The Centers for Medicare and Medicaid Services (CMS) has responded to comments from America’s Blood Centers (ABC) and other stakeholders in the blood community via OPPS and Physician Fee Schedule final rules. Specifically, the agency released an unpublished version of the hospital outpatient prospective payment system (OPPS) final rule and released an unpublished version of the Physician Fee Schedule final rule. The OPPS and Physician Fee Schedule final rules are set to be officially published in the Federal Register. Blood reimbursement reform is a key part of the ABC Advocacy Agenda and remains a priority for the blood community.
In the OPPS final rule, the agency finalized OPPS payment rates for hospitals and Medicare ambulatory surgical centers (ASCs) that meet applicable quality reporting requirements by 3.1 percent. This update is based on the projected hospital market basket percentage increase of 3.3 percent, reduced by a 0.2 percentage point for the productivity adjustment.
Beyond that, the final rule addresses ABC comments that were generally about the inclusion of blood as an essential medicine. Under the proposed rule, CMS had solicited public comments about the potential to pay for a “buffer stock” of essential medicines under the inpatient prospective payment system (IPPS) and OPPS payment rules. The list of essential medicines was pulled from an “Essential Medicines Supply Chain and Manufacturing Resilience Assessment” developed by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and published in May 2022.
In the OPPS final rule, CMS noted the following:
- “CMS is not finalizing any changes at this time, but intends to propose future policy addressing aspects of hospital practices with respect to pharmaceutical supply, including in future payment rules and through Conditions of Participation.”
- CMS noted the lack of consensus of stakeholders on the proposal. “The majority of commenters however, including MedPAC, stated they did not support the specific potential payment policy as described and discussed in the request for comment.”
- They cited comments about the use of alternative lists of essential medicines (which ABC proposed). “Many commenters agreed with the use of the 86 essential medicines prioritized in the report “Essential Medicines Supply Chain and Manufacturing Resilience Assessment (also referred to as ‘ASPR’s list’ by commenters).” Other commenters proposed other lists, including the list the U.S. Food and Durg Administration (FDA) was directed to issue under Executive Order (EO) 13944 (referred to as the “FDA list” by many commenters), the World Health Organization’s Essential Medicines List, Vizient’s Essential Medications For High-Quality Patient Care, a list of drugs developed by the National Association of EMS Physicians, and a Pediatric Drug List. Many commenters stated the EO 13944 list is more inclusive (including blood products) than ASPR’s list and some stated that health care workers are most familiar with it.”
Stated next steps included, “we appreciate the broad consensus regarding the need to curtail pharmaceutical shortages of essential medicines and promote resiliency in order to safeguard and improve the care hospitals are able to provide to beneficiaries. We agree with commenters that a multifaceted approach is likely necessary. As part of our initial efforts, we intend to propose new Conditions of Participation in forthcoming notice and comment rulemaking addressing hospital processes for pharmaceutical supply. Although in this final rule with comment period we are not adopting a policy regarding payment under the IPPS or OPPS for establishing and maintaining access to essential medicines, in response to the comments received, we continue to seek feedback from interested parties on ways to address the additional costs hospitals face to address pharmaceutical shortages and prepare for future emergencies. We will consider this feedback in future payment policy. We look forward to continuing to engage with the public on this critical issue in future rulemaking.”
In the unpublished Physician Fee Schedule final rule, CMS said the following concerning joint comments submitted by the blood community regarding therapeutic apheresis: “[s]everal commenters were in favor of establishing a specific new Therapeutic Apheresis Nurse Specialist labor category for CPT codes 36514, 36516, and 36522 because they did not believe the current RN/LPN labor code accurately captured their nurses’ specialized skills, experience, work, and time. Commenters pointed out that recruiting and retaining nursing personnel has been challenging, and when competing for an experienced specialized apheresis nurse, salary demands are higher to attract and keep them. The nominator also mentioned that a typical apheresis nurse tends to have an extensive clinical background and specialized therapeutic apheresis experience. Additionally, commenters noted that these nurses spend significant time with patients during apheresis procedures, often not leaving the patient’s bedside during the long procedure. Commenters noted that these nurses are trained to set up specialized equipment, work with hospital blood banks to acquire blood products, work with pharmacies for required medications, and consult with medical and nursing staff. [We] thank commenters for their detailed description of the typical duties of an apheresis nurse and how they might differ from a general RN/LPN nurse. Several commenters opposed the nomination of CPT codes 36514, 36516, 36522 as potentially misvalued and advised us to review the results of the forthcoming American Medical Association (AMA) Physician Practice Information Survey (PPIS) before making any changes. One commenter added that there might be a clinical labor type gap that CMS could resolve. We thank commenters for their feedback and for acknowledging the forthcoming AMA PPIS survey. After considering the public comments, we believe there may be a possible disparity with the clinical labor type for this service and that these codes would benefit from additional review in future rulemaking. We believe that it is likely that a general RN/LPN labor category is not adequately equivalent to an Apheresis Nurse Specialist and while there is currently no Apheresis Nurse category listed in the [physician fee schedule], there may be existing nurse categories that can act as a substitute, such as an oncology nurse. Therefore, for CY 2024, we are finalizing CPT codes 36514, 36516, and 36522 as potentially misvalued.”