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.

After more than 50 years of use, some Michigan lawmakers say naloxone may not be the best choice in an overdose situation.

Naloxone is sometimes called the "Lazarus drug" because of its powerful ability to seemingly resurrect people after a drug overdose.

Sen. Kevin Hertel, D-St. Clair Shores, and some of his colleagues have introduced a bill which would open the door for what they say are more costly, but more powerful, antidotes.

"Given the prevalence of fentanyl in our communities, and how much stronger some of these drugs that we're now seeing are, we believe -- and in talking with others -- that there should be other tools to respond to an overdose," Hertel explained. "To make sure we're doing everything we can to save somebody's life."

Not everyone is on board with the proposed legislation, Senate Bill 542. Opponents argued the more expensive naloxone alternatives are not necessary, and using them would only increase profits for the pharmaceutical industry.

Jonathan Stoltman, director of the Opioid Policy Institute in Grand Rapids, said while the naloxone alternatives do help in overdose situations, they can also cause nasty side effects.

"The newer approaches, they put people into more severe withdrawal," Stoltman pointed out. "That's a pretty profound negative side effect. The one approach is very inexpensive and works great; the other approach is far more expensive and has this strong negative side effect."

Sponsors of the bill say they're hoping to give Michigan residents a chance to chime in on the issue in a public hearing sometime in June. Michigan saw more than 3,000 opioid overdose deaths in 2021.


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New Mexico saw record enrollment numbers for the Affordable Care Act this year and is now setting its sights on lowering out-of-pocket costs - those not reimbursed by insurance. More than 56,000 New Mexicans are enrolled in a medical health insurance plan on the state exchange - an increase of 12,000 people overall.

Colin Baillio, deputy superintendent with the state's Office of Insurance, said the state has boosted its outreach and made efforts to improve the overall consumer experience.

"We saw a 40% year-over-year increase, and New Mexico saw the biggest percentage increase during the open-enrollment period among all of the state-based marketplaces," he explained

Part of the enrollment increase is due to what's called the "unwinding" - a federal directive that required all states to redetermine Medicaid eligibility following a three-year pause on checks during the COVID pandemic. He said by using expanded tools made available by the federal and state government, 8% of New Mexico's population is now uninsured - down from 23% in 2010.

Following approval by lawmakers in the 2024 legislative session, the New Mexico governor signed seven health care-related bills into law - one of which requires annual reporting of prescription drug pricing. Baililo said the Affordable Care Act built the foundation that has allowed the state to pursue additional affordability initiatives.

"I'm really glad to see that there's so much interest in the next step of health reform, really leaning into these out-of-pocket cost issues and making it easier for people to afford to stay covered and see their doctors," he continued.

Two years ago, the state also passed a one-of-a-kind law that did away with behavioral health co-pays for people in certain insurance plans.

New York's medical aid-in-dying bill is gaining further support. The Medical Society of the State of New York is supporting the bill. New York's bill allows terminally ill people with only six months to live to use this option, with safeguards requiring two physicians' approval.

The bill's Assembly sponsor Amy Paulin, D-Westchester, said despite the growing support, other hurdles lie ahead.

"Now we have what I believe, if it came to the floor, a majority. There's still a hesitation on the part of leadership. You know, we need members to assure leadership that they no longer have reservations," she said.

Other newly resolved concerns center on making sure insurance companies and doctors who don't support this aren't held liable. She's optimistic the bill will pass after nine years in the Legislature. New York would be the 11th state along with Washington, D.C. to have medical aid in dying legislation.

Corinne Carey, senior New York campaign director with Compassion and Choices finds the pandemic drew a vivid picture of a person's end-of-life experience. There were images of people dying on ventilators, apart from loved ones, and unable to communicate. She said people began thinking about a "good death."

"And, what is a good death is being surrounded by loved ones, having some measure of control, experiencing the touch of your loved ones, and being the one in the driver's seat," she explained.

Now people have different options for end-of-life care, each of which presents various challenges. Polls show medical aid in dying has garnered considerable support since being introduced in 2015. A 2022 Compassion and Choices poll finds 57% of nurses support medical aid in dying professionally, although fewer support it personally.