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
The House of Representatives and Senate recently passed an omnibus spending bill that funds the Federal government through Fiscal Year 2023 and contains various provisions affecting healthcare providers. Among other things,...more
On November 2, 2022, Centers for Medicare & Medicaid Services (CMS) filed its final rule implementing changes to the Medicare Physician Fee Schedule for CY 2023 (Final Rule). Embedded within this Final Rule are important...more
On July 15, 2022, the D.C. Circuit issued a decision in favor of the American Clinical Laboratory Association (ACLA) in American Clinical Laboratory Association v. Becerra. The decision is the latest chapter in long-pending...more
Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...more
Health Care providers have been advocating for Congress to avert a series of impending Medicare reimbursement cuts slated to take effect in January of 2022 – an issue that has garnered bipartisan support. Congressional...more
• On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare & Medicaid Innovation (CMMI) published a proposal to implement a new mandatory Medicare payment model in select geographic...more
Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the...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 December 11, 2017, the American Clinical Laboratory Association (ACLA) filed suit on behalf of its membership against the Secretary of HHS, challenging the Secretary’s implementation of the Protecting Access to Medicare...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various...more
On October 3, 2016, OIG released a report monitoring CMS’s progress on preparing for the implementation of the new payment system for clinical laboratory tests. The new payment system was mandated by the Protecting Access to...more
On August 5th, CMS published final rules updating the Medicare payment rates for skilled nursing facilities (SNFs) and inpatient rehabilitation facilities (IRFs) for FY 2017. The rules, both of which go into effect on October...more
On July 29, 2016, the Centers for Medicare & Medicaid Services (CMS) released a final rule outlining FY17 Medicare payment policies and rates for the Skilled Nursing Facility Prospective Payment System (SNF PPS). The rule has...more
On June 23, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule implementing Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which established a new payment methodology for...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
Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the...more
Overall, the Proposed Rule details CMS’s proposals for SNFs in CMS’s accelerating pace of shifting Medicare payment from volume to value toward the administration’s goals and timeline for moving the Medicare program, and the...more
As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories...more
As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...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
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
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more