Congress’ Last Ditch Efforts
As December 31st approaches, Congress is looking to pass multiple large pieces of legislation to close out the year. Lawmakers are facing a December 20th deadline to pass government funding bills. If they fail to pass legislation they may either approve another continuing resolution (CR) through January or there will be a government shutdown like last year. It is likely that either the spending bills will pass or there will be a CR. Additionally, there have been several discussions about passing drug pricing legislation before year’s end. There has been many different amendments and provisions added to the House bill over the last couple of weeks which has caused infighting amongst the majority regarding whether or not the bill will be voted down. Additionally, GOP lawmakers in the House introduced their own piece of drug pricing legislation. The House Majority intended to vote on the drug pricing legislation before breaking for winter recess, however, it looks as though negotiations have stalled. Senate Finance committee also released an updated version of their bill which they do not expect to pass prior to the winter recess.
Congress is also looking to address surprise billing legislation. The President released a statement from the press secretary that said the House and Senate have reached bipartisan agreement on the legislation that would require price negotiation between institutions and private payers to be publicly released for better transparency. Many physician and hospital groups are still opposed to the legislation and are lobbying the Hill to stop it from passing into law.
ASTCT Government Relations (GR) representatives will be meeting with CMS staff in December to discuss options for a potential FY2021 CAR T-call immunotherapy DRG. ASTCT will be joined by ASH in the staff level meeting along with one of ASTCT’s prominent physicians. We are hoping to receive feedback on our letter to the agency and hope to give staff further explanation of our asks which include: extending the NTAP and additional year and if not, to create a new CAR-T DRG that accounts for clinical trial cases. The hope is to lay the ground work for the larger DRG discussion in 2020.
Drug Pricing Legislation Updates
Drug pricing legislation has begun to stall in the 116th Congress as the end of the year draws near. The Administration has made a strong push for drug pricing legislation to be passed in 2019. In May 2018, President Trump’s Administration laid out its Drug Pricing Blueprint, which put forth a number of different policy ideas on how to lower the cost of prescription medication. The suggestions included, transparency, drug importation, the International Pricing Index, value based purchasing and Medicare program redesign. With the end of the Congressional year quickly approaching, there is pressure from the Administration to get legislation passed.
The most recent movement in the drug pricing space is with Speaker Pelosi’s bill, H.R. 3, Lower Drug Costs Now Act of 2019. The House bill aims to establish price negotiations in the Medicare program to protect from excessive price increases and to cap out-of-pocket costs for Part D enrollees. The bill also includes language regarding the International Pricing Index (IPI) model that was proposed in the Administration’s 2018 blueprint. The IPI model looks at prices for a list of certain drugs in other countries and compares U.S. costs against those and limits American prices charged in similar countries.
In the last couple of weeks there have been a number of edits and amendments added to the bill that has made it difficult to move on the House floor. Of note, the additions include: Part D out-of-pocket on Rx drugs capped at $2,000, require manufacturers to pay rebates on drug prices that increase “faster than inflation,” invest $10 billion in biomedical research funding at NIH, increase FDA funding $2 billion and to further address the opioid crisis. In opposition to the Democrat House bill the Republicans introduced their own version of drug pricing legislation, H.R. 19 the Lower Costs, More Cures Act of 2019, which was introduced as a messaging bill by Rep. Walden. There is healthy skepticism whether or not Congress will be able to pass anything at all before year end.
Earlier this year the Senate Finance Committee held a markup on S. 2543, The Prescription Drug Pricing Reduction Act of 2019 (PDPRA) and passed the bill out of committee in July. The text of that bill can be found here. However, the committee recently released a revised version of their bill which can be found here. Senator Grassley is pushing this legislation forward in conjunction with Rep. Walden’s H.R. 19. Grassley and Wyden added measures to their drug-pricing package and plan to use the bills’ savings to cancel two years of cuts to disproportionate share hospital (DSH) payments and fund healthcare extenders. The changes would lower costs for beneficiaries who exceed their deductible but do not reach the Medicare part D benefit, allow Medicare beneficiaries to spread drug costs over time, allocate discounts more evenly across drug makers, and pass price concessions negotiated by pharmacies to consumers. Senate Majority Leader Mitch McConnell has not agreed to bring the Grassley bill to the floor for vote. There has been Senate objections to the bill making it unlikely to be passed before the end of the year. Grassley hopes these changes increase GOP support for the bill. Both efforts by the GOP in the House and Senate have deluded the negotiations and aim to compete with Pelosi’s H.R. 3 bill. The likelihood of seeing any passage this year is unlikely. It looks like 2020 will be a packed legislative schedule with the 2020 election nearing.
MS-DRG for CAR T-cell Immunotherapy
On November 1, ASTCT Government Relations Committee submitted a letter to CMS on the potential for a new MS-DRG for CAR T-cell immunotherapies for FY 2021. The Agency solicited input on the potential for a new payment for these therapies and ASTCT ran a number of simulations to determine the most beneficial option for this therapy. The letter asks CMS to continue the NTAP payment through FY 2021 for an additional year and to delay the creation of an MS-DRG. Although the Society has previously made this request of the Agency and it has not yet been adopted, we are again making this request to the Agency to express the need to collect further accurate case data for an additional year. The volume of CAR-T cases has been lower than anticipated and there has been high variability in the data submitted. This created an inaccurate depiction of the actual costs of what it takes an institution to deliver these therapies. Additionally, the inclusion of clinical trial cases in the current DRG claims will unfairly determine the weight of a new DRG because the price of the drug is not included for those cases and an accurate cost cannot be determined.
We believe a new DRG for CAR-T is still premature and that the best solution would be to extend the NTAP payment. However, there is no precedent for the Agency extending the NTAP payment. Thus, we put forth additional options for CMS to consider if it chooses to proceed with creating a new DRG for FY 2021 rather than FY 2022. ASTCT has worked with other stakeholders to come to an agreement that works best in this space and it has been agreed upon that at a minimum CMS must handle the clinical trial cases for CAR-T. There is wide agreement that the Agency should consider the impact these cases have on the overall costs and subsequently reimbursement for these therapies. ASTCT understands that CMS does not want to over pay for claims, nor underpay, so our letter addresses this issue by offering options that balance the scales.
ASTCT asks that if the Agency chooses to continue with creating a new DRG for FY 2021 that it use the data from FY 2019 CAR-T claims data with no clinical trial diagnosis codes and with pharmacy charges greater than $373,000. This request will show the Agency a majority of the commercial cases to gauge the cost of care and will hopefully remove the clinical trial cases that don’t accurately depict the cost of delivering care for this therapy. We also ask that CMS use an off-set mechanism to pay for a new DRG where centers receive the product cost at no charge to account for clinical trial claims. ASTCT further recommends that the Agency provide sub-regulatory guidance on billing, coding, and charging practices so that there is more accurate reporting going forward.
While we have seen some movement out of the Agency this year on CAR-T therapies, such as the finalization of the NCD which included ASTCT’s recommendation not to include coverage with evidence development, and the increase of NTAP payments from 50 to 65% of the product cost in the finalized IPPS rule, we also know that there is a lot more work to be done in this area. ASTCT reminds the Agency that this is the first of many therapies of its kind and that we will continue to work with them to get these reimbursement (and coverage in Medicaid) issues correct.
This issue will be something largely focused on in 2020 and in ASTCT’s advocacy efforts for next year.
Looking Back on 2019
This year ASTCT GR Committee has been hard at work to accomplish many advocacy objectives on behalf of the Society. With drug pricing and transparency constantly in the news alongside the development of new therapies, it has been a challenge to emphasize the importance of patient access in the nation’s capital. However, ASTCT was successful in its advocacy efforts when it came to CAR T-cell therapies this year.
CMS released a final National Coverage Decision (NCD) for CAR-T that was largely influenced by ASTCT’s efforts in engagement with the Agency and lawmakers on Capitol Hill. Also, ASTCT helped to move the needle on the IPPS final rule (even though it was not what we had hoped for) made an increase to the NTAP percentage from 50 to 60% of the product cost for all new therapies. ASTCT GR also spent time in lawmakers’ offices advocating for this field of medicine and explaining how these innovative therapies are helping patients with life-threatening diseases. By holding a Hill Day in May, the GR committee came to Capitol Hill and got ASTCT’s (new) name recognized, making the Society the leaders in this space. GR also held a number of webinars to keep membership informed of the latest in regulatory changes that affect institutions, physician practices, and all others working in BMT. ASTCT also co-hosted four Congressional Briefings which educated Members of Congress and their staff on CAR-T therapies, sickle cell disease, and the issues with reimbursement and coverage in both the Medicare and Medicaid programs. Some of the additional accomplishments include multiple letters sent to CMS and attendance at agency meeting for: the NCD, IPPS and OPPS proposed rules, physician fee schedule modifications, ICD-10 CRS diagnosis codes, ICER value frame assessment suggestions, and HCPCS product codes.
It has been a very busy year for the newly formed Government Relations committee and we will continue to expand our advocacy role in 2020. Thank you to all of the incredible members who volunteer their time and dedication to further the ASTCT’s mission of improving the application and success of blood and marrow transplantation and cellular therapies for patients.
ASTCT Mention in Politico Pulse—The Society was mentioned in Politico Pulse for our work on CAR-T and for our November 1 DRG letter sent to CMS.
CMS Beyond the Policy Podcast—CMS released a new episode on their podcast that addresses transparency in health care and the Agencies deliverable on the President’s drug pricing blueprint.
KHN What the Health Podcast—Kaiser Health News released a new episode that discusses the costs of healthcare costs in the United States and the current funding bills that Congress still has to pass in 2019.
New Therapies for Sickle Cell Disease—FDA recently granted accelerated approval for two therapies for sickle cell disease patients.
Politico Exclusive on Administrator Verma—Politico recently published an article that discusses Administrator Verma’s request for reimbursement for the expenses she endured when her luggage was stolen on a recent trip. Namely, she submitted a reimbursement claim to HHS that totaled around $47,000 for her stolen luggage that contained her jewelry.