pointed out, states are not even required to track the same data.

Several experts said they assumed that millions of Americans who have been left without health insurance or forced to line up at food banks would vote for politicians favoring universal health care, paid sick leave, greater income equality and other changes.

But given the country’s deep political divisions, no researcher was certain what the outcome of the coming election would be.

Dr. Redbird said her polling of Americans showed “little faith in institutions across the board — we’re not seeing an increase in trust in science or an appetite for universal health care or workers equity.”

The Trump administration did little to earn trust. More than six months into the worst health crisis in a century, Mr. Trump only last week urged Americans to wear masks and canceled the Republican convention in Florida, the kind of high-risk indoor event that states have been banning since mid-March.

“It will probably, unfortunately, get worse before it gets better,” Mr. Trump said at the first of the resurrected coronavirus task force briefings earlier this month, which included no scientists or health officials. The briefings were discontinued in April amid his rosy predications that the epidemic would soon be over.

Mr. Trump has ignored, contradicted or disparaged his scientific advisers, repeatedly saying that the virus simply would go away, touting unproven drugs like hydroxychloroquine even after they were shown to be ineffective and sometimes dangerous, and suggesting that disinfectants or lethal ultraviolet light might be used inside the body.

Millions of Americans have lost their jobs and their health insurance, and are in danger of losing their homes, even as they find themselves in the path of a lethal disease. The Trump presidency “is the symptom of the denigration of science and the gutting of the public contract about what we owe each other as citizens,” said Dr. Joia S. Mukherjee, the chief medical officer of Partners in Health in Boston.

One lesson that will surely be learned is that the country needs to be better prepared for microbial assaults, said Dr. Julie Gerberding, a former director of the C.D.C.

“This is not a once-in-a-century event. It’s a harbinger of things to come.”

 

 

 

Hospitals lose legal challenge to 340B drug payment cut

Posted on by • Posted in 2020 Election Issues, American Hospital Association (AHA), District Court of Appeals, Health Policy, Health System, Hospital, Hospital Industry, Medicare, Medicare 340B Drug Discount Program, Medicare Site Neutral Payment, Safety Net Hospitals, Safety-Net Providers • Leave a comment

https://www.healthcaredive.com/news/hospitals-lose-legal-challenge-to-340b-drug-payment-cut/582717/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20Healthcare%20Dive:%20Daily%20Dive%2008-01-2020&utm_term=Healthcare%20Dive%20Weekender

340B Program: Important, but Weaknesses Cited - Pharmacy Practice News

Dive Brief:

  • A significant rate cut for some medications for 340B hospitals was based on a “reasonable interpretation of the Medicare statute” and can stand, the U.S. Court of Appeals for the District of Columbia ruled Friday.
  • The 2-1 ruling overturns a district court decision that HHS overstepped its bounds when it cut the reimbursement rate for a certain category of outpatient drugs by 28.5% for hospitals enrolled in the 340B drug discount program.
  • The American Hospital Association, which challenged the rate cut along with three individual hospitals, did not immediately respond to a request for comment. An advocacy group for 340B hospitals said in a statement it was disappointed in the ruling and that the rate change has “caused real and lasting pain to safety-net hospitals and the patients they serve.”

Dive Insight:

The decision is another major blow for hospitals, coming two weeks after the same court ruled HHS also acted within its authority when it reduced payments to off-campus hospital outpatient departments.

AHA said this week it is seeking to have that ruling overturned.

HHS made the cut to 340B hospital outpatient drug reimbursement in the 2018 Outpatient Prospective Payment System rule, arguing that those hospitals, which primarily serve low-income populations, get the drugs at a deep discount and thus could be incentivized to overuse them.

The cut was from 106% of the average sales price to 22.5% less than ASP. Hospitals immediately sued, but HHS retained the reduction in the 2019 OPPS. The department has said the change would save Medicare $1.6 billion in 2018.

Writing for the court, Chief Judge Sri Srinivasan said the department did indeed have the authority to make the reduction, “so as to avoid reimbursing those hospitals at much higher levels than their actual costs to acquire the drugs.”

He also called the cut “a fair, or even conservative, measure of the reduction needed to bring payments to those hospitals into parity with their costs to obtain the drugs.”

In a partially dissenting opinion, Circuit Judge Cornelia Pillard wrote that she believes the statute only allows HHS to make the change for a specific group of hospitals under a clause that requires the agency to use a certain data set it did not use.

 

 

 

 

Coronavirus update: July marked the worst month on record for new infections. In excess of 1,000 died per day which represents greater than 50% of those who died during the entire Vietnam War (this in just 1 month).

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U.S. Hits Another Record for New Coronavirus Cases - The New York ...

The United States saw a devastating surge in coronavirus infections during July, with more than 1.9 million new cases in total reported — by far the most tallied in a single month and a grim sign that the country had lost its grip on the pandemic.

The month’s infection total reported by states was more than double that of June and represents about 42 percent of the 4.5 million cases the country has logged since the outbreak started, according to tracking by The Washington Post. Nationwide, testing has steadily increased — in July, it rose from about 600,000 to 820,000 tests per day — but soaring positivity rates and hospitalizations made clear that virus transmission was accelerating.

Coronavirus-related deaths also rose after declining during April and May: The country saw 25,259 fatalities in July, up more than 3,700 from the previous month, according to The Post’s data. Health experts predicted daily deaths would continue to trend upward in August, trailing spikes in infections by a few weeks. To date, more than 150,000 people in the United States have died of covid-19, the disease the novel coronavirus causes.

Here are some significant developments:

  • Over the past week, 24 states surpassed a case increase of more than 100 cases per 100,000 people — a metric the White House and Deborah Birx, the coronavirus response coordinator, have defined as “red zone” states, where the spread of the virus is serious enough to warrant stricter public health precautions.
  • The United States tallied 1,315 coronavirus deaths Friday, the fifth day in a row the country has reached a four-digit death toll, according to data analysis by The Post.
  • Anthony S. Fauci, the country’s leading expert on infectious diseases, told Congress on Friday that a “diversity of response” from states had hampered efforts to bring down the number of new infections. In contrast, he said, many European nations went into near-total lockdowns.
  • Students can return to college safely if they are tested for the coronavirus every two days, according to a JAMA study by researchers from the Yale School of Public Health, Harvard Medical School and Massachusetts General Hospital.

Amid the rise in infections and deaths, the country’s virus response remains fractured and halting. Officials at all levels of government spent July sparring over whether to roll back reopening plans and institute mask mandates and other public health requirements recommended by leading health experts.

The pandemic has also had a harsh impact on the economy, with the nation’s gross domestic product shrinking at an annual rate of 32.9 percent in the second quarter. At midnight Friday, tens of millions of American workers lost $600 weekly unemployment payments after congressional leaders failed to reach an agreement on how to extend the benefit, which has helped keep many households afloat the past four months.