Closing out the 2019 Calendar Year and the Government Funding Bill
Congress managed to pass a government funding bill right in the nick of time that was signed into law on the December 20th deadline. Many provisions of the bill benefit medical research, patient access, and therapeutic innovation. This bill provides a total of $41.7 billion for National Institutes of Health (NIH) funding, a $2.6 billion increase above 2019 enacted levels. The bill continues to support specific research initiatives such as Alzheimer’s disease research, HIV/AIDs research, the Cancer Moonshot Initiative, Childhood Cancer Data Initiative and Childhood Cancer Star Act, as well as research for the development of a universal flu vaccine. The FDA received an increase in funding to $3.16 billion with a focus on continuing FDA’ s efforts to advance generic drug reviews and increase medical product manufacturing in the United States. The bill also appropriates $75 million as authorized in 21st Century Cures Act for accelerated medical product development. The Centers for Disease Control and Prevention (CDC) funding was increased to $8 billion which is $1.4 billion above the President’s budget request. There was also funding to specifically support firearm injury and mortality prevention research. Health Resources and Services Administration (HRSA) also received increased funding of $7.3 billion for health center programs, the Ryan White program, and for HRSA’s Bureau of Health Professions programs to support the medical workforce.
Of great significance to ASTCT and the BMT community, the signed appropriations bill included language from the PACT Act regarding hematopoietic stem cell acquisition payments. Under Division N Section 108 of the bill, it provides payment for acquisition cost of stem cells for all transplants beginning with the cost reporting period that begins October 1, 2020. This important piece of legislation is a big step for the transplant community and treats stem cell procurement similar to that of solid organs. ASTCT will be working with CMS on implementation of the bill to ensure that our providers are informed as to reporting. ASTCT and NMDP’s advocacy efforts helped get the PACT Act signed into law.
Drug Pricing Saga Continues
Unfortunately, Congress was not able to pass any drug pricing legislation prior to the winter recess. However, conversations surrounding drug pricing have begun again in D.C. and it is believed that there could be a package that is introduced early in 2020. With the election on the horizon, there is large disagreement on what the legislation should contain and the passage of such a piece of legislation may face opposition.
Last year, H.R. 3, Lower Drug Costs Now Act of 2019, was introduced in the House with hope of passage out of both chambers prior to the close of the year. The negotiations on drug pricing stalled in December and even though the House passed the bill on December 12, the Senate did not take up the bill for a vote. 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 early 2019, 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 released a revised version of their bill late last year which can be found here. Senator Grassley introduced this legislation in the Senate in conjunction with Rep. Walden’s H.R. 19 that was introduced as the House Republican alternative pricing bill. 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 neither the Grassley bill nor the House passed version of H.R. 3 to the Senate floor for vote. There has been Senate Majority objections to the legislation and the need for an agreement is imperative for any type of package to be passed. With the 2020 election nearing, the Senate Majority is concerned with addressing drug pricing legislation as it remains a top priority for voters. Non-action on this issue could be problematic for Senate Republicans who wish to hold the majority. The election will largely play into what occurs legislatively in 2020.
ASTCT Advocacy Efforts
ASTCT Government Relations (GR) representatives meet with CMS staff in December to discuss options for a potential FY2021 CAR T-cell immunotherapy DRG. ASTCT attended the meeting with ASH regarding the November 1 DRG letter the Societies submitted to CMS. CMS staff was receptive to the continued issues with CAR-T therapy and recognized the urgent need to act. ASTCT explained the importance of extending the NTAP for an additional year to get better and more accurate data. However, the likelihood of that occurring is not promising, so we also discussed the creation of a new CAR-T DRG that accounts for clinical trial cases. We noted the issue with large variations in the data from the pharmacy charges and the need for more clarity into the product cost. We put forth the proposals from our letter and explained that this will be a precedent setting decision for both the agency and the department.
In further advocacy efforts, ASTCT and ASH in partnership with BIO will be meeting with an HHS senior advisor to Secretary Azar. We will discuss the importance of this therapy to this specific hematologic patient population and the continued barriers to patient access that exist. The meeting will hopefully discuss next steps for the therapy and the pipeline of products to come and what to expect for 2020 both from the Administration and from Congress.
FYI: ASTCT will be hosting a Hill Day this summer where volunteer members will attend meetings to meet with their Congressional Representatives in both the House and Senate to advocate on behalf of patients and to discuss the importance of these innovative therapies for this field of medicine. Keep an eye for information to come!
Looking Ahead to 2020
At the start of this New Year, ASTCT looks forward to continuing its 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 2019 with its advocacy efforts when it came to CAR T-cell therapies and will continue to do so in 2020.
ASTCT will continue to have discussion with various stakeholders about the creation of a new MS-DRG for T-cell immunotherapies. We will also focus our efforts on the upcoming Inpatient Prospective Payment System (IPPS) proposed rule that is due to be released in April. ASTCT will also be engaged in working closely with CMS to correctly implement the provisions laid out in the funding bill regarding hematopoietic stem cell acquisition costs. ASTCT will continue its participation in the CAR-T Working Group and looks forward to more opportunities of engagement with other stakeholder groups. We are going to continue the ball rolling on our successes from last year and look forward to a productive year in 2020.
BGov Article—Health Care is a top priority for voters and Congress is split on which issues to address.
Cancer Therapy Advisor Article—Discusses a CAR-T clinical trial for solid tumors.
AJMC Paper—Medicare cost drops after completion of CAR-T therapy.
Cancer Therapy Advisor Article—The next generation of T cell therapies could be “CAR-less.”
Kaiser What the Health Podcast Episode—This episode discusses the latest with the ACA lawsuits and the Medicare for All supporters.