Cures All

Just as 2016 drew to a close, President Obama signed the 21st Century Cures Act into law. This 1,000-page bipartisan bill, which started in the House’s Science, Space, and Technology Committee and the Senate’s Commerce, Science, and Transportation Committee, ranks as one of the most heavily lobbied in recent history, with as many as three lobbyists per each member of Congress.

All in, the sweeping bill allocates $6.3 billion in funding, mostly for the National Institutes of Health. This includes $1 billion over two years to fight the opioid epidemic, $1.8 billion for Vice President Joe Biden’s cancer-fighting “moonshot” initiative, $1.56 billion for the BRAIN Initiative that aims to map the human brain, and $1.4 billion for the Precision Medicine Initiative, a project that will collect genetic data on one million American volunteers to help develop new treatments. The bill promises $500 million in new funding for the FDA over the next 10 years to speed up product approvals and will allow companies to submit observational and “in house” registry data as evidence for the safety and efficacy of a new product. The Cures Act also strengthens mental health parity laws.

Source: energycommerce.house.gov

President Obama signed the 21st Century Cures Act into law December 13, 2016.

Some provisions will have a greater effect on the practice of dermatology than others.

Moving Closer Toward EHR Interoperability

The new bill includes provisions on the use and regulation of electronic health records (EHRs). The holy grail is interoperability, and Cures refocuses efforts toward achieving this, establishing steep penalties against “information blocking” by vendors and healthcare providers. Moreover, the US Department of Health and Human Services (HHS) will require EHR developers to attest that they have not and will not engage in such information blocking tactics to become certified. And if an EHR is decertified because of information blocking, HHS can exempt doctors and hospitals from payment adjustments under the Meaningful Use EHR incentive program or the Merit-Based Incentive Payment System (MIPS) for one year. The hope is that this will encourage vendors to play nicely in the sandbox and open up their application program interfaces (APIs) in the name of interoperability.

Cures also aims to help fight orphan diseases, many of which are dermatologic in nature, such as epidermolysis bullosa (EB) and xeroderma pigmentosum (XP). There are an estimated 7,000 rare diseases that each affect 200,000 or fewer Americans, according to the National Organization for Rare Disorders. Nearly 95 percent of rare diseases have no treatment, and the majority of these diseases are life altering or life limiting.

The bill also extends the Rare Pediatric Disease Priority Review Voucher Program, which incentivizes the development of new therapies and streamlines of FDA review of genetically targeted and protein variant therapies for rare diseases. Hopefully, we will see some interest and activity in rare diseases as a result of Cures.

A Step in the Right Direction

The 21st Century Cures Act is a step in the right direction for dermatologists, health care providers, and patients. It will help to foster innovation, and allow us to overcome some of the roadblocks that have thwarted our progress thus far.

Mark D. Kaufmann, MD is an associate Clinical Professor of Dermatology, Dept of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City.