Updates from CMS
ASTCT and the American Society of Hematology had a joint call with members of CMS’ Hospital and Ambulatory Policy Group to reiterate our recommendations to improve payment for CAR-T therapy in FY 2020 and to share our early thinking about how to reimburse equitably for the therapy in FY 2021 and beyond. Dr. Dianna Howard, co-chair of the new ASTCT Government Relations Committee, participated in the call and shared the challenges they are facing at Wake Forest establishing a CAR-T program because of the institution’s concerns about reimbursement. We expect CMS to release the final FY 2020 Inpatient Prospective Payment System rule in early August.
We are still waiting for the release of CMS’ CY 2020 Physician Fee Schedule and Hospital Outpatient Prospective Payment proposed rules. At press time, their release is almost a month behind schedule. We expect the former to include significant changes to the payment and documentation of outpatient evaluation and management services and the latter to include policies related to CAR-T therapy. Upon their release, we will provide updates to membership.
Congress and the White House Reach a Deal to #RaisetheCaps
Prior to adjourning for the August recess, Congressional leadership and the White House agreed to a deal to raise the budget caps and the debt ceiling. It passed the House by a vote of 284-149 on July 25. The measure provides for an additional $324 billion to be added to the spending caps over the next two years and avoids spending cuts of approximately 10 percent to federal agencies for FY 2020. The Senate is expected to vote on the bill before they adjourn for recess on August 2. Upon their return, the Senate Appropriations Committee will begin considering its FY 2020 spending bills. Unlike the House that passed its spending bills earlier this summer, the Senate was waiting until a deal to raise the caps was finalized. Congress will have to pass a continuing resolution (CR) to fund the government when FY 2020 begins on October 1 because of the late start the Senate is getting on its work. Without a CR, federal agencies, including the National Institutes of Health, the Health Resources and Services Administration, and the Department of Defense, will be forced to shut down because of a lapse in funding.
Latest on Drug Pricing Policy from Capitol Hill
Congress continues to work on a bipartisan basis to address the high cost of prescription drugs. On July 23, the Senate Finance Committee released a draft of the Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and two days later held a markup on the bill. The text of the bill can be found here. The package is projected to save the federal government $85 billion over 10 years, and is estimated to save beneficiaries $27 billion in out-of-pocket costs and $5 billion in premiums over 10 years.
The bill includes drug pricing reforms to Medicare Part B, Part D, and to Medicaid. For Medicare Part B, provisions make changes to reporting of Average Sales Price by manufacturers, payment of new drugs, biologicals and biosimilars, and rebate requirements. For Medicare Part D, the bill includes a significant redesign of the Part D benefit, along with other provisions. For Medicaid, there are a variety of provisions that address drug pricing, rebates and value-based agreements for outpatient drugs. Notably for ASTCT members, the bill provides states with a novel method to pay for high-cost treatments, including cellular and gene therapies, shifting to a value-based system. Under the provision, states would negotiate with drug manufacturers directly to develop long-term payment arrangements for certain therapies with the potential to cure or reduce a patient’s symptoms. States would be able to pay installments, which would be dependent on outcome benchmarks.
Of note, the Finance Committee rejected an amendment during its markup that would set Part B drug prices based on the price in other countries similar to the administration’s International Pricing Index (IPI) model. ASTCT submitted comments on an advance notice of proposed rulemaking last fall expressing our concerns about this policy. The administration’s IPI model proposed rule is currently under review by the Office of Management and Budget.
Moving forward, the provisions in the Prescription Drug Pricing Reduction Act of 2019 are expected to be combined with drug pricing provisions from the Senate Judiciary Committee and the HELP Committee’s Lower Health Care Costs of 2019 bill. The full Senate will vote on the measure after the August recess, and we expect several amendments to the bill before that time. This legislative package will then have to be reconciled with the House’s drug pricing legislation, which is expected to be released by Speaker Pelosi in September. The White House has put out a statement of support for the Senate Finance Committee’s bill, as it aligns with the Administration’s initiatives to lower prescription drug costs.
Surprise Billing Legislation Also Waiting until After Recess
This summer the House and Senate were working on legislation to stop surprise billing, the bills passed onto patients when they see an out-of-network provider at an in-network facility. Despite their best efforts, neither chamber was able to pass legislation prior to the start of the August recess.
While stakeholders all agree that patients should be protected from these unexpected bills, they have not coalesced around a policy to address the issue. The legislation as introduced in the House and Senate both tied payment rates to a benchmark based on in-network rates in certain geographic areas. However, physician group stakeholders have expressed concern about this approach and have strongly advocated for the inclusion of an arbitration process to address payment disputes. In a July 17 Energy & Commerce Committee mark-up, an arbitration amendment was added to the House’s No Surprises Act. Concerned stakeholders support the change, but are still lobbying for the provision to be strengthened.
Full Senate consideration of the HELP Committee’s Lower Health Care Costs Act was expected prior to the August recess, but has been delayed giving stakeholders more time to advocate for the addition of an arbitration process to the bill
Update on NIH’s Center for Cellular Engineering
Construction is underway at the National Institutes of Health’s new Center for Cellular Engineering (CCE), formerly the Department of Transfusion Medicine. The goal of the CCE is to enable intramural researchers to be on the leading edge” of cellular engineering, according to NIH Director Francis Collins.
The CCE will provide leadership, best-practices research, support and training in cellular engineering in order to meet the increasing demand for customized cellular-therapy products and services that are needed for personalized treatments. Products include CAR-T cells for cancer immunotherapies; pluripotent stem cells to treat macular degeneration; and gene therapies for epithelial cancer. There are already 34 clinical-trial protocols underway that rely on the CCE; by 2020, 12 more protocols are expected to be added. Within the year, additional labs will be built to meet the increasing demand for novel cellular products.
Progress on PCORI Reauthorization
On July 17, the House Energy & Commerce Health Subcommittee passed the Community Health Investment, Modernization, and Excellence Act (H.R. 2328). The bill includes a provision to reauthorize the Patient-Centered Outcomes Research Institute (PCORI) for three years, with no other changes to the original authorizing language from the Affordable Care Act (ACA).
Last month, the House Ways & Means Committee, which shares jurisdiction over PCORI, passed H.R. 3439, The Protecting Access to Information for Effective and Necessary Treatment (PATIENTS) Act. The bill would extend PCORI for seven years and would make only minor changes to PCORI’s authorized research priorities to include substance use and maternal mortality.
The long anticipated Senate legislation, which is expected to make meaningful, substantive changes to the original statute, should be public “soon.” Senator Chris Van Hollen (D-MD) recently underscored his support for PCORI reauthorization stating that it was his highest priority.
The original PCORI authorization expires this September 30, the end of fiscal year 2019.
HHS Announces Quality Summit
On July 9, Health and Human Services (HHS) Deputy Secretary Eric Hargan announced the formation of a Quality Summit that will bring together key stakeholders and government leaders to discuss how current quality programs administered by HHS can be further evaluated, adapted, and ultimately streamlined to deliver a value-based care model focused on improving outcomes for American patients. Click here for more information about the Quality Summit.
New Yorker Article on Cellular Therapies
Health Affairs’ Take on the Senate Hearings on Drug Prices
What the Health Podcast on the Future of the ACA
Science Editorial on How to Balance Sharing Scientific Knowledge with Security Concerns
Alycia Maloney is ASTCT's Director of Government Relations.