ASTCT’s FY2020 IPPS Proposed Rule Response
On June 24th, ASTCT submitted comments to the Centers for Medicare and Medicaid (CMS) on the FY2020 Hospital Inpatient Prospective Payment System (IPPS) proposed rule. ASTCT’s comments respond to both the proposals put forth by CMS as well as the request for comment on certain items. Some of the recommendations ASTCT made to the agency include:
- ASTCT supports CMS’ proposal to increase the new technology add-on payment (NTAP) for all new technologies, but recommends that the agency increase the percentage from 50 percent to 80 percent rather than 65 percent as proposed for all NTAPs.
- ASTCT recommends that CMS implement cost to charge ratio (CCR) of 1.0 by requiring providers to report value code 86 on their claims and utilize the actual CAR-T product acquisition cost information from this field to calculate NTAP and outlier for CAR-T cases only. ASTCT always intended for the concept “CCR of 1.0” be implemented in this manner.
- ASTCT recommends that CMS eliminate CAR-T clinical trial claims in determining the relative weight of MS-DRG 016 and in future CAR-T rate setting.
- ASTCT urges CMS to use its authority to apply a different rate setting methodology in FY 2021 for CAR- T therapy in order to avoid the issues of charge compression of the product acquisition cost and address the shortcomings of existing data. The Society offers our preliminary thoughts on this.
ASTCT’s submitted comment letter can be found here.
ASTCT also held a webinar on June 12th outlining the policy rationale behind the comment letter. The slides and recording of the webinar can be found here.
ASTCT Meeting with CMS
On June 6th, ASTCT and ASH representatives met with CMS leadership to discuss the IPPS proposed rule. The two groups thanked the agency for its continued engagement on improving payment policies for CAR T-cell therapy. ASTCT presented the asks included in the comment letter:
- Increase all NTAPs to 80% of the product cost.
- Implement a CCR of 1.0 to calculate NTAP and outlier for CAR-T products only.
ASTCT and ASH explained that these recommendations were based on review of the available data with the goal of ensuring appropriate patient access to the therapy. ASTCT walked through the FY2018 case volume data and the reimbursement rates for PPS hospitals. Additionally we highlighted for CMS leadership the issue with hospital pharmacy charge data and the issues related with markup for this product and explained the inconsistencies we’ve seen from the data.
ASTCT also presented the sample claims data that we have been using in our discussions. CMS leadership asked why there is such a disparity in the hospital charging practices for this therapy and we stated that it is unclear from the data why this is happening. We presented the options we considered when recommending what would be most appropriate for the FY2020 rule making cycle. ASTCT explained that implementing a CCR of 1.0 would neutralize charging practices through the use of revenue code 0891. The use of the new revenue code for CAR-T makes the implementation of a CCR of 1.0 a solution that is unique to CAR-T and will help with data collection for future rate setting.
ASTCT and ASH also discussed FY2021 and beyond and suggested that clinical trial cases should not be used in the weight of the DRG because of the inaccurate representation of costs. We also discussed NUBC value codes and the ability for CMS to require coding that would allow for better data collection that will result in the most appropriate future rate setting.
CMS appeared interested in our recommendations and requested that we include our charts in the appendix of our comment letter which can be found here.
ASTCT and ASGCT Senate Briefing
On June 18th, ASTCT in partnership with the American Society of Gene and Cellular Therapy (ASGCT), American Society of Hematology (ASH), and the Sickle Cell Disease Association of America (SCDAA) held a Senate Briefing with the Sickle Cell Disease Caucus to discuss the progress in Sickle Cell Disease (SCD) treatment and current policy implications. The Senate briefing was hosted by Sens. Tim Scott and Cory Booker. The briefing addressed the value of gene therapy for SCD and the recent results from clinical trials that have shown near elimination of symptoms of the disease.
The briefing also touched on ways Congress can help support access to these therapies for SCD, namely through increased NIH funding, novel payment models for approved gene therapies, improved Medicare reimbursement and appropriations to the SCD prevention and treatment program.
More information on the briefing can be found here.
Executive Order
On Monday June 24th, President Trump signed an executive order (EO) on price transparency aimed at lowering rising healthcare costs. The order requires hospitals to publish prices that reflect what people pay for services. The intention is to lower costs through price transparency to allow patients to “shop around” for services thus making market forces drive down the costs.
Alex Azar, the Secretary of the Department of Health and Human Services (HHS), said, “The president knows the best way to lower costs in health care is to put patients in control by increasing choice and competition.” The executive order directs HHS to draft a new rule that would require hospitals to disclose prices that patients and insurers will actually pay. Azar also noted that the new rule should “require health care providers and insurers to provide patients with information about the out-of-pocket costs they’ll face before they receive health care services.”
Other provisions in the EO include:
- Directs HHS to propose rules that require hospitals to make prices available for patients (negotiated rates);
- Requires HHS to propose rules for providers & insurers to provide out-of-pocket costs to patients before providing services (advanced Explanation Of Benefits);
- Roadmap to quality—improves and consolidates the quality measures;
- Increases access to de-identified data for research, with the goal of improving quality of care;
- Increases access to health savings accounts, by adding additional services that are covered under HSAs.
The EO put out by the White House “seeks to enhance the ability of patients to choose the healthcare that is best for them. To make fully informed decisions about their healthcare, patients must know the price and quality of a good or service in advance.” The order itself does not specifically outline in detail many provisions, so there is room for HHS interpretation with implementation of the order.
The text of the Presidential Executive Order can be found here. ASTCT will continue to monitor this closely.
Hill Activity
The House and Senate have been in session the entire month of June. In the House, on June 12th the Energy and Commerce Committee held a hearing entitled “No More Surprises: Protecting Patients from Surprise Medical Bills.” The hearing addressed the No Surprises Act discussion draft that aims to prevent surprise medical bills and limits patient cost-sharing to the in-network amount for emergency services. The intent is to resolve the payment dispute between providers and insurers by requiring that the insurer pay at minimum the median in-network negotiated rate for the service in the geographic area where the service was delivered. More information on the hearing and the discussion draft can be found here; a recording of the hearing can be found here.
On June 12th, the Ways and Means Committee held a hearing entitled, “Pathways to Universal Health Coverage” which addressed the issues in insurance coverage and the need for better health outcomes. The hearing discussed H.R. 1384, Medicare for All Act of 2019, which was introduced in the House. The testimony of the witnesses can be found here and the recording of the hearing can be found here. Additionally, the Ways and Means Committee held a markup on healthcare legislation on June 26th that included the following pieces of legislation:
The recording of the markup can be found here.
The House passed all of the FY2020 Appropriations funding bills as follows:
On June 19th, the House passed a four-bill Appropriations package (H.R. 2740) for FY202 that includes funding under Health and Human Services Education and related agencies; Department of Defense and related agencies; State and Foreign Operations and related agencies; and Energy and Water Development and related agencies. The package totals $982.8 billion for FY2020 with $645.1 billion in defense funding and $261.7 billion in nondefense funding. The division-by-division summary can be found here.
Additionally, on June 25th the House passed a five-bill Appropriations package (H.R. 3055) for FY2020 that includes funding under Commerce, Justice, Science, and Related Agencies; Agriculture, Rural Development, FDA, and related agencies; Interior, Environment, and related agencies; Military Construction, Veterans Affairs, and related agencies; and Transportation, Housing and Urban Development, and related agencies. The package totals $383.3 billion in discretionary budget authority for FY2020. The division-by-division summary of the bill can be found here.
The House also passed H.R. 3351 on June 26th, which provides FY2020 funding for Financial Services and General Government appropriations. The summary of that bill can be found here.
In the Senate, the Health Education, Labor and Pensions (HELP) Committee held a hearing on June 18th that considered the draft legislation of Lower Health Care Costs Act of 2019. The bill is aimed at lowering costs through prescription drug price transparency efforts, ending surprise medical billing, improving transparency and public health and improving the exchange of health care information. The recording of the hearing can be found here.
On June 25th, the Senate Finance Committee introduced S. 3120, Helping to End Addiction and Lessen Substance Use Disorders Act of 2018. The bill establishes a series of requirements under Medicare and Medicaid relating to substance-use disorder prevention and treatment, including educational programs, screening requirements, and prescription drug monitoring.
PCORI Reauthorization
On June 26th, the House Ways and Means Committee voted to release H.R. 3439, The Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act of 2019. The bill extends PCORI for seven years and makes minor changes to PCORI’s national research priorities to include mental health, substance use, and maternal morbidity and mortality. The bill was adopted by vote and will be moved through committee.
The Senate has yet to release any legislation on PCORI reauthorization which expires in September.
ICYMI
ASTCT Article in MediaPlanet USA—ASTCT teamed up with MediaPlanet USA on its transplants campaign, which supports people in need of lifesaving organs. ASTCT’s feature shares further insight into the field of cellular BMT, including cellular therapy, and the advancements being made in the field.
CMS: Beyond the Policy Podcast—CMS released its fourth podcast episode which is a throwback to the 2019 HIMMS Conference. The episode features highlights from attendees at the 2019 Healthcare Information Management Systems Society (HIMSS) Annual Conference. This year, Administrator Verma gave two keynote presentations on the agency’s vision for the future and its focus on interoperability.
Kaiser Permanente’s “An Arm and a Leg” Podcast—In this month’s episode of an “Arm and a Leg” podcast, the host discusses the varying prices in prescription drugs across the market.
First Democratic Primary Debate—On Thursday June 26th, MSNBC hosted the first live Democratic Primary Debate for the 2020 election cycle, which touched on healthcare reforms.