McDermottPlus Check-Up: December 15, 2023

THIS WEEK’S DOSE

• House Healthcare Legislation: The House passed the Lower Costs, More Transparency Act and the Support for Patients and Communities Reauthorization Act.
• House Hearing on AI: The House Energy & Commerce Committee held a hearing on artificial intelligence (AI) leadership and innovation.
• Senate Markup of Healthcare Bills: The Senate Health, Education, Labor & Pensions (HELP) Committee held a markup to advance bills on cancer screening, substance use disorder and opioid treatment.
• Senate Hearing on Diabetes Epidemic: The Senate HELP Committee held a hearing to discuss the underlying causes of the diabetes epidemic.
• Senate Hearing on Substance Use Trends: The Senate Special Committee on Aging held a hearing to examine substance use among older adults.
• Administration Data-Sharing Initiative: The Office of the National Coordinator for Health Information Technology (ONC) announced the operational establishment of a nationwide health data exchange.
• ONC HTI-1 Final Rule: ONC released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.
• CMS HCBS Guidance: The Centers for Medicare & Medicaid Services (CMS) released new guidance to improve access to home- and community-based services (HCBS).
• CMS Revised Guidance for Medicare Prescription Drug Inflation Rebate Program: The agency released revised guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate programs.

CONGRESS

House Passes Healthcare Legislation. The House brought two key bipartisan healthcare bills to the floor this week. The Lower Costs, More Transparency Act (H.R. 5378) was approved by a vote of 320–71, and the Support for Patients and Communities Reauthorization Act (H.R. 4531) was approved by a vote of 386–37.

The Lower Costs, More Transparency Act includes measures to enact site-neutral payment policies for drug administration; ban spread pricing for payment arrangements with pharmacy benefit managers (PBMs) in Medicaid; require providers, PBMs, health insurers and others to adopt certain transparency rules around charges and costs; extend funding for Community Health Centers and Teaching Health Centers with graduate medical education programs; and prevent hospital disproportionate share payment cuts.

The Support for Patients and Communities Reauthorization Act would reauthorize the SUPPORT Act, which provided grants to states for prevention and treatment services for those with opioid use disorders. The SUPPORT Act expired on October 1, 2023, and H.R. 4531 would reauthorize these programs through FY 2028. Across the Capitol, the Senate HELP Committee approved the Senate’s bill to reauthorize the SUPPORT Act, the SUPPORT for Patients and Communities Reauthorization Act (S. 3393), this week (see related story below).

With the passage of these bills, the House is positioning itself to negotiate with the Senate in the new year on a healthcare package that could potentially be attached to the January 19, 2024, government funding bill.

House Energy & Commerce Committee Holds Hearing on AI. The hearing examined concerns and opportunities related to the development and use of AI, emphasizing the need for federal oversight and safeguards. The discussion highlighted the importance of a comprehensive data privacy standard that would address information outside of traditional health records protected by HIPAA. The discussion noted the US Food and Drug Administration’s (FDA’s) involvement in approving AI applications in healthcare, with a notable increase from 400 to almost 700 approvals in a short span. The hearing also highlighted the collaboration between ONC and the FDA to coordinate requirements for AI-enabled health technologies and ensure transparency to prevent stakeholder confusion.

Senate HELP Committee Holds Markup. The markup included consideration of four bills, three of which were health related. All were bipartisan and advanced by wide margins.

A full list of the bills, including section-by-section summaries and proposed amendments, can be found here. The outcomes of the three health-related bills are as follows:

• S. 1840, SCREENS for Cancer Act of 2023, to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program through FY 2028
  • Advanced by a vote of 20 yeas and zero nays
• S. 3393, SUPPORT for Patient and Communities Reauthorization Act, to reauthorize through FY 2028 SUPPORT Act programs that provide grants to states for prevention and treatment services for those with opioid use disorders
  • Advanced by a vote of 19 yeas and one nay
• S. 644, Modernizing Opioid Treatment Access Act, to expand the take-home prescribing of methadone through pharmacies
  • Advanced by a vote of 16 yeas and five nays

Senate HELP Committee Holds Hearing on Diabetes. The hearing examined factors that lead to diabetes. The discussion focused on the role of ultra-processed foods in contributing to negative health outcomes, including Type 2 diabetes, as well as treatment solutions and the need for more research to achieve a cure for Type 1 diabetes. There was bipartisan concern about private payer patients being unable to access insulin at $35 per month. The panelists focused on Type 1 diabetes and called for increased research for a cure and affordable insulin until a cure is found.

Senate Special Committee on Aging Holds Hearing on Substance Use Trends. The hearing highlighted the goal of achieving true parity in access to treatment and recovery services for individuals with Medicare or Medicaid coverage. The focus remains on addressing existing gaps in the current system. The hearing noted the catastrophic impact of fentanyl on the opioid crisis, emphasizing its role in driving the surge in overdose deaths, particularly among older adults. Senators emphasized the importance of building on existing legislative frameworks, such as the SUPPORT Act, to enact comprehensive measures that address the unique challenges faced by older Americans with substance use disorders. Technology and preventive measures such as wastewater monitoring were discussed as crucial tools to enhance intelligence gathering, track drug flows and prevent the influx of illicit substances, all of which would contribute to a more proactive approach to drug abuse prevention.

ADMINISTRATION

Administration Launches New Data-Sharing Initiative. On December 12, the US Department of Health and Human Services (HHS), through ONC, announced that the nationwide health data exchange governed by the Trusted Exchange Framework and Common Agreement^SM (TEFCA^SM) is now operational.

The following organizations were officially designated Qualified Health Information Networks™ (QHINs™) after completing the TEFCA onboarding process:

• eHealth Exchange
• Epic Nexus
• Health Gorilla
• KONZA
• MedAllies

These designated QHINs can immediately begin supporting the exchange of data under the Common Agreement’s policies and technical requirements. Read the HHS press release here.

ONC Releases Health IT Certification Final Rule. This long-awaited final rule implements sections of the 21st Century Cures Act and updates the ONC Health IT Certification Program with new and revised standards including transparency requirements for AI, implementation specifications and certification criteria.

The major provisions in the rule, as outlined in ONC’s fact sheet, include:

• Algorithm Transparency: Establishes first of its kind transparency requirements for AI and other predictive algorithms that are part of certified health IT. The agency’s regulatory approach will promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness and safety.
• USCDI Version 3: Adopts the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program as of January 1, 2026. Developers of certified health IT will also have the ability to move to USCDI v3 sooner. USCDI v3 includes updates to prior USCDI versions focused on advancing more accurate and complete patient characteristics data that could help promote equity, reduce disparities and support public health data interoperability.
• Enhanced Information Blocking Requirements: Revises certain information blocking definitions and exceptions to support information sharing, and adds a new exception to encourage secure, efficient standards-based exchange of electronic health information under the TEFCA^SM.
• New Interoperability-Focused Reporting Metrics for Certified Health IT: Implements the 21st Century Cures Act’s requirement to adopt a Condition of Certification for developers of certified health IT to report certain metrics as part of their participation in the Certification Program. These metrics will give more insight into how certified health IT is used in support of care delivery.

ONC will host information sessions in early 2024 to explain the final rule. Additional details are included in the fact sheet.

HHS Takes Actions on Medicare Drug Pricing: 

• CMS released revised guidance for the Medicare Prescription Drug Inflation Rebate Program that includes key requirements and procedures for calculating rebates and invoicing manufacturers that owe rebates to Medicare under the Medicare Prescription Drug Inflation Rebate Program for certain drugs covered under Medicare Part B and Part D. CMS also released the list of 48 prescription drugs for which Part B beneficiary coinsurances may be lower between January 1, 2024, and March 31, 2024. Some Medicare beneficiaries who take these drugs may save between $1 and $2,786 per average dose starting January 1, 2024, depending on their individual coverage. Read the CMS press release here, the Medicare Part B Prescription Drug Inflation Rebate revised guidance here and the Medicare Part D Prescription Drug Inflation Rebate revised guidance here. A fact sheet on the Medicare Prescription Drug Inflation Rebate Program revised guidance is available here.
• HHS issued a new drug price negotiation report that provides an in-depth review of the 10 drugs selected for the first cycle of Medicare drug price negotiations under President Biden’s Inflation Reduction Act (IRA). In its press release, HHS noted that it is making fair pricing a standard part of contract negotiations for medical products developed or purchased as part of its commitment to obtain best value for the US taxpayer.
• CMS sent a letter to PBMs, Medicare Part D Plans, Medicaid Managed Care Plans and Private Insurance Plans outlining an increasing number of concerns about actions taken by certain plans and PBMs that threaten the sustainability of pharmacies.

CMS Releases Guidance to Improve Access to HCBS. The guidance reminds states of tools to better connect direct support workers to individuals receiving Medicaid-covered HCBS. The agency’s new guidance focuses on building and maintaining worker registries so more individuals receiving Medicaid-covered services can receive care in a setting of their choice. The guidance also notes significant federal funding available to help states build these registries through the American Rescue Plan (ARP).

CMS also released data on how enhanced funding for HCBS provided through the ARP has been invested to strengthen access to HCBS across the country. Read the CMS press release here.

QUICK HITS

• MACPAC Holds December Meeting. The Medicaid and CHIP Payment and Access Commission hosted its two-day December meeting, during which it discussed sexual orientation and gender identity data collection, Medicaid financing, disproportionate share hospital allotments, beneficiary engagement, Medicaid unwinding and Medicare-Medicaid plan transition monitoring.
• CMS Releases National Health Expenditures 2022 Highlights. CMS noted that US healthcare spending grew 4.1% to reach $4.5 trillion in 2022, faster than the increase of 3.2% in 2021. The analysis provides a breakdown of health spending by type of service or product. Read the CMS fact sheet here.
• Supreme Court Issues Order on Mifepristone. The Supreme Court of the United States issued an order indicating that it will hear a case on expanded access to the abortion drug mifepristone. The Court is likely to hear oral arguments in spring 2024 and issue a decision by the end of its term in June 2024. In the same order, the Court denied a request to hear a broader case challenging the longstanding initial approval of mifepristone.
• HHS Releases National Plan on Alzheimer’s Disease. The National Plan is a roadmap of strategies and actions for how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors.
• GAO Releases Report on AI. The US Government Accountability Office (GAO) released a report reviewing the implementation of AI at major federal agencies. GAO made 35 recommendations to 19 agencies, including OMB, to fully implement federal AI requirements.
• White House Releases Blog Post on AI. The White House released a blog post, Delivering on the Promise of AI to Improve Health Outcomes, noting that 28 providers and payers announced voluntary commitments on the safe, secure, and trustworthy use and purchase and use of AI in healthcare.  According to the White House, these commitments will serve to align industry action on AI around the “FAVES” principles—that AI should lead to healthcare outcomes that are Fair, Appropriate, Valid, Effective, and Safe.

NEXT WEEK’S DIAGNOSIS

The House is scheduled to be out of session until January, while the Senate is scheduled to remain in session next week to continue to work toward an agreement on funding for Ukraine, Israel and US border reform, as well as nominations and other non-health related issues.  As Congress heads toward recess for the holiday season, the weekly Check-Up will also be taking a holiday break. We will resume our regular publication schedule on January 5, 2024. Happy holidays!

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