The Sunshine Act, also known as OPEN PAYMENTS, requires pharmaceutical, biologic, and medical device manufacturers (collectively, Manufacturers) to annually disclose to the Department of Health and Human Services (HHS) all payments and other transfers of value (collectively Payments) furnished to U.S.-licensed physicians and certain non-physician practitioners (collectively, Covered Recipients).
Consistent with the Sunshine Act, Knoa Pharma LLC and its subsidiaries (the “Company”) will collect and report to the government all payments and transfers of value to Covered Recipients from all Company sources. We will annually submit data to Center for Medicare & Medicaid Services (CMS) no later than March 31. CMS is expected to make the data publicly available no later than June 30 each year.
Covered Recipients will have an opportunity to review the Manufacturer-submitted information and submit disputes via a CMS portal for at least 45 days before the information becomes publicly available on the government website.
Why does Knoa Pharma interact with Healthcare Professionals?
We value our relationships with healthcare professionals (HCPs), and recognize that by partnering with HCP colleagues, we learn from their expertise and experience. We engage HCPs in a variety of ways, including but not limited to:
- Research & Development activities, including clinical studies that investigate the safety and efficacy of our products; and
- Various advisory and consulting capacities, where we interact with academic researchers and various HCPs to gather insights that help us develop and improve our products and provide input on the design of clinical studies in the advancement of R&D activities
What is reportable under the Sunshine Act?
Examples of Reportable Payments include:
- In-service meals – meals accompanied by an educational presentation by a sales representative in a HCP’s office
- Meals consumed at promotional speaker programs, investigator meetings, advisory boards, and product theaters, and the like, provided the identity of participants is known
- Any travel costs for activities such as speaker programs, advisory boards
- Fee-for-service arrangements such as consultant, speaker, advisory board member, clinical trial investigator
- Grants
- Donations
- Educational materials that are not intended for use by a patient
Examples of Non-Reportable Payments include:
- Indirect Payments made through a third party where the manufacturer does not know the identity of the recipient (e.g., blinded market research)
- Anything less than $10.00 in value, unless the total value of all Payments during the calendar year to that particular Covered Recipient is more than $100.00 in value
- It is recommended that Covered Recipients assume that any Payment, even one valued at less than $10.00, will be reported. If the aggregate amount is $100.00 or less, we will not report it.
- In accordance with the regulation, these values are adjusted annually consistent with the consumer price index. Please refer to https://www.cms.gov/openpayments/ for updates.
- Educational materials that directly benefit patients or are intended for patient use (e.g., journal for a patient to chart own symptom level, anatomical charts)
What level of detail will be reported?
Each line item that is reported to CMS will be available on the public report in detail, including but not limited to:
- Applicable manufacturer’s name
- Name of Covered Recipient
- Specialty (physician only)
- Business address
- Amount of Payment or other transfer of value
- Date of Payment
- Form of Payment (e.g., cash, in-kind items or services, stock)
- Nature of Payment (e.g., consulting, food, travel, education)
- Name(s) of the related covered drug, as applicable
Want more information about the Sunshine Act?
- See information on the CMS website:
The Centers for Medicare and Medicaid Services (CMS) website - Review Knoa Pharma’s OPEN PAYMENTS Tear Sheet:
Knoa Pharma’s OPEN PAYMENTS (aka The Sunshine Act) tear sheet
Dispute Resolution
When manufacturers submit Payments to the OPEN PAYMENTS Enterprise Portal, Covered Recipients will have an opportunity to review the data that has been submitted about them prior to publication of the data. If the Covered Recipient finds discrepancies with the submitted data, a dispute can be initiated by the Covered Recipient in the CMS Enterprise Portal. Once the dispute is reviewed, it can be resolved in one of three ways:
- Resolved – the manufacturer updates and resubmits the disputed data
- Resolved No Change – indicates that manufacturer and the Covered Recipient have resolved the dispute in accordance with the guidance in the Final Rule
- Withdrawn – a Covered Recipient can withdraw a dispute initiated against a record. In this instance, no action is taken by the manufacturer
Research Spend – Each research payment record is attributed to the Covered Recipient or non-covered recipient that received the payment. As appropriate, the names of principal investigator(s) associated with the research payment are also provided. If you are an HCP who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name. This does not necessarily mean the payments are attributed to you. The dollar amount of the record corresponds to the total payment; the amounts do not accrue to each individual physician, meaning these dollars are not included in any aggregate amount reported against the physician typically.
Are you a Healthcare Professional under contract with Knoa Pharma? If so, click these links as needed.
Still Have Questions?
- Please send in your question via e-mail from your preferred address to SunshineAct@pharma.com
- If you are a Covered Recipient and wish to receive a report of spend that our Company has collected year-to-date that we plan to report to CMS, please send a signed request on your company/institution letterhead making the request. Be sure to include your NPI (National Provider Identifier) number in the request. Such requests may be sent to SunshineAct@pharma.com or to the following address:
Sunshine Act Team
c/o Ethics & Compliance
Knoa Pharma LLC
201 Tresser Blvd. 9th Floor
Stamford, CT 06901