Cures Act: Healthcare innovation, grab bag giveaway, or both?
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For all the media attention that it is getting, the impending repeal of the Affordable Care Act (ACA) that Republicans are promising when the 115th Congress convenes is arguably only the second most significant piece of legislation in terms of its impact on U.S. healthcare.  

The real showstopper may very well be the 21st Century Cures Act (the Cures Act), which has passed the House and Senate and is currently awaiting President Obama’s signature. Ultimately, it could have a more immediate impact. 

The Cures Act has managed to bring together bipartisan support from Democrats and Republicans and from patients and big pharma to support its allocation of $4.8 billion for health research over the next decade. Its highlights include $1.8 billion for the Cancer Moonshot Initiative championed by Vice President Joe BidenJoe BidenBiden blasts Dems for ignoring working-class concerns The Hill's 12:30 Report Cornell unveils Biden ice cream MORE in memory of his son, Beau, whose diagnosis of brain cancer led to an untimely passing at age 46.

In addition, the Cures Act allocates $1.5 billion for President Obama’s Precision Medicine Initiative, which focuses on identifying treatment and prevention strategies specifically tailored to people’s unique characteristics, including their genome sequence, microbiome composition, health history, lifestyle, and diet.

Another $1.5 billion of the funding is focused on the BRAIN initiative to advance understanding of the brain to help find a cure for Alzheimer’s.  

While the bulk of funding is focused on biotech research, the addiction treatment community is excited by federal funding of an additional $1 billion on anti-opioid efforts.  Among other promising developments, the Cures Act creates a new position of Assistant Secretary for Mental Health and Substance Abuse, to be appointed by the president, which will raise the profile and consciousness about addiction treatment and mental health issues. It allocates money to combat and treat the narcotic opioid epidemic, and directs federal agencies to increase enforcement of the Mental Health Parity and Addiction Equity Act of 2008. 

Given the worry on the part of behavioral health community that the incoming Donald TrumpDonald TrumpHuckabee on Trump priorities: ‘A beheading is still worse than a sunburn’ Dan Rather pleads for Trump to pay attention to Portland murders Trudeau says Trump was ’robust,’ 'frank’ with him MORE administration and Republican Congress might be in a cost cutting mode with respect to U.S. healthcare, the public support for behavioral health treatment resources has offered reason to be hopeful.

The Cures Act also provides for reforms to accelerate the FDA drug and device review process.  Among other things, the Cures Act clarifies several categories of medical software that will not be regulated as medical devices, including clinical decision support software. 

With its basket of “goodies”, the 21st Century Cures was embraced by the medical research community, the biotech and digital health industry, and addiction treatment providers.  At the same time, it has drawn the ire of both progressives and conservatives for its array of handouts.

Massachusetts Senator Liz Warren was outspoken about her complaint that the bill was a hand-out to the drug industry.  She also complained about the proposed relaxation of regulatory transparency requirements imposed by the “Sunshine Act,” specifically an allowance (ultimately removed from the bill before it passed) that would have exempted companies from having to disclose amounts paid for physician continuing medical education and textbooks.   

It looks as though Big Pharma will need to wait until the 115th Congress to try to roll back the Sunshine Act provisions.  Nonetheless, the pharmaceutical industry appears to have been winners under both the ACA and whatever comes next. 

On the Right, the Heritage Foundation also opposed the Cures Act, criticizing it as unnecessary overspending in light of the tens of billions of already established funding for medical research through the National Institutes of Health. Conservatives also derided the Cures Act for its mandatory “autopilot” nature given the ordinary discretionary budget process.  Despite Heritage opposition, the Cures Act handily passed both the House and Senate by wide margins with the backing of the Obama administration, and enactment appears to be a fait accompli.

While the ACA repeal may dominate headlines in coming weeks, it is expected to be delayed and will ultimately take years to unwind, pushing off its impact on patients and the healthcare industry indefinitely. Meanwhile, with bipartisan support, the Cure's Act's mandate will translate to significant immediate funding for medical research, investment and treatment for people suffering from mental health illness and addiction. 

Harry Nelson is founding and managing partner of Los Angeles-based healthcare law firm Nelson Hardiman, LLP.


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