News & Analysis as of

Sunshine Act

CMS Releases 2018 Open Payments/Sunshine Act Reporting Thresholds

by Reed Smith on

CMS has announced inflation-adjusted de minimis reporting thresholds for 2018 under the Open Payments/Physician Payments Sunshine Act program. Specifically, payments or transfers of value of less than $10.49 do not need to...more

Ontario introduces bill to promote transparency in healthcare industry

by DLA Piper on

On September 27, 2017, Ontario’s Minister of Health and Long-Term Care, Dr. Eric Hoskins, introduced proposed legislation that aims to add transparency to certain marketing practices employed by the medical industry, in...more

CMS Corrects Sunshine Act CMP Regulations due to Inflation Adjustment Error

by Reed Smith on

CMS has just corrected an error in a 2016 rulemaking that inadvertently called for a 10-fold increase in certain “Sunshine Act” civil monetary penalties (CMPs). Under section 1128G of the Social Security Act, applicable...more

CMS Open Payments: A Look Behind the Curtain

by McGuireWoods LLP on

Compliance officers often lament that it is impossible to identify, assess and manage the compliance risks of financial relationships they know nothing about. Too often they are limited to relationships brought to their...more

MedPAC Takes Anti-POD Stance in Report to Congress, Echoing an Increasingly Uniform Consensus

by Ropes & Gray LLP on

On June 15, 2017, the Medicare Payment Advisory Commission (MedPAC), a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

by Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

France: Again the Life Science Industry Will Have to Take a Close Look at a New Set Of Regulations Reshaping Transparency-Related...

by Reed Smith on

The relationship between the life sciences industry and health-care practitioners is being reshaped in France through regulatory developments under both the French Anti-Gift Law and the French Sunshine Act. The...more

ITC Grants Oral Argument

by Jones Day on

As we have previously reported, the Commission recently heard its first Section 337 oral argument in nearly ten years. Hot on the heels of that proceeding, the ITC has again granted an oral argument in a Section 337...more

House Passes 21st Century Cures Act

by King & Spalding on

On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more

House Passes 21st Century Cures Act

by Cozen O'Connor on

On November 30, 2016, the House overwhelmingly passed (392-26) the 21st Century Cures Act (“Bill”). The Bill moves on to the Senate next week and it is projected to pass in the Senate as well. Notably, the Bill seeks to...more

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

by Reed Smith on

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

by Foley & Lardner LLP on

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

Physician-Owned Distributor (POD) Update

by Reed Smith on

For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors ("PODs"). From the Department of Health and Human Services Office of Inspector General’s ("OIG") issuance...more

Economic Incentive Applications and Florida’s Public Records and Sunshine Law

by Carlton Fields on

If you are considering locating—or relocating—your business to Florida, and are interested in applying for an economic incentive, you should be aware of Florida’s Public Records and Sunshine Law, which provides that certain...more

Delay in Final Rule Implementing PAMA: Sunshine Act Revisited?

As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most...more

CMS Call on Opportunity to Review Open Payments/Sunshine Act Data (April 12)

by Reed Smith on

CMS is hosting a provider call on April 12, 2016 to discuss the Open Payments program, including the process for physicians and teaching hospitals to review applicable data on payments or transfers of value prior to...more

Financial Trade Secrets Exemption from Florida’s Sunshine Laws

by Nossaman LLP on

On Wednesday, February 24, 2016, Florida’s Governor Rick Scott signed two bills which exempt trade secret financial information from the state’s Sunshine Laws. The change is significant in a state known for expansive open...more

French Bribery Act Would Be Anti-Corruption Revolution

by Reed Smith on

We’ve covered the French Sunshine Act, which requires French pharmaceutical companies to disclose their links to healthcare providers, extensively over the past few years and most recently here. France on the whole, however,...more

The Brown Act – Reminding Local Governments that the Sun Continues to Shine in California

by Nossaman LLP on

Transparency in government is a staple of American democracy. The Federal Freedom of Information Act and California’s Public Records Act are two examples of laws that are intended to provide transparency for government’s...more

A "French Bribery (and Sunshine) Act" is about to be launched - a legal revolution is underway in France

by Reed Smith on

France has been for a long time lagging behind on the field of anti-corruption laws. In 2012, the Organisation for Economic Co-operation and Development raised serious concerns regarding the lack of bribery convictions in...more

SEC Expected to Propose Liquidity Risk Management Programs for Funds

The Securities and Exchange Commission announced that it will consider proposals for liquidity risk management programs and related disclosures for open-end management investment companies. The Commission will consider the...more

OIG Reviews Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors (PODs) of Spinal Devices

by Reed Smith on

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a report on “Overlap Between Physician-Owned Hospitals and Physician-Owned Distributors.” The OIG reviewed 12 hospitals that...more

Open Payments Update: End of CME Exception for Sunshine Reporting

by Baker Ober Health Law on

On July 17, 2015, CMS announced updates to the Law and Policy page on the Open Payments website to provide additional guidance regarding the termination of the continuing medical education (CME) exception for reporting under...more

SEC to Consider Adoption of Pay Ratio Disclosure Rules at August 5 Opening Meeting

On July 29, the Securities and Exchange Commission, pursuant to a “Sunshine Act” notice, stated that it will hold an open meeting on Wednesday, August 5, to consider, among other things, whether to adopt proposed rules for...more

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