The last word: Will 21st Century Cures Act harm patient safety?

The 21st Century Cures Act, which the U.S. House of Representatives passed in July, isn’t likely to emerge from the full Congress in its present form. The Senate will have its say first and so action from the full Congress likely won’t occur until next year, say Washington watchers.

Sen. Lamar Alexander (R-TN), chairman of the powerful Health, Education, Labor & Pensions Committee, has indicated he wants something more narrowly focused than the 21st Century Cures Act to come out of the Senate. Assuming that happens, the measures will go to conference and then need to be approved in final form, a process that will run into 2016, says Peter Pitts, president of the Center for Medicine in the Public Interest.

Provisions of the House measure that affect doctors include the possibility of faster approvals for new drugs and a requirement for electronic health records interoperability.

Supporters of 21st Century Cures, such as Pitts, say the bill will lead to more medications being available with which to treat patients, a positive development. But opponents say the bill could jeopardize patient safety by allowing for drug approvals without the level of rigorous testing now required.

The legislation allows the Food and Drug Administration to eliminate a third stage of clinical testing for a new drug if its second stage testing shows significant effectiveness.

Next: Opposition argument

The FDA already has ways to speed the time-to-market for promising new drugs, notes Aaron S. Kesselheim, MD, MPH, associate professor of medicine at Harvard Medical School, who has written about the legislation in the New England Journal of Medicine. “There’s no evidence that there are really important cures out there that are being unnecessarily delayed,” he says.

Opponents also argue that the drugs coming to market will be high-priced specialty drugs and thus lead to higher overall drug costs for the U.S. healthcare system. That could produce a squeeze on doctor reimbursements from Medicare and Medicaid as those programs seek savings in other areas to compensate for higher drug spending.

The act “would lead to less effective drugs being put on the marketplace,” says James Rickert, president of the Society for Patient Centered Orthopedic Surgery in Bloomington, IN. “People are always looking for new and better treatments but new and better treatments that are not properly vetted come with considerable risk,” he says.

Pitts, a former FDA associate commissioner, counters that “The idea of giving the FDA the authority to do more things more creatively and in a more 21st century way is important.”

Pitts admits that if the act becomes law doctors will need to do their homework when it comes to using newly-approved drugs. “Doctors are actually going to have to read the package insert,” and schedule time with pharmaceutical reps to learn about new offerings, he advises.

The American Academy of Family Physicians (AAFP) hasn’t take a position on the bill, seeing both good and bad in it, notes President-elect John Meigs, MD.

Next: Will Congress address EHR interoperability?

While it’s noncommittal on the bill, the AAFP is hoping Congress will address EHR interoperability. The 21st Century Cures Act mandates full interoperability, meaning all patient information can be transferred from one certified EHR system to another.

Today, “interoperability is not there, the systems are not where they need to be,” says Meigs. Vendors who fail to meet interoperability standards should be financially penalized, he contends. Currently, doctors are penalized if their systems fail to meet meaningful use requirements regarding interoperability. “The problem is with the vendor and it’s the providers that are being held accountable,” he says.

John N. Frank has more than 39 years experience as a professional journalist, including coverage of healthcare. He is a contributing author to Medical Economics.