Biden’s Latest Order Could Boost Private Equity, End State Licensing

Biden order may boost healthcare private equity, end state licensingSource: Modern Healthcare, by Michael Brady

Vaccine Mandates More Likely Once FDA Grants Full Approvals, Health Experts Say

Vaccine mandates more likely once FDA grants full approvals, health experts  say

Source: NBC News, by Shannon Pettypiece

The United States could see a wave of Covid-19 vaccine mandates as soon as the Food and Drug Administration grants full approval to one or more of the shots, public health experts predicted.

The three vaccines authorized by the FDA for emergency use against the coronavirus have proven safe and effective under that expedited review process and in the real world, and doctors and the nation’s top public health officials have said there’s no need for anyone to wait to get inoculated.

But as the pace of vaccinations lags and concerns about the highly-contagious delta variant grow, the official regulatory signoff would remove a significant legal and public relations barrier for businesses and government agencies that want to require vaccinations for their employees and customers, former health officials from the Biden and the Obama administrations said.

“I think once the vaccines go through full FDA approval, everything should be on the table, and I think that everything will be on the table at the level of municipalities, states, employers, venues, government agencies,” said Andy Slavitt, who stepped down as President Joe Biden’s Covid response coordinator last month and remains in close contact with administration officials.

Many institutions, including colleges and universities, have long required certain immunizations. Still, the suggestion of Covid vaccine mandates, whether by local governments for school children or by businesses for their customers, has so far been met with sharp resistance — primarily from conservative lawmakers and activists.

At least 20 state legislatures have passed bills or are considering measures that would ban businesses and state and local governments from placing restrictions on unvaccinated people. Even so, some colleges, concert venues and employers have already started requiring Covid vaccinations.

But the expedited review process for Covid vaccines has been cited as a safety concern by some people yet to get vaccinated and as a legal hurdle for organizations that have hesitated to put a mandate in place.

Institutions that have put vaccine requirements in place have already faced lawsuits, with opponents arguing that the statute creating the emergency use authorization indicates people should have the option to refuse a treatment. One such lawsuit by health care workers at Houston Methodist was thrown out last month.

But with the new delta variant spreading and hospitals once again filling up, there is a renewed sense of urgency by public health officials to find ways to reach the nearly 1 in 3 eligible Americans who have yet to get their first dose. Pfizer, maker of the first vaccine authorized for emergency use in the United States, said Friday it expects the FDA to grant full approval by January 2022 at the latest. Acting FDA Commissioner Janet Woodcock has said a decision should come well before then.

Health officials said they believe vaccine requirements could be that last push for people who haven’t made getting vaccinated a priority or have been indifferent about needing it.

“Shame on us if we sit here in July and don’t do something to increase the vaccination rates and then we can’t open schools or have a situation where, God forbid, the economy takes another hit because businesses have to shut back down,” said Kathleen Sebelius, who served as health and human services secretary under President Barack Obama.

Biden’s administration has so far resisted any vaccine requirements, opting instead to offer incentives. But Slavitt said he expects that to change with full FDA approval.

He said he believes some federal agencies should then begin requiring vaccinations for their employees, including members of the military, health care workers at Veterans Affairs hospitals and nursing homes, and other federal workers in close contact with the public, like airport security screeners.

“I think every government agency ought to rethink what’s appropriate,” Slavitt said. “There are a number of people in surveys, by the way, who say precisely these words, ‘I’m not going to take it, unless it’s required.’”

White House press secretary Jen Psaki declined to say Friday whether the administration was considering making the vaccine a requirement for the military or the federal workforce. The federal government already requires members of the military to get certain vaccinations. Immigration applicants must also be vaccinated against a range of ailments.

It is unclear how much authority the Biden administration could have as far as requiring vaccinations beyond the federal workforce. No federal vaccination mandate has ever been tested in court and none has ever been issued for the general population. Instead, much of the power to require vaccinations has rested with state and local governments following a Supreme Court ruling in 1905 that upheld a city board of health law requiring all adults get vaccinated against smallpox.

Just a handful of major companies, businesses and venues have put in place any vaccine mandates so far. Delta Air Lines and United Airlines are among the few companies requiring new employees to get vaccinated, but the policy doesn’t apply to current employees.

Several other companies, like BlackRock, have said only vaccinated employees can return to the office but have yet to say what will happen with unvaccinated ones. Madison Square Garden and Yankee Stadium have both limited their events to vaccinated attendees, but many other venues have only encouraged guests to get vaccinated.

Even hospitals and nursing homes have been hesitant about making vaccines compulsory for employees. Among nursing home employees, the rate of vaccination is below that of the general population and in some states, including Florida and Georgia, the vaccination rate is under 50 percent for workers, according to data from the Centers for Medicare and Medicaid Services.

“I do think it is a responsibility of employers and others that have the ability to mandate it at their sites,” Zeke Emanuel, a health adviser in the Obama administration, said of requiring vaccines for health care workers. “It is not like it is easy, but this is a moment of leadership and sometimes when you are a leader, you have to do hard things.”

Hundreds of colleges have required students to be fully vaccinated against Covid before returning to campus, but it’s unclear how those mandates will be enforced and there has already been pushback, including lawsuits. A federal judge on Monday upheld Indiana University’s vaccine requirement. Most colleges already had vaccine requirements in place for other diseases.

Slavitt said one compromise employers could offer those who are firmly against getting vaccinated would be to requiring them to get tested several times a week.

Biden’s administration has been supportive of private companies putting vaccine requirements in place and his chief medical adviser, Dr. Anthony Fauci, said July 11 he believes there should be more vaccine mandates at the local level.

The Biden administration’s strategy has focused heavily on trying to make vaccinations more accessible, spreading information about the vaccines and warning about the risks of not getting the shots.

“We know that some employers, hospitals, health systems, colleges, universities and local leaders have chosen to take this step, and we expect others to do so as well,” Psaki said regarding vaccine requirements. “But our role we’re playing from here is continuing to go community by community, person to person, making sure we are meeting people where they are to get the vaccine out.”

Last week the White House turned to the pop star Olivia Rodrigo to try to reach younger people, who have the lowest vaccination rates. The surgeon general also released a report on the influence that misinformation on social media has had on vaccination efforts. Biden said Friday that those social media platforms, including Facebook, were “killing people” by allowing lies about the Covid vaccines to spread on their websitesHewalked back the criticism Monday, saying those posting the false information were to blame.

The rate of vaccinations has fallen by half since June 1, when the administration declared a “month of action” to redouble efforts as the delta variant spread. By the end of last week, new cases had risen 70 percent over the past seven days with the bulk of infections in four states with relatively low vaccination rates, and the number of deaths had increased by 26 percent to 211 a day, according to the CDC.

“We’ve got a chance to really continue the progress, the incredible progress that’s been made since January,” Sebelius said. “But we also have some real warning signs across the world that we should pay close attention to.”

Report: Only 5% Of Hospitals Fully Compliant With Controversial Price Transparency Rule

Report: Only 5% of hospitals fully compliant with controversial price  transparency rule | FierceHealthcare

Source: Fierce Healthcare, by Robert King

A new analysis found only 5.6% of hospitals were fully compliant with a major price transparency rule, with most failures centered on not posting payer-negotiated prices.

The analysis released Friday by the group PatientRightsAdvocate.org is the latest evidence of widespread noncompliance with the rule, which went into effect back in January.

“These findings align with previous research indicating that hospitals are undermining the rule with incomplete information, burdensome access restrictions, code to block prices from being displayed on search engines and tools to obfuscate access to mobile app developers and to patients,” the analysis said.

Another problem has been price estimator tools that don’t enable meaningful accessible comparison of discounted cash prices, researchers said.

The group examined a random sample of 500 hospital websites out of the roughly 6,000 facilities subjected to the rule’s requirements.

Only 5.6% of the websites were compliant with all the rule’s requirements. It found that 471 facilities did not post a complete machine-readable file of standard charges.

A large majority (80.6%) of hospitals did not publish payer-specific negotiated charges that were clearly associated with each payer and plan, a controversial requirement of the rule. It found that 258 hospitals (51.6%) didn’t publish any negotiated rates at all and 198 hospitals (39.6%) didn’t publish any discounted cash prices.

The rule required hospitals to also publish 300 shoppable healthcare services in a list or an estimator tool. The group found that 96 hospitals presented them in a “consumer-friendly display for customary charges. However, a significant number of these hospitals presented incomplete data fields and were therefore noncompliant.

There were 378 hospitals that posted a price estimator tool. However, the tools were inconsistent and limited researchers’ ability to determine if the tool was compliant with the rule.

The analysis is the latest finding that many hospitals are not complying with the new rule. A study published last month found that 83 out of 100 randomly sampled hospitals were not compliant with the regulation.

The Centers for Medicare & Medicaid Services has sent out warnings to some hospitals for noncompliance. There is a $300-per-day penalty for hospitals for each day they aren’t fully following the regulation.

But the analysis posits that the penalty is nowhere near enough.

“Scaling the penalty to $300 per hospital per bed per day and robustly enforcing the rule will result in a meaningful financial incentive for hospitals to comply, while providing proportional fairness to smaller and rural hospitals,” the group said.

PatientRightsAdvocate.org also wants CMS to scrap the requirement for a price estimator tool and instead require hospitals to provide “guaranteed price quotes.”

GOP Joins Dems In Taking On Big Pharma

GOP joins Dems in taking on Big Pharma

Source: Axios, by Hans Nichols

Senators working to keep the bipartisan infrastructure deal alive are zeroing in on Medicare prescription drug rebate formulas to offset up to $60 billion of the $1.2 trillion package, people familiar with the matter tell Axios.

Why it matters: Targeting those funds puts the bipartisan infrastructure plan in competition with the $3.5 trillion, Democrat-only plan proposed by Sen. Bernie Sanders (I.-Vt.). It also assumes new money from altering complicated prescription drug formulas.

  • * Bipartisan negotiators are looking at drug payments after Republicans backtracked on additional funding for the IRS, a move that would have raised an estimated $60 billion.
  • * One source familiar with the negotiations cautioned that the final amount could be less than the $60 billion the bipartisan group thinks it can get from stepped-up IRS enforcement.
  • * A conservative group, led by Marc Short, chief of staff for former Vice President Mike Pence, targeted GOP lawmakers for considering adding financing to IRS enforcement efforts. It’s now dead in the bipartisan talks.
  • * Democrats plan to revive it in their reconciliation package and seek an $80 billion IRS boost.

Driving the news: Senate Majority Leader Chuck Schumer (D-N.Y.) plans to force a preliminary vote on the bipartisan package Wednesday, but the so-called Group of 20 behind the measure is struggling with how to pay for their “hard” infrastructure plans.

  • * “We’re competing with their $3.5-trillion plan. They want everything reasonable on their side, not helping us,” Sen. Bill Cassidy (R-La.) said, referring to Sanders’ plan, on “Fox News Sunday.”
  • * “I just don’t know how you have a cloture vote when you don’t have the bill written, when you don’t have the pay-fors established,” said Cassidy.

The big picture: Both the bipartisan bill and the $3.5 trillion reconciliation bill face significant obstacles.

  • * The first would fund traditional infrastructure like roads and bridges; the second is focused on what Democrats call “human infrastructure,” including money for universal preschool, free community college and medical care.
  • * Democrats have no margin for error in the Senate, and key centrists, like Sens. Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.), haven’t publicly endorsed the $3.5 trillion cost of the reconciliation bill.
  • * Republicans in the G20 who say they support the bipartisan deal, which includes $579 billion in new money for traditional infrastructure, could get cold feet if the Democrat-only bill gets too big. Their concern: too much spending in one year.

Go deeper: Sanders is looking at prescription drug formulas for two pots of money, which he expects will raise more than $600 billion, Axios reported last Thursday.

  • * Roughly $500 billion will come from forcing pharmaceutical companies to negotiate their drug prices directly with Medicare.
  • * And additional money — estimated at between $10 and $20 billion per year — could be counted if the Biden administration never implements changes proposed by the Trump administration.
  • * They would alter payments from drugmakers to pharmacy middlemen.

CMS Proposes Extension Of Medicare Telehealth Coverage

Medicare and Telehealth: Coverage and Use During the COVID-19 Pandemic and  Options for the Future | KFF

Source: Healthcare Dive, by Shannon Muchmore

CMS is proposing to extend Medicare coverage of certain telehealth services granted for the COVID-19 public health emergency to the end of 2023 to help gather data that can determine whether the services should be permanently covered.

The agency similarly suggested allowing for some mental healthcare to be provided on an audio-only basis going forward in the proposed Physician Fee Schedule for 2022, released Tuesday. The annual rulemaking also includes changes to the Quality Payment Program and seeks feedback on how to improve data gathering from providers in an effort to better health equity.

“Over the past year, the public health emergency has highlighted the disparities in the U.S. health care system, while at the same time demonstrating the positive impact of innovative policies to reduce these disparities,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “CMS aims to take the lessons learned during this time and move forward toward a system where no patient is left out and everyone has access to comprehensive quality health services.”

But provider groups were not happy with the payment adjustment included — a 3.75% reduction to the conversion factor, due to budget neutrality requirements. The Medical Group Management Association, which represents physician practices, said in a statement that it would seek congressional intervention to avoid the cut.

Industry lobbies were pleased, however, the proposed rule delays enforcement of the Appropriate Use Criteria program, which requires providers to use clinical decision support mechanisms when ordering certain advanced diagnostic imaging.

The requirement was set to go into effect in January but has now been extended for a year. The American Hospital Association said the change, “will enable hospitals and other providers to maintain their ongoing response to the COVID-19 crisis while allowing essential education and operations testing of the AUC program to occur.”

Groups representing accountable care organizations, meanwhile, applauded another delay, wherein CMS proposed waiting on a transition in the Medicare Shared Savings Program to electronic quality measure reporting.

The agency said in a fact sheet on the PFS that the temporary extension of Medicare telehealth coverage is meant to serve as a “glide path to evaluate whether the services should be permanently added to the telehealth list following the COVID-19 PHE.”

Lawmakers, patient advocates and many industry groups have said they support permanently adding many of the services to the coverage list, but CMS said it wants more information on their efficacy. The agency declined some proposals for permanent coverage as not meeting the criteria on the books.

“We view the draft rule as a modest positive for telehealth stakeholders; however, we continue to believe bigger impact changes will require additional legislation,” Cowen analysts wrote in a Tuesday note on the rule.

Telehealth use has declined as people have received vaccinations and felt more comfortable going into a doctors office, but visit rates are still much higher than before the pandemic. Most stakeholders expect that to hold.

The rule would put into effect a law that removes geographic restrictions for diagnosis, evaluation or treatment of a mental health disorder and allows a patient’s home to serve as an originating site for a telehealth visit. It places some restrictions, however, including a requirement that the patient had an in-person visit some time within six months before the virtual visit.

Patient advocates and some providers may see this as too restrictive, citing the potential loss of access to care.

The proposed overhaul of the QPP includes the introduction of Merit-based Incentive Payment System Value Pathways for the 2023 MIPS performance year and the end of traditional MIPS at the end of the 2027 performance year.

Also, subgroup reporting would be allowed in an effort to provide “more comprehensive and granular” data sets. And clinical social workers and certified nurse-midwives would be added to the list of clinicians eligible for the program.

The initial set of MVP clinical areas would be: rheumatology, stroke care and prevention, heart disease, chronic disease management, lower extremity joint repair (e.g., knee replacement), emergency medicine and anesthesia.

CMS said the changes should allow clinicians to see “greater returns on their investment in the program as we see higher payment adjustments as well as begin to see a more equitable distribution within our scoring system and small practices no longer bearing the greatest share of the negative payment adjustments.”

For health equity data collection, CMS could give providers confidential reports with data points including race, disability, rural populations and LGBT status. This information would support initiatives to close equity gaps and allow providers to identify disparities, the agency said.

Biden’s July Executive Order Includes Drug Pricing Provisions. But Will They Do Enough?

Biden's July Executive Order Includes Drug Pricing Provisions. But Will  They Do Enough? | Kaiser Health NewsSource: Kaiser Health News, by Victoria Knight

President Joe Biden’s executive order of July 9 included various steps toward making good on campaign promises to take on pharmaceutical companies by allowing the importation of prescription drugs and curbing the high cost of medicines.

These issues were key to candidate Biden’s 2020 health care platform, which stated he would “stand up to abuse of power” by drugmakers. Biden promised on his campaign website that he would allow consumers to buy prescription drugs from other countries, as long as the Department of Health and Human Services deemed it safe. In speeches, candidate Biden also pledged to bring down drug costs by 60%.

Nearly six months into his term, Biden issued an executive order on promoting economic competition, which included moves toward fulfilling these promises.

KHN has teamed up with our partners at PolitiFact to analyze Biden’s promises during the 2020 presidential campaign — and, so far, experts generally say the jury is still out on how meaningful these efforts will be.

Drug Importation

The July 9 executive order directed the Food and Drug Administration commissioner to work with states to develop a program allowing prescription medications to be brought in from other countries, particularly Canada.

However, several drug pricing experts told us that, of all the policy ideas aimed at reducing the cost of drugs, importation seems the least likely to happen.

“Other countries are not interested in facilitating this,” said Benedic Ippolito, a senior fellow in economic policy studies at the American Enterprise Institute.

Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy, agreed.

“This policy is unlikely to ever work as intended because Canada is unlikely to allow the export of drugs to the United States,” Fiedler wrote in an email.

That’s because drug manufacturers would then probably demand higher prices in Canada, since those would become the de facto U.S. prices, he said. “That would cause a big increase in prices in Canada that Canada likely wishes to avoid.”

This is not the first time a president has suggested importing drugs, notably from Canada. President Donald Trump put forward the same idea during his time in office. Democrats and Republicans alike have supported similar proposals.

During the Trump administration, a rule was finalized allowing states to seek the FDA’s permission to import drugs. Several states then passed laws to that end, but Florida is the only state to have formally applied to the FDA. The agency has yet to make a decision on the request.

The Pharmaceutical Research and Manufacturers of America, the trade industry group representing major pharmaceutical companies, sued HHS in 2020 in an attempt to get this drug importation rule overturned. The litigation is ongoing, though the Biden administration has asked for the case to be dismissed.

In a May court filing, the administration argued the case was pointless because it’s unclear whether any state importation plan would be approved anytime soon.

Canada has signaled its concern that exporting drugs to the U.S. could trigger shortages within its borders, and after the Trump-era rule was finalized, the country moved to block bulk exports of medications in short supply.

Still, Rachel Sachs, a law professor and drug pricing expert at Washington University in St. Louis, said Biden’s “rehabbed” policy isn’t a bad thing.

“Drug pricing has been a big problem for several years now, and there are many policy ideas on the table. We don’t lack for policy ideas — we lack for actual implementation of those ideas,” Sachs wrote in an email. “So I don’t think it’s concerning at all if the administration chooses to advance existing policy ideas rather than developing new ones from scratch.”

It’s also important to remember that Biden has just released an executive order directing that these things happen. It is just a first step in a long line of steps, including issuing rules and allowing time for public comment.

That means details of how this importation policy would work are not yet available. The executive order calls for a report to be issued 45 days afterward with a plan outlining specific efforts to reduce prescription drug prices.

“I assume we’ll know more then,” Sachs said.

The High Cost of Drugs

On this pledge, the recent executive order outlined the president’s vision for how to proceed.

The order included an initiative designed to shore up the approval framework for generic drugs and biosimilars, working with the Federal Trade Commission to address efforts to impede competition for these types of drugs and help Medicare and Medicaid incorporate new payment models to cover them.

Experts so far have offered measured reactions.

The administrative actions outlined in this executive order do have the potential to reduce prescription drug prices, said Fiedler of the USC-Brookings Schaeffer Initiative. But it depends on more than just what the order says.

“In each of these areas, whether prices actually fall will depend on the details of the proposals the administration ultimately puts forward,” Fiedler wrote in an email. “However, these are all areas where there are opportunities to make changes that would have a meaningful impact.”

Again, more will be known in 45 days, the deadline for the release of the plan to reduce prescription drug prices.

It’s important to note that the FTC is an independent agency, so Biden’s principal means of influencing drug policy comes from his appointments to the agency, said Fiedler. It does seem likely, though, he added, that the newly appointed FTC chair would be sympathetic to cracking down on market conduct that delays the entry of generic drugs or biosimilars.

Still, reducing drug prices by 60% would require legislation, said the AEI’s Ippolito.

“And the most disruptive drug pricing reforms — those that could even sniff that kind of price reduction — are also the most unlikely to pass,” Ippolito wrote in an email. “In short, I suspect that this executive order isn’t going to make much headway.”

Trump also promised last year on the campaign trail that he would lower drug prices by 60%, after repeatedly promising to reduce medication costs during his four years in office. However, little progress was made toward that goal despite several related executive orders in 2020.

While Biden’s executive order has a different focus than most of the Trump-era drug pricing orders, the Biden administration has signaled it may still be open to embracing some of those policies.

Trump’s directives focused on rebates paid to pharmacy benefit managers being rerouted to beneficiaries, reducing the cost of insulin by compelling federally qualified health centers to make the drugs available at low prices to low-income people, importing drugs from Canada and tying drug prices to the prices paid in other countries.

Three proposed rules that resulted from Trump’s orders are being kept around by the Biden administration — at least for the time being. One is the “Most Favored Nation Model.” This rule is supposed to match U.S. prices for certain classes of drugs with the lower amounts paid in countries that negotiate drug prices.

According to Politico, the Biden administration’s regulatory office received the rule this month, which means there may be a new public comment period before the rule is finalized — though it’s likely this would take some time.

And, of course, there’s the pending Trump administration rule on drug importation, currently tied up in court.

Trump’s rebate rule, meanwhile, has also been delayed. The Biden administration pushed back its effective date to January 2023. Freezing the rule was part of the Biden administration’s policy to review any rules finalized in the final months of Trump’s term.

No other Trump drug pricing efforts made much headway. Instead, they drew a fair amount of industry pushback.

And it remains to be seen whether Biden’s directives will fare any better.

Experts agreed that most likely congressional action would be needed to achieve a 60% reduction in prices. With over three years left in Biden’s term, who knows what could still happen?

For now, we rate these promises “In the Works.”

Newsom Promised Big On California Health Care. Where Do His Bold Plans Stand Now?

Noelle Tuominen helps Eleanor, 4, test her blood glucose levels at their Livermore home. Eleanor, who was diagnosed with type 1 diabetes at one year old has been doing her own finger pricks since the age of two. (Anne Wernikoff — CalMatters)

Source: CalMatters, by Ana B. Ibarra

Early in his term, Gov. Gavin Newsom positioned himself as the governor who would champion health care. He vowed to target rising prescription drug costs and find a way for the state to pay for care for all Californians, a key campaign promise. He also set a goal of creating a blueprint to better serve the Golden State’s growing population of seniors.

But two and a half years after taking office and still struggling to control a pandemic, the governor has had to focus much of his attention on COVID-19, so timelines for other health efforts have been pushed back.

Two of Newsom’s boldest health care promises — affordable medications and universal, state-funded health care — have made little progress during his term. And a third — a master plan for seniors — has been drafted yet actions will be phased in over the next 10 years. So enacting each of them in some form will likely come after Newsom’s term ends — even if he isn’t recalled in September.

Health advocates and experts praise the efforts, but some are less convinced that Newsom can deliver on mammoth goals like creating a state-funded, single-payer health system.

“It’s important not to lose sight of some historic steps taken in expanding coverage,” said Thad Kousser, a political science professor at UC San Diego. “But to be clear he campaigned on a single-payer pledge that a lot of people didn’t think was realistic, and I think the last few years have shown us that it will be incredibly hard to achieve.”

Even before the pandemic, the governor acknowledged that full-fledged plans for reforming health care would take years.

His team says the work is ongoing, pointing to the billions of dollars in this year’s budget to expand health coverage and services. “Governor Newsom is working in partnership with the Legislature to make health care more affordable and accessible for all Californians — regardless of their age, immigration status, or income,” a spokesperson for the governor’s office told CalMatters in an email.

“I’ve only seen prices go up”

Newsom has often claimed California is leading the fight against prescription drug prices.

But drug prices are still rising. Last year, drug manufacturers reported price increases of more than 16% on more than 1,200 prescription drugs to state regulators.

Noelle Tuominen and her husband, Richard Pollari, of Livermore know personally about the high cost of medications because they have two children with Type 1 diabetes — their second-born was just diagnosed a few weeks ago.

The list price for ther daughter Eleanor’s insulin, Eli Lilly & Co.’s Humalog, is $274.70 per vial. Some Type 1 diabetics can go through two or three vials per month — although younger patients may need less. What a person ends up paying depends on their insurance.

Tuominen is grateful her family has good health insurance so last year they paid just $600 in co-pays for their daughter’s insulin. But in total, they spent about $17,000 on health care costs last year.

Her daughter, now 4, was diagnosed when she was 1. “It was a shock. We went to the ICU and ended up with a hefty hospital bill,” Tuominen said.

Now money that could be going to her kids’ college fund is going to an insulin fund — a backup plan in case her family is ever without health insurance. She said the pandemic taught her family that job security and the insurance that comes with it is never a guarantee.

“It’s very easy to say we’re going to tackle it, but harder to see action behind it,” Tuominen said of the promises around reducing health care costs. “Every day someone is getting diagnosed and every day someone has a new bill they need to cover to keep their child alive.”

Annemarie Gibson in San Diego has two sons, 11 and 13, also on the drug Humalog. She pays about $200 a month for their insulin, although she has to first pay a $2,900 per-person deductible before coverage kicks in.

“We started in 2011… and since then I haven’t seen any improvement. I’ve only seen prices go up,” Gibson said. She worries that when her sons age out of their parents’ insurance, they could have a hard time affording their insulin.

“You hear a lot about young adults who are on their own for the first time, they can’t afford their prescription and unsuccessfully ration their insulin,” she said.

About three in 10 adults reported not taking their medications as prescribed at some point in the past year because of the cost, according to a recent Kaiser Family Foundation survey.

But going after pharmaceutical companies during a pandemic could prove to be risky. “This is probably not the right political moment to be bashing drug companies…when vaccines have been so central to the state’s recovery to Covid,” Kousser at UC San Diego said.

Last year, Newsom signed a bill by Sen. Richard Pan, a Sacramento Democrat, that allows the state to take the first steps in creating state-run generics. The state would partner with manufacturers to make or distribute less expensive generic drugs, including one form of insulin, that would be widely available.

“It’s quite feasible. California is big enough that it can do this. But it’s still going to be hard,” said Geoffrey Joyce, director of health policy at the University of Southern California Schaeffer Center.

It will likely be several years before California makes any of its own generic drugs because many steps must be taken first, such as researching manufacturers and approving funding. An initial report on which drugs the state could target first is due next summer.

“We’ve started some important efforts; they haven’t necessarily yielded their full fruit yet,” said Anthony Wright, executive director of Health Access, a Sacramento-based consumer advocacy group that supported Pan’s bill.

The savings that could be passed on to consumers would likely be modest because the generics industry is already fiercely competitive, Joyce said. In the U.S., “nine out of 10 prescriptions filled are generics, but generics only make about 22% of overall drug spending,” he said.

In the meantime, “one thing the state can do is educate people on where to get the cheapest drugs, or say ‘we’ll pay your Costco membership fee to get the best prices until generics in California are up and running,’” he said. One recent USC study found that the federal government in 2018 overpaid by about $2.6 billion for generic drugs compared to what Costco members paid.

Rather than trying to lower drug prices, other states have limited what people pay out of pocket. In 2019, Colorado became the first state to cap insulin copays at $100 a month. Fifteen other states have followed suit with some type of co-pay cap on insulin. In California, two current bills aim to prohibit health plans from imposing a deductible on certain prescription drugs — one bill addresses insulin specifically and a second bill targets prescription drugs for some chronic diseases.

Newsom also issued an executive order on his first day in office directing the state to transition all Medi-Cal pharmacy services from a managed care system, in which the state pays health plans an annual fee for each person covered, to fee-for-service, where the state pays for each service provided. That move was expected to result in $612 million in savings for the state in fiscal year 2021-22.

But that transition, first slated for January of this year, has been delayed.

Where are we on universal health care?

Newsom’s boldest and most controversial promise was to push for government-funded health care for all Californians.

In 2019, Newsom established a Healthy California for All Commission, tasked with figuring out how to get the state closer to universal coverage, including the possibility of a single-payer system. In a single payer system, the government pays for all or most health costs, like in Taiwan and Canada.

Because of the pandemic, the commission postponed several of its meetings last year, pushing back its original timetable. It started meeting again more regularly this year.

Experts say California can get closer to covering everyone by continuing to remove eligibility and affordability barriers. In the most recent budget, for example, Newsom approved opening full-scope Medi-Cal to undocumented Californians 50 and older and agreed to remove what is known as the Medi-Cal asset test, which often forced seniors and people with disabilities to spend down their savings to qualify for free or low-cost coverage. Those two moves alone would allow approximately 250,000 more Californians to get covered.

But some of Newsom’s strongest supporters are holding him to the more ambitious goal of creating one state-funded health plan for everyone.

“We now have a willing federal partner, we have AB 1400, we have this commission, we can act now,” said Stephanie Roberson, government relations director for the California Nurses Association, one of the biggest proponents of single-payer health care.

Assemblymember Ash Kalra, a Democrat from San Jose, pulled AB 1400 or CalCare, which would create the framework for state-paid health care, from consideration earlier this year to iron out financing details.

The bill will be back next year. But the overarching question of how to pay for it has yet to be answered. A single-payer bill that was killed in 2017 carried a $400 billion price tag.

The commission is also exploring other options to pay for the program, including new taxes.

Although some members have expressed concern about the political pushback that comes with new taxes.

“Sometimes in these groups everyone says, ‘oh yeah, no problem it should be easy to get Democrats or progressives to vote for taxes,’ but this is also the land of Prop. 13. If you want to stay an elected official, you’ve got to think carefully about imposing taxes on people,” Pan, who serves on the commission,  said at a recent virtual meeting.

While rolling out such a program would be costly at first, University of California researchers found that single-payer systems could save the U.S. money as soon as the first year of operation — with an average drop of 3.5% in total health care spending. Costs would continue to drop over time and the largest savings would come from lower administrative costs and reduced drug costs, according to their review of 22 single-payer strategies.

What California can accomplish isn’t just tied to money and political will. The state also would have to secure waivers to bypass federal rules and get flexibility on how to spend federal dollars. In May, Newsom made the initial ask in a letter to President Joe Biden.

“The big determinant of whether Sacramento will be able to move on single payer is who is in charge in Washington, DC,” Kousser said. “It probably would have taken a Bernie Sanders victory for any state to move forward. Trump would actively block it, but Joe Biden won’t actively encourage it.”

A ‘master plan’ for older Californians

Before the pandemic, Newsom recognized the state was falling short of meeting the needs of its 65 and older population, which is expected to grow by 4 million people by 2030. In mid-2019, he ordered the creation of a blueprint that would set targets to make California more “age friendly.”

The state unveiled its Master Plan for Aging in January with goals around housing affordability, health care, caregiving and economic security. But the work to meet its goals is just beginning. The plan comes with a scorecard that will track the state’s progress over the next 10 years.

Aging advocates say the state’s goals have become more important than ever after a pandemic most dangerous to seniors. Almost three-quarters of all California’s COVID-19 deaths were among residents 65 and older. The master plan comes with recommendations to redesign nursing homes, noting that their residents made up a third of all pandemic deaths.

This year’s state budget allocates $3.3 million to roll out the plan. Separately, the budget also includes boosts in nutrition and food assistance programs for older Californians, and permanently restores a 7% cut in hours for Medi-Cal’s in-home supportive services that aid seniors and people with disabilities.

“The best news about progress in the master plan is that this new budget includes significant new investments in aging, health care and long-term care programs that are really going to help us move faster,” said Kevin Prindiville, executive director at Justice in Aging, who serves on one of the plan’s committees.

One big win is $805 million to renovate and expand residential care facilities for seniors who  have been homeless or are at risk of homelessness, he said.

Budget dollars, however, are a mix of ongoing and one-time funding, which means that in tougher economic times, it could be difficult to retain the money needed to build these programs.

“This will require ongoing work to make sure the funding is there in the future,” Prindiville said. “But we’re definitely on an on-ramp and this budget gives us real momentum to build out these systems.”

California ‘Epsilon’ Strain Of COVID-19 Could Evade Vaccines, Study Says

California's coronavirus strain looks increasingly dangerous - Los Angeles  Times

Source: New York Post, by Natalie O’Neill

A new study has found that COVID-19 vaccines may be somewhat vulnerable to the California “Epsilon” strain of virus.

The variant has three spike protein mutations it uses to weaken current vaccines by up to 70 percent, according to researchers from University of Washington and the San Fransisco-based lab Vir Biotechnology.

The strain’s mutations break down neutralized antibodies, which are produced by vaccines such as Pfizer and Moderna and protect against infection, according to the study, published in the journal Science on July 1.

The spike mutations may also be able to side-step the naturally produced antibodies a person forms after being infected with the coronavirus, according to the report.

The effectiveness of current shots could be reduced by 50 to 70 percent against the strain, which was first found in May 2020, according to the study.

During a probe of one of the spike proteins, the researchers found the mutation weakened 14 out of 34 of the vaccine-safe neutralizing antibodies, according to sciencedaily.com.

Overall, roughly 97 percent of the 49,221 cases of the variant — also known as the  B.1.427 and B.1.429 strains  — reported worldwide have been in the US, with over half in California.

Meanwhile, the Delta strain, which was first detected in India, became the most dominant strain of coronavirus in the world Wednesday, according to the Centers for Disease Control and Prevention.

The strain makes up more than half of all new cases in the U.S. and is the second-most dominant variant in New York City.

U.S. Officials Say Fully Vaccinated Don’t Need Booster

Fully vaccinated people don't need Covid boosters, U.S. health agencies say

Source: Reuters, by Eric Beech

U.S. health officials, after meeting with vaccine maker Pfizer PFE.N>, reiterated on Monday that Americans who have been fully vaccinated do not need to get a booster shot, a spokesperson for the Health and Human Services Department said.

Pfizer said last week it planned to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine, based on evidence of greater risk of infection six months after inoculation and the spread of the highly contagious Delta variant.

HHS officials had a briefing from Pfizer on Monday regarding their latest, preliminary data on vaccinations and will continue to discuss when and if booster shots will be needed in the future, the spokesperson said.

Pfizer said it planned to publish “more definitive data” in a peer-reviewed journal.

“Both Pfizer and the U.S. government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow,” said Pfizer spokesperson Sharon Castillo.

The spread of the Delta variant, first detected in India and now the dominant form of new coronavirus infections in many countries, has raised concerns over whether available vaccines offer enough protection. Several experts say a booster shot would be warranted if there is a substantial increase in hospitalizations or deaths among vaccinated people. read more

For its part, the World Health Organization said on Monday that rich countries should not order booster shots for their vaccinated populations while other countries have yet to receive COVID-19 vaccines. read more

What Is the Great Resignation of 2021? (If You Don’t Know, You’ll Want to Read This)

Why The 'Great Resignation' Is Greatly Exaggerated

Source: Foundation for Economic Education, by Hannah Cox

If you don’t spend your days on TikTok or Reddit, you may be blissfully unaware of a growing movement urging people to quit their jobs en masse this fall.

It’s called “The Great Resignation of 2021,” and for businesses already struggling to attract workers back to the office it could spell very bad news.

The social media trend coincides with broader disruptions in the labor market. Monster, a global employment website, recently reported 95 percent of employees are considering changing jobs. This is on top of the 4 million people who already followed through and resigned in April.

The country’s labor market is in a precarious position. The policies of the pandemic spurred the sharpest economic contraction in US history, millions lost their jobs and are still out of work, and yet businesses have been unable to fill their open positions.

On top of all this, reports indicate employers may soon face more disruption from what is being described as “the Great Resignation,” as millions of workers prepare to say, “I quit.”

According to TikTok user @Katieyowyow, a recruiter with over 300,000 followers on the platform, as many as 1 in 4 employees are planning to leave their job this fall. These employees, she says, intend to spend the summer months using their vacation days and enjoying the benefits of full-time employment before they jump ship and turn in their notice in autumn.

Daniel Zhao, a labor economist with the employment website Glassdoor said, “We haven’t seen anything quite like the situation we have today.”

Why is this happening? A multitude of reasons. Large numbers of Americans transitioned to working from home last year, and now that they’ve enjoyed the quality of life increase that remote work brings they are unwilling to return to the monotony of a desk-job. Lots of managers have announced plans to bring employees back to the office this fall, and it seems many people are simply unwilling to do so. And given the plethora of open jobs at the moment, the best workers have their pick of employment.

Other workers used their down time during the pandemic to develop new skills or passions, and now they want to find roles that allow them to incorporate those interests into their day to day lives. Some are seeking roles that require less of their time out of a desire to allocate more time to their families or children. And then there are those who simply just don’t want to work.

Jeremy Golembiewski is one example of a worker who has already taken the plunge. The 26-year veteran of the restaurant industry realized just how much of his children’s childhood he was missing while he was furloughed over the pandemic. He decided it was no longer acceptable to spend so much time away from them and quit his job in search of a more steady schedule and a 40 hour work week.

Angel Perkins is another case in point. She resigned her role as a recruiter during the pandemic over health concerns, and in the meantime she launched an online jewelry business. She quickly replaced her income and found the financial and time freedom her old work would not afford.

The reality is it’s an employee’s market. There’s never been a better time to job hunt. The Labor Department recently reported 9.3 million job openings and there are hiring signs everywhere you look.

Taking that into consideration, it makes sense that workers might be experiencing more freedom and confidence in the job market than usual—leading them to make bold career moves they would be less likely to take under other circumstances.

And there’s nothing wrong with that. Good employees should seek the greatest quality of life, highest pay, and the ability to spend their time on work they find meaningful. Those are strong incentives in a free market that encourage a good work ethic, innovation, and efficiency.

What this means is that employers will have to compete with attractive incentives to earn the placement of the best employees, or even to fill openings in general. Much of this can be seen in a favorable light. Competition is a good thing, and market incentives that encourage employers to offer better working arrangements create a better quality of life for all (and higher productivity in general).

Unfortunately, though, trends like “The Great Resignation” are far from being fueled by market incentives and demands alone. Rather, they are the repercussion of bad, big government policies that have severely tampered with the market for the past year.

The federal government has continued to send an increased amount of unemployment benefits to workers, even as the businesses they shut down struggle to open back up. Workers are responding to this perverse incentive in entirely predictable ways, choosing to stay home or work less—often for more pay than they were able to earn in the workforce—for an extended period of time.

Obviously, without the guarantee of a cushy taxpayer-funded unemployment payment, many of these employees would not have the luxury of simply quitting their jobs. They would have to increase their value if they wanted to demand new working arrangements on the market, or build their way into new career paths while still holding down employment in the meantime.

The Stanford Encyclopedia of Philosophy paraphrased a quote of F.A. Hayek’s like this, “no one can decide that people won’t respond in predictable ways to perverse incentives unintentionally created by a central plan, in the same way that no one can decide that insects will not become resistant to an insecticide.”

Central planners were warned that these kinds of problems would result from their policies, and yet they persisted anyway. As a result, it is likely we will all continue to see supply shortages and an increase in the price of goods and services.

Last Updated 07/21/2021

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