Although our fearless leader in health policy is no longer with us, the work we do for ASBMT rolls on. As the ASBMT leadership continues the hiring process for Stephanie’s replacement, we will be working with a dedicated team of experts from Cavarocchi – Ruscio – Dennis (CRD) Associates. Erika Miller, JD, is a Senior Vice President & Counsel with CRD, and will be spearheading ASBMT’s policy and government relations work along with Stefanie Rinehart, VP. They are both subject matter experts with years of experience in payment and reimbursement policy, the Medicare program, and the appropriations process. We are looking forward to partnering with CRD on our ongoing projects and continuing to provide expert policy analysis and advocacy during this time of transition.
Outpatient Prospective Payment System Final Rule
On November 2, CMS released its final rule for the Hospital Outpatient Prospective Payment System (OPPS) finalizing payment policies for 2019, including policies related to CAR-T therapy. ASBMT had submitted detailed comments in September on the proposed rule, and in response, the agency adopted some, but not all, of the Society’s recommendations.
This year, ASBMT worked with the American Society of Hematology, the American Society of Clinical Oncology, and the College of American Pathologists to develop new Category III CPT codes for CAR-T therapy. These codes were not included in Category I because of the limited number of providers delivering the service and amount of data available. CMS had assigned the whole family of codes a status indicator of “B” which is not separately payable, and ASBMT requested that the agency revise this assignment to “S” which would allow for separate payment. The agency did not reassign the entire family, but did reassign 0540T (Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous). This change is significant since the agency recognizes that the CAR-T cell infusion cannot accurately be described by the chemotherapy administration codes.
Despite multiple requests from ASBMT, CMS did not remove the patient care services (“leukapheresis and other dose preparation procedures”) from the definition of the CAR-T product Q-codes for both FDA-approved CAR-T products. The agency also did not convert the Q-code to a J-code which are for drugs that are not administered orally. However, CMS is deleting the existing Novartis Q2040 and replacing it with Q2042 which will reflect cell dosage for both the pediatric and adult indication and changed the description for both Q-codes slightly so that it reads, per therapeutic dose rather than per infusion.
CMS also addressed the error in the rate-setting process for the existing allogeneic transplant C-APC 5244 that the National Marrow Donor Program identified. The agency had inadvertently excluded revenue code 0815 (Allogeneic Stem Cell Acquisition Services) from the packaged revenue code list, but corrected this omission for CY 2019 rate setting.
ASBMT will be holding a town hall on this topic Dec. 12, 12 p.m. CST. Click here to sign up.
Medicare Physician Fee Schedule Final Rule
On November 1, CMS released its final rule for the 2019 Medicare Physician Fee Schedule, which determines the payment rates for physicians participating in Medicare (for a more detailed summary of the rule, click here). In the proposed rule, CMS outlined a policy to revise how outpatient evaluation and management (E/M) visits are paid and documented. The physician community was united in its opposition to the proposal, expressing concern that the payment changes could potentially impact beneficiary access to care. In response, CMS has significantly revised its policy and is not implementing any payment changes until January 1, 2021. The agency has reiterated that they will continue to engage with stakeholders on the policy and refine it through upcoming rulemaking cycles. They also note that the delay will allow them to consider what comes out of the AMA CPT/RUC working group focused on E/M coding, as well as additional proposals from stakeholders.
CMS has provided this chart outlining changes to payments under the new E&M rule, and CMS Administrator Seema Verma directly addressed clinicians in this letter. ASBMT will continue to monitor new developments and report to members on any relevant changes.
CMS Releases Medicare Advantage and Part D Proposed Rule
On October 26, CMS issued a proposed rule updating Medicare Advantage (MA) and Medicare Part D for 2020. The proposal would allow MA and Part D plans to cover additional telehealth benefits for beneficiaries, with CMS allowing more leeway “to meet the needs of their enrollees.” Additionally, the proposal would update the methodology for calculating star ratings for MA and Part D plans, modifying existing measures and allowing for rating adjustments in the case of external uncontrollable events. CMS also recently expanded supplemental benefits for MA plans through the Bipartisan Budget Act of 2018, with at least 40 percent of MA plans offering new benefits such as home meal delivery, nicotine replacement therapy, and transportation to doctors’ offices.
To read a fact sheet on the proposal from CMS, click here.
Administration Announces International Drug Pricing Index Model
On October 25, President Trump and HHS Secretary Alex Azar proposed a new model for drug pricing in the Medicare program. Known as the International Pricing Index model (IPI), Medicare’s payments would be correlated with international prices for certain drugs, with the intention of reducing list prices and out-of-pocket expenses for Medicare beneficiaries. Currently, Medicare Part B prices physician-administered drugs with an average sale price plus an additional 6 percent add-on fee. Under President Barack Obama, a similar, but less far-reaching proposal was almost universally panned by Republicans.
For a CMS fact sheet on the IPI proposal, click here. For a deeper examination of the proposal and responses from Congress and the pharmaceutical industry, click here.
CMS Releases New Guidance on State Insurance Market Waivers
On October 22, CMS and the Treasury Department jointly released new guidance for states seeking to develop State Innovation Waivers for state insurance marketplaces under Section 1332 of the Affordable Care Act (ACA). Section 1332 permits states to apply for waivers of certain requirements under the ACA to pursue innovation in providing access to health insurance for their residents. The guidance aims to direct states to more easily develop waiver applications, by providing information on the process for application reviews and operational considerations. Under Section 1332, waiver applications must provide coverage that is at least as comprehensive as would be provided without the waiver, provide coverage and cost-sharing protections at least as affordable as without the waiver, cover at least a comparable number of residents as without the waiver, and not add to the federal deficit.
The administration has made it clear that they will continue to work with states to encourage additional waiver applications, by providing additional guidance and releasing model concepts to be used to spur state waiver developments.
HRSA Moves Up 340B Rule Implementation
The Health Resources and Services Administration announced that it will implement its rule on price ceilings and monetary penalties on January 1, 2019, moving up the date from the planned July 1 start date. The rule would punish pharmaceutical companies that overcharge hospitals in the 340B program and set price ceilings for drugs, and has been delayed five times since its issuance in January 2017. Large healthcare organizations including the American Hospital Association and 340B Health had sued the department for repeated delays. To read more about the announcement, click here.
ASBMT Participates in Capitol Hill Briefing and Visits on CAR-T
ASBMT, the American Society of Hematology, the Lymphoma Research Foundation, and the National Comprehensive Cancer Network sponsored a briefing for Capitol Hill staff on November 13 to discuss the reimbursement challenges facing providers who provide CAR-T therapy. President-elect Dr. Navneet Majhail from the Cleveland Clinic and Dr. Joseph Alvarnas from City of Hope walked staff through the science of CAR-T, the current Medicare reimbursement pathways for CAR-T, and outlined short and long term solutions to the reimbursement challenges. Staffers in the room had the opportunity to ask both Drs. Majhail and Alvarnas questions at the end of the presentation, and the inquiries focused on how to protect patient access to CAR-T while ensuring that the Medicare program remains sustainable, as well as how long it will be until a value-based purchasing model for CAR-T can be developed.
After the briefing, Dr. Majhail participated in meetings with the majority staff for the Senate Finance Committee and the majority and minority staffs for the House Ways & Means Committee. Both of these committees have jurisdiction over Medicare payment. ASBMT will be following up with these staff members with additional information.
ICYMI
Why Doctors Hate Their Computers – Atul Gawande explores the pitfalls of EHRs in his New Yorker column.
What the 2018 Midterm Elections Mean for Health Care – A former Democratic staffer gives an overview of potential implications in the health care space for the 116th Congress.
What Does the Outcome of the Midterm Elections Mean for Medicaid Expansion? – The Kaiser Family Foundation examines the state of play for Medicaid after several ballot initiatives passed in November.