In The News

Fighting Current and Future Coronaviruses with a Single Vaccine

National Institutes of Health / By Sharon Reynolds

Vaccines against SARS-CoV-2, the virus that causes COVID-19, have greatly reduced the risk of severe disease and death. However, SARS-CoV-2 continues to mutate in unpredictable ways that can reduce the effectiveness of the current vaccines. The risk of a new coronavirus spilling over from animals to people also remains a serious concern.

Researchers are trying to produce a vaccine that would protect people from both future SARS-CoV-2 variants and related coronaviruses that might pose a threat. To this end, an NIH-funded team led by Dr. Pamela Bjorkman from the California Institute of Technology created a nanoparticle-based vaccine that prompts B cells, which produce antibodies, to recognize parts of coronaviruses that mutate less often.

Current COVID-19 vaccines target parts of the SARS-CoV-2 virus that quickly mutate. Like those, the nanoparticles in the investigational vaccine display a part of the coronavirus spike protein called the receptor binding domain (RBD), which coronaviruses use to enter human cells.

However, the team combined RBDs from eight different coronaviruses for their vaccine. Each nanoparticle included 60 RBDs, so that any two adjacent RBDs were rarely from the same coronavirus. B cell receptors bind strongly to identical targets that are near each other. So, this design encouraged B cells to target areas that were similar across the RBDs—ones that tend to mutate more slowly.

The researchers tested the new vaccine, called mosaic-8, as well as a nanoparticle vaccine made only with RBDs of SARS-CoV-2. Results were published on August 5, 2022, in Science.

The team used mice that were engineered to make the human ACE2 protein—the target of the SARS-CoV-2 spike. Following vaccination with mosaic-8, the mice produced antibodies that recognized a range of coronaviruses. As expected, the antibodies recognized parts of the RBDs that remained similar between coronaviruses.

When challenged with SARS-CoV-2, mice that received either of the nanoparticle vaccines were protected against symptoms of severe COVID-19. However, only the mosaic-8 vaccine also protected mice against a related virus, SARS-CoV, which caused the SARS outbreak of 2003. This protection occurred even though SARS-CoV wasn’t part of the mosaic-8 nanoparticle.

Similar results were seen in non-human primates. Monkeys that received either the mosaic-8 nanoparticle or the SARS-CoV-2 nanoparticle were protected against severe COVID-19. But those that received the mosaic-8 vaccine were also protected against the SARS-CoV-2 Delta variant and SARS-CoV, neither of which were included in the vaccine.

“We can't predict which virus or viruses among the vast numbers in animals will evolve in the future to infect humans to cause another epidemic or pandemic,” Bjorkman says. “What we're trying to do is make an all-in-one vaccine protective against SARS-like [coronaviruses]. This sort of vaccine would also protect against current and future SARS-CoV-2 variants without the need for updating.”

The researchers are now preparing to test mosaic-8 in a human clinical trial.

 

Apply for APTACO's Young Leadership Scholar Program

We Want to Invest in YOU!

Deadline to Apply: Saturday, September 10, 2022

APTA Colorado is excited to continue the Young Leadership Scholar Program, intended to recruit and develop leadership within our newest members. The program will entail structured learning in the areas of leadership, professional development, strategic planning, project development, and APTA structure/governance. 

Who: Current APTA Colorado Members who are recent graduates from a PT or PTA program and currently licensed in Colorado. (Graduated within last year.) Up to one (1) PT and one (1) PTA will be selected for this program.

What: The PT and PTA Scholars will be provided with an APTA Board member mentor with whom they will work closely throughout the course of their one-year program. Training described above will also be provided. The Scholar will complete a capstone project to benefit APTA Colorado in the area of their choice.  A stipend (up to $1,500.00) is included with the scholar program to cover any of the following: APTA dues, travel to a National APTA event, and APTA Colorado Conference attendance. Attendance at the APTA Colorado annual conference as well as quarterly Board meetings will also be expected. Structure beyond these requirements will be delineated in partnership with the mentor and program facilitator. 

For more information & to apply, click here

 

APTA's 2022 Emerging Leader Award

APTA Colorado member, Dr. Cynthia Rauert, has been selected as a 2022 recipient of the APTA Emerging Leader Award!

The Emerging Leader Award was established to annually honor individuals who have demonstrated extraordinary service to the profession and APTA early in their careers. Here’s an excerpt of what APTA Colorado leadership had to say about Dr. Rauert's abilities and accomplishments: 

“Dr. Rauert serves APTA Colorado as the board Secretary and a first time Delegate for the Mile-High District. Dr. Rauert has also become an outstanding mentor to our first cohort of Colorado Early Professional Leadership Scholars. Within these roles she advocates for students, early career professionals, physical therapist assistants in Colorado and nationally. Her unique perspectives from her broad clinical practice and career background are instrumental in supporting APTA Colorado initiatives. Dr. Rauert has demonstrated her leadership skills for many years within the APTA in additional roles such as on the Communications & Public Relations Committee, as a Federal Advocacy Key Contact, within the APTA Colorado PAC, Mile High District Chair, Governmental Affairs Committee Member, Sunset Committee member, and many more.” 

Dr. Rauert is one of 32 members of APTA to merit this honor and will be recognized in the November issue of APTA Magazine. Congratulations, Dr. Rauert & thank you for all that you do! 

 

Here are 4 key Health Policy Items in the Inflation Reduction Act

Fierce Healthcare | By Robert King

The House passed on late Friday a sweeping healthcare, climate and taxes package that includes major reforms on drug prices and extends boosted Affordable Care Act subsidies through 2025.

But the sweeping Inflation Reduction Act, which now heads to President Joe Biden for his signature, could reshape many other aspects of the healthcare industry. It would give Medicare the power for the first time to negotiate a small subset of Part D and Part B drugs.

Here are four other health policy changes to look for in the bill:

  • Expands eligibility for low-income Part D subsidies. The bill expands who can qualify under the Low-Income Subsidy Program that helps meet Part D cost-sharing burdens like deductibles. Currently, a beneficiary qualifies for the program if they earn up to 135% of the federal poverty level and get partial benefits for 135% to 150% of the level. The law would expand full benefits to those who earn between 135% and 150%, according to an analysis from the Kaiser Family Foundation.
  • Gets rid of the cost sharing for adult vaccines for Medicare Part D. It also requires states to cover all vaccines for Medicaid and Children’s Health Insurance Program beneficiaries. The benefit though only applies to any vaccines that get cleared by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.
  • Delays the controversial Part D rebate rule, again. The Trump-era rule would get rid of the safe harbor for Part D rebates, leaving them open to prosecution under federal anti-kickback laws. The rule passed at the tail end of Trump’s term but has never gone into effect. The law would delay the rule from going into effect again into 2032.
  • Limits the premium growth on Medicare Part D to no more than six percent a year from 2024 through 2029. The cap on premium growth is intended to mitigate the impact of other changes to Part D, said Ryan Urgo, managing director of the policy practice at consulting firm Avalere Health. The legislation includes a $2,000 out-of-pocket cost cap on Part D drugs, spread out in installments for the beneficiary over a calendar year. Part D plans will also have to pick up more of the costs for spending in the catastrophic coverage phase, which a beneficiary reaches when their drug costs reach a certain level.

Experts say regulating the bill will have a big impact on providers, including those that rely heavily on reimbursements for Medicare Part B drugs. 

Some providers purchase their own products under a buy and bill model and then get reimbursed by Medicare for the average sales price of the Part B drug plus 4% for storage and handling costs. The problem is that model doesn’t work if Medicare will reimburse for a smaller negotiated rate, experts say.

“If you are buying high and getting paid low you are, in essence, underwater,” Urgo told Fierce Healthcare. “If you are buying a drug at $1,000 and the reimbursement under Medicare with [the negotiated price] is only $800 you are $200 in the red. To address that there is going to be a need for providers to purchase products at the [negotiated rate] as opposed to market prices.”

The Community Oncology Alliance has raised concerns about this potential change. 

“History has clearly documented that bluntly cutting Medicare payments like proposed in the reconciliation bill, will lead to cancer practice closures and consolidations,” said COA Executive Director Ted Okon in a statement back in July when the drug price reform text was introduced. 

Sen. John Barrasso, R-Wyoming, proposed an amendment to the bill that would have required drugmakers to rebate the government any excess costs above the negotiated prices. The amendment was not agreed to before the final passage earlier this month. 

 

Special Report — Complying with Wage and Hour Regulations

The SESCO Report July/August, 2022 (Part 1 of 3*)

Common Misconceptions and Compliance Issues

SESCO is available through a Professional Service Agreement or through a per diem fee to conduct a thorough Wage and Hour as well as HR and employment law audit. Contact SESCO to learn more about our Professional Service Agreement and services provided to clients in all industries across the country — [email protected] or 423-764-4127.

Salary Basis

To qualify for exemption from overtime, Administrative, Executive and Professional employees have to be paid at least $684 per week on a guaranteed basis. Note that the Outside Sales Exemption requires no guaranteed salary, more less minimum wage. The Computer Exemption requires at least $684 per week on a salaried basis or paid on an hourly basis at a rate not less than $27.63 per hour.

Misconception 1: If an employee is paid on a guaranteed salary basis of at least $684, regardless of duties, they are exempt from overtime. This is incorrect as to be exempt from overtime under the white-collar exemptions as noted, the employee must meet the duties test as set forth under each exemption by the FLSA and meet the salaried basis requirements.

Misconception 2: Nonexempt employees cannot be paid on a salaried basis. Nonexempt employees are simply required to receive overtime for hours worked in excess of 40 hours per week (federal basis) based on their regular rate of pay. They also must meet at least federal or state minimum wage requirements. As such, a nonexempt employee can be paid on a salaried basis, salary plus commission, commission only, hourly plus commission or other types of pay plans. As long as the employee receives on average for each hour worked minimum wage and receives time and one-half of their regular rate for hours in excess of 40 hours per week, the pay plan is compliant.

In computing the regular rate for overtime purposes, the regular rate is determined by totaling all monies earned for the given workweek (hourly/salary wages, commissions and bonuses, spiffs and other incentives). These total earnings are then divided by total hours worked. The additional half-time is calculated by multiplying the overtime hours times half-time of this regular rate.

Misconception 3: Under the salaried basis rule, we cannot deduct from the salary for any reason. An exempt employee's salary can be reduced for specific reasons. These include:

  • Deducting pay for violations of safety rules
  • Suspending an exempt employee for disciplinary reasons
  • Reducing pay, even on a partial day's absence for intermittent family and medical leave
  • When an exempt employee is out sick for the whole day and does not have any accrued or earned sick/leave/PTO time

Please note that the only time we can deduct from the salary in partial day's work is for intermittent family and medical leave. However, we can require the exempt salaried employee to utilize any earned, unused sick time/leave/PTO. Once exhausted, an exempt employee missing time in partial day increments must be paid for the full day.

If out of accrued/earned time, an employer can deduct in full-day increments for those reasons as noted above.

Misconception 4: We can make deductions from an exempt employee's salary while they are out for jury duty. An employer cannot make deductions from the pay of an exempt employee for absences caused by jury duty, attendance as a witness or a temporary military leave. However, an employer can offset fees received such as jury fees, witness fees or military pay for a particular week against the salary for that week.

Misconception 5: If an exempt employee is separated from the company, we must pay him/her for the full week of salary regardless of the number of days worked. An employer is not required to pay the full salary in the first or last week of employment if the employee does not work the full week. You are only required to pay the salary for the actual days worked.

Misconception 6: If we have exempt employees working more than 40 hours or performing extra duties and we pay them overtime or additional monies based on hours of work, they lose their exemption status. The only requirement for an exempt position's compensation is the guaranteed salary basis of $684 per week (less Outside Sales Exemption). An employer can provide additional monies based on hours worked, commissions based upon results, etc. without losing the exemption status.

*Tune-in next newsletter for Part 2 of 3

 
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