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AMIA is saddened to hear of the passing of Virginia K. Saba. Virginia was an early leader in emerging technologies in nursing and healthcare, and was a mentor to many. Her contributions to nursing informatics have made a lasting impact on patient care. Our thoughts are with Virginia's family and friends.

Top News

Biden Signs Infrastructure Bill, House Approves Build Back Better Act

President Biden signed the bipartisan Infrastructure Investment and Jobs Act (IIJA) into law last week, which will invest over $1 trillion to rebuild the country's roads and bridges and fund new climate resilience initiatives. The House of Representatives had voted 228-206 to approve the package 10 days earlier. The vote on the IIJA had been delayed by House progressives who insisted that the White House's Build Back Better Agenda bill pass first, then by Democratic moderates who demanded additional Congressional Budget Office (CBO) cost estimate of that bill. A deal was reached when progressives agreed to vote for the IIJA and moderates promised to vote for Build Back Better, upon seeing a CBO score that shows no increase in the deficit. Six House Democrats ultimately voted against the bill.

Among many funding provisions in the package is $65 billion in new funding for expanding broadband access. The funding will serve as a follow-up to the tens of billions of dollars already appropriated by the Consolidated Appropriations Act of 2021 and American Rescue Plan Act to achieve the goals of universal broadband access. In 2017, AMIA asserted that access to broadband was a social determinant of health. The Infrastructure Investment and Jobs Act (IIJA) allocates:

  • $42.5 billion to states to fund network deployments, prioritizing areas currently lacking a network capable of offering a 25 Megabits per second (Mbps) download and 3 Mbps upload service.
  • $14.25 billion to fund a $30 per month subsidy for low-income Americans to purchase broadband.
  • Instructions for the Federal Communications Commission to improve “its effectiveness in achieving the universal service goals for broadband in light of this Act.”
  • $2.75 billion to address digital training and literacy to ensure that “individuals and communities have the information technology capacity that is needed for full participation in the society and economy of the United States.”

The House additionally passed the Build Back Better (BBB) Act last Friday morning, almost entirely on party lines. This followed an eight hour and 32 minute speech by House Minority Leader Kevin McCarthy (CA) on Thursday night/Friday morning that was designed to delay the vote. The bill will likely be pared down after it moves to the Senate, who may not act on it until next month. It is unlikely that any Republican senator will support the bill, leaving Democrats with no votes to spare. Decisive votes Sen. Joe Manchin (D-WV) and Sen. Kyrsten Sinema (D-AZ), have balked at aspects of the legislation and have yet to give it their support. A summary of the health provisions in the BBB Act can be found here.


CMS Finalizes Physician Fee Schedule, Expands Telehealth Reimbursement

On November 2, the Centers for Medicare & Medicaid Services (CMS) released its Physician Fee Schedule (PFS) final rule for calendar year 2022. This rule sets policies for Medicare physician payments for non-hospital providers, as well as the Quality Payment Program (QPP), under which MIPS and Alternative Payment Models (APMs) are administered. CMS payment rules are the primary pathway that the agency uses to encourage adoption and use of new health informatics tools and health IT functionality. Among numerous other reimbursement updates, CMS finalized several policies expanding telehealth and other telecommunications technologies for behavioral and mental health care. The final rule:

  • Will continue to include, through 2023, telehealth services on the Medicare list that would otherwise have been removed as of the later of the end of the COVID-19 public health emergency or December 31, 2021.
  • Implements provisions of the Consolidated Appropriations Act of 2021 that will allow the home of the beneficiary as a permissible originating site for telehealth services when used for the purposes of diagnosis, evaluation, or treatment of a mental health disorder.
  • Requires that there be an in-person, non-telehealth service with the physician or practitioner within 12 months prior to the initial telehealth service, with exceptions to be made based on beneficiary circumstances.
  • Amends the definition of telecommunication systems to include audio-only technology when used for telehealth services for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients in their homes. This is limited to mental health services furnished by practitioners who have the capability to furnish two-way, audio/video communications, but where the beneficiary is not capable of, or does not consent to, the use of two-way, audio/video technology.

As for the QPP, CMS finalized its proposal to sunset the traditional MIPS program after the 2027 performance year and eventually requiring all eligible providers to meet program requirements by reporting through MIPS Value Pathways (MVPs) ̶ subsets of connected and complementary measures and activities, established through rulemaking. CMS has also finalized the initial set of seven MVP clinical areas: rheumatology, stroke care and prevention, heart disease, chronic disease management, lower extremity joint repair, emergency medicine, and anesthesia. In addition to this overarching program goal, CMS has also finalized:

  • Requiring reporting of the Immunization Registry Reporting and Electronic Case Reporting measures under the Public Health and Clinical Data Exchange Objective of the Promoting Interoperability MIPS performance category.
  • A new measure where MIPS eligible clinicians must attest to conducting an annual assessment of the High Priority Guide of the Safety Assurance Factors for EHR Resilience Guides (SAFER Guides).

A fact sheet and overview of the final rule can be found here, while detailed QPP resources can be downloaded here.

Biden Nominates Califf to Once Again Lead FDA

The White House announced on November 12 that President Biden has nominated former Food and Drug Administration (FDA) Commissioner Robert Califf to become the agency's leader once again. Califf had previously headed the agency in the last year of the Obama administration. The White House has struggled to find a candidate who it felt was both qualified and could win Senate confirmation. It reportedly ruled out the current acting commissioner, Janet Woodcock, after it became clear she would face opposition from a group of senators. By law, Woodcock can no longer serve as acting commissioner after today, unless a permanent commissioner has been nominated.

Califf's potential nomination points to the White House's desire for a confirmable, steady hand to calm recent internal turmoil at the agency. Last month, the top two officials of the FDA's vaccine office, Marion Gruber and Phil Krause, announced they are leaving the agency this fall, reportedly over frustration with the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices involvement in COVID-19 vaccine decisions that they think should be left to the FDA. 

During his time at FDA, Califf was instrumental in expanding the agency's activities in leveraging real-world evidence (RWE) to monitor post-market safety and adverse events and to make regulatory decisions. He has continued to be involved in thought leadership in this area since leaving FDA, as well as keynoted the AMIA Health Informatics Policy Forum in 2019.

Legislation & Politics

Cures 2.0 Sponsors Releases Updated Draft

Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) released an updated draft of their Cures 2.0 Act last week. The legislation includes numerous FDA reforms, as well as establishes the White House's proposed new biomedical research agency, the Advanced Research Projects Agency for Health (ARPA-H). The bill also aims to permanently ease certain Medicare telehealth requirements, codify a Medicare coverage pathway for innovative device coverage and require that CMS and FDA communicate on breakthrough drugs, in addition to funding and creating several pandemic-related programs. Other provisions in the updated legislation include:

  • Increasing funding to support the capacity of the Immunization Information System (IIS) within the CDC.
  • Requiring an update from FDA on efforts to improve diversity in clinical trials;
  • Requiring FDA to fully consider all patient experience data collected during the clinical trial;
  • Allowing Medicare to cover the costs of their beneficiaries in PCORI-funded clinical trials;
  • Requiring HHS to outline approaches to maximize and expand the use of real-world evidence;
  • Establishing a task force to develop recommendations on ways to encourage patients to engage in real-world data generation;
  • Requiring a Government Accountability Office report on recommendations to enhance Medicare coverage and reimbursement for innovative health technologies.

DeGette and Upton are hoping to introduce the bill on the House floor before the end of the year. However, continued negotiations with the Senate on the BBB Act and the looming fiscal cliff will likely push action on this bill into 2022. The full text of the Cures 2.0 Act can be found here and a section-by-section summary here.

Bipartisan Bill Targets Big Tech Algorithms

A bipartisan group of House members are reportedly introducing a bill that would require certain tech companies (e.g. Facebook and Twitter) to provide users with an option to opt out of algorithmic content feeds based on personal data. Cosponsored by Reps. Ken Buck (R-CO), David Cicilline (D-RI), Lori Trahan (D-MA) and Burgess Owens (R-UT), the Filter Bubble Transparency Act would require internet platforms to let people use a version of their services where content is not selected by “opaque algorithms.” Rather, a subset of online content providers would be required to offer users an “input-transparent algorithm.” The bill text describes this as, “an algorithmic ranking-system that does not use user-specific data to determine the order or manner that information is furnished to any given user on a covered internet platform, unless the user-specific data is expressly provided to the platform by the user for such purpose.”

The bill effectively targets only the large tech platforms, as it exempts smaller companies with fewer than 500 employees, those with annual gross receipts lower than $50,000,000 in the last three-year-period, and those that gather data on fewer than one million users annually. The imminent introduction of this bill in the House (as Senate version was introduced in June) is indicative of growing bipartisan anger over how tech platforms use their users' data. Nonetheless, few legislative days remain in 2021 for the House to act on the bill. Look for it to get renewed attention in 2022.

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AMIA's Washington Download is your source for health informatics policy news and information from around the Beltway, covering action from the Hill, the Administration and important AMIA collaborators.