Policy Communications

Policy Communications Updates

Monitoring New Administration Policies and Executive Orders

The American Association for the Study of Liver Diseases (AASLD) is monitoring the new administration’s policies and Executive Orders as they are released. On January 21, the Acting Secretary of the Department of Health and Human Services (HHS) Dorothy Fink issued a memo requiring health agencies to pause their public communications through February 1. This applies to the publication of documents, regulations, guidances, grant announcements, website updates, press releases, and social media. This pause prohibits meetings with agency officials, including speaking engagements. Additionally, work-related travel for HHS staff has been suspended indefinitely. Other administrations have taken similar actions at the start of a new president’s term as the new team assumes their roles. 

This policy created significant disruptions at the National Institutes of Health (NIH). It has been reported that study sections and institute and center council meetings have been suspended during this period. This means that no new grants will be reviewed and issued. Acting NIH Director Matthew Memoli informed staff that during this pause purchases for laboratory supplies and contracting for anything related to human safety, human or animal health care, security, biosafety, biosecurity, or IT security could continue.

Since we understand this pause in public communications will be temporary, we encourage members to wait for further updates after February 1. 

On January 27, the Office of Management and Budget (OMB) released a memo temporarily freezing all federal grants, loans, and other financial assistance programs to ensure that this spending complies with the administration’s Executive Orders related to DEI, clean energy, etc. Federal agencies were directed to complete a spreadsheet providing information on all programs that have funding or activities planning through March 15, 2025 by February 10. Despite clarification from OMB that this freeze would be limited, it still caused a great deal of anxiety and confusion regarding its scope—it was unclear if it applied to Medicaid payments and was expected to apply to some NIH grants. The memo was challenged in court, and a federal judge delayed the implementation of the freeze order until February 3. 

In response, the OMB rescinded the memo to make it clear that the administration will comply with the court order and end the court case. However, White House Press Secretary Karoline Leavitt acknowledged that the OMB memo has been rescinded but stated that the administration is still blocking federal spending it opposes. This continues to be an evolving situation that AASLD is closely monitoring and will update members as we learn more.

AASLD will convene a virtual Hill Day on Friday, March 14, to engage with Congress on these issues and its 2025 public policy agenda. This event is open to all AASLD members, and we encourage your participation and advocacy. For more information, contact Mike Providence, Director of Policy & Planning, at mprovidence@aasld.org. 

HHS Releases 2023 Viral Hepatitis Report

• On August 14, the U.S. Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy released updates on viral hepatitis. While much has been achieved, much more needs to be done. Here is a progress report on the current Viral Hepatitis Strategic Plan.

NIH Reform & Appropriations

• Recently, the House Appropriations Committee released its report accompanying its FY25 Labor-Health and Human Services bill. A link to the bill text released a few weeks ago can be found here.  
  
  In this report, the House Appropriations Committee adopted a proposal from Energy and Commerce Committee Chair Cathy McMorris Rodgers to restructure the NIH without any public hearings on the topic. AASLD signed a letter expressing concern about the restructuring of the NIH, including reducing the number of agencies from 27 to 15, and consolidation of the NIDDK into a larger institute. The letter went to the House Appropriations Committee leadership on 7/9/2024 with 223 organizations having signed. AASLD is gravely concerned that NIH’s investment in liver disease research will suffer substantially if this policy is enacted as proposed and will be submitting comments by the deadline of August 16. Members are encouraged to send their concerns to Chair McMorris Rodgers by highlighting the impact the policy would have on their research. 

HCV Elimination

• In June, the Congressional Budget Office (CBO) released a report examining policies that would increase treatment of hepatitis C in the Medicaid population and requested research and data related to HCV prevalence and elimination strategies. AASLD received expert feedback from our special interest groups and coalition partners in providing feedback to the CBO. AASLD is hopeful that legislation to eliminate hepatitis C, stemming from the White House HCV Elimination Plan, will be introduced in 2024.

CMS News

• The Centers for Medicare & Medicaid Services (CMS) just released the CY 2025 Medicare Physician Fee Schedule (MPFS) proposed rule. Notably, payment rates under the MPFS are proposed to be reduced by 2.80% and the proposed conversion factor is $32.36, a decrease of $0.93, in CY 2025. 

Here are the rule, press release, and fact sheet for your review.

• CMS has included expansion of access to hepatitis B vaccines in Medicare Part B as part of its 2025 MPFS proposed rule. Specifically, CMS is proposing to expand the definition of those at intermediate risk of contracting hepatitis B – to include those who did not complete their hepatitis B immunization series and those whose vaccination status is unknow – and proposing to eliminate the requirement that a doctor's order be needed for the administration of a hepatitis B vaccine. Therefore, Medicare Part B recipients would be able to receive a vaccination at a pharmacy, a senior center, or another venue that would be more convenient. Hepatitis B vaccines would also be added to the Medicare Part B "mass immunizer program" which allows for broad access to vaccines. The proposed rule also specifically mentions that this change would assist the nation's efforts to eliminate viral hepatitis.

AASLD has met with CMS and key Hill offices as well as signed a coalition letter advocating for this change.
CMS is accepting public comments through September 9, and we will need comments from as many community members and other stakeholders as possible to make sure this rule is finalized and that more individuals will have access to hepatitis B vaccinations.

Other Advocacy Updates

AASLD provided feedback via comment or sign-on letter for the following legislation:

• The Pay PCPs Act: expressed our support for the creation of a technical advisory committee, which would adopt an evidence-based approach to valuing evaluation and management and other cognitive services.
• Expedited Consideration of NCD for HCV Screening in Non-Primary Care Settings
• Preserving funding for the AHRQ (Agency for Healthcare Research and Quality)
• Opposing reductions to non-defense discretionary appropriations in fiscal year 2025

For more information, contact Erika Miller.

Previous Efforts

AASLD is committed to educating Congress and key federal officials on the growing burden of liver disease, to inform policies that support research and treatment of hepatic disorders. Along these lines, the Public Policy Committee has recently:

Increasing Hepatitis C treatment in the Medicaid population (6/17/2024)

On June 14, the Congressional Budget Office (CBO) released a blog post and report on increasing hepatitis C treatment in the Medicaid population, which shows that there will be savings if more Medicaid beneficiaries are treated. This is not a score, and the CBO called for more research in the following three areas:

• The effectiveness of outreach and other efforts in increasing testing, treatment initiation, and adherence among targeted populations (which would also depend on the specific populations included in the program);
• The costs of treating hepatitis C with DAAs; and
• The costs of treating complications from hepatitis C if the disease is untreated.

Besides these three areas, the CBO is also interested in updated data on the costs associated with untreated hepatitis C and the longer-term effects of expanded hepatitis C treatment. The CBO did not provide a deadline for submitting this information and other comments. AASLD will be working to compile information that can be shared with CBO in response and will be convening the HCV elimination coalition to solicit feedback from the group. 

For more information, contact Erika Miller.

HCV Plan Rural Health Impact

On behalf of the 70 undersigned organizations representing patients, providers, and public health organizations, we urge Congress to adopt legislation to eliminate hepatitis C and deliver better outcomes for hepatitis patients living in rural communities. These communities are disproportionately impacted by hepatitis C, seeing infection rates that are often estimated to be twice as high as those in urban areas. Fortunately, hepatitis C is curable with an 8-to-12-week oral therapy that is highly tolerated and over 95 percent effective. This epidemic does not have to continue in our most vulnerable communities, and passing legislation to eliminate hepatitis C will ensure that all Americans can know their hepatitis status and be connected to a low-cost cure. See the letter here.

Capitol Hill 2024 in Review

On April 4, AASLD welcomed 51 advocates, including AASLD members, patient advocates, and society staff, in support of advancing priorities related to the prevention and treatment of liver disease. Advocates joined 54 meaningful conversations with members of Congress and their staff to discuss AASLD’s top priorities. Specifically, participants urged members to (1) support authorizing legislation to implement the White House’s national plan to eliminate hepatitis C in the United States in five years; and (2) support for the development of a Department of Health and Human Services-wide strategic plan to combat all liver diseases. AASLD’s fact sheets on both requests can be found here.

Advocates met with the staff of members of Congress who are on committees relevant to these legislative requests. Additionally, they shared personal perspectives regarding their experience living with or caring for patients with liver disease. They also shared key liver disease statistics and findings relevant to their state and district. AASLD members and patient advocates made a lasting impact through these conversations, and we look forward to staying engaged with members of Congress and continuing to reinforce the need to prioritize the prevention, treatment, and study of liver diseases.  

Quick stats:

• 51 advocates from 16 states and Washington, D.C.
• 54 meetings – 32 in the Senate and 22 in the House
  • 7 meetings with Committee Leadership
  • 27 meetings with members on Committees relevant to AASLD requests

If you have any questions regarding AASLD’s advocacy, please contact Erika Miller.

Friends of NIDDK

As a member of the Friends of the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), AASLD joined with 30 other patient, provider, and research organizations to urge Congress to finalize the fiscal year (FY) 2023 omnibus funding bill with at least $47.5 billion for the base budget of the National Institutes of Health (NIH) and a comparable increase of at least $2.485 for the NIDDK to ensure the US continues to lead the world in providing new and better cures, diagnostics, and treatments while protecting all patients and the research enterprise. See the letter here.

Combatting Liver Disease: Eliminating Hepatitis C

On Wednesday, March 15, 2023, AASLD convened for the third installment in the Combatting Liver Disease briefing series focusing on the elimination of hepatitis C. The briefing included a robust discussion on the public health burden of hepatitis C and the Biden Administration's plans to develop a national hepatitis C elimination program. AASLD was fortunate to be joined by a panel of experts in the field, including:

• Dr. Francis Collins, Special Project Advisor to President Joe Biden and Former Director of the National Institutes of Health
• Dr. Norah Terrault, AASLD President, and Professor of Medicine and Chief of Gastroenterology and Liver Diseases at Keck Medical Center of the University of Southern California
• Dr. Julius Wilder, AASLD Public Policy Committee Co-Chair and Assistant Professor of Medicine at Duke University School of Medicine
• Ryan Clary, Hepatitis Advocate and Non-Profit Consultant

If you were unable to join us live, we recommend watching the recording below to learn more about the three main components of the White House's elimination plan: details on the disease progression and burden of hepatitis C if no action is taken, perspectives of a long time hepatitis C advocate who has been personally impacted by the disease, and the significant actions AASLD is taking to eliminate hepatitis C. 

RECORDING LINK: HERE

Combatting Liver Disease: Liver Cancer

On December 6, 2022, AASLD held its second briefing in the Combatting Liver Disease series focused on liver cancer – the third leading cause of cancer death in 2020 – and important public policy implications. The briefing was moderated by Dr. Steven Lidofsky, Chair of AASLD's Public Policy Committee, and featured remarks from several distinguished leaders in the field and insights from the patient perspective.

Specifically, panelists included:

• Dr. Doug Lowy, National Cancer Institute
• Dr. Liz Pomfret, University of Colorado
• Dr. Lewis Roberts, Mayo Clinic
• Tony Villiotti, Founder of NASH kNOWledge, and a liver cancer and liver transplant survivor

By watching the briefing, you will hear an overview of the issue, a discussion of what it’s like to live with liver cancer, and both the public health practitioner and medical research perspective on policies that can help combat liver cancer.

RECORDING LINK: HERE

Combatting Liver Disease: Alcohol-Associated Liver Disease

On Tuesday, September 20, 2022, AASLD sponsored the first Congressional briefing in their Combatting Liver Disease series for policy makers focusing on alcohol-associated liver disease. Moderated by AASLD Governing Board President Dr. Laurie DeLeve, speakers included:

• Dr. George Koob, Director of the National Institute on Alcohol Abuse and Alcoholism
• Dr. Vijay Shah, Mayo Clinic (AASLD Board Treasurer)
• Dr. Jessica Mellinger, University of Michigan (AASLD Member)
• Brian Bourgault, a person living with ALD

Speakers briefed the audience on changes to the ALD population, the challenges of securing funding for ALD-related research, and the perspective of someone who lives with a liver transplant due to ALD. Additional discussion focused on the future of digital health and AI in clinical trials and managing patient care for people who are at risk or develop ALD.

RECORDING LINK: HERE

Advocacy for Telehealth

Telehealth flexibilities have improved access to hepatology specialists during the COVID-19 pandemic and will remain an important tool for delivering comprehensive care to patients with liver disease. In March 2022, Congress approved a 151-day extension of certain telehealth flexibilities, including the elimination of the originating site and geographic restrictions and coverage of audio-only services, once the public health emergency concludes. AASLD will continue to advocate for these flexibilities as well as continued payment parity between in-person and telehealth services.

Telehealth Stakeholder Letter to the Senate

AASLD Weighs in on ARPA-H

President Biden proposed the creation of a new research accelerator called the Advanced Research Projects Agency for Health (ARPA-H) in his Fiscal Year 2022 budget request. Congress appropriated the first $1 billion for the new entity in its FY 2022 omnibus spending package. AASLD supports the new entity in concept and believes it has the potential to advance our understanding of liver disease. However, the society is concerned that funding for the new entity will supplant, not supplement, money for the National Institutes of Health (NIH). To prevent the lines between the two entities from blurring, AASLD is advocating for ARPA-H to be placed outside NIH.

Policy Agenda

Each year, the Public Policy Committee develops a policy agenda, which is then approved by the Governing Board, to guide our annual advocacy activities. While the agenda serves as a framework for implementing strategic initiatives, it is recognized that AASLD is prepared to respond dynamically to unforeseen opportunities or threats that may reshape its actions.

COVID-19 Checklists and Tools to Accelerate Relief for State Medicaid & CHIP Programs

• 1115 Waiver Opportunity and Application Checklist
• 1135 Waiver Checklist
• 1915(c) Appendix K Template
• Medicaid Disaster State Plan Amendment Template

On Monday, March 30, 2020, CMS released an interim final rule and blanket waivers to provide additional flexibilities to providers during the COVID-19 emergency. AASLD’s Government Relations Consultant CRD Associates prepared this summary [PDF].
CMS released additional waivers on April 9. All of the waivers can be found online [PDF].

Joint GI Society Message: CMS encouraged to pay for telehealth services at level with in-person visits

Joint GI Society Message: COVID-19 Telehealth Information for Gastroenterologists and Gastroenterology Care Providers