Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
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.
Don’t Trust a Negative At-Home COVID-19 Test Result, FDA Warns
The agency is recommending repeat testing with at home COVID-19 antigen tests, regardless of actual symptoms.
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.
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.
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.
OIG and CMS Clash on Medicare Overpayment Recoveries
OIG says the agency is leaving millions of dollars on the table, but CMS doesn’t want to hear it.
Eight Charged in Alleged $150M Crestar Labs Fraud Scheme
Individuals were supposedly paid kickbacks to obtain genetic samples for unnecessary genetic testing, which was then falsely billed to federal healthcare programs.
Most Lab Professionals Work in Understaffed Labs, Are Burnt Out
According to a recent survey of 1,112 respondents, despite modest salary increases, most medical lab professionals are struggling in understaffed labs.
Medicare Billing Alert: Be Sure to Use the New ABN Form
Renewed Advance Beneficiary Notice of Noncoverage (ABN) Form (OMB 0938-0566) must be used as of August 31.
