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Sunshine Act Compliance - Perspectives on the Final Rule for Implementation

The long-awaited final rule for implementing the Physician Payment Sunshine Act was released by the Center for Medicare & Medicaid Services (CMS) on Friday, February 1, 2013 and published in the Federal Register on February 8, 2013.

The Sunshine Act, a subsection of the Patient Affordable Care Act of 2010, requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make annual reports of certain payments and transfers of value to physicians and teaching hospitals. Applicable manufacturers and group purchasing organizations (“GPOs”) are also required to make annual reports of certain physician ownership or investment interests. CMS is scheduled to publish these reports on a public website by September 30, 2014.

In addition to announcing the data collection and reporting dates, the Final Rule also addresses many outstanding questions including:

  • Definitions for applicable manufacturers, common ownership and consolidated reporting
  • Special rules for reporting research related payments, food and beverage expenses and continuing education programs
  • Details about the CMS public website where the data will be published, as well as the secure website for reporting and correcting the data
  • Federal preemption of similar state laws

Here we provide perspectives and expert insights on the Sunshine Act and the implications on life sciences company operations, ranging from written standards and training and education, to auditing, monitoring, tracking, collecting and reporting.

Perspectives

Compliance Keys - Repeatable Process and Automated Monitoring

Navigant’s Life Sciences Disputes, Compliance, Regulatory and Investigations practice leaders address regulatory and health care compliance risks for the life sciences industry.

 Article
Sunshine Act Alert – Complexities in Allocating the Value of Food and Beverage

Read Navigant’s perspectives and experts insights on complexities relating to the attribution methodology for allocating the value of food and beverage provided to Covered Recipients in the Sunshine Act.

 Article / White Paper
PPSA Reporting: Extend your Sunshine to your Primary Customer, the Physicians and Teaching Hospitals

In this article, Navigant provides guidelines for a successful communications approach around the Sunshine Act and potential areas of risk for life sciences companies to consider.

 Article / White Paper
Saul Helman quoted in Pharmaceutical Executive

Saul B. Helman was quoted in the Pharmaceutical Executive article titled, “The Sunshine Act: Cloudier Still?”

 Article
Sunshine Act Readiness Diagnostic

In response to the publication of the final rule of the Sunshine Act, Navigant has developed a readiness diagnostic to assist life sciences companies with assessing their state of preparation for Sunshine Act data collection, aggregation and reporting requirements.

 Link
Sunshine Act Alert – Considerations for Federal Reporting of Research Payments

Navigant experts offer insights and guiding concepts relating to the Sunshine Act and reporting research payments to the Federal government.

 Article / White Paper
Aggregate Spend 2.0 - An Integrated Systems Approach Managing All That Sunshine Brings

Navigant outlines the key components of an integrated, comprehensive aggregate spend system and how companies can get the most out of their data and prepare for the final rule of the Sunshine Act.

 Article
Fair Market Value is Critical in Implementing the Physician Payments Sunshine Act

Navigant outlines strategies for companies to prepare for the Sunshine Act with a consistent and supportable approach to determine the FMV for services being provided by HCPs and HCIs.

 Article
The Fundamentals of Sunshine Compliance and Aggregate Spend Solutions

Navigant examines the laws and requirements related to HCP spend transparency and foundational knowledge around the key components of an aggregate spend solution.

 Conference Presentations

Experts

Saul B. Helman, M.D.

Dr. Saul Helman is a Managing Director in the Disputes and Investigations practice. He provides support in investigations, litigation and compliance integration matters involving life sciences companies.

Jack T. Tanselle

As a Managing Director in the Disputes and Investigations practice, Jack Tanselle has extensive experience in the pharmaceutical, biotechnology, and medical device industries by assisting clients in identifying and mitigating key business risks.

Kevin Cornish

Kevin Cornish is a Managing Director and the national leader of the Healthcare Disputes & Investigations segment, which specializes in providing financial, economic, investigative, clinical, operational expertise to health sciences, providers, payers, physicians and the health law community.

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