sunshine act documents

Novo Nordisk Sunshine Report Accepted by CMS

The Centers for Medicaid and Medicare Services (CMS) accepted Novo Nordisks first Sunshine disclosure report of payments and transfers of value to Health Care Providers and Institutions (HCPs and HCIs) on July 1, 2014. As awareness around Sunshine grows, Novo Nordisk employees, especially those interacting with HCPs and HCIs, may be approached with requests for information. Please remember the following items in regards to the Sunshine disclosure report, the Sunshine act, or the CMS dispute process:

1. Do not respond to HCP or HCI questions individually. Direct all questions to the Compliance Department at [email protected].

2. Respond immediately if contacted by the Compliance Department with inquiries regarding expense disputes to ensure Novo Nordisk meets its obligations.

3. Consult the Sunshine GlobeShare page for information, resources, and Frequently Asked Questions (FAQs) to help guide you through Sunshine.

4. Direct questions of your own to the Compliance Department at [email protected]. Questions, once answered, will become part of the Sunshine FAQs.

Additionally, the Compliance Department sent a letter to all vendors reminding them to review their obligations around Sunshine data reporting and invoicing. All vendor contract owners and vendor relationship managers should also examine the contract terms to enable assistance when required.

Key Dates

Sunshine Update

Important Points

Pre-submission reports were shared with a subset of NNI KOLs / physicians in February, which may increase questions from customers

If a physician contacts you directly about Sunshine dispute-related expenses, please direct him/her to [email protected]. Do not respond individually.

Respond immediately if contacted by the Compliance Dept. with a dispute expense inquiry

Timely review communications and GlobeShare resources

Continue accurate reporting in Concur and InterFace

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June 18 Novo Nordisk submitted report to CMS Covers activity from 31-Aug31-Dec 2013

Sunshine Filing Dispute & Corrections Public Posting

August & September* Physicians review of data on government site Do not respond if physicians ask expense questions *awaiting confirmation from CMS

By September 30th CMS will make data available on a public website

In-Office Meal Reminders

Call ahead to obtain expected headcount and non- meal/snack participants

Accurately enter HCPs and count of Staff

Stay within the NNI policy limit of $25 per person for in-office meals

Ensure Concur entries reconcile with in-office attendance sheet

Interface Program Reminders

All attendee must sign into the program

Close out interface programs within 2 days

Ensure reported attendees reconcile with attendance sheet

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Systems & Services > General Legal > US Healthcare Reform & Novo Nordisk > Open Payments Sunshine Act

FAQs

Attendance Sheets/ Concur Health Care Professionals

Reportable Marketing Materials

NNI Attendance Sheets

Completing In-Office Attendance Sheets & Submitting HCP Information into

Concur FAQs

Concur In-Office Program FAQs

NNI In-Office Meal Allocation (leave behind)

Sunshine Letter for Healthcare Professionals And Institutions

Sunshine Q&A Guideline

NNI Policies: Found on Sunshine Toolkit page under key documents

Reportable Marketing Materials Distribution Guidelines

Sunshine & State Reporting reportable marketing materials decision tree

Understanding What

Materials and Persons are Reportable

Please remember that there is an array of resources available on the Sunshine Globeshare Page to help guide you through Sunshine related questions and to assist you with Sunshine Act compliance:

Sunshine Act Tools and Resources:

Questions [email protected]

Compliance Helpline: (609) 937-3816

Policies Business Ethics Interactions with U.S. Health Care Professionals and Health Care Institutions [Policy 140845] Employee Expense Reimbursement [Policy 140841]

Sunshine Review and Dispute Period closes X date The review dispute and correction period closed on X date. Data is expected to be published by CMS on or about September 30, 2014. As a reminder, Physicians have to the end of the year to submit disputes.

Direct all questions to the Compliance Department at [email protected] or consult the Sunshine GlobeShare page

Please remember: If a physician approaches you about reported information, or an inquiry/dispute please forward questions to [email protected]. A team from Compliance will investigate all inquiries/disputes and respond to the physician or teaching hospital. Updates will be provided to applicable NNI employees.

If you are contacted by the Compliance Department for additional information or supporting

documentation related to a reported payment please respond in a timely manner. If you are contacted by a member of the media, refer the contact to a media relations representative in

the Communications and Public Affairs department via the Communications Hotline at (609) 514-8400.

Sunshine Review and Dispute Period closes X date The$review$dispute$and$correc2on$period$closed$on$X$date.$$$Data$is$expected$to$be$published$by$CMS$on$or$about$September$30,$2014.$As$a$reminder,$Physicians$have$to$the$end$of$the$year$to$submit$disputes.$$

Direct all questions to the Compliance Department at [email protected] or Consult the Sunshine GlobeShare page

Please remember: If a physician approaches you about reported information, or an inquiry/dispute please forward questions to [email protected]. A team from Compliance will investigate all inquiries/disputes and respond to the physician or teaching hospital. Updates will be provided to applicable NNI employees.

If you are contacted by the Compliance Department for additional

information or supporting documentation related to a reported payment please respond in a timely manner.

If you are contacted by a member of the media, refer the contact

to a media relations representative in the Communications and Public Affairs department via the Communications Hotline at (609) 514-8400.

Sunshine Communication Timeline July 14: Vendor Letter

From NNI Sunshine July 17: High Level sunshine Update

All employee (NovoLink, plasma screen) Tip of the week (sales POA handout)

o Check w/ BioPharm/ CMR/ DE/ Trade July 22: Dispute Process

Leadership mess (CMR LT/ BLT/ DE/ Trade/ Sales) Jeff to determine list Talking points to be included

July 23: Dispute Process

Managers (more specific leadership) July 24: Dispute Process

NovoLink (general) Sales (specific) Plasma screens Ad space

Beginning August: High Level Sunshine update

All sales organization Updated FAQ

Mid- August: Dispute Process

Plasma screen (reminder) AD space (reminder)

Mid- September: Data goes public (w/ talking points)

NovoLink Plasma screens Sales commnuications (specific)

End September: ET Sunshine Update October: ET Sunshine Update

Weekly Field Communications Biopham: Monday/Tuesday CMR: every other Thursday (1 edition) Diabetes Sales: every Thursday (management, all field) DE: ??? Trade: ???

TBD List

Sunshine HCP brouchure Action

ABYR: watermark IAAW: plasma screen DAVE: High level update IAAW/ ABYR: import to InfoPath

sunshine act documents

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