Karen S. Lovitch

Karen S. Lovitch

Mintz Levin

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Provisions of Interest to Labs in the Protecting Access to Medicare Act of 2014

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

4/3/2014 - Clinical Laboratories Healthcare Medicare Pharmaceutical

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 - CLIA Clinical Laboratories CMS Healthcare HHS HIPAA OCR

Changes Ahead for Laboratories Doing Business in Pennsylvania

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

1/6/2014 - Clinical Laboratories Department of Health

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 - Charitable Donations CMS EHR OIG

OMB Extends Review of Rule That Would Require Labs to Release Results to Patients

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

12/20/2013 - Clinical Laboratories HIPAA OMB Patients PHI

GlaxoSmithKline Announces Further Limits on Payments to Physicians and on Sales Compensation

GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more

12/19/2013 - GlaxoSmithKline Healthcare Professionals Pharmaceutical Physician Payments Sales Commissions

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 - Clinical Laboratories CMS 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 - CMS Data Collection GPOs Medicaid Medicare Physician Payments Sunshine Act

New Bill Proposes to Eliminate Stark Law Exception for Certain In-Office Ancillary Services

Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...more

8/8/2013 - Ancillary Agreements Civil Monetary Penalty GAO HHS Medicare OIG Stark Law

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 - Clinical Laboratories CMS 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 - 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 - 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 - 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 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 - CMS Drug Manufacturers Joint Purchasing Programs 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 - CLIA CMS 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 - CMS Compliance Continuing Medical Education Data Collection Drug Manufacturers Enforcement GPOs Medicaid Medical Devices Medical Supplies Payment Records Physicians Reporting Requirements Sunshine Act

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

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

2/4/2013 - Biologics CME CMS Data Collection Drug Manufacturers GPOs Medical Devices Pharmaceutical Reporting Requirements Stark Law Sunshine Act

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