Advocacy News

• CLIA paperless notification delivery set for next year
• CMS furloughs nearly 50% of staff during shutdown
• Pathologists Quality Registry unaffected by federal shutdown
• Medical coalition seeks J-1 visa protections for physicians
• Gene patent bill threatens ability for second opinions

The Centers for Medicare & Medicaid Services (CMS) is requiring all laboratories to switch to electronic notifications for CLIA fee coupons and certificates by March 1, 2026.

The impact: Paperless delivery will be mandatory after March 1, as paper copies of fee coupons and certificates will no longer be available, the CMS says. 

CMS officials reached out to the CAP and asked us to share this information with our members and laboratories.

• The CAP has already shared contact emails for CAP-accredited labs with the CMS to help facilitate the transition to paperless.

To ensure the CMS has an updated email address for your lab, the agency says you can:

• Email your state agency with written notification—including your laboratory name, director or owner’s name, CLIA number, and a signature—to switch to electronic notifications.
• Contact your lab accreditation organization to update or add email addresses.
• Fill out the CMS-116 application form and check “Receive notifications including electronic certificates via email” to make the switch.

Go deeper: Read a CMS factsheet with additional instructions.

We're one week into the government shutdown and as of today, there’s been little progress by Congress to end it.

We noted last week that the Medicare program will continue covering and paying for physician services backed by advance appropriations.

• The CMS is also maintaining payments for Medicaid, the Children’s Health Insurance Program (CHIP), and continuing essential federal insurance marketplace activities.

By the numbers: During the shutdown, the CMS retains 53% of its staff to ensure that essential operations continue, while 47% are furloughed.

• Medicare Administrative Contractors (MACs) have been instructed to temporarily hold claims for 10 business days, though this should have minimal effect on physicians due to the 14-day payment floor.
• Physicians may continue to submit claims during this period, but payment will not be released until the hold is lifted.
• For the latest information, physicians should monitor their MAC's website and this CMS webpage.

Go deeper: Read more information on how the shutdown affects the Department of Health and Human Services.

Despite the government shutdown, operations for the Pathologists Quality Registry continue as normal.

• Practices should submit data per their usual processes to ensure that all information is true, accurate, and complete.
• If there are changes to processes, deadlines, or expectations, participating practices will be notified ASAP.

Regarding a recent announcement about QPP 491, Mismatch Repair or Microsatellite Instability Biomarker Testing Status, please continue to submit data as usual. 

• Please do not modify or discontinue coding or reporting of this measure.
• No action is needed at this time. If there is a change to the reporting process, we will notify you immediately. 

Finally, for practices whose 2024 final score was calculated incorrectly, please continue to submit for targeted reviews (PDF) following the normal process. 

• Although it’s unclear when these requests will be processed, we do not have any information indicating that the CMS will extend the deadline.
• So please ensure that you submit targeted review requests well in advance.

The CAP has joined dozens of other medical associations in calling for J-1 physicians to be exempt from new visa rule changes.

What we're saying: In a letter addressed to the Department of Homeland Security (DHS), the groups recommend maintaining the current duration of status for J-1 physicians to ensure uninterrupted service.

The impact: Physicians here on J-1 visas are vital to the US health care system, and they often work in underserved and rural areas.

• The proposed DHS rule requiring frequent visa renewals could disrupt both their training and patient care.
• This change poses risks to the continuity of care and may exacerbate physician shortages.

The big picture: Nearly 20% of US doctors are trained abroad, and international medical graduates (IMGs) are crucial to filling gaps in primary care and specialty areas.

• The administrative burden and uncertainty introduced by the new rule could deter IMGs from practicing in the United States.
• It may lead to increased costs and processing delays, affecting hospitals and patient access.

The CAP has warned lawmakers about the potential negative effects of the Patent Eligibility Restoration Act (PERA) on health care innovation and patient care.

In a statement for the record, we continue to oppose the controversial bill, arguing that allowing patents on genes and natural phenomena could lead to increased costs for patients and hinder medical advancements.

• Such patents could result in exclusive licensing agreements, driving up prices and limiting access to essential genetic tests.
• We note that PERA could block patients from seeking second opinions on genetic tests, as patents would prevent independent labs from offering confirmatory testing.
• By potentially allowing patents on foundational scientific tools, PERA could restrict the exchange of critical genetic information, hindering research and the development of new treatments.

Go deeper: Read our full comments. CAP members can also urge Congress to oppose PERA in our Action Center.