News & Analysis as of

New Jersey Federal Court Allows “Self-Help” Counterclaims Against Potential FCA Whistleblowers To Proceed

Last week, a New Jersey federal court allowed medical device maker Boston Scientific Neuromodulation Corp. (“Boston Scientific”) to proceed with counterclaims against two of its former employees for violating their contracts...more

Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

What’s an MDDS? And Why Should I Care?

Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014. This is the process that allows physicians and teaching hospitals to review...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

Physician Owned Distributorship Concerns Continue to Make News

On June 17, 2014, Southern California Public Radio affiliate KPCC broadcasted a report about physician-owned distributors of implantable medical devices (“PODs”) and the legal and ethical concerns that are raised when POD...more

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

Doctors Settle SEC Insider Trading Charges

The Commission filed two settled insider trading cases against medical practitioners who traded while in possession of material non-public information regarding clinical trials for a drug. SEC v. Lama, Case No. 5:14-cv-00996...more

PODs Continue To Attract Scrutiny From OIG And Congress

In the wake of a recent U.S. Department of Health and Human Services Office of Inspector General ("OIG") investigation, physicians with ownership interests in medical device distributorships and hospitals should prepare for...more

New OIG Report Examines Cost-Effectiveness of Physician-Owned Spinal Device Distributorships

On Thursday, October 24, the HHS Office of Inspector General (OIG) released a report responding to a request from members of the Senate Finance Committee to determine the extent to which physician-owned distributorships...more

Health Alert (Australia) - 14 October 2013

In This Issue: - Judgments - Legislation - Reports - Excerpt from Judgments: JUDGMENTS - Commonwealth - 8 October 2013 - Faye Mason v Military Rehabilitation and Compensation Commission...more

Data Collection Under The Sunshine Act

Data collection requirements under the Physician Payment Sunshine Act commenced August 1, 2013. This provision of the Patient Protection and Affordable Care Act and the corresponding regulations require an entity that is...more

Client News Alert: Regarding Physician Payments Sunshine Act

On August 1, 2013 a new reporting obligation under the federal Physician Payments Sunshine Act (“Sunshine Act”) takes effect. The Sunshine Act was originally signed into law on March 23, 2010, as part of the Patient...more

Doctors, Enforcement Risks And Compliance Programs

Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - July 2013

In This Issue: - Is There a Problem? Let Us Count the Ways - A Growing Awareness - Getting Objective Information - Recent Health Care News You Should Know About - Excerpt from Navigating Through Medical...more

Senate Finance Committee Hearing Discusses Transparency in Healthcare Pricing

On June 18, 2013, the Senate Finance Committee held a hearing entitled, “High Prices, Low Transparency: The Bitter Pill of Health Care Costs.” Senators Max Baucus (D-MT) and Orrin Hatch (R-UT) gave statements on ways to...more

Clinical Trials And Corruption Risks

Pharmaceutical and medical device companies have enough to worry about when it comes to enforcement risks....more

OIG Special Fraud Alert Labels Physician-Owned Distributorships (PODs) as “Inherently Suspect”

The U.S. Department of Health & Human Services, Office of Inspector General (the “OIG”) issued a Special Fraud Alert (“Alert”) on March 26, underscoring its heightened focus on fraud and abuse risks posed by physician-owned...more

OIG and CMS Issue Proposals to Extend Safe Harbor and Exception for EHR Donations

In the April 10 Federal Register, two agencies within the U.S. Department of Health and Human Services published proposed rules that many healthcare providers have been anxiously awaiting affecting donations of electronic...more

OIG Issues Special Fraud Alert for Physician-Owned Entities

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued a Special Fraud Alert expressing concern that physician-owned entities "that derive revenue from selling, or arranging for the...more

Increased Government Scrutiny of Physician-Owned Device Distributorships

On March 26, 2013, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) increased its scrutiny of and pressure on physician-owned entities (particularly medical device distributorships) by...more

Health Care Reform Update -- April 2, 2013

In This Issue: Implementation of the Affordable Care Act (ACA); Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more

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