Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more
10/4/2023
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Billing ,
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Clinical Laboratories ,
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Department of Health and Human Services (HHS) ,
Health Care Providers ,
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Healthcare Reform ,
OIG ,
Physicians ,
Risk Management
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
8/1/2022
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Department of Health and Human Services (HHS) ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part C ,
PAMA ,
Proposed Amendments ,
Reimbursements
In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more
The Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations. The bill currently awaits the Governor’s...more
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
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Remuneration ,
Safe Harbors ,
Secretary of HHS
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
In the recently published proposed rule related to the CY 2018 Hospital Outpatient Prospective Payment System (OPPS), the Centers for Medicare & Medicaid Services (CMS) announced that it is considering changes to the...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
On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more
9/29/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
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Cost-Sharing ,
Data Collection ,
Diagnostic Tests ,
Medicaid ,
Medicare ,
Medicare Part B ,
MPFS ,
PAMA ,
Proposed Regulation ,
Reimbursements ,
Reporting Requirements
Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more
The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals. This legislation (the “Bill”) originally...more
The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more
Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more
New legislation enacted last month will change the way many laboratories do business in Pennsylvania. Senate Bill 1042 (SB 1042), which amends Pennsylvania’s Clinical Laboratory Act (the Act), now prohibits several practices...more
The Office of Management and Budget has extended its review of a proposed rule that would require HIPAA-covered laboratories to make test results available to patients. In our previous post on this issue way back in...more
On the day before Thanksgiving and a little over one month after the end of the government shutdown, the Centers for Medicare & Medicaid Services (“CMS”) published a rule finalizing revisions to payment policies under the...more
Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for...more