November 2023

Congress Passes Continuing Resolution Avoiding Government Shutdown

With only a few days to spare, Congress has passed a continuing resolution (CR) funding federal agencies and programs beyond the expiration of the existing CR that was set to expire at midnight this Friday, November 17. The CR, which passed the House on November 14 and passed the Senate the following day, will extend government funding to January 19 for some federal agencies and programs, including the Food and Drug Administration (FDA). Funding for most other public health and research programs – including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) – is extended through February 2. The measure has been sent to President Biden, who is expected to sign it into law before Friday.

Meanwhile, the House has continued efforts to try to advance individual fiscal year (FY) 2024 spending bills, the latest of which was the Labor, Health and Human Services, Education and Related Agencies bill, which funds NIH, CDC, and most other federal public health programs. After voting on over 100 amendments to the bill this week, House Speaker Mike Johnson (R-LA) was forced to postpone further action on the bill until after the Thanksgiving break at the earliest. Significant cuts to healthcare, education, and other programs that the public depends on drew the opposition of most Democrats and many Republicans, making it unlikely the bill would pass the House. Among the amendments adopted during the debate on the bill are several that would impose roughly $3.8 billion in net additional reductions to the NIH budget (beyond the $2.8 billion cut contained in the underlying bill), bringing the total cut to the NIH to roughly $6.6 billion, or approximately 14 percent, below the FY 2023 funding level.

The ongoing lack of a final FY 2024 budget leaves NIH and other public health programs in limbo and the prospect of a flat or reduced final budget may delay progress. Until a final deal is reached on the FY 2024 budget, grassroots support is critical to show your elected officials the importance of sustained and predictable NIH funding. Simply visit the ASH Advocacy Center, enter your contact information, and click “Submit Email” to quickly and easily send a message to your elected officials.

ASH Submits Comments for the Cell and Gene Therapy Access Model for Sickle Cell Disease

ASH recently sent a letter to the Centers for Medicare & Medicaid Services (CMS) Innovation Center (CMMI) outlining important items for CMMI to consider in the development of the Cell & Gene Therapy Access Model (CGT Access Model) for Sickle Cell Disease (SCD). The letter builds upon ASH’s advocacy for comprehensive care and outlines a thorough and inclusive “wishlist” for treatment considerations that are crucial to this model. ASH will continue to engage CMS and CMMI about care for individuals with SCD to improve access to high-quality, comprehensive, and clinically and culturally appropriate care.

ASH Comments on Budget Neutrality Policies

ASH submitted comments on the Provider Reimbursement Stability Act of 2023 to reform the budget neutrality policies applied to the Medicare Physician Fee Schedule. The provisions in this legislation seek to improve Medicare physician payment to promote the delivery of high-quality care for a growing population of Medicare beneficiaries. ASH strongly supports the proposed reforms to increase the budget neutrality threshold, allow for regular updates to direct cost inputs that inform prices, and connect inflationary updates to the conversion factor.

ASH also signed onto a letter led by the American Medical Association (AMA) Federation which thanked House leadership for drafting legislation aimed at reforming budget neutral policies, and highlighted the need for stability and predictability to Medicare physician payments.

ASH Joins Sign-On Letter to FDA on LDT Proposed Rule

In late September, the U.S. Food & Drug Administration (FDA) released a proposed rule to classify in vitro diagnostics (IVDs), and more specifically laboratory developed tests (LDTs), as medical devices. There is a 60-day public comment period for this rule and ASH is exploring the opportunity to submit comments on the rule’s potential impact. However, given the breadth of the proposed rule and the short timeframe to provide thoughtful comments, ASH joined a sign-on letter to extend the comment period by an additional 60 days.

Dr. Monica Bertagnolli Takes the Helm as 17th NIH Director

On November 9, physician-scientist Dr. Monica Bertagnolli began as the 17th director of the National Institutes of Health (NIH). She is the first surgeon and the second woman to hold the position. President Biden announced his intent to nominate Dr. Bertagnolli in May 2023 and she was confirmed by the U.S. Senate on November 7. She transitioned from her role as the 16th director of the National Cancer Institute (NCI), a position she held since October 2022.

Dr. Bertagnolli's key priorities as she takes office are ensuring clinical trials reflect the diversity of Americans to yield the best results; embracing the rapid expansion of new learning based analytical tools such as artificial intelligence and machine learning and ensuring their use serves to advance our understanding of and improving care for people; and restoring trust in science by making it accessible to all communities and inspiring the next generation of doctors and scientists.

Federal Cancer Parity Act Reintroduced in U.S. House of Representatives

Earlier this month, bipartisan legislation was reintroduced in the U.S. House of Representatives that would ensure that patients enrolled in certain federally regulated health plans have access and insurance coverage for all anti-cancer regimens. The Cancer Drug Parity Act (H.R. 6301) would require any health plan that provides coverage for cancer chemotherapy treatment to provide coverage for orally administered and self-injectable anticancer medications at a cost no less favorable than the cost of IV, port administered, or injected anticancer medications. A Senate version of the legislation (S. 2039) was reintroduced in June 2023 The Cancer Drug Parity Act represents one of ASH’s ongoing legislative priorities. Visit the ASH Advocacy Center to send a message to your elected officials urging their support for these important bills.

NIH Revises Grant Review Process

On October 19, the NIH announced it is taking steps to simplify its process to assess the scientific merit of research grant applications and mitigate elements that have the potential to introduce bias into review. Previously, five criteria were individually scored using a common scale; the simplified review framework reorganizes these criteria into three factors. Two of these factors – importance of research and rigor and feasibility – are scored using a common scale. A third factor, expertise and resources, is evaluated for sufficiency only and not given a numeric score. The simplified review framework will be implemented for grant applications received on or after January 25, 2025.

NIH has been gathering feedback from the extramural community on the grant application review process. In December 2022, the agency issued a request for information (RFI) outlining a revised framework for scoring peer review criteria for research project grant (RPG) applications, which ASH responded to with comments that supported NIH’s focus on ensuring that the RPG review process recognizes proposals with the greatest scientific merit.

NHLBI Solicits Feedback on Strategic Vision Refresh

The National Heart, Lung, and Blood Institute (NHLBI) is refreshing the NHLBI Strategic Vision, developed in 2016, to address emerging scientific opportunities in accordance with new National Institutes of Health (NIH) strategic plan requirements.

NHLBI is considering whether additional compelling questions and critical challenges are needed to address topics that have surfaced as priorities over the past five years to drive important scientific and health advances. The institute is seeking input on novel research needs and approaches across six focus areas;

1. Harnessing data science and new technologies to drive scientific discovery and precision health
2. Using novel approaches for addressing health disparities and tackling their biological underpinnings for heart, lung, blood diseases, and sleep disorders
3. Leveraging the power of community and patient engagement
4. Furthering the science on the importance of lifestyle behaviors
5. Supporting women’s health through the lifespan
6. Addressing and reducing the impact of “place” (geography, climate, rural/urban, neighborhood) on heart, lung, blood, and sleep health

Help the NHLBI identify scientific priorities, make decisions, and allocate resources by sharing your input to refresh the Strategic Vision. ASH encourages members of the hematology research community to submit provide input directly to NHLBI through December 15 via an online submission form on the NHLBI website.

2024 Medicare Physician Fee Schedule Finalizes Payment for Complex Patient Care

On November 2, the Centers for Medicare & Medicaid Services (CMS) released a final rule that updates payment policies for the 2024 Medicare Physician Fee Schedule. The agency finalized policies, supported by ASH, that implement several significant changes including payment for HCPCS code G2211, an add-on for services associated with complex patient care, payment for dental services inextricably linked to other covered services used to treat cancer prior to or during chemotherapy services, chimeric antigen receptor T-cell therapy, and the use of high-dose bone modifying agents (antiresorptive therapy).

The conversion factor for 2024 is set to decrease by approximately 3.37% from $33.89 to $32.74. Without Congressional action, CMS does not have the authority to mitigate or eliminate this cut. ASH submitted comments on how continued cuts to physician payment affect the specialty of hematology and continues to work with Congress and other stakeholders to reform physician payment policy.

Additionally, CMS will continue to pay for telehealth services at the non-facility rate for telehealth services performed in the Medicare beneficiary’s home. This will apply to telemedicine services delivered to Medicare beneficiaries until December 31, 2024, unless Congress passes legislation extending or permanently waiving the originating site requirement. In addition, the agency finalized the use of virtual supervision using real-time audio-video telehealth services through the end of 2024. ASH advocated for the continuation of telehealth services and is pleased to see this in the final rule. ASH staff will prepare a more detailed analysis of the final rule in the coming weeks. In the meantime, a CMS fact sheet and press release are also available for review.

2024 Medicare Outpatient Prospective Payment System Finalizes Payment for Dental Services

In addition to the Medicare Physician Fee Schedule (MPFS), CMS also released the 2024 final rule for the Outpatient Prospective Payment System (OPPS). This rule finalized a positive 3.3% payment update for services performed in the outpatient hospital setting, which is based on the increases in the cost of providing these services. Updates to the OPPS are required by law, unlike the MPFS.

In addition to the payment update, the rule finalized payment for over 240 dental procedures and associated codes to align with the updated dental services payment policies of the MPFS. This was provision supported by ASH in its response to the proposal.

The rule also addressed comments regarding the maintenance of a buffer stock of essential medicines within hospitals, as the agency asked for comments on this topic. While the agency did not finalize any policy, they did note that the comments received will be taken into consideration as future policy is developed. ASH submitted comments  and will continue to follow the issues as needed.  A CMS  fact sheet on the final rule is available for additional information.

Information Blocking Penalties on the Horizon

On November 1, the Centers for Medicare & Medicaid Services released a proposed rule that establishes penalties for healthcare providers that have committed healthcare information blocking, defined as “a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.”  The proposed policies would implement provisions contained in the 21st Century Cures Act, which established the sharing of electronic health information as the expected norm in health care. In addition to holding an information session on the proposed rule, additional resources on information blocking are available from the Office of the National Coordinator for Health Information Technology. CMS is accepting comments on the proposed rule until January 2, 2024.

There are two proposals within the rule that directly affect physicians. The first is under the Quality Payment Program. If a physician commits “information blocking” and is an eligible participant in the Medicare Merit-based Incentive Payment System (MIPS), then the physician would not be a meaningful user of electronic health records, and therefore would receive a score of zero in the MIPS meaningful use of the Electronic Health Record component, which comprises a quarter of physician’s total MIPS score.

Second, if a physician is participating in an accountable care organization (ACO), and the physician has been determined to be an information blocker, the physician will be banned from participating in an ACO for one year. Banning the physician from participation in an ACO prevents them from receiving additional revenue they might have gained under the shared shavings of the ACO.