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In this Issue: - Top News ..Large Hospital Systems Settles for $25.5 Million for False Claims Act Allegations ..Catholics’ Challenge to Contraceptive Coverage Mandate Dismissed As Not Ripe - States...more
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
The Office of the Inspector General for the United States Department of Health and Human Services (OIG) issued a Special Fraud Alert on March 26, 2013 (the "2013 POD alert"), that identifies physician-owned distributorships...more
Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more
After years of deliberation, the Center for Medicare & Medicaid Services (CMS) published its long-awaited regulations to implement the specific requirements of the Physician Payment Sunshine Act (Sunshine) on February 1,...more
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-delayed final rule that is intended to implement the Physician Payments Sunshine provisions that were included in the Patient...more
People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more
The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more
In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule (Rule) to implement the “Sunshine” provisions of the Affordable...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more
Recent weeks have seen two significant developments with respect to federal and state laws regulating financial interactions between pharmaceutical and medical device companies and health care providers: (1) the Centers for...more
Pharmaceutical companies, medical device manufacturers, and biotech companies are gearing up for the January 1, 2013 deadline set by the Centers for Medicare and Medicaid Services (“CMS”) for companies to begin collecting...more
The Supreme Court’s decision upholding most of the Affordable Care Act increased compliance responsibilities for healthcare companies. The ACA amended the False Claims Act (FCA), which was amended in 2009 in the Fraud...more
In a roundtable discussion of the Senate Special Committee on Aging last week, Senators Chuck Grassley and Herb Kohl called on CMS to issue final regulations implementing the Physician Payment Sunshine Act, which was enacted...more
French Law No 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products, dated 29 December 2011 (known as the French Sunshine Act), imposes new disclosure obligations to health products companies. ...more
On August 14, 2012, four industry groups sent a letter to Marilyn Tavenner, the Acting Administrator of the Centers for Medicare & Medicaid Services (CMS), asking CMS to publish the final rule implementing the Physician...more
In March 2010 the hotly contested Affordable Care Act (Public Law 111-148) (ACA or the Act) was signed into law by President Obama. Since its enactment, some health care providers have struggled to meet the Act’s current...more
Margaret Tavenner, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS or the “Agency”), issued a letter to Senator Chuck Grassley on May 3, 2012 formally responding to a letter sent to her by Senator...more
In a blog entry on May 3, 2012, CMS announced it was delaying the Sunshine Act requirement for data collection until January 1, 2013. CMS’s stated rationale was...more
With little fanfare, the Centers for Medicare & Medicaid Services (CMS) announced today on the CMS Blog that it is delaying data collection under the Sunshine Act until 2013. Pharmaceutical and medical device manufacturers...more
Centers for Medicare & Medicaid Services (CMS) issued on December 14, 2011 its much-anticipated proposed rule interpreting the requirements of the Physician Payment Sunshine Act (Act), enacted by Congress as Section 6002...more
Originally published in Health Care Fraud Report, 16 HFRA 80, 01/25/2012. Pharmaceutical and medical device manufacturers as well as group purchasing organizations (GPOs) finally received some insight into how the...more
Bright-Light Scrutiny on Payments by Drug and Device Makers to Physicians and Teaching Hospitals and Certain Physician Ownership Interests The Centers for Medicare and Medicaid Services (CMS) published in the Federal...more
Considerably after the statutory deadline of October 1, 2011, the Centers for Medicare and Medicaid Services (CMS) finally has issued proposed regulations aimed at implementing what is known as the "Physician Payment Sunshine...more
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