Mar 27, 2017 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
CMS Director speaks at ACLA meeting; acknowledges that labs are alerting the agency to problems with Protecting Access to Medicare Act (PAMA) private payer market reporting, but did not say whether a delay in implementing either reporting or lab test fee cuts would be possible
WASHINGTON, DC—Last week, it was symbolic that, as members of the American Clinical Laboratory Association (ACLA) assembled for their annual meeting, members of the House of Representatives were preparing to vote on the first of several bills intended to “repeal and replace” the Affordable Care Act.
The symbolism comes from the fact that the nation’s medical laboratories and the United States Congress find themselves at major crossroad. For medical laboratories, the issue is the substantial cuts to Medicare Part B clinical laboratory test fees that are scheduled to take effect on January 1, 2018. Predicted by the federal Centers for Medicare and Medicaid Services (CMS) to be a total cut of $400 million in 2018 alone, many expect these Medicare fee cuts to be the single most financially-disruptive event to hit the medical laboratory profession in 25 years.
There’s a similar make-or-break issue unfolding in Congress. Republicans in the House and Senate are caught up in battles to design and pass a series of bills intended to “repeal and replace” the ACA. At their respective crossroads, it remains unclear which path forward each group will follow. (more…)
Jul 27, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market
Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.
One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.
Announced in a May 2016 statement, the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).
Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? (more…)
Apr 14, 2014 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Leaders from ACLA, AdvaMedDx, CAP, NILA will be at Executive War College on April 29-30 for first medical lab industry debate about the best and worst of the new law
Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists remain unaware of the significant negative financial impact this law will have on their lab’s revenue and fiscal stability.
On April 1, President Barack Obama signed H.R. 4302: Protecting Access to Medicare Act of 2014. The law’s primary purpose is to extend the Sustainable Growth Rate (SGR) formula for 12 months. The House had passed the bill on the previous Thursday and the Senate passed the bill on the following Monday, March 31. (more…)
Dec 20, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Pathologists and medical laboratory managers have only nine months to prepare their labs for ICD-10 implementation
Most clinical laboratory managers and pathologists know that October 1, 2014, is the date for implementation of ICD-10. After that date, each Medicare claim submitted by a medical laboratory must include the ICD-10 code provided by the referring physician.
This is a unique reason why clinical laboratories and pathology groups have keen interest in a smooth transition from ICD-9 to ICD-10. Medicare will reject clinical laboratory test claims that either don’t have an ICD-10 code or have an incorrect ICD-10 code. Thus, labs hope that their client physicians make a smooth transition from ICD-9 to ICD-10. (more…)
Dec 4, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Managed Care Contracts & Payer Reimbursement, Management & Operations
Radiology and pathology associations are supporting a new bill in Congress to address self-referrals made by urologists
Criticism is mounting against urologists who refer their patients to radiation providers in which they have an ownership relationship. This criticism is strikingly similar to concerns that pathologists and others have expressed about situations where urologists refer their patients to anatomic pathology laboratories in which they have an ownership relationship.
Study about Radiation Therapy Referrals Published in NEJM (more…)
