After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
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
Subscribe today for full access
to all of these articles.
Biden administration blames the decision on Congress’ failure to provide the additional funding necessary to keep the program going.
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.
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.
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.
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.
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.
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.
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.
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.
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.