This bill would ban federal use of QALYs

Today, a House subcommittee will consider legislation that would ban the federal use of QALYs, and we review USDA’s new report on access to seeds. (622 words, 3 minutes, 6 seconds)

P.S. Happy International Women's Day – check out and share our compilation of 25 women in biotech to know.

Legislation would ban federal use of discriminatory QALYs

This afternoon, in the year’s first markup of health care bills, the House Energy and Commerce Health Subcommittee will discuss legislation to eliminate federal use of QALYs, a yardstick for treatments criticized as discriminatory.

What’s a QALY? Quality Adjusted Life Years (QALYs) is a formula attempting to measure a treatment’s value by combining the number of years added to a person’s life with the quality of their life during those years.

What’s wrong with that? “Quality of life is difficult to define,” says the National Council on Disability, which opposes QALYs because they arbitrarily assign a lower value to a year of life with a disability, making them inherently discriminatory. QALYs devalue “lives of older adults, people with disabilities and chronic conditions, and communities of color,” says the Alliance for Aging Research.

“QALY is very discriminatory. If you’re disabled, you’re downgraded,” says Daniel Durham, BIO’s EVP for Health Policy. QALYs can ignore the value of treatments that improve the lives of cancer patients and others, including those with rare disease. During the 2020 presidential campaign, then-candidate Biden promised “I will ensure people with disabilities are not denied coverage based on the use of the quality-adjusted life year (QALY ) and related enterprises in making coverage and payment determinations in public programs. In 2010, the ACA created a statutory ban on their use to determine what Medicare could cover, an acknowledgement that their use could lead to Medicare restricting coverage of treatments and services that were most needed by people with chronic conditions and diseases and disabilities.”

The legislation:H.R. 485 would prohibit the use of QALYs—already banned by some agencies—in any federal health program.

For one co-sponsor, it’s personal: Subcommittee Chair Cathy Rodgers (R-WA), a co-sponsor, says QALYs ignore “the most vulnerable … People like those with cystic fibrosis, ALS, and people like my son with Down syndrome.”


More Health News:

Wall Street Journal (Opinion): Biden’s tax and rationing plan for Medicare
“President Biden on Tuesday rolled out a plan he says will shore up Medicare for decades, and we’re all supposed to believe the spin: looming insolvency averted. But this proposal is really a huge tax increase paired with prescription-drug rationing that does nothing to reform the health entitlement, and the tax ratchet is only beginning...The Inflation Reduction Act is already dampening investment, particularly in cancer drugs, but the Biden crowd is betting Americans won’t notice the cures that never happen,” says the WSJ Editorial Board.

Why we need strong IP protection for seeds

Federal government efforts to increase access to the seed market are commendable, but reforms must protect the intellectual property that enables biotech innovation, says BIO. 

ICYMI: The U.S. Department of Agriculture (USDA) published its report, “More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs.” The report is based on public comments regarding “the impacts of concentration, market power, and intellectual property in the market for seeds and other agricultural inputs.”

The importance of IP safeguards: BIO is reviewing the report “to identify potential concerns about weakening intellectual property protections for biotech companies,” says BIO. “Strong patents, and an efficient, predictable and objective patent system, are critical to the seeds industry, which depends on patent-driven activities to fuel the development of new inventions and products that benefit the public.”

A complex system: The report says many commenters questioned the complexity of the current IP system. But BIO says that’s because any developments to improve seeds, increase harvests, allow conservation, and feed our growing population are regulated by various government agencies, including USDA, FDA, and EPA.

Why it matters: The cost of regulation for biotech trait commercialization has grown more than 23% while regulatory timeframes grew 75%, even though scientific advances should be reducing commercialization time.

What we need: Reducing regulations would address “challenges to expanding biotech’s benefits to more producers, as well as growing agriculture’s sustainability and the world’s food security,” BIO says. 

President Biden’s Wednesday: No public events scheduled. ICYMI, the Biden administration has proposed expanding the Medicare drug price controls, reports STAT News – here is the Wall Street Journal Editorial Board's take.

What’s Happening on Capitol Hill: We’ll be watching the House Judiciary Courts, Intellectual Property, and the Internet Subcommittee hearing on “Intellectual Property and Strategic Competition with China” to learn what’s being said about biotech IP protections. The House Science Space and Technology Committee hearing on the Department of Energy’s role in research will include discussion of a draft bill on joint DOE-USDA research activities.