21st Century Cures Act Passes Unanimously
Information that follows is courtesy of NASL of which Reliant Rehabilitation is a Board of Governors member.
On May 21st, the House Energy & Commerce (E&C) Committee unanimously passed H.R. 6, the 21st Century Cures Act, by a vote of 51 – 0.
The bi-partisan bill was first introduced as draft legislation in January 2015 by House E&C Chairman Fred Upton (R-MI) and Representative Diana DeGette (D-CO). The bill includes ideas proposed by both Republicans and Democrats, whose goal was to “conduct a comprehensive look at the cycle of cures – from discovery to development to delivery.”
NASL has been tracking the 21st Century Cures Initiative, which the Committee launched as a nationwide conversation with patients, providers, innovators, regulators and researchers in 2014. Over the past year, the E&C Committee gathered ideas from stakeholder responses to white papers, hearings and roundtable discussions, which were hosted both at the Committee and by Members in their home districts across the country.
NASL appreciates Congress’ comprehensive look at how to incentivize changes that encourage greater adoption and use of health IT and speed the pace of new medical cures and treatments. NASL has provided technical feedback and comments on multiple iterations of key sections that would impact both healthcare and ancillary service providers in the long term and post-acute care sector (LTPAC), including the SOFTWARE Act, telehealth, pharmacy and interoperability provisions detailed below.
The bill’s sponsors say that the “21st Century Cures Act will help to modernize and personalize health care, encourage greater innovation, support research and streamline the system to deliver better, faster cures to more patients.” The bill provides increased funding for the National Institutes of Health (NIH) for effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Additionally, it provides some Food & Drug Administration (FDA) funding to establish a “priority review program” for certain breakthrough medical devices technologies.
Just prior to marking up the bill, the Committee revealed that $13.2 billion in offsets were allocated to help pay for the 21st Century Cures Act and increased funding. These offsets, which are considered controversial since they include an unprecedented non-healthcare pay-for, are as follows:
- Limiting federal reimbursement for a state’s Medicaid spending on certain durable medical equipment (DME) to what Medicare would have paid in the same state for the same services ($2.8 billion);
- Accelerating the modernization of x-ray imaging technology from cassette-based imaging to digital imaging ($200 million);
- Modifying the timing of pre-payments on Medicare Part D ($5 – 7 billion); and
- Selling off 8 million barrels of the strategic petroleum product reserves a year between 2018 and 2015 ($5.2 billion).
Modifications to Final Bill
Prior to the Energy & Commerce Committee vote on H.R. 6, the Committee released yet another revision to the legislation with new language that was absent from the first two drafts of the bill. The language sets up a framework on interoperability for health information technology, sunsets the Health IT Standards Committee in favor of contracting with standards development organizations and outlines a more aggressive timeline for achieving widespread interoperability, among other changes to language in previous drafts.
The interoperability section would apply to health information technology, rather than just electronic health records. It also identifies specific categories for interoperability standards, including: vocabulary and terminology; content and structure; transport of information; security standards; and service standards. These categories generally align with standards work that is already being done under the auspices of HHS’ Office of the National Coordinator for Health Information Technology (ONC).
The bill would require HHS to release a report no later than July 2017 detailing an initial set of interoperability standards; strategies for achieving widespread interoperability; barriers preventing interoperability; and HHS’ plan and milestones for achieving interoperability. An HHS follow-up report on whether interoperability has been achieved, along with a list of vendors that are in compliance with interoperability requirements would be due at the end of 2019.
Language throughout the interoperability provision looks to address “information blocking,” which was the subject of a recent ONC report to the Congress. Consequently, the provision focuses on health IT vendors and providers, who could face penalties or have IT products decertified.
NASL continues to work with Committee staff on this and other provisions that would have a direct impact on the LTPAC sector.
Part D & Pharmacy Lock-in
The updated provisions, which according to the E&C Committee, “aims to curb prescription drug abuse” amends the pharmacy lock-in measure to exempt patients in nursing homes, hospice, intermediate care facilities for the mentally retarded and facilities that contract with a single pharmacy to dispense frequently abused drugs. The draft released last week exempted hospice providers, but left it to HHS’ discretion to exempt others, such as nursing homes.
NASL had advocated against a Part D e-prescribing provision found in earlier discussion drafts, which was eliminated from the final bill. NASL is pleased that instead of the earlier section, there is a “Sense of Congress” statement about e-prescribing.
The final bill also includes language based on the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act that was introduced by Representatives Marsha Blackburn (R-TN) and Gene Green (D-TX). NASL worked with Congressman Blackburn’s office on the 2013 legislation, and continues to weigh in on the updated language found in the 21st Century Cures Act. The language in the Cures bill provides greater specificity regarding how “health software” is defined and takes a risk-based approach to determining whether or not a product requires FDA oversight.
Telehealth Service under the Medicare Program
The provisions that address “Telehealth Service under the Medicare Program” were primarily unchanged from the May 14, 2015 discussion document. The Energy & Commerce Bipartisan Telemedicine Member Working Group has been seeking improvements that would allow for new telehealth services under the Medicare Program.
The Cures Act requires the Centers for Medicare & Medicaid Services (CMS) and the Medicare Payment Advisory Commission (MedPAC) to submit studies that address Medicare reimbursement for telehealth services. Within one year, CMS and MedPAC would be required to provide Congress with recommendations regarding which beneficiaries would be improved by the expansions of telehealth services, which diagnosis are suitable to furnishing telehealth services under the Medicare program, and what should be covered by Medicare Advantage plans.
Additionally, the Act includes a “Sense of Congress” that states should collaborate – through the use of state medical board compacts or other mechanisms – to create common licensure requirements for providing telehealth services to facilitate multistate practices and allow for health-care providers to provide telemedicine across state lines.
The 21st Century Cures Act is expected to go to the House floor in June. The Senate does not have a companion bill ready and is on a much slower track. NASL is reaching out to key Senate HELP Committee Members that will craft the Senate bill.