Karen Lovitch on Centers for Medicare & Medicaid Services (CMS)

Key Takeaways from CMS’s Final Rule Requiring the Disclosure of Affiliates during Provider Enrollment

The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the “Final Rule”) that is designed to increase CMS’s ability to identify and prevent bad actors from participating in...more

9/13/2019 / Affiliates , Bad Actors , Centers for Medicare & Medicaid Services (CMS) , Children's Health Insurance Program (CHIP) , Comment Period , Disclosure Requirements , Enrollment , Final Rules , Health Care Providers , Health Insurance , Medicaid , Medicare

DOJ Seeks Dismissal of FCA Qui Tam Case to Escape Onerous Discovery Obligations

On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator’s qui tam suit because of the defendant’s burdensome discovery demands, in Polansky v. Executive...more

8/24/2019 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Discovery , Dismissals , EHR , False Claims Act (FCA) , Health Care Providers , Qui Tam , Relators , The Granston Memo , Two-Midnight Rule

Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule

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

7/30/2018 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , MCLFS , Medicare Part B , PAMA , Physician Fee Schedule , Proposed Rules , Provider Payments , Reporting Requirements

CMS May Decide to Permit Labs to Bill for Certain Tests Provided to Outpatients

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

8/11/2017 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Diagnostic Tests , Hospitals , Laboratory Developed Tests , Medicare , Outpatient Prospective Payment System (OPPS) , Outpatient Services , Provider Payments

At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes

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

6/20/2016 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Final Rules , Laboratory Developed Tests , MCLFS , Medicare , PAMA , Provider Payments

Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

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

3/31/2016 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratory Testing , Final Rules , PAMA , Sunshine Act

The Final 60-Day Rule Is Finally Here!

The Centers for Medicare & Medicaid Services (CMS) has finally published the long-awaited final rule establishing a process for Medicare Part A and B providers and suppliers to report and return overpayments within 60 days...more

2/12/2016 / 60-Day Rule , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Health Care Providers , Medicare Part A , Medicare Part B

Laboratories – 2015 Year in Review [VIDEO]

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

12/31/2015 / Aetna , Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , CIGNA , CLIA , Department of Health and Human Services (HHS) , Enforcement Actions , False Claims Act (FCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , OIG , PAMA , Stark Law

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

CMS Publishes Long-Awaited PAMA Proposed Rule

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 , Comment Period , Cost-Sharing , Data Collection , Diagnostic Tests , Medicaid , Medicare , Medicare Part B , MPFS , PAMA , Proposed Regulation , Reimbursements , Reporting Requirements

CMS Finalizes OPPS Rule Packaging Pathology Services Ordered for Hospital Outpatients

As part of the Outpatient Prospective Payment System (OPPS) Rule issued last week, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to conditionally package certain ancillary services assigned to APCs...more

11/7/2014 / Centers for Medicare & Medicaid Services (CMS) , Healthcare , Hospitals , Inpatient Billing , OPPS

CMS Finalizes HIPAA and CLIA Amendments Intended to Increase Patient Access to Test Results

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

2/5/2014 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Department of Health and Human Services (HHS) , Health Insurance Portability and Accountability Act (HIPAA) , Healthcare , OCR

OIG and CMS Permit EHR Donations Through 2021, Except for Labs

At long last, the Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized regulations amending the Anti-Kickback Statute safe...more

12/24/2013 / Centers for Medicare & Medicaid Services (CMS) , Charitable Donations , EHR , OIG

CMS Issues Medicare Physician Fee Schedule Without Finalizing Proposal Most Harmful to Independent Laboratories

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

12/4/2013 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Healthcare , Medicare , MPFS , Physician Fee Schedule , Physicians

CMS Continues To Issue Guidance On Sunshine Act Reporting

Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers...more

8/23/2013 / Centers for Medicare & Medicaid Services (CMS) , Data Collection , GPOs , Medicaid , Medicare , Physician Payments , Sunshine Act

Proposed Medicare Cuts Would Significantly Impact Independent Laboratories

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

7/22/2013 / Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Medical Research , Medicare , Payment Plans

CMS Conducts First Call on Physician Payments Sunshine Act Implementation

In anticipation of the start of data collection under the Physician Payments Sunshine Act, the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance on data collection and reporting in an effort to...more

5/28/2013 / Centers for Medicare & Medicaid Services (CMS) , Data Collection , GPOs , Physician Payments , Reporting Requirements , Sunshine Act

Updated Self-Disclosure Protocol Clarifies Disclosure Process and Obligations

Individuals and entities subject to the Civil Monetary Penalty Law (CMP) have received clarification regarding the process for disclosing and resolving potentially unlawful conduct involving the federal health care programs...more

4/23/2013 / Centers for Medicare & Medicaid Services (CMS) , Damages , Disclosure Requirements , OIG , Overpayment , Self-Disclosure Requirements

CMS Officially Launches National Physician Payment Transparency Program Website

The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources, including Fact Sheets and...more

4/16/2013 / Centers for Medicare & Medicaid Services (CMS) , GPOs , Physician Payments , Sunshine Act , Transparency

Extension of EHR Donation Sunset Date Proposed by OIG/CMS

The Office of Inspector General for the Department of Health and Human Services (OIG) and the Centers for Medicare & Medicaid Services (CMS) have proposed to extend the sunset date on the safe harbor and exception for...more

4/9/2013 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , EHR , Healthcare , OIG , Proposed Regulation , Sunset Provisions

CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions

Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013. The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more

3/7/2013 / Centers for Medicare & Medicaid Services (CMS) , Joint Purchasing Programs , Pharmaceutical Industry , Physicians , Sunshine Act

CMS Publishes Proposed Changes to CLIA’s Proficiency Testing Regulations

Yesterday the Centers for Medicare & Medicaid Services (CMS) filed a proposed rule (the Proposed Rule) that would make significant changes to existing regulations governing the proficiency testing (PT) process mandated by the...more

2/5/2013 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Medicaid , Medicare , Proficiency Testing

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

2/5/2013 / Centers for Medicare & Medicaid Services (CMS) , Compliance , Continuing Medical Education , Data Collection , Enforcement , GPOs , Medicaid , Medical Devices , Medical Supplies , Payment Records , Pharmaceutical Industry , Physicians , Reporting Requirements , Sunshine Act

Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations