Summary
Both the House and Senate are in session this week, for a busy two week stretch before recessing for the winter holidays. This week the House is set to take up a series of bills including the TRANQ Research Act, which would require the National Institute of Standards and Technology to coordinate science and research activities regarding illegal drugs containing the horse tranquilizer xylazine, new synthetic opioids and other substances of concern. The House unanimously passed a version of the bill in May but is now voting on minor tweaks made by the Senate. The House is also set to vote on the Elizabeth Dole Home Care Act, which would expand caregiver support for veterans outside of nursing homes.
In the Senate, Majority Leader Chuck Schumer (D-NY) has said he would bring the President’s $105 billion-plus supplemental foreign aid request to the floor this week. While most Senate Republicans agree that additional aid for Ukraine, Israel, and Taiwan is needed, they are also insisting on meaningful border policy changes. A bipartisan group negotiating border policy changes, however, have not come to a resolution yet, leaving the question if the bill will pass. House Republicans are insisting that H.R. 2, the House GOP’s border security bill be a part of any package, which is a non-starter for the White House and Congressional Democrats. Time is ticking as the Administration conveyed in a letter from OMB Director Shalanda Young to Congressional leaders stating that if Congress does not pass a bill with additional funding, the Pentagon will run out of resources to provide funding and more weapons to Ukraine. The Senate could also bring up the National Defense Authorization Act this week, but timing is dependent upon the supplemental.
Hearings and Markups
Senate Finance Committee: The Senate Finance Committee will hold a hearing on Tuesday titled Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective. The hearing will examine drug shortages, focusing on supply challenges, impacts, and policy solutions from a federal health program perspective.
Energy & Commerce Committee: On Tuesday the House Energy & Commerce Committee will hold a markup of 44 various bills across the Committee’s jurisdiction. The health-related bills being marked up include:
- H.R. 2365, National Plan to End Parkinson’s Act
- H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023 \
- H.R. 2880, Protecting Patients Against PBM Abuses Act
- H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D.
- H.R. 5385, Medicare PBM Accountability Act
- H.R. 5386, Cutting Copays Act
- H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program.
- H.R. 5389, National Coverage Determination Transparency Act, as amended.
- H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act, as amended.
- H.R. 5396, Coverage Determination Clarity Act of 2023
- H.R. 5371, Choices for Increased Mobility Act of 2023
- H.R. 5388, Supporting Innovation for Seniors Act
- H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage.
- H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023, as amended.
- H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023, as amended.
- H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to revise the phase-in of clinical laboratory test payment changes under such program.
- H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models.
- H.R. 5555, DMEPOS Relief Act of 2023
- H.R. 6545, Physician Fee Schedule Update and Improvements Act
- H.R. 6364, Medicare Telehealth Privacy Act of 2023
- H.R. 1352, Increasing Access to Biosimilars Act of 2023
Regulatory Update
The Office of Management and Budget (OMB) completed reviewing an interim final rule that would establish rules regarding CMS enforcement of states’ compliance with reporting requirements and renewal requirements during the period that begins on July 1, 2023 and ends on June 30, 2024. The interim final rule may codify existing guidance and provide more details on how CMS may enforce the requirements.
OMB is also reviewing the following rules:
Medicare, Medicaid, or Both:
- Appeals Process – The propose rule, pursuant to a court order, would establish new appeals processes for Medicare beneficiaries who have an inpatient hospital admission changed to outpatient by a hospital.
- Healthcare System Resiliency and Modernization – The proposed rule would establish culturally competent and person-centered requirements for all provider and supplier types that participate in Medicare and Medicaid programs.
Other Topics:
- Conscience Rights in Health Care – The final rule would safeguard the rights of federal conscience and religious nondiscrimination while protecting access to care, including abortion.
- Health Data Interoperability – The final rule would implement certain provisions of the 21st Century Cures Act and make several enhancements to the ONC Health IT Certification Program to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.
OIG Report
OIG Issues Semiannual Report to Congress With Summaries of Work From March Through September
The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released the Semiannual Report to Congress providing an overview of the Agency’s activities from March 2023 through September 2023 including data on reports, audits, investigations, and other statistics. OIG highlights that HHS could recoup $3.4 billion in recoveries from OIG audits and investigations.
The report describes OIG’s work on identifying significant problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs and operations during the reporting period. Highlights include discussions on:
- Medicare payment for psychotherapy services during the COVID-19 public health emergency (PHE);
- Reporting of health, fire safety, and emergency preparedness in nursing homes;
- FDA enforcement against tobacco retailers with a history of violations;
- Program integrity risks from telehealth;
- Treatment of opioid use disorder among Medicaid enrollees; and
- Placement and transfer of unaccompanied refugee children.