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With unusual bipartisan support, a new piece of legislation of about 1,000 pages was signed into law on Dec. 13, 2016 – the 21st Century Cures Act. The Act will allocate about $6 billion to a variety of medically related needs. While the bill has received both applause and criticism from various interest groups, there are many relevant points to mention.

National Institutes of Health (NIH) Funding: The Act provides billions of dollars of new funding to the NIH for research into diseases such as cancer and Alzheimer’s.

Health Information Technology: Recognizing current IT challenges, the Act allows for reduction of some documentation burden and creates an electronic medical record (EMR) tool to assist with EMR-related decisions. In addition, it gives authority to the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) to investigate claims of IT sharing obstacles.

Site-of-Service Cost Disclosure: The Centers for Medicare & Medicaid Services (CMS) will create a website with a guide to estimate payment amounts for outpatient surgeries, along with the beneficiary’s liability amount.

Medicare Part A Inpatient/Part B Outpatient Surgical Code Comparator: This is a juxtaposition of the inpatient surgical codes to related outpatient codes for 10 common procedures.

Socio-Economic Status Adjustment for Readmissions: This is a risk adjustment calculation meant to account for various socio-economic factors, initially using a temporary method, but eventually requiring a permanent methodology.

Medicare Advantage for ESRD: This is an option for MA plan enrollment for ESRD patients as of 2021.

Opioid Abuse Prevention: Designates funds for opioid abuse prevention and therapy programs.

Ambulatory Surgical Center (ASC) MACRA Exclusion: Temporarily excludes providers that primarily practice in ASCs from Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Merit-Based Incentive Payment System (MIPS) requirements.

Telehealth: Requires CMS to provide information on expanding telehealth coverage, along with comparative information for commercial insurers.

“Breakthrough” Technologies and Combination Products: A program will be established for expediting approval for breakthrough technologies. Certain criteria will be put in place to determine validity of the “breakthrough” label. A dedicated center for combination products is to be created to streamline the review of new products.

Antimicrobial Stewardship: The Food and Drug Administration (FDA) shall continue to monitor antimicrobial resistance. For a serious or life-threatening infection, the FDA may approve a new agent in a limited patient cohort, even with a lack of evidence to establish a satisfactory benefit/harm ratio in a broader population.

Experience Data Gathering: Prior to granting approval, the FDA will be seeking broader input regarding the experience of patients, beyond that of just the manufacturer. The experience data can be derived from any person or entity.

Qualification of Drug Development Tools: Establishes a process for the qualification of new drug/biologic development tools. The purpose is to encourage the development of genetically targeted agents for rare diseases. It includes expansion of the process for grants and vouchers for priority review of drugs for such conditions.

Trial Design and Level of Evidence: The FDA will now consider inclusion of sources other than randomized controlled trials (RCTs) for new drug reviews. A new set of guidelines will be developed utilizing broad input from industry sources, academic institutions, professional societies, patient advocacy/consumer groups, disease research foundations, etc.

Patient Access to Therapies: Developers of investigational therapies for serious diseases will make available policies for inclusion of patients on a publicly accessible website. Applications for regenerative therapy, such as cell therapy and human cell/tissue products, will be eligible for an accelerated review.

While there is much to like in this Act, its fate is unknown with the new Trump administration having taken office. The changes to the FDA approval process should also scare the heck out of every doctor who is tired of the constant TV ads for medications for toenail fungus, lung cancer, and of course, erectile dysfunction.

While the president has been talking a lot about high drug prices, he is clearly pro-business and anti-regulation. The Act will allow drugs to be approved based on data other than controlled clinical trials, perhaps only requiring drug companies to prove safety with no requirement for efficacy data. Scary times could be ahead.


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