Advocacy succeeds! CMS withdraws proposed restrictions on post-transplant blood tests

The patient voice was heard by policymakers! Read Honor the Gift’s statement on the August 2024 CMS decision to retire a proposed draft coverage policy to restrict coverage for post-transplant blood tests.

In the Media:

MedPage Today

• CMS Drops Controversial Proposal for Blood Tests After Organ Transplant

POLITICO

• Pulse Newsletter: Around the Agencies: Reversing Course

WSJ

• Hallelujah, a Transplant Test Reversal

Read more from the media on Honor the Gift’s campaign to oppose coverage restrictions on innovative post-tranplant diagnostics:

USA Today

• Why Lifesaving Tests for Organ Transplant Patients are Now Out of Reach for Many

WSJ:

• A Double Standard on Transplant Tests. Medicare won’t cover kidney monitoring that a private insurer considers to be ‘medically necessary.’

• Biden’s Organ Transplant Rejection. Medicare rations blood tests to save money, but it will hurt patients.

• Medicare’s Organ Transplant Face Plant. Patients and doctors explain the damage from denying crucial blood tests in the name of saving money.

• Medicare’s Bad Call on Transplant Tests. Blood tests can save organs. Why are the feds denying coverage?

• Medicare’s Bureaucracy vs. Doctors: The government ignored its own medical experts on transplant tests.

The Hill:

• Medicare ignored expert advice to cut tests for transplant patients: Report

MedPage Today:

• Transplant Advocates Sound Alarm Over Proposed Medicare Test Coverage Policy

Real Clear Politics:

• Private Contractors Gaslighting Transplant Patients, by Newt Gingrich

• Medicare Restricts Coverage for Vital Transplant Tests, by Dr. Ken Sutha

 STAT:

• Transplant patients say new Medicare guidance puts their donated organs at risk.

Charleston Post & Courier:

• Medicare cut puts SC transplants at risk: Vital monitoring tool lost

New York Daily News:

• Al B. Sure!: A health crisis for people of color

CMS Ignores:

Leading transplant medical societies strongly condemn March Medicare rollbacks published by MolDX. 

• American Society for Transplant Surgeons;

• American Society of Transplantation;

• The International Society for Heart and Lung Transplantation.

Bipartisan letter signed by 14 House Members, led by Reps. Anna Eshoo (D-CA) and Dr. Michael Burgess (R-TX).

• Rep. Anna Eshoo Remarks at House Energy and Commerce Committee Subcommittee.

• Follow up letter sent to CMS on October 13, 2023 asking for answers on why Medicare contractors rolled back coverage without public comment and through a billing article.

• Congressional Black Caucus letter to Secretary Becerra and Administrator Brooks-LaSure highlighting the disproportionate impact of the policy change on transplant recipients in the minority, marginalized, and under-resourced populations.

A December 2023 Letter from Congressional Black Caucus Chair Rep. Steven Horsford (D-NV).

An April 2024 Letter from 26 transplant clinicians urging Medicare to remove restrictions as more patients experience organ rejection episodes.

Subject matter experts during a November 2022 advisory committee meeting, which was uncovered in a FOIA request.

CMS Response Stating No Medicare Changes Made vs. Patient and Clinician Perspective:

• CMS statement inaccurately states that , …”neither CMS nor the MACs have made changes that affect patient’s ability to have blood tests used to monitor organ transplantation.”

• Quotes from patients and clinicians describing how blood testing stopped after the Medicare coverage rollbacks occurred.

• The American Society for Transplant Surgeons (ASTS) response to CMS statement.

MAC Billing Articles from 2017 and 2021 Publicly Endorse “Surveillance Testing”:

• Since 2017 and reaffirmed in 2021, the MACs publicly endorsed "surveillance" testing, that is using non-invasive blood tests when symptoms were not apparent or serious enough to justify the riskier and more expensive biopsies as an option. 

Patients and Clinicians Advocate for Restoring Medicare Coverage:

• Newt’s World – Episode 641: Patients Push Back – The Struggle Against Big Government in Transplant Care - Featuring Dr. Steven Potter, Rep. Michael Burgess, MD, and heart transplant recipient Eddie Garcia

• 12.5.23 Capitol Hill Press Conference

• Honor the Gift Action Day Press Release: Hundreds of transplant patients, physicians, and health equity advocates join Honor the Gift rally on Capitol Hill to implore President Biden and HHS Secretary Becerra to immediately restore Medicare coverage of critical blood tests that detect organ transplant rejection

• Quotes from patients and clinicians describing how blood testing stopped after the Medicare coverage rollbacks occurred.

• “Since the Medicare coverage guidance came out in March 2023, I haven’t received my regular donor-derived cell-free DNA test— and this has left me in the dark about the health of my donated kidney.”—Margaret Gamble, 2x kidney transplant recipient

• “The recent and discreet cutbacks to Medicare coverage saw the discontinuation of the phlebotomy service at my transplant center in George Washington University Hospital that was providing me with regular non-invasive molecular diagnostic blood tests to monitor my donated kidney.”—Evan Dame, kidney transplant recipient

• Video of MolDX open meeting held on September 18. Transcript here.

• Video of Noridian open meeting held on September 20. Transcript here.

• Video with Rep. Eshoo, and patients, clinicians advocating for restoring coverage.

• Survey results shows that 95% of patients are concerned that a new Medicare billing article limits coverage of non-invasive post-transplant tests.

• Press release announcing creation of Health Equity in Transplantation Coalition launched by Al B. Sure! and Rev. Al Sharpton

• Fact sheet on test utilization for heart and kidney transplant patient management