Congress is considering legislation to place more oversight on diagnostic lab tests currently not regulated by the Food and Drug Administration.
Advocates and medical experts argued the legislation is needed to reduce false positives which can delay critical treatment for cancer patients.
Mark Fleury, policy principal of emerging science for the American Center Action Network, said cancer patients in particular rely on molecular diagnostic tests. He noted the pandemic has given most people the experience of relying on a lab test for accurate information about their health.
"I certainly think over the past few years, people have made very significant decisions based on diagnostic tests in the form of COVID tests," Fleury observed. "Anybody who's gone through that experience wants to know: if they get a positive that it truly means a positive, and if they get a negative, it really is a negative."
In the FDA Safety and Landmark Advancements Act, co-sponsored by Sen. Richard Burr, R-N.C., companies would have to register their tests with the FDA, provide performance information, and report any cases of harm. Senate lawmakers approved the bill in June, and Congress is negotiating a final version.
Shannon Routh, an ovarian cancer survivor and advocate for the Ovarian Cancer Research Alliance and founder of TEAL Diva, explained her physician used a diagnostic blood test measuring levels of a protein called CA 125 to detect ovarian cancer. Routh acknowledged the CA 125 test is important, but does not always detect elevated levels, making the results less certain than a Pap smear for cervical cancer, or mammograms for breast cancer.
"Both screenings have saved lives," Routh stated. "But ovarian doesn't have one. And so, I think there is an extreme need for accurate screening tests, whether it be a blood test or whatever we have. It saves lives."
Fleury emphasized laboratory-developed tests are mostly accurate and of high quality. But he pointed to cases like the company Theranos and its founder, Elizabeth Holmes, who claimed to develop rapid diagnostic blood testing, which was revealed to be a scam. He contended without third-party review of such tests, there's a lack of certainty for patients, and he believes the legislation is needed.
"Bring up the oversight system to the modern era," Fleury urged. "Treat it as a diagnostic test rather than as an artificial hip, and ensure that if two tests perform the exact same function, that they've been looked at in the exact same way."
A Pew poll released last year finds one in 10 Americans who've received a clinical lab test report inaccuracy, and most said they support policies to improve oversight.
Support for this reporting was provided by The Pew Charitable Trusts.
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In rural Arkansas, access to healthcare can be a distant dream - literally - as almost 60 counties in the state do not have enough providers to serve their populations. A new initiative with the Health Resources and Services Administration is working to improve access in these areas, through telehealth.
Heather Dimeris, director, Office for the Advancement of Telehealth at the Health Resources and Services Administration, said delivering care remotely online fills a crucial gap. Arkansans can visit telehealth.hhs.gov to explore their options, including behavioral and mental-health services.
"You can look at anxiety or depression screening through telehealth," she said. "You can also receive treatment for your anxiety or depression and other mental health needs, through one-on-one therapy as well as group therapy. And telehealth has also been extremely helpful in treating patients with substance-use disorders."
Dimeris noted 40% of all behavioral healthcare is now done virtually, including therapy, addiction counseling, and mental-health screening. She adds HRSA also provides telehealth services for treatment of chronic diseases, like diabetes, and information for healthcare providers.
However, the growth of telehealth spotlights another challenge for rural Arkansas - the lack of reliable, affordable internet service. Dimeris added some people can use their cell phones for telehealth services. Or they can apply for discounted internet access through two programs offered by the Federal Communications Commission.
"The Affordable Connectivity Program, as well as the Lifeline Program," she continued. "Both of these programs have eligibility requirements. But if you meet them, you really are able to access either free or reduced cost for broadband services and cell phone services."
Lower-income households can get up to $30 a month off their internet service bill, or $75 a month if they live on tribal lands, according to the FCC.
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California's medical aid-in-dying law is back in court. Three patients with disabilities and two doctors are asking to intervene in a lawsuit challenging the law - and they want the judge to dismiss the suit.
In April, a coalition of disability rights groups and people with disabilities sued to stop the End of Life Option Act, claiming it is discriminatory and "coerces" people with disabilities into using medical aid in dying.
Jess Pezley is the senior staff attorney with Compassion & Choices, which supports the bill.
"It's not discriminatory to offer an additional end-of-life option," said Pezley. "And there's a lot of safeguards built in within the act to make sure that this law is not being used by people who do not want it. The only people who qualify for it are terminally ill with a prognosis of six months to live, and who have the capacity to make the decision."
California is one of ten states - plus Washington, D.C. - that allow doctors to prescribe medication that would allow mentally capable, terminally ill adults to peacefully end their suffering if they choose to take it.
Peter Sussman is a retired journalist and author from the Bay Area who said he lives with constant and disabling pain after a series of spinal surgeries. He said he supports medical aid in dying, and has joined the motion to intervene in the lawsuit.
"When my time comes and I am certified by doctors to be dying within six months, I do not want to die suffering needlessly," said Sussman. "The government shouldn't be able to tell me the manner of my own death."
The State of California, the defendant in the lawsuit, has also filed a motion to dismiss.
Earlier this year, the same judge dismissed a different challenge to the suit brought by the Christian Medical and Dental Association - after it reached a settlement with the state that said doctors who have a religious objection don't have to record a patient's request for medical aid in dying on their chart.
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Open enrollment begins soon for employer-sponsored health insurance for coverage starting Jan 1.
Most people will have multiple options to choose from. Some are complex, so now is the time to do your research. According to the website USA Facts.org, about 7.5% of Indiana residents do not have health insurance. Experts say it is important to shop for plans, see exactly what they offer, and if a choice fits a family's needs and budget.
Dr. Rhonda Randall, chief medical officer of Employer and Individual for UnitedHealthcare, said understanding some of the basic insurance jargon is a good place to start.
"Things like deductibles, copays, coinsurance, premiums, etc.," Randall outlined. "Be familiar with what those terms are and what the costs associated with each one is for the plans that you're offered and the plans that you're considering."
Randall advised paying close attention to out-of-pocket costs and monitoring changes which can occur within a plan each year. She suggested the online health insurance glossary Just Plain Clear, which UnitedHealthcare has compiled. In 2021, more than one-third of Indiana's population was covered by public health insurance funded by governments at the federal, state or local level.
Nearly 17% of Indiana's population is 65 or older and eligible for Medicare. But it does not cover everything, so most people also buy a supplemental policy for added coverage, and a prescription drug plan. The Medicare annual enrollment period starts Oct. 15 and ends Dec. 7, when people can get new coverage or change what they've had.
Randall noted UnitedHealthcare has also compiled an online guide to help people navigate those plans.
"Medicare beneficiaries want to make sure they're understanding and learning the difference between original Medicare -- Medicare Parts 'A' and 'B' -- and Medicare Advantage, Medicare Part 'C' and 'D,' the prescription drugs," Randall explained.
Randall encouraged Hoosiers to consider insurance plans including coverage for telehealth -- virtual 24-hours-a day, 7-days-a-week mental and behavioral health services, or management of chronic conditions, such as migraines, plus physical therapy and wellness visits.
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