Home 5 Lab Industry Advisor 5 Essential 5 Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years

Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years

by | May 4, 2023 | Essential, FDA-lir, Laboratory Industry Report

The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.

Producers of innovative medical and diagnostic devices got a dose of good news when lawmakers in the US House of Representatives tabled a bill (H.R. 4043) designed to provide Medicare beneficiaries faster access to such technology approved by the FDA.1 Under the Ensuring Patient Access to Critical Breakthrough Products Act, products that receive breakthrough device designation from the FDA would be covered by Medicare for at least four years until the Centers for Medicare & Medicaid Services (CMS) decides whether to make coverage permanent. Here’s a look at the bill and what’s at stake.

Rewarding vs Thwarting Medical Innovation

While capitalism may have its detractors, few would argue against the power of the profit motive in driving innovation. And while government regulation may have detractors of its own, such rules are essential to protect public safety, particularly in the field of medical technology. The overall mission of the FDA is to strike the right balance between regulation and innovation. But, as even the agency occasionally recognizes, FDA regulation can be heavy-handed, costly, and slow.

The Breakthrough Devices Program is one of many initiatives the FDA has taken to expedite and facilitate its regulatory process.2 Purely voluntary, the program empowers the FDA to grant a breakthrough designation to new medical devices or device-led combination products for life-threatening or debilitating conditions for which there are currently no approved alternatives or which offer demonstrated and significant advantages over such alternatives.3

Securing breakthrough device designation enables companies to get their products to the US market more rapidly than would have been able possible via pursuit of traditional FDA pathways. The result is that providers and patients get access to the product sooner. At least that’s the theory. In reality, barriers remain.

Just reaching the market is only the first step. To generate profits, companies must get providers and patients to actually use their products. That often involves securing coverage from payers. And the simple fact that the FDA has cleared a product isn’t always enough to persuade insurers that the product is safe, suitable, and effective for their beneficiaries.

In the US, no payer is more important than Medicare. In addition to more than 65 million enrollees, Medicare has tremendous influence over the coverage decisions made by other public and private payers. CMS is responsible for making Medicare coverage decisions. Unfortunately, the Medicare coverage determination process is notoriously slow, taking up to three years, according to bill co-sponsor Suzan DelBene, D-Wash. Such delays mean seniors have to wait to access potentially life-changing new diagnostic and treatment options, DelBene notes.4

The New H.R. 4043 Bill

The goal of the new bill is to eliminate these barriers so that providers can order, patients can use, and producers can get paid for new medical devices immediately after they receive breakthrough designation from the FDA.

“Guaranteeing Medicare coverage of breakthrough medical devices would encourage future innovation and investment in next-generation medical technologies while improving the quality of life for millions of seniors,” says DelBene in a statement. “We can’t let the coverage approval process be a barrier to life-saving treatments or care.”4

If the concept sounds familiar, it’s because we’ve been down this road before. In August 2020, CMS proposed a rule requiring Medicare to cover medical devices that receive Section 510(k) breakthrough device designation for at least four years. Specifically, the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” rule would have recognized such devices as meeting the “reasonable and necessary” standard set out in Section 1862(a)(1)(A) of the Social Security Act for purposes of Medicare coverage. This initial determination would have stood over a four-year period starting on the date of FDA market authorization.5

Once the initial four-year period ended, CMS would have had to perform a new “reasonable and necessary” evaluation of the device based on clinical and real-world evidence of improved health outcomes. Based on the results, devices would then have received:

  • An affirmative national coverage determination (NCD) from CMS;
  • A negative NCD from CMS; or
  • A coverage determination made by the Medicare Administrative Contractor (MAC) via local coverage determinations (LCD) or on a claim-by-claim basis.

Takeaway: Passage of the New Bill Is Anything but Assured

One of the first things the Biden administration did upon taking control was to put a hold on what it deemed questionable CMS rules proposed and finalized in the final days of the Trump regime, including the breakthrough coverage rule.6 In November 2021, CMS officially rescinded the rule.7 The new bill is pretty much a legislative version of the CMS rule that the Biden administration rejected. However, the fact that it comes from Congress and enjoys bipartisan support may not be enough to offset the objections that led to that previous rejection.

Aside from the politics, there were and are legitimate clinical concerns that automatic Medicare coverage of breakthrough devices would expose seniors to unproven and potentially dangerous products. Critics of the original CMS rule, including the bipartisan Medicare Payment Advisory Commission (MedPAC), pointed out that the FDA breakthrough device and Medicare “reasonable and necessary” coverage criteria are an apples-to-oranges comparison requiring completely different forms of medical evidence. Moreover, MedPAC contends that forcing CMS to cover breakthrough devices would strip the agency of its independent scientific review responsibilities in deciding what Medicare should cover.8

Still, H.R. 4043 is a potentially significant piece of legislation that could have a direct impact on not only medical device, but also diagnostics companies and labs.


  1. https://delbene.house.gov/uploadedfiles/breakthrough_bill_text.pdf
  2. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
  3. https://www.fda.gov/combination-products/about-combination-products
  4. https://delbene.house.gov/news/documentsingle.aspx?DocumentID=3430
  5. https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-19289.pdf
  6. https://www.g2intelligence.com/cms-to-create-new-breakthrough-device-medicare-coverage-rule/
  7. https://www.cms.gov/newsroom/press-releases/cms-repeals-mcitrn-rule-will-consider-other-coverage-pathways-enhance-access-innovative-medical
  8. https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/comment-letters/04132021_mcit_medpac_comment_with_2020_letter_sec.pdf


Here are some of the key new FDA EUAs and clearances that were announced in April 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s) Product
Selux Diagnostics 510(k) clearance for Selux Gram-Negative Panel run on firm’s Next Generation Phenotyping System for rapid antimicrobial susceptibility (AST)
Meridian Bioscience 510(k) clearance for Curian Shiga Toxin immunoassay
Azure Biotech, Inc. EUA for Azure Fastep COVID-19 Antigen Pen Home Test, rapid test for over-the-counter use
Magnolia Medical Technologies 510(k) clearance for 19 new configurations of Steripath® Micro blood culture collection instruments
Leica Biosystems (subsidiary of Danaher) 510(k) clearance for BOND MMR Antibody Panel to identify Lynch syndrome in colorectal cancer patients
BioSynchronicity EUA for point-of-care C-Sync COVID-19 Antigen Test
BioFire (subsidiary of BioMérieux) 510(k) clearance for Global Fever Special Pathogens Panel to detect bacterial, viral, and protozoan pathogens in patients with suspected febrile illness
Abbott 510(k) clearance for update to real-time PCR-based Alinity m STI Assay for detection and differentiation of DNA from Neisseria gonorrhoeae and ribosomal RNA from Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium
Healgen Scientific 510(k) clearance for Accurate Oral Fluid Drug Test lateral-flow chromatographic immunoassay for simultaneous detection of marijuana and cotinine (COT) consumption
Healgen Scientific 510(k) clearance for Accurate Oral Fluid Drug Test COT over-the-counter lateral-flow chromatographic immunoassay for detection of COT


New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s) Product(s)
Syantra CE-IVD mark for Syantra DX Breast Cancer test
Beckman Coulter Life Sciences IVDR marking for 270 flow cytometry reagents
Q’Apel Medical Walrus balloon guide catheter to arrest blood flow during procedures to remove blood clots in the brain


Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
bioLytical Laboratories Canada INSTI® multiplex HIV-1/2 Syphilis Antibody Test
Lucira Health Australia COVID-19 & Flu Home Test at-home molecular diagnostic combo assay to detect influenza and COVID-19
Amoy Diagnostics Japan AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic to direct the use of Eli Lilly’s Retevmo® (selpercatinib) in RET fusion-positive non-small cell lung cancer

Subscribe to view Essential

Start a Free Trial for immediate access to this article