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Lessons Learned from FCA Settlement Involving Waiver of Medicare Coinsurance Amounts

The waiver of copayments, coinsurance, and deductibles owed by patients treated by out-of-network laboratories and other providers is a hot topic in the health care industry. Despite the near absence of clear legal...more

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

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

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

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 After publishing draft guidance regarding the regulation of laboratory...more

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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