2018 Physician Payment Advocacy Highlights

2019 Medicare Inpatient Hospital Rule

ASH offered comments on the 2019 proposed rule for the Inpatient Prospective Payment System (IPPS). The rule determines payment levels and related provisions for Medicare patients who are admitted to the hospital. ASH’s comments focused on reimbursement for chimeric antigen receptor (CAR) T-cell therapy. ASH did not believe that the proposal outlined by the Centers for Medicare and Medicaid Services (CMS) would provide equitable reimbursement for this innovative treatment, limiting patient access when institutions determine they cannot afford to deliver this therapy. ASH outlined an alternative reimbursement proposal that was site-neutral and product agnostic.

The final IPPS rule was issued in August. The final rule assigned CAR T-cell therapy to the renamed MS-DRG 016, Autologous Bone Marrow Transplant with a Complication or Comorbidity / Major Complication or Comorbidity (CC/MCC) or T-cell Immunotherapy and created a temporary New Technology Add-on Payment (NTAP) for the two currently approved FDA products. ASH is very concerned that this policy is insufficient and that due to inadequate reimbursement for the therapy, institutions will not be able to handle the financial strain and it will ultimately impact patient access to this therapy.

2018 Medicare Physician Payment Rule and Hospital Outpatient Prospective Payment System Rule

In July, the Centers for Medicare and Medicaid Services (CMS) released its annual proposed changes to the Medicare Physician Fee Schedule (PFS) that would be implemented on January 1, 2019. The rule updates payment policies and payment rates for services provided in the physician office. ASH’s comments focused on the proposed changes to Evaluation and Management (E/M) visits. ASH thanked CMS for addressing the documentation requirements for E/M codes in the proposed rule; however, the Society expressed strong concerns about the consolidation of E/M services into a single payment level and the establishment of an indirect practice cost index for E/M services. ASH opposes these proposals, which for hematologic services, will negatively impact patient access to care and physician workforce.

The Hospital Outpatient Prospective Payment System (HOPPS) proposed rule was also released in July. This rule outlines changes in payment policies for services rendered in hospital outpatient settings. ASH requested an Autologous Transplant Comprehensive Ambulatory Payment Classification (C-APC). The Society also supported the recommendation by the CMS Advisory Panel on Hospital Outpatient Payment to change the status indicators for the new Category III CAR-T CPT codes from “B” to “S,” and to cross-walk these codes to the stem cell transplants APCs. Lastly, ASH commented on the proposal to use a Competitive Acquisition Program (CAP) to help address the reimbursement shortfalls for institutions providing CAR T-cell therapy. The Society does not think that a CAP model is appropriate for CAR T-cell therapy payment because the model is not site neutral and does nothing to address the cost of care. 

The final rules for the PFS and HOPPS were published in early November and an oral report regarding the rules’ impact on hematology services will be provided to the Committee on Practice during its December meeting. Regarding the proposed changes to E/M visits, CMS finalized certain documentation changes for January 1, 2019, but changes to payment will not be implemented until January 1, 2021. Beginning in 2021, CMS will pay a single rate for E/M outpatient visit levels 2, 3, and 4 (one for established and another for new patients). The agency chose to not finalize the inclusion of level 5 visits in the single payment rate, to better account for the care and needs of particularly complex patients. CMS did finalize its policies to create complexity add-on and extended service codes that can be billed with all level 2-4 new and established outpatient visits. If the payment changes outlined in the final rule go into effect in 2021, CMS estimates hematology E/M reimbursement will be held harmless. In the HOPPS final rule, CMS did change the status indicator from “B” to “S” for one of the four CAR-T Category III CPT codes. This change means that this particular code will now be recognized as payable for outpatient services.

AMA, CPT Coding, RUC, and Medicare Payment Policies for Hematology-Specific Services

Dr. Gamini Soori and Dr. Chancellor Donald, both members of ASH’s Committee on Practice, continue to serve as ASH’s delegates to the American Medical Association (AMA) House of Delegates (HOD) and represented ASH at the 2018 AMA meetings. This year, Dr. Amar Kelkar served as ASH’s delegate for the Resident and Fellow Section (RFS) of the AMA HOD. Dr. Samuel Silver continues to serve as the ASH representative for the AMA Current Procedural Terminology (CPT) Advisory Committee and the AMA RVS Update Committee (RUC) Advisory Committee. Dr. Silver, along with ASH staff, attends the CPT and RUC meetings to ensure that hematology services continue to be properly coded and appropriately paid. Dr. Jamile Shammo, a member of ASH’s Committee on Practice, now serves as ASH’s Alternate Advisor to the AMA RUC Advisory Committee and Dr. Donald is in the process to be approved as ASH’s Alternate Advisor to the CPT Advisory Committee.

ASH, along with the American Society of Blood and Marrow Transplantation (ASBMT), the American Society of Clinical Oncology (ASCO), and the College of American Pathologists (CAP), requested four new Category III CPT codes to identify CAR T-cell therapy services. These four codes were approved at the May CPT meeting and will be effective January 1, 2019. Category III codes allow for data collection and utilization tracking for new procedures or services.

ASH continues to be actively involved in the Cognitive Care Alliance, which was established to ensure that evaluation and management (E&M) service code definitions and valuations accurately reflect the intensity of the cognitive work performed. ASH staff participated in meetings on Capitol Hill to educate key policy makers on the potential impact of the proposed changes to E&M visits in the Physician Fee Schedule. The Cognitive Care Alliance and ASH believe that a CMS-commissioned study will determine what improvements could be made to the description of work and documentation requirements so that new codes could be added that better describe the services provided by hematologists.

Reimbursement and Coverage for CAR T-Cell Therapy

Since approval by the Food and Drug Administration (FDA) of the first two CAR T-cell products, ASH has been working to establish adequate reimbursement for institutions providing this therapy. Reimbursement is needed not only for the cost of the product, itself, but also the high costs of care for patients receiving the therapy. ASH continues to work closely with the American Society of Blood and Marrow Transplantation (ASBMT) on this issue.

In June, ASH submitted comments on the National Coverage Analysis for CAR T-cell Therapy for Cancers. ASH argued that a National Coverage Determination (NCD) for CAR T-cell therapy is premature because this is an evolving area of medicine and therefore, it is impossible to know what the ultimate applications of this therapy will be; an NCD has the potential to limit access to a life-saving therapy for patients; and because the of complex nature of the national coverage process it is time-consuming and difficult to revise already existing NCDs.

In mid-July, ASH co-hosted a Capitol Hill briefing in the House of Representatives on CAR-T with the Lymphoma Research Foundation (LRF) and the National Comprehensive Cancer Network (NCCN). And in mid-November, ASH co-hosted a Capitol Hill briefing in the Senate on reimbursement and access for CAR-T with LRF, NCCN, and ASBMT.

In September, ASH was approached by the office of Dr. Ned Sharpless regarding the Society’s proposal for reimbursement for CAR-T therapy, outlined in ASH’s IPPS comment letter. ASH staff, joined by Dr. Sam Silver, Chair of ASH’s Reimbursement Subcommittee, briefed Dr. Sharpless on the proposal.

Additionally on November 1, ASH, jointly with ASBMT, submitted a letter to CMS Administrator, Seema Verma, outlining short-term and long-term reimbursement solutions for CAR-T therapy.

Merit-based Incentive Payment System (MIPS)

ASH continues to submit comments on proposed changes to the Quality Payment Program (QPP), and specifically to the Merit-based Incentive Payment System (MIPS). This year the proposed changes were part of the Physician Fee Schedule proposed rule. ASH’s comments included support for expansion of the low-volume threshold, which will help ensure that small practices and rural providers can be excluded from MIPS. ASH, however, opposed the proposed increase of the performance threshold, arguing that providers are still adjusting to and understanding how this program applies to their practice. Other areas ASH commented on included the increased weight of the cost category, the promoting interoperability performance category, topped-out measures, facility-based scoring, and the Medicare Advantage Qualifying Payment Arrangement Incentive Demonstration.

ASH is again offering for members to sign up to report data for MIPS through Healthmonix’s MIPSPRO, a 2018 Qualified MIPS Registry. MIPSPRO will walk users through the measure selection process, ensuring the appropriate requirements are met. Clinicians can register and report individually, or a representative from a practice can report for multiple providers within that practice. Healthmonix submits the data directly to the Centers for Medicare and Medicaid Services (CMS). 

Medicare Contractor Advisory Committee Meeting

In July, ASH, in conjunction with the American Society of Clinical Oncology, held the annual meeting of the hematology / oncology carrier advisory committee (CAC) network. This annual event brings together the hematologists and oncologists who serve as representatives to regional Medicare Contractors, Medicare Contractor Medical Directors, leaders from hematology and oncology state societies, and members of ASH and ASCO practice committees. The meeting is intended to provide attendees with a better understanding of the CAC process; discuss issues of common concern and develop solutions; and improve the overall CAC process throughout the year. Topics at this year’s meeting included the National Coverage Determination for Next Generation Sequencing, a case study on evidence-based medicine, proposed changes to the evaluation and management codes, and the financial implications of CAR T-cell therapy. Topics are chosen based on issues relevant to the attendees and the discussion provides an opportunity for different regions to learn from the experts and each other.

Center for Medicare and Medicaid Innovation

ASH participated in a meeting at the Center for Medicare and Medicaid Innovation (CMMI) to provide feedback on the Oncology Care Model (OCM) and also arranged for CMMI staff to meet with ASH members who are participating in this new payment model during the ASH Annual Meeting.

ASH Committee on Practice Capitol Hill Day

Members of the ASH Committee on Practice visited more than forty congressional offices to advocate for issues related to sickle cell disease and reimbursement for new hematologic therapies. The ASH advocates encouraged congressional offices to cosponsor the Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018. Slightly different versions of this legislation have now passed both the House and the Senate. The group also educated members of Congress about reimbursement policies for CAR T-cell therapy. ASH continues to have meetings on this issue with key members of Congress.

ASH Palliative Care Working Group

The Palliative Care Working Group continues to focus its efforts on coverage for palliative blood transfusions in hospice care. ASH staff, with input from the working group, drafted a policy statement on this issue. Once the statement has gone through the ASH process of approval, it will be housed on ASH’s website and used to educate providers, patients, and hospices. Members of the working group are also working on developing a demonstration project/payment model that could be considered by the CMMI for Medicare patients with hematologic malignancies who want to receive palliative blood transfusions while in hospice care.