This week, the U.S. Senate passed the 21st Century Cures Act. The U.S. House passed the bill last week. After nearly three years of development, the bill seeks to spur medical innovation through additional research funding and ease federal research administrative burdens. President Obama is expected to sign the bill into law.
Congress also used this legislative vehicle to pass year end Medicare-related provisions impacting clinical GI, including items that ACG members advocated for during the April 2016 Washington D.C. fly-in, and throughout 2016. One of ACG’s top legislative priorities for 2016 was to reduce reporting and administrative burdens associated with Meaningful Use. Thank you ACG Members for your advocacy this year! In the Cures bill:
- Reducing EHR Reporting Burdens. The Cures bill requires that HHS work with specialty societies and stakeholders to reduce regulatory and administrative reporting burdens associated with EHRs (including participation in MIPS and APMs), as well as making EHRs more user-friendly and interoperable.
- Excludes ASC services for Meaningful Use calculations. The Cures bill allows physicians who perform “substantially all” of their services in the ASC setting to claim an exclusion and avoid a Meaningful Use payment cut in 2017 and 2018. This exclusion also ends 3 years after HHS can determine that EHR technology is suitable for the ASC setting (ACG advocated for the Electronic Health Fairness Act of 2015, S. 1347; HR 887).
Does this exclusion carry over to MIPS? See the “MACRA Tidbit” below.
- Improves transparency of Medicare local coverage determinations. The Cures bill requires Medicare contractors to publicly post information on Medicare’s website regarding proposed local coverage determinations, and the rationale of such decisions, 45 days prior to the policy becoming effective (ACG Governors have heard from many ACG members on local contractor issues, and conveyed these issues to policymakers).
- Medicare site-of-service price transparency. The Cures bill requires HHS to publish a comparison of cost-sharing for services performed in the ASC vs. the hospital outpatient department (similar to provisions in a bill ACG advocated for, the Ambulatory Surgical Center Quality and Access Act of 2015, S. 2071; HR 1453).
- Guidance on cleaning and reprocessing medical devices. The Cures bills requires HHS to publish a list of reusable devices, together with cleaning and repossessing instructions as well as validation data. HHS must also provide guidance regarding when a premarket notification under section 510(k) is required if there are changes to the device.
The primary focus of the Cures bill:
- Funding for medical research and approvals: Provides $4.8 billion over 10 years to the NIH for disease research and precision medicine. Also provides $500 million over 10 years to the FDA to improve the drug and device approval process. Provides $1 billion over 2 years for state grants to respond to opioid abuse.
- Reducing research application administrative burdens: Requires HHS to review and streamline policies related to conflict of interest and financial disclosure for NIH research grants.
- Fostering collaboration: Requires HHS (NIH, FDA, others) to develop policies that foster research and data sharing, as well as to convene working groups to increase and enhance research partnerships.
- Other FDA: the bill requires patient experience data when drugs are approved, requires better pathways to shorten drug development timeframes, better guidance documents on clinical trial models during new drug applications, and establishes a “breakthrough” pathway for medical devices.
- Other: Hospital off-campuses in “mid-build”: Previous legislation prevents hospitals from receiving the outpatient facility fee for offices off-campus. The Cures bill provides an exemption for off-campus offices that are in “mid build,” or for those hospitals having a binding agreement to construct offices prior to November 15, 2015.
Whitfield L. Knapple, MD, FACG
Chair, ACG National Affairs Committee