Karen S. Lovitch

Karen S. Lovitch

Mintz Levin

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Latest Publications


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

5 Takeaways from the HHS OIG’s Guidance for Health Care Governing Boards

Tuesday, the HHS OIG, in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association (AHLA), and the Health Care Compliance Association, released a guidance document entitled...more

4/22/2015 - AHLA Chief Compliance Officers Corporate Governance Hospitals Internal Audit Functions Internal Controls OIG

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

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

3/27/2015 - Anti-Kickback Statute Clinical Laboratories OIG Patient Referrals Physicians

Illinois Legislature Passes Anti-Markup Law Applicable to Pathology Services

Last Thursdday both chambers of the Illinois legislature voted to override the Governor’s amendatory veto and passed Public Act 098-1127, which prohibits a physician from charging a markup on anatomic pathology services if...more

12/8/2014 - Healthcare New Legislation Physician Payments Physicians

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 - CMS Healthcare Hospitals Inpatient Billing OPPS

Federal Court Rejects Relator’s Swapping Allegations in False Claims Act Case

This week a federal district court in Ohio ruled in favor of Mobilex USA (Mobilex), the country’s largest mobile medical imaging company, on a motion for summary judgment in a False Claims Act (FCA) suit filed by a former...more

8/18/2014 - False Claims Act Healthcare Medicare Medicare Part A Medicare Part B

New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services

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

7/21/2014 - Clinical Laboratories Healthcare New Legislation Physicians Self-Referral

Can a Relator Be Held Liable for Using Confidential Company Documents to Support a Qui Tam Case?

Last week, the U.S. District Court for the Eastern District of Pennsylvania issued a decision in Walsh et al. v. Amerisource Bergen Corp. et al denying the Relator’s motion to dismiss a counterclaim that alleged the Relator...more

6/25/2014 - Confidentiality Agreements False Claims Act Qui Tam Relators

Keeping Legal Advice In-House: Protecting the Attorney-Client Privilege

Given that laboratories operate in a heavily regulated environment, the advice of legal counsel is integral to ensuring compliance with the many laws and regulations that govern the laboratory industry. Luckily the...more

5/30/2014 - Attorney-Client Privilege Corporate Counsel False Claims Act Whistleblowers

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

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