On August 7, 2014, the Centers for Medicare & Medicaid Services (CMS) announced that the Open Payments system is “temporarily” off-line. The CMS announcement did not state when the Open Payments system would be back on-line....more
In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more
The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that includes a plan to eliminate the continuing medical education (“CME”) exclusion to the reporting requirements under the federal Physician...more
On June 11, 2014, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued two reports to Congress summarizing activities in calendar years 2011 and 2012. The Annual Report to Congress on...more
In the May 23, 2014 issue of the Federal Register (79 FR 29732), the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) that would change the so-called meaningful use stage...more
On April 26, 2014, the Federation of State Medical Boards (FSMB) House of Delegates adopted The Model Policy on the Appropriate Use of Telemedicine Technologies (FSMB Telemedicine Policy). FSMB is a national organization of...more
On April 9, 2014, the Centers for Medicare and Medicaid Services (“CMS”) released the Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (the “Data File”). The Data File contains...more
On March 28, 2014, the U.S. Department of Health and Human Services (“HHS”) announced the release of a security risk assessment (“SRA”) tool to assist small- to mid-sized providers in conducting risk assessments of their...more
The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released guidance on its website describing a two-phase process for applicable manufacturers and group purchasing organizations (“GPOs”) to register and submit...more
In the December 27, 2013 edition of the Federal Register, the Office of Inspector General (“OIG”) and Centers for Medicare and Medicaid Services (“CMS”), both within the U.S. Department of Health and Human Services (“HHS”),...more
One day after Christmas, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced that a Massachusetts-based dermatology practice (Practice) agreed to a $150,000 payment and entered into a...more
The federal government invests significant resources in combating health care fraud and abuse. The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Strategic Plan...more
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to comply with new HIPAA rules is fast approaching....more
On July 8, 2013, WellPoint, Inc., a managed care company (“WellPoint”), agreed to pay a $1.7 million fine to settle a self-reported breach of HIPAA, a key federal health privacy law, that led to the unauthorized disclosure of...more
In June 2013, the Department of Health and Human Services, Office of Investigator General (OIG) published a review of its audit of an outpatient therapy services provider. The OIG concluded that the outpatient therapy...more
A recent federal court decision illustrates how “loan” arrangements between physicians and their employers, if not properly structured, may be treated as the payment of taxable compensation and the employers may be hit with...more
In This Issue:
- Third Circuit Panel Liberalizes “Protected Activity” Immunity for Employees Claiming Whistleblower Status
- Doing Time: A Requirement for White Collar Crime?
- Casting a Smaller Net:...more
4/23/2013
/ Centers for Medicare & Medicaid Services (CMS) ,
Continuing Medical Education ,
Financial Conduct Authority (FCA) ,
Fraud ,
GPOs ,
Protected Activity ,
Publicly-Traded Companies ,
Sarbanes-Oxley ,
Settlement ,
Shareholders ,
Sunshine Act ,
Transparency ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
The final regulations implementing the Physician Payments Sunshine Act take effect April 9, 2013. Pharmaceutical manufacturers, group purchasing organizations, academic medical centers and physicians need to be ready to...more
Physician-owned distributorships continue to attract federal scrutiny. A new OIG Alert highlights health care transactions that make these distributorships vulnerable to enforcement activity.
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The OIG recently posted an Advisory Opinion which concluded that a hospital's proposal to provide free access to an electronic interface between the hospital and area physicians for laboratory and diagnostic services was not...more
On October 30, 2012, the Office of Inspector General, Department of Health and Human Services ("OIG") posted an Advisory Opinion stating it would not challenge an arrangement in which a non-profit hospital pays per diem...more