Tag: ACA

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults

What Does the CHIP “Fix” from Congress Break?

Breaking something else, seems like a poor way of fixing something.

But that seems to be the way that Congress chose to go with their short-term fix for CHIP – the Children’s Health Insurance Program.

Before leaving Washington for the holidays, Congress passed a stop-gap spending bill to keep CHIP and the rest of the government going.
Before leaving Washington for the holidays, Congress passed a stop-gap spending bill to keep CHIP and the rest of the government going.

Remember that instead of simply reauthorizing CHIP when it expired on September 30, as has been done with broad bipartisan support in the past, this Congress chose to let it expire. That has left several states freezing enrollment and sending warning letters to parents that their kids might soon lose their insurance.

Children’s Health Insurance Program

Do you even know what CHIP is?

The Children’s Health Insurance Program (CHIP) is an insurance program that covers 9 million kids in the United States. It also covers about 370,000 pregnant women.

Who has CHIP?

Lower and middle income families that don’t qualify for Medicaid, but don’t make enough money to buy their own, private insurance, have CHIP. And depending on how much a family makes, CHIP is either free, like Medicaid, or is partially subsidized.

Because CHIP is paid for with federal and state funds, most Republicans in Congress don’t want to reauthorize or extend the program unless it’s funding can be cut from somewhere else.

What Does the CHIP “Fix” from Congress Break?

Now instead of finally getting around to reauthorizing CHIP, Congress gave it some money as part of a stopgap spending bill that keeps the government going.

The problem? In addition to the simple fact that they likely didn’t give the program enough money to run for the planned six months – they gave it about half – there is an issue about where they got the money.

Some of the money came from a $750 million cut from the Prevention and Public Health Fund.

What is the Prevention and Public Health Fund?

“The Prevention Fund supports critical public health activities—including lead poisoning surveillance, vaccination initiatives and other programs—in every state and community across the country. Cutting this significant funding source would leave communities without the vital resources needed to keep children and families happy, healthy and safe.

It is even more alarming and contradictory that this cut will be used to provide very short-term funding for CHIP and community health centers. Our organizations are united in support of CHIP and community health centers, which are vital to improving children’s health. But losing the Prevention Fund would just create another hole in the public health support children need.”

Statement from Leading Public Health Groups: Using the Prevention Fund to help fund CHIP: A Serious Mistake

In addition to all of the other important programs that are supported by the Prevention and Public Health Fund, it has helped protect children by:

  • providing 40% of the total funding for the CDC’s immunization program, including Section 317 program funds that buy vaccines for underinsured children not eligible for VFC, and uninsured adults.
  • improving HPV vaccination coverage
  • developing school vaccination clinics
  • building local public health infrastructure (your county health department) that can detect, control, and prevent outbreaks of vaccine-preventable diseases.

Cutting these funds could once again could put vaccines on the “chopping block.”

The Section 317 Immunization Program was already slated for a big drop in President Trump’s FY 2018 Budget.

What happened the last time we saw big drops to funding for our immunization programs? When Ronald Reagan was President, federal support for vaccine programs reached a low point, as rates of children living in poverty and without health insurance increased.

It took the immunization action plan of President George HW Bush in 1991 to stop the measles outbreaks that resulted.

Are we headed in that direction? Will it be even worse now, considering that you will be adding that to kids that are already skipping or delaying some vaccines because their parents have been scared by anti-vaccine propaganda?

Current Status of CHIP

CHIP still needs to be reauthorized and fully funded.

Tragically, even with the temporary ‘fix,’ many states are still planning for the worst.

That’s probably a good idea, as the CHIP ‘fix’ only provided about 1/2 of the money that they needed to keep the program going, even temporarily.

“I do not think this is anywhere close to enough money,” Bruce Lesley, the president of First Focus, a child advocacy group, recently told the New York Times.

Others say it is too little too late.

“By failing to extend long-term funding for the Children’s Health Insurance Program (CHIP), Congress falls far short of the reassurance and relief families deserve. Instead, they will enter into a new year with no assurance that CHIP will continue to be there for them in the months ahead. What should be a time of comfort, celebration and reflection will instead be one of anxiety, fear and stress.

Congress also failed to fund the Maternal Infant, and Early Childhood Home Visiting Program (MIECHV), which serves at-risk pregnant women and parents with young children, and several other vital public health and safety net programs. The communities these programs serve already face uncertainty when it comes to their health care, which is now exacerbated by Congress’ failure to extend the programs long-term.”

Fernando Stein, MD, FAAP, President, American Academy of Pediatrics

What is going to happen to CHIP, the 9 million children on CHIP, and their families?

“Congress’ failure to extend CHIP funding long-term has resulted in a manufactured emergency that has real consequences for children, families and pregnant women. It doesn’t have to be this way. There is bipartisan policy ready to be passed right now to extend CHIP funding for five years. Both chambers of Congress support it; the only thing preventing it from passing is political will. Congress must take the opportunity to pass a five-year CHIP funding extension on a bill this week to fund the federal government.

Right now, the greatest threat to children’s health care coverage is congressional inaction.”

Statement of Leading Children’s Health, Medical and Advocacy Organizations: Short-Term CHIP Funding Falls Short for Children

Take action and tell Congress to #ExtendCHIP and to #PutKidsFirst. We want a five-year extension of CHIP without harmful offsets, especially any that could lead to fewer kids getting vaccinated and protected against vaccine-preventable diseases.

What to Know About the CHIP “Fix” From Congress

By taking money from other important programs, including many that involve helping kids get vaccines, the long overdue short-term “fix” for CHIP by Congress likely created new problems and it still has many parents worried that their kids could lose their health insurance early next year.

More About the CHIP “Fix” From Congress