The 21st Century Cures Act, an already sweeping package of legislation, appears to be getting a last-ditch push from several industry and advocacy groups that are counting on using the bill to get new traction on measures that have stalled.
On Monday industry groups continued to examine the 996-page draft of the new biomedical innovation package known as the 21st Century Cures Act that Republicans introduced over the weekend. A vote is scheduled for Wednesday, although tensions remain and Congress has yet to find the funding to pay for the provisions.
Sen. Elizabeth Warren (D-Mass.) took to the floor of the Senate Monday to voice her opposition. In the closing days of this Congress, Big Pharma has its hand out for a bunch of special giveaways and favors that are packed together in something called the 21st Century Cures bill,” Warren said. “Why pretend to give any money to NIH or opioids? Because this funding is political cover for huge giveaways to giant drug companies.”
The bill has morphed into a sprawling piece of legislation that touches almost every corner of the healthcare industry, including the Food and Drug Administration, Medicare Advantage plans and hospitals.
FDA reforms, along with new funding for the National Institutes of Health, were the core of the bill when it was first considered in 2015. The latest iteration includes $500 million over 10 years to help the FDA speed the approval of drugs and medical device, which the pharmaceutical industry has cheered. Consumer advocates, however, say the changes will expose patients to products that haven't been appropriately vetted.
Mental health advocates praised the potential inclusion of legislation from Rep. Tim Murphy (R-Pa.) to reform mental health treatment. The House will vote Wednesday on whether to include several provisions from the Mental Health Reform Act with the Cures Act.
These include creating the position of assistant secretary for mental health and substance abuse within HHS' Substance Abuse and Mental Health Services Administration and efforts to improve coordination and oversight of mental health programs. It also would add several grant opportunities for states and communities.
John Snook, president of the Treatment Advocacy Center, said the Cures Act will likely now include several important mental health and substance abuse provisions that show Congress is acknowledging there is a mental health crisis that needs to be addressed.
“The overarching message is that we're really pleased that the focus on severe mental illness has continued,” he said.
Snook said he was particularly pleased to see included aspects of the Mental Health and Safe Communities Act from Sen. John Cornyn (R-Texas) that would help create and expand programs that divert people away from incarceration and toward treatment for mental illness and substance abuse.
“We don't want to lose this momentum,” Snook said. “There's so much to do, and with a new Congress you never know what's going to happen.”
Several other industry and advocacy groups are finding enough parts of the Cures Act they support to get behind it.
“The 21st Century Cures initiative reflects more than two years of bipartisan collaboration focused on a single goal: capitalize on scientific opportunity and American ingenuity to save more lives. That's what this bill does,” wrote Ellie Dehoney, vice president of policy and advocacy for Research!America, an organization that lobbies on behalf of universities, healthcare companies and patient advocacy groups.
The Association of American Medical Colleges sent a statement in support of provisions that would take patients' socio-economic status into account in the Medicare readmissions reduction program and also exempt off-campus hospital outpatient departments already under construction from payment cuts under Medicare's new site-neutral payment policy.
One concession to drug companies had Sen. Chuck Grassley (R-Iowa) joining Warren in opposing the bill in its current form. Grassley said he would object to taking up the bill in the Senate unless exemptions to the Physician Payments Sunshine Act he co-authored were removed. The Sunshine Act, part of the Affordable Care Act, created a database of drug and device company payments to physicians. The Cures Act would remove the reporting requirement for continuing medical education, or CME; medical journal reprints; and textbooks, as well as exempt doctors who receive indirect payments for speaking fees.
“With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever,” Grassley said in a statement. “Watering down sunshine provisions is counterproductive and goes against the trend in healthcare to have more transparency, not less.”
Daniel Carlat, editor-in-chief of a psychiatric CME newsletter, has studied the disclosure efforts for years and said evidence has shown that even small payments from companies to doctors can prompt doctors to prescribe more brand-name drugs when generic drugs are available. This can increase costs significantly for patients who face drasticly higher copays for brand-name drugs, he said.
The change to no longer report payments on CME courses is also of concern because companies were beginning to use this method more often and researchers were waiting to study the effects and better understand the influence of the industry in this area, Carlat said.
“Companies are trying to funnel money in whatever way they can in order to continue to get docs to accept the money,” he said. “And when docs realize that some of the payments will be publicized, they're more reluctant.”