The Latest on ASBMT’s Outreach on CAR-T
It is still early in the new year, but ASBMT has been busy advancing potential reimbursement solutions for CAR-T therapy with key staff at the Centers for Medicare and Medicaid Services (CMS) and on Capitol Hill. The Society is following up with CMS leadership on the solutions outlined in the November 1 letter we sent with the American Society of Hematology. We hope to hold a meeting with agency leadership in the coming weeks to discuss these solutions in more detail. CMS will draft the FY 2020 Inpatient Prospective Payment System (IPPS) proposed rule in the coming months and we remain hopeful that it will include policies to improve CAR-T reimbursement. We will continue to keep membership updated on these discussions.
Besides focusing our advocacy on CMS, ASBMT has also been educating key staff on Capitol Hill on the reimbursement solutions we have developed. Members of Congress, particularly those with centers in their states or districts, have expressed concern about the impact CMS’ current reimbursement policy has on patient access to CAR-T therapy as well as other cell and gene therapies.
We have been focusing our advocacy on staff for the committees with jurisdiction over Medicare, the House Ways & Means Committee and the Senate Finance Committee, as well as the staff for members who sit on these committees. We do not expect that Congress will introduce or pass legislation specific to CAR-T, but there are other ways for Congress to be helpful. Our hope is that key members will be willing to urge CMS to include a reimbursement solution in the proposed FY 2020 IPPS rule. We are still in the early stages of our work on the Hill. Please watch for additional information and calls to contact your members of Congress in support of these efforts.
ACA Lawsuit Update
Last month we updated you in this space on the ruling in Texas vs. United States, the lawsuit to invalidate the Affordable Care Act. While the status of the case has not changed, there have been updates from Capitol Hill.
Some of the first actions by the new House Democratic leadership were two votes to authorize the House to join the lawsuit. The House filing argues that Congress has the authority to defend federal laws when the Justice Department does not. Remember, the Justice Department declined to defend the patient protections portion of the law - this is why the law is being defended by 17 state attorneys general.
Besides these legal steps, we anticipate that House Democrats will continue to focus on the ACA. This issue is a priority for the new House majority, having run on health care issues during the midterms. The Ways & Means Committee will likely hold a hearing on the issue soon, but is not expected to legislate until the lawsuit has worked its way through the appeals process.
NIH Posts Guidance for Implementing the Revised Common Rule
The National Institutes of Health (NIH) posted new guidance for the implementation of the final rule on the Federal Policy for the Protection of Human Subjects (the “Common Rule”), for which the compliance date is January 21st. The changes to NIH policies and procedures include: “1) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications and contract proposals related to research; 2) a new requirement for clinical trial informed consent documents to be posted on a public federal government website; 3) changes to categories of research that qualify for an exemption; and 4) removal of the requirement for annual IRB reviews for certain categories of research.”
FDA Issues New Framework for Oncology Drug Development
In late December 2018, the Food and Drug Administration (FDA) issued new guidance providing recommendations to applicants on endpoints for clinical cancer trials submitted to the FDA to support effectiveness claims in applications. The guidance represents an updated and revised version of a previous document released in May 2007. These updates clarify how different endpoints can serve different purposes (i.e., for traditional, surrogate, and accelerated approvals). The FDA continues to recommend meeting with the agency before submitting trial protocols as well.
Read FDA’s announcement here.
Congressional Drug Pricing Bills
On January 9, Senate Finance Committee Chairman Chuck Grassley (R-IA) and Sen. Amy Klobuchar (D-MN) introduced the Safe and Affordable Drugs from Canada Act of 2019. The legislation would permit importation of certain branded drugs from Canadian pharmacies, a policy meant to drive drug costs down. Grassley has vowed to make drug pricing a priority of his tenure as Chairman.
Read more on the bill from Grassley’s office here.
Democrat legislators have also introduced a package of bills aimed at “dramatically” reducing U.S. drug prices. Led by Sen. Bernie Sanders (I-VT), House Oversight Committee Chairman Elijah Cummings (D-MD) and Rep. Ro Khanna (D-CA), the bicameral legislation includes the Prescription Drug Price Relief Act, which would tie prescription drug prices to median prices in other major countries, the Medicare Drug Price Negotiation Act, which would allow Medicare to negotiate lower prices for Part D benefits, and the Affordable and Safe Prescription Drug Importation Act, which would allow patients, pharmacists, and wholesalers to import prescriptions from Canada (and other countries in future years).
Read Sanders’ press release here.
Administration Eyes Medicaid Block Grants
Politico has reported that the Trump administration is in the process of developing a plan to bypass Congress and provide block grants to states for Medicaid. The plan would introduce spending limits to Medicaid programs in a push to rein in spending in the safety net. Any attempt to tinker with the Medicaid program on a broad scale would face stiff opposition from Democrats, as well as potential legal action on the scope of the executive action allowed without congressional approval.
Read more from Politico here.
ICYMI
LISTEN: What’s Ahead for Health Care in 2019 – Politico’s “Pulse Check” podcast details the health care agenda for Congress and the Trump administration.
Pfizer, Glaxo to Create Over-the-Counter Drug Giant – The Wall Street Journal examines the pending merger of the drug manufacturer’s consumer healthcare units and their plans to spin off the entity from their prescription medicine businesses.
A Huge Lawsuit Accuses Nearly 20 Big Drug Companies, a Billionaire, and 2 Brothers-in-Law of Cozying Up to Hike Drug Prices – Business Insider reports on a massive suit brought by 47 state attorneys general alleging price-fixing between generic-drug makers.
The $9 Billion Upcharge: How Insurers Kept Extra Cash from Medicare – The Wall Street Journal explores how health insurers’ annual cost forecasts include routine overestimations resulting in increased revenue from the Medicare program.