Clinical Lab Reimbursement Experts Discuss PAMA Pressure and Leaving Money on the Table
Attorney Danielle Tangorre and TELCOR’s Darla Wanitschke answered questions during webinar
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National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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US Government Suspends Free At-Home COVID-19 Antigen Test Program
Biden administration blames the decision on Congress’ failure to provide the additional funding necessary to keep the program going.
Final Surprise Billing Regulations Cut Insurer Control—Sort Of
It remains far from clear whether the new surprise billing rule goes far enough to fix the problem of insurers having too much power in disputes.
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FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
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Federal Enforcers Crack Down on Telehealth Genetic Testing Scams
After the DOJ announced a massive National Health Care Fraud Enforcement Action on July 20 targeting telehealth and telemarketing scams, labs need to be extremely wary, especially if they provide genetic testing.
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OCR Doles Out Record Fine for Right of Access Violation
On July 15, the Department of Health & Human Services Office for Civil Rights announced 11 new enforcement actions, including the biggest penalty doled out since the agency began the right of access program back in April 2019—$240,000 against Texas nonprofit Memorial Hermann Health System.
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Be Sure to Use New ABN Form, Starting August 31
As of August 31, 2022, labs and other providers must use the new ABN labeled with the appropriate federal OMB Number (0938-0566) and CMS-R-131 to ensure they can bill Medicare beneficiaries for any lab tests or other services that Medicare doesn’t cover.
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CMS Bristles at Criticism It’s Not Recovering Medicare Overpayments
According to a recent OIG report, CMS is not doing a good job collecting the Medicare overpayments OIG auditors are uncovering. However, CMS recently rejected almost all of the recommendations in that report, suggesting all is not well between the two federal agencies.
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LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
CMS Proposes CLIA Fee Increases and Nurses Doing High-Complexity Testing
In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here’s what lab managers need to know about the proposed rule.
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Guidance on HIPAA Abortion Privacy Rights Post-Roe-v-Wade
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.
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