Leading off this month are two big announcements for our policy and advocacy work going forward. First, as detailed here, we recently announced we're changing our name to the American Society for Transplantation and Cellular Therapy (ASTCT). We are also excited to welcome our newly appointed Director of Government Relations, Alycia Maloney. Maloney will lead ASBMT in our renewed commitment to advancing smart and patient-centered policy in the realm of transplantation and cellular therapies, and we look forward to a productive future under her policy leadership. For details on Alycia’s background, please see our official announcement here.
As mentioned in past newsletters, and as part of the refined focus of ASBMT going forward, we will be launching a Government Relations Committee that will play an integral role in CAR-T and other policy issues. If you are interested in joining this committee, please email a statement of interest to .
CAR-T – Coverage with Evidence Development
On February 15, the Centers for Medicare and Medicaid Services (CMS) released the National Coverage Analysis (NCA) for CAR-T therapy for cancer. ASBMT reviewed the proposed policy carefully and is in the process of developing comments for submission by the March 17 deadline. The final National Coverage Determination (NCD) will be effective in May.
During the initial comment period last June, ASBMT submitted comments urging CMS not to proceed with this NCA. The Society shared our concern that finalizing a coverage policy will cause significant and ongoing barriers to providing current and future CAR-T therapies to beneficiaries in need of breakthrough treatments. Our comments expressed concerns about the detrimental impact a policy of coverage with evidence development (CED) would have on patient access and recommended that the CMS should implement a NCD providing coverage to the label with a data collection requirement.
CMS did not follow our recommendations and is proceeding with the coverage process that includes CED. The NCA proposes to “cover autologous treatment with T-cells expressing at least one CAR through coverage with evidence development when prescribed by the treating oncologist, performed in a hospital…” Coverage would be limited to patients with relapsed or refractory cancer. This will cover the currently approved products. However, we are concerned that this limitation will mean CARs currently in the pipeline will not be covered, since NCDs are not regularly revised and the reconsideration process is lengthy.
The CED requirement in the policy seems less onerous than others that have previously been imposed, which is positive. It requires data reporting to an approved registry. Preliminary analysis indicates that CIBMTR would qualify, but there are still many questions about how this requirement will operate in practice. Most notably, ASTCT is concerned about whether the policy as drafted would allow centers to opt out of the registry reporting requirement, creating additional access problems. There are several issues besides this one on which we are seeking clarification from CMS in order to provide informed comments.
Above all, ASTCT wants to ensure that the implemented NCD will not create additional access barriers for patients and we are committed to ensuring patients have access to the currently approved CARs and other yet to be approved therapies. The Society has devoted significant time and resources to improving Medicare reimbursement for CAR-T because of the access challenges the current reimbursement rate has created. Any coverage policy should not create new barriers to access. We will continue to keep membership updated on both coverage and payment policies.
ASBMT Members Asked to Participate in AMA RUC Survey on E/M Codes
You may have been selected to participate in an AMA/Specialty Society RVS Update Committee (RUC) survey for physician office visits (99202-99205, 99211-99215) and a new prolonged services code (99XXX). As you may know, the components of the Medicare Physician Payment Schedule are physician work, practice expense and professional liability insurance. This survey will help ASBMT, in concert with the RUC, recommend accurate relative values for physician work and direct practice expense to the Centers for Medicare and Medicaid Services.
The CPT guidelines and descriptors to report office visit codes will undergo extensive revision for implementation in 2021. Code level selection will either be based solely on medical decision making or total time on the date of the visit. The extent of history and physical examination will no longer be an element in the code level selection of office visits. When you receive this important survey, please be sure to read the new CPT guidelines and code descriptors in detail before taking the survey. A link to the survey, with the new guidelines for office visits, will be provided in an email for you to participate.
Please note that the second section of this survey is intended to capture practice expense in the physician office. When you get to the practice expense section of this survey, please be prepared to work with your clinical staff and practice manager to capture information such as nurse time spent related to each code level of the office visits and the typical medical supplies and equipment used in the provision of the visit.
For more information on the RUC survey process, please watch the following YouTube video: Understanding the RUC Survey Instrument.
This survey is very important to ASBMT and the medical profession. To ensure integrity of the data, we ask that you do not collaborate with any other physician on your responses to the physician work portion of this survey.
CMMI Announces Part D/MA Payment Modernization Models
CMS has announced new payment models, developed through the Center for Medicare and Medicaid Innovation (CMMI), that would aim to decrease drug spending in Medicare Part D and Medicare Advantage, especially in the catastrophic coverage phase. The model updates the Value-Based Insurance Design model launched in 2017, and introduces the option for plans to take on upside and downside risk in order to incentivize lower spending on beneficiaries’ drug benefits. To read CMS’ press release on the model, click here. For an overview of both models from FierceHealthcare, click here.
PBM Rebate Proposal Released
On January 31, HHS and the Office of the Inspector General released a new plan aimed at the Trump administration’s stated goal of reducing drug prices by proposing to end safe harbor protections for drug rebates through pharmacy benefit managers (PBMs). The plan would do away with certain price reductions offered by drugmakers to PBMs, Part D plans, and Medicaid managed care organizations, instead aiming to create a new avenue for direct discounts given to patients purchasing drugs. For an outline of the proposed policy, click here.
Major payers and PBMs largely came out in public opposition to the plan, which could upend commercial drug pricing models. For an overview of the response to the proposal, click here.
HIV Moonshot
At his State of the Union address in February, President Trump announced a pledge to stop the transmission of HIV by 2030 – a “moonshot” drawing comparisons to former President Barack Obama’s goal to bring about a decade’s worth of cancer research advances in five years, announced at the 2016 State of the Union. The plan will provide additional funding to 48 high-risk counties, as well as Washington, DC and San Juan, Puerto Rico, and will target seven states with especially high rates of rural transmission. For views of the proposed plan and response from the health policy community, click here.
Major Stakeholders Release Plan to Tackle Surprise Billing
As Congressional scrutiny over hospital “surprise billing” intensifies, stakeholders across the healthcare community are banding together to address the issue and guide potential Congressional action. A coalition of payer groups, including America’s Health Insurance Plans, the Blue Cross Blue Shield Association, and the National Retail Federation, released a set of guiding principles aimed at protecting patients who receive these bills. Soon after, a coalition of hospital groups, including the American Hospital Association, the Federation of American Hospitals, and America’s Essential Hospitals, released a joint letter to Congress outlining their critical principles for addressing surprise billing. Payers placed more blame on providers for lack of participation in networks, while the hospital coalition pointed the finger at payers for inadequate network coverage. To read more, click here.
Finally, the Brookings Institution released an analysis of state approaches to surprise billing, which can be found here.
ICYMI
CMS: Beyond the Policy Podcast – The Centers for Medicare and Medicaid Services recently launched “Beyond the Policy,” a new podcast highlighting updates and changes to policies and programs in an easily accessible and conversational format. The inaugural epsidoe focuses on the recent changes to Evaluation and Management (E/M) coding, which we have covered in past editions of the Policy Perspectives newsletter. This episode and a transcript can be found here, and is available for download on iTunes and the Google Play stores.
Hospital Prices, Not Physicians, Drive Cost Growth, Health Affairs Says – A recent study in Health Affairs found that hospital prices for inpatient care grew substantially faster than growth in physician prices from 2007-2014, and found similar results with outpatient care. Study authors stated that their findings suggest a needed policy focus on antitrust enforcement, reference pricing, and referral incentives, but hospital organizations have pushed back on the results, citing the use of “limited data to draw broad conclusions.” You can view the full study at Health Affairs here.
As Value-Based Efforts Lag, Push for Price Regulation Gains Momentum – Modern Healthcare examines a growing movement to address healthcare spending through price setting, rather than focusing on unnecessary and wasteful services.
Medicaid Fights, ACA Lawsuits, and Drug Pricing – Politico’s “Pulse Check” podcast provides a roundup of the latest developments in Medicaid expansion, a court battle over Affordable Care funding, and Congress’ moves on drug pricing.