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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

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 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

Health Headlines: Also in the News - May 2014

CMS Releases Proposed Rule on Prior Authorizations for DMEPOS Items – On May 22, 2014, CMS released a Proposed Rule setting out a prior authorization process for certain types durable medical equipment, prosthetics,...more

Health Care Reform Implementation Update - May 2014

Congress held several hearings last week ranging from Sylvia Burwell’s nomination for Secretary of the Department of Health and Human Services (HHS), to Medicare payment oversight, to post-acute care in Medicare. The Centers...more

Chance to Comment on Future of DMEPOS Payments

CMS recently took the unusual step of issuing an Advance Notice of Proposed Rulemaking (ANPR) regarding changes to Medicare payment methodologies for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS)...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - This Week’s Hearings: - Wednesday, January 15: The House Committee on Veterans’ Affairs will hold a hearing titled “Vendors in the OR- VA’s Failed Oversight of Surgical Implants.” The House...more

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

Health Reform + Related Health Policy News - October 2013 - Issue 3

In This Issue: - Top News ..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law ..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues ..Kaiser Study...more

Tax Talk -- Volume 6, No. 3 -- October 2013

In This Issue: A Primer on the Medical Device Excise Tax; FATCA Registration Begins; In re Downey Financial Corp. (U.S. Bankr. Court Dist. of Delaware 10/8/2013); In re NetBank (11th Cir. 9/10/2013); and In re...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

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...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

Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...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

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

The Physician Payment Sunshine Act Final Rule: Key Change From Proposed Rule Affecting Foreign Entities

We now have only 36 days to go until August 1, 2013, when the new data collection obligations imposed on “applicable manufacturers” and group purchasing organizations under the physician payment “sunshine” rules of the...more

Getting Over the Goal Line: Congress Shows Strong Support for Medical Device Tax Repeal, but Issues Remain

Introduction - The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...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

Getting Ready For The Physician Payment ‘Sunshine’ Rule

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

Here Comes the Sun: What You Need to Know about the Sunshine Act and Its Implementing Rules

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

ProPublica's "Dollars for Docs": Will The Physician Payments Sunshine Provisions Clear The Haze?

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

CMS Issues Rules On Physician Payments Sunshine Act

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

Final Sunshine Act Arrives: Now the Hard Part

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

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