Happy Birthday, 21^st Century Cures Act!

Yesterday, the 21^st Century Cures Act turned four years old. Unfortunately, like many 2020 birthday celebrations, we are not able to celebrate together in person this year, so I wanted to take a moment to reflect on the promise of the legislation, how far we’ve come in four years, and all the unfinished work ahead of us.

Cures was truly a triumph of the 21^st Century. Increasing partisan gridlock in Congress means that sweeping bipartisan legislation on any issue is rare, and even more rare if it is on health policy – yet Cures passed 94-5 in the Senate and 392-26 in the House. Members on both sides of the aisle came together around the goal of improving discovery, development, and delivery of cures to patients across the country. Cures brought crucial funding for the All of Us Research Program, the BRAIN Initiative, and the Cancer Moonshot. The law also included provisions that are top-of-mind for many eHI members – provisions to improve interoperability, stop information blocking, and update decades-old regulatory pathways for digital health technologies.

Despite the success and ongoing promise of Cures, our experiences with COVID-19 have highlighted that we still have much left to do to ensure a high-quality, effective, and equitable health care system for all. This is a goal to which eHI is dedicated through our policy and advocacy work. Over the summer, eHI’s COVID-19 Federal Policy Work Group crafted recommendations focused on how to fully leverage health IT and digital health to fight COVID-19 and future public health challenges (Building a Modern Health Care System).

Last week, eHealth Initiative (eHI) convened members virtually for our 2020 Government Affairs Retreat, where Members of Congress, virtual care experts, and Congressional staff spoke about pressing health policy issues. We also presented our 2021 Policy Principles, which, in conjunction with eHI’s expert Policy Steering Committee, will direct the organization’s policy and advocacy activities over the upcoming year. Some other highlights from the event:

• Virtual Care Panel Recording
• Member of Congress interviews
  
  • Congresswoman Lisa Blunt Rochester (D-DE)
  • Congressman Michael Burgess, MD (R-TX)
• Event materials and additional recordings

eHI strives to provide useful and unique educational opportunities and resources to our members. Legislation is key to get the wheels turning, but many of our members are on the ground every day doing the difficult work of transforming the health care system. We hope you join us for our upcoming educational webinars and events:

• Webinar: Expert Perspectives on Virtual Care on December 16^th
• Webinar: SDOH Impact on Equity and Diversity in Clinical Trials on January 12^th
• eHI Annual Meeting on January 26^th – 28^th

So, while we hope you all take a minute today to reflect on how far we’ve come in these past four years, we also hope you will join us in our continued work to actualize the promise of the law.

We applaud Congress for its recent steps to increase access to health care services via telehealth. While we seek permanent reforms to enable Medicare beneficiaries to continue to access services via telehealth once the COVID-19 public health emergency (PHE) ends, we write today to express our support for provisions, proposed by a bipartisan group of Senators, that would extend temporary telehealth flexibilities until the end of 2021 in an end-of-year package to fund the federal government.

From unprecedented Congressional and regulatory action on telehealth reimbursement to the release of final interoperability and information blocking rules, 2020 was a busy year for health technology professionals – and 2021 shows no signs of slowing down. eHI staff and Policy Steering Committee members discussed the latest in health technology policy, eHI’s advocacy work, and a look ahead to the 117th Congress. This event also includes interviews with special guests Congresswoman Lisa Blunt Rochester and Congressman Michael Burgess.

Key Takeaways

• Many healthcare institutions saw a large spike in the utilization of telehealth services beginning in March 2020.
• While the current administration has provided waivers and flexibilities surrounding telehealth reimbursement, many of these will end as soon as the public health emergency (PHE) period ends.
• Regulatory priorities should be surrounding areas such as reimbursement, licensure, broadband equity, and DEA prescribing issues.
• Although telehealth has been an instrumental tool in providing greater access to care, some on Capitol Hill and in the administration still cite significant concerns about telehealth costs/utilization as well as fraud, waste, and abuse.
• Behavioral health is another area where telehealth proved to be beneficial. The demand for telebehavioral health services is still high; however, workforce shortage issues, which were a problem before the pandemic, have continued. 

Speakers and moderators included:

• Peter Antall, MD, President and Chief Medical Officer, Amwell
• Colby Tiner, Policy Analyst, Policy Research and Translation, American Heart Association
• Virginia Whitman, Public Policy Associate, Alliance of Community Health Plans
• Brad Wolters, Director, Federal Government Relations, Marshfield Clinic Health System
• JP Paluskiewicz, House Energy & Commerce Health Subcommittee
• Orriel Richardson, House Ways & Means Health Subcommittee
• Jay Gulshen, House Ways & Means Health Subcommittee
• Maddie Davidson, Senate Finance Committee
• Aliza Silver, Senate Committee on Health, Education, Labor & Pensions
• Lauren Conaboy, Vice President of National Policy, Centerstone

On November 12th, eHI Assistant Vice President, Policy, Catherine Pugh, presented on the impact of the 2020 elections on health IT policy to the Health Data Unbound virtual conference. Catherine discussed the election outcomes, what is on the to-do list for the lame duck session, and the outlook for the 117^th Congress and Biden Administration health regulatory agenda.

Key takeaways from the presentation:

• Health care was not a top issue to voters, as was expected
• Even more division and gridlock in Congress
• Both parties face internal reckoning between moderates and wings
• Health IT issues have largely been bipartisan – interoperability, telehealth, for example – but division in Congress means it will be difficult to move any legislation
• Not all of President Trump’s health care regulatory actions were partisan. Regulations on transparency, patient health data access and interoperability, and telehealth (among others) had support on both sides of the aisle
• The Department of Health & Human Services under a Biden Administration will focus immediately on COVID-19

Background:

In December of 2016, the 21st Century Cures Act was signed into law, and in March 2020, the Office of the National Coordinator for Health Information Technology (ONC) released its 21st Century Cures Final Rule (“Final Rule”) in order to implement key provisions of the law. This Final Rule was set to go into effect on June 30, 2020. However, due to the coronavirus pandemic (COVID-19), the health care industry shifted focus and resources to caring for patients impacted by the virus.

Although ONC previously announced a delay of many compliance deadlines to November 2, 2020, many of the key actors did not feel ready or prepared to comply due to COVID-19. The purpose of this Interim Final Rule (IFC) letter is to outline the newly delayed compliance dates. This will allow actors to continue focusing primarily on combating COVID-19, without the added pressure of meeting strict compliance rules. The flexibility of these dates aims to strike a balance between relieving pressure on actors and care providers, while also working to establish greater interoperability to enhance patient care in a timely manner.

Download the full summary below. 

eHealth Initiative Releases Survey on ONC and CMS Final Rules

Survey Provides Insights on Industry Readiness to Comply with Regulations

The eHealth Initiative (eHI) released the results of a survey on industry readiness to meet the requirements of the ONC Cures Act and CMS Interoperability and Patient Access Final Rules by the applicability date. The survey provides insight into industry awareness of the regulation, impact of COVID-19 on implementation, and readiness to comply.

Key Findings of the Readiness Survey

• Payers, providers, and vendors each identified implementing and maintaining the Patient Access Application Programming Interfaces (APIs) as a top area of concern (43%)
• Providers indicated the greatest impact of COVID-19 on their readiness (57%) in comparison to the other groups
• 47% of the respondents indicated preparedness to meet the applicability date
• The biggest data challenges to overcome are lack of data standardization (47%), lack of technical operability (44%) and shared data quality (44%)
• 44% of respondents identified that readiness is most impacted by the lack of prioritization across the industry due to internal competing priorities
• Payers and providers are most concerned with cost in choosing a vendor, with the former more willing to accept vendor assistance than the latter

“Despite the recent delays that push back the applicability date of many of the requirements in the Final Rules, the results reveal that payers, providers, and vendors have several areas of concern related to readiness,” said Jen Covich Bordenick, Chief Executive Officer of eHI. “For example, providers have been most significantly impacted by the current pandemic, but all stakeholder groups remained concerned about the capability to implement and maintain Patient Access APIs.”

(Members only)

From unprecedented Congressional and regulatory action on telehealth reimbursement to the release of final interoperability and information blocking rules, 2020 was a busy year for health technology professionals – and 2021 shows no signs of slowing down. Join eHI staff and Policy Steering Committee members for a deep-dive on the latest in health technology policy, eHI’s advocacy work, and a look ahead to the 117th Congress.

On October 26^th, eHI joined 84 other organizations in sending a letter to the Acting Administrator of the Drug Enforcement Agency (DEA) urging the agency to expedite and complete its efforts to implement a telemedicine special registration process enabling providers to safely prescribe controlled substances remotely. The agency was required to promulgate rulemaking on a telemedicine special registration process in the SUPPORT for Patients and Communities Act (P.L. 115-271), but has yet to do so nearly two years after enactment of the law.