Huge new health law has provisions for research, opioids, mental health, faster approval of drugs and medical devices, and more

By Melissa Patrick
Kentucky Health News

Congress passed legislation Wednesday, Dec. 7 that will, among other things, increase funding for medical research and speed up the federal approval of new drugs and medical devices. It now heads to President Barack Obama’s desk for his signature.

Sen. Mitch McConnell

“Sending this bipartisan legislation to the president’s desk is an important step in helping foster solutions when it comes to heartbreaking illnesses like Alzheimer’s, opioid addiction, mental-health disorders and cancer,” U.S. Senate Majority Leader Mitch McConnell said in a news release.

The Kentucky Republican was a leading advocate of the $6.3 billion 21st Century Cures bill, which the Senate passed 94-5 after the House passed it 392-96 the previous week. Dissenters called it a giveaway to the pharmaceutical industry.

Obama said in a statement, “We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need. . . . This bill will make a big difference.”

Vice President Joe Biden

The legislation provides $1 billion for the heroin and opioid epidemic, $1.8 billion for Vice President Joe Biden’s “moonshot” initiative to cure cancer and nearly $3 billion for the BRAIN and Precision Medicine Initiatives, which targets diseases like Alzheimer’s. It also has measures to improve mental-health treatment and to speed up the federal approval process for drugs and medical devices.

The $1 billion for opioid prevention efforts and expanded access to treatment for substance use disorders is to be spent over the next two years in $500 million allotments. The money will be allocated through need-based grants.

Agriculture Secretary Tom Vilsack

“These additional resources are particularly critical in rural areas, where rates of opioid misuse and overdose are high, access to treatment is limited, and patients who seek treatment are often met with waitlists that can mean the difference between life and death,” Agriculture Secretary Tom Vilsack said in a statement.

NPR reports that the bill is “the most significant piece of mental health legislation since the 2008 law requiring equal insurance coverage for mental and physical health,” called parity.

Among other things, the measure strengthens the enforcement of requirements to treat behavioral disorders like other diseases, includes grants to increase the number of mental-health providers, works to promote early intervention for psychosis and creates a new position to oversee the Substance Abuse and Mental Health Services Administration. It also eliminates the Medicaid “same day” exclusion, which prohibits separate payment for mental health and primary care services to a Medicaid enrollee on the same day.

“On behalf of the Kentucky Hospital Association and our 127 member hospitals, I would like to commend and thank Senator McConnell and Congress for the passage of the 21st Century Cures Act,” Mike Rust, KHA president, said in a statement through McConnell’s office. “The legislation overhauls drug development, accelerates new cures and treatments and includes a number of provisions important to Kentucky hospitals and their work to improve patient care.”

But not everyone loves the bill.

Public Citizen, a consumer watchdog group that fought the legislation, called the Cures Act a holiday gift to drug makers. “It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a statement. “This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.”

Sen. Elizabeth Warren, D-Mass.

Sens. Elizabeth Warren, D-Mass., Bernie Sanders, I-Vt., and Jeff Merkley, D-Ore., warned that the bill will weaken regulatory standards on drugs, doesn’t provide enough money for medical research and does nothing to address the rising cost of medications, Fortune. Other senators voting against the bill were Ron Wyden, D-Ore. and Mike Lee, R-Utah.

Most Democrats were pleased about the funding for medical research they wanted in the bill, many still have concerns that the amount isn’t adequate and that it will have to be approved in future legislation and re-authorized every year.

“While the bill authorizes $4.8 billion to the N.I.H. over the next 10 years — on average, a mere $480 million a year — this is barely a quarter per year of what the House passed last year,” Representative Rosa DeLauro, D-Conn., told The New York Times. “There is also no guarantee that the appropriators will follow through and provide funding each year.” DeLauro voted against the measure.

And others weren’t pleased with how it’s being paid for.

Rich Hamburg, interim president and CEO of Trust for America’s Health, the preventive-medicine advocacy group,said in a statement that his organization was “deeply disappointed” that Congress used the Prevention and Public Health Fund to offset the bill’s cost. Kaiser Health News in a reported, in listing the winners and the losers from the bill, that it cuts $3.5 billion, or about 30 percent, from the fund.

Hamburg said the fund “is the nation’s first and only substantial investment in moving from our current ‘sick care’ system to a true preventive health system. Cutting the Prevention Fund will limit the nation’s ability to improve health and quality of life and prevent disease.”

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