The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
Hospital Executive and Three Physicians to Pay More Than $880,000 to Resolve Kickback Allegations - On Monday, December 4, 2023, a Lexington, Texas, hospital executive and three health care providers agreed to pay more...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more
On December 19, 2022, OIG released its annual report analyzing Medicare Part B spending on laboratory tests over the past year. According to OIG, Medicare Part B spending on laboratory tests increased 17% from $8.0 billion in...more
A False Claims Act case can easily turn into a criminal prosecution. The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more
On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (the “Interim Rule”) which – among other things – makes changes to Medicare requirements for ordering...more
In connection with its efforts to expand COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) announced last week that it will increase payment for high-throughput COVID-19 lab tests to $100. Before this...more
On March 27th, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). On both the federal and state levels we have seen efforts to support social distancing in the...more
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed by the President on March 27, 2020, includes several provisions affecting group health plans, as discussed below. Health Plan Rules and...more
On Mar. 25, the Senate passed H.R. 748, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The House of Representatives passed the CARES Act on Mar. 27, and President Trump signed the bill later in the day,...more
Insurance coverage - In a statement on March 6, 2020, the Board of Directors for America’s Health Insurance Plans (AHIP) announced that insurers are voluntarily covering the diagnostic testing of COVID-19 (coronavirus)...more
Defense Vehicle Manufacturer Accused of Defrauding the Government by $1.2 Billion - On Tuesday, December 3, the United States District Court for the District of Columbia unsealed a six-year-old False Claims Act complaint...more
The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more
The OIG added 12 new items to its Work Plan in the August 2018 update. Hot topics related to Centers for Medicare & Medicaid Services (CMS) oversight in this month's Work Plan include: state oversight of opioids; potential...more
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more
On June 9, 2017, the U.S. District Court for the District of Columbia denied a motion to dismiss brought by a laboratory in U.S. ex rel. Groat v. Boston Heart Diagnostics Corp., 2017 WL 2533341. Part of the grounds for...more
On June 23, 2016, the Centers for Medicare and Medicaid Services (CMS) published a long-awaited final rule making major changes in the way Medicare will pay for clinical diagnostic laboratory tests (CDLTs). The changes were...more
Market Based Payment for Clinical Diagnostic Laboratory Tests - Summary - On June 17, 2016 the Centers of Medicare & Medicaid Services (CMS) issued the long awaited Medicare Clinical Diagnostic Laboratory Tests...more
On June 17, 2016, CMS released a long-anticipated final rule revising the Medicare payment system for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) (the Final Rule). In 2018,...more
Proposed rule will create significant, retroactive reporting requirements for private payor payment rates to clinical laboratories. Many clinical laboratories will need to expend significant resources to track, collect...more
First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more
We’ve discussed in the past certain risks of which investors should be aware with laboratory investments. Last week, TA Associates portfolio company Millennium Health agreed to pay $256 million to resolve claims that it...more
Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more
CMS recently published a proposed rule that would substantially revise the methodology used to pay for clinical laboratory tests that continue to be compensated separately by Medicare. Medicare Program; Medicare Clinical...more