News & Analysis as of

Is CMS Feeling the Sunshine Heat?

As we told you about here, the Centers for Medicare & Medicaid Services (CMS) has been dealing with issues related to its Open Payments database of payments and transfers of value reported by manufacturers and group...more

CMS Re-Opens Open Payments System

As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the...more

CMS Shuts Down Sunshine Act Online Verification Process

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

CMS Temporarily Closes the Open Payments System

Open Payments is the website through which pharmaceutical and medical device manufacturers (“Manufacturers”) report payments and transfers of value to physicians and teaching hospitals, as required by the Sunshine Act. ...more

Dark Clouds Over Sunshine Act

Once again the Obama administration has been tripped up in launching a healthcare-related online system. This time the problem concerns the Physician Payments Sunshine Act—the act that is supposed to enable the public to see...more

Health Care Reform Implementation Update

Congress begins its summer recess this week, but last week legislators were busy holding hearings on management issues regarding HealthCare.gov, introducing legislation to increase payments to primary care doctors under...more

FDA Issues Updated Draft Guidance on Reporting Drug Samples

The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...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

CMS Proposes Elimination of CME Exemption From Sunshine Act

Teaching hospitals and physicians who speak at continuing medical education (CME) programs should be interested in a July 11, 2014, announcement by the Centers for Medicare & Medicaid Services (CMS). The announcement proposes...more

CMS Announces Dates for Sunshine Payment Review, Dispute & Correction Process

The Centers for Medicare & Medicaid Services (CMS) announced today that the Open Payments review, dispute and correction process will begin on Monday, July 14, 2014 and continue through September 11, 2014. ...more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

CMS Proposes Elimination of CME Exception to Sunshine Act Reporting

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

Snapshot of Sunshine Rules in EU Countries for The Pharmaceutical Industry

Since the enactment of the Physician Payments Sunshine Act (US Sunshine Act) by the United States, a number of EU Member States have adopted similar rules or strengthened pre-existing regulation in order to improve the...more

As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...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

Health Headlines: Also in the News - May 2014

CMS Seeks Additional Comments on Sunshine Rule Dispute Resolution and Correction Procedures – CMS is seeking additional comments on dispute resolution and correction procedures under the Sunshine Rule. According to the...more

Physician and Teaching Hospital Sunshine Act Registration to Begin June 1

Under the Physician Payments Sunshine Act, pharmaceutical and medical device manufacturers and group purchasing organizations (GPOs) are required to annually report payments or other transfers of value made to physicians and...more

Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

Registration and Data Submission Begin Pursuant to the Sunshine Act

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

Open for Business: CMS Open Payments System Begins in Phases

With the Open Payments System rollout, came the phased approach for data submission, requiring aggregate data in Phase 1 and detailed data reporting in Phase 2. ...more

The Physician Payment Sunshine Act – The Top Five Steps for Physicians: The law defines “payment” to include almost any imaginable...

The Physician Payment Sunshine Act is a minor part of the Affordable Care Act, but it could result in major headaches for physicians. The chief purpose of the Sunshine Act is to make any payments made by medical manufacturers...more

CMS Announces Sunshine Act Open Payment Registration To Begin on February 18, 2014

On Friday, February 7, 2014, CMS announced that Open Payments registration is scheduled to begin on Tuesday, February 18, 2014 for applicable manufacturers and applicable group purchasing organizations (GPOs). ...more

CMS Releases Long-Awaited Details for Sunshine Act Compliance

The Physician Payment Sunshine Act (the "Act") was enacted as part of the Patient Protection and Affordable Care Act for the purpose of promoting transparency between the medical industry and health care providers. It...more

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