Global Spend Transparency Reporting
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US Transparency & State Reporting Requirements
Dates
Submission: 31st March
Publication: 30th June
Authority
Department of Health and Human Services
Centers for Medicare and Medicaid Services
Who must report?
Applicable Pharmaceutical, Medical device manufacturers, and Group purchase organizations (GPO)
- Physicians
- Physician assistants
- Nurse practitioners
- Clinical nurse specialists
- Certified registered nurse anesthetists
- Certified nurse midwives
All payments, gifts and other transfers of value made to U.S. physicians and teaching hospitals:
- Consulting Fees
- Compensation for services other than consulting
- Honoraria
- Gift
- Entertainment
- Food and beverage
- Travel and lodging
- Research
- Charitable contributions
- Royalty or license fees
- Current or prospective ownership
- Compensation for serving as faculty or as a speaker for an unaccredited continuing education program/accredited CE program
- Grant
- Space rental or facility fee
- Debt forgiveness,
- Long term medical supply or device loan, and
- Acquisitions
All Applicable Pharmaceutical, medical device manufacturers and group purchase organizations (GPO) that fill the following criteria:
- Operates in USA
- Manufactures at least one “Covered Product” i.e drug or biological reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program that requires a prescription (or physician’s authorization) to administer OR produces a device or medical supply that requires premarket approval or premarket notification by the FDA.
OR
- Purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply (as per criteria mentioned above) for a group of individuals or entities, but not solely for use by the entity itself.
- Companies with less than 10% revenue generated through “covered products” do not have to report all Transfers of Value, only the ones that are related to one or more covered drugs, devices, biologicals or medical supplies.
- Entities contributing to the manufacturing process of a covered product but have no business presence in the United States.
- Entities manufacturing raw materials or components only, which are not themselves covered products. However, entities that are under common ownership with an applicable manufacturer and assist such manufacturer with the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply, do not qualify for this exemption.
- Hospitals, hospital-based pharmacies and laboratories that manufacture a covered product solely for internal use itself or by an entity’s own patients.
- Wholesalers or distributors who don’t hold the title of a covered product will not be subject to the reporting requirements, with the exception of those who are under common ownership with an applicable manufacturer and assist or support with respect to a covered drug, device, biological, or medical supply.
- Applicable manufacturer does not manufacture a covered drug, device, biological, or medical supply, with exception of manufacturing the covered product for another entity under a written agreement, does not hold the FDA approval, licensure or clearance for the product, and is not involved in the sale, marketing or distribution of the product, then the manufacturer is only required to report payments or other transfers of value related to the covered product.
Annual reports must be submitted to the Centers for Medicare and Medicaid Services through the online portal.
Dates
Submission: 1st March
Authority
Nevada Board of Pharmacy
Who must report?
Pharmaceutical manufacturers
Pharmaceutical manufacturer sales representatives
- Healthcare providers (HCPs) who are licensed, certified or registered in Nevada;
- Pharmacies and employees thereof; operators and employees of medical facilities, and
- Persons licensed or certified under the provisions of title 57 of NRS.
A list of HCPs to who have been provided by a pharmaceutical sales representative:
- Any type of compensation with a value that exceeds $10 or Total compensation with a value that exceeds $100 in aggregate
- The name and manufacturer of each prescription drug for which the pharmaceutical sales representative provided a free sample to an HCP
- The name of each person who was given a free sample
Data points to be disclosed:
- Manufacturer name
- Representative State ID
- Transaction Date
- Recipient First, Middle and Last Name
- Recipient Professional Designation (a list of applicable designations are provided)
- NPI
- Zip Code of Practice
- Compensation Amount
- Compensation Type
If a sample drug was provided, the following fields are also required:
- Drug Name
- NDC
Pharmaceutical Manufacturer means a person who:
- Derives, produces, prepares, compounds, mixes, cultivates, grows or processes any drug or medicine;
- Repackages any drug or medicine for the purposes of resale; or
- Produces or makes any devices or appliances that are restricted by federal law to sale by or on the order of a physician.
Pharmaceutical sales representative means a person who markets prescription drugs to providers of health care licensed, certified or registered in this State, pharmacies or employees thereof, operators or employees of medical facilities or persons licensed or certified under the provisions of title 57 of NRS.
Note: Reporting for Pharmaceutical Representatives, is both the individual’s responsibility as well as the manufacturer’s.
- A pharmaceutical manufacturer has to report information of all representatives and each representative’s HCP interactions but no medical device representative information is required to be submitted.
- Only manufacturers that produce drugs found on the current “List of Essential Drugs for Treating Diabetes” are required to report/notify the Department as outlined in SB539 Sec. 3.8 and 4.
- Submit the template file as an attachment via email to: [email protected]
Dates
Submission: 1st April
Authority
U.S. Food and Drug Administration
Who must report?
Applicable Pharmaceutical manufacturers
Healthcare Professionals
According to the section 6004 of the ACA, manufacturers and authorized distributors of applicable drugs must submit the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed, aggregated by the name, address, professional designation, signature of the practitioner who made request, and signature of the practitioner or someone designated by the practitioner for receiving the distributed drug samples.
Data points to be disclosed:
- Submission year
- Business name
- Practitioner professional designation
- First name, middle initial, last name of the recipient
- Address
- Drug trade name and dosage
- Package size
- Package/quantity requested
- Package/quantity received
- Signature received
- All Applicable Pharmaceutical Manufacturers defined as:
“[T]he person who performs all of the following operations that are required to produce the product: (1) Mixing, (2) granulating, (3) milling, (4) molding, (5) lyophilizing, (6) tableting, (7) encapsulating, (8) coating, (9) sterilizing, and (10) filling sterile, aerosol, or gaseous drugs into dispensing containers.”
- All Authorized distributor of record (ADR) defined as:
“[T]hose distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products.”
Note: An entity that is an ADR under section 503(d) of the FD&C Act is also an ADR under section 1128H of the SSA.
When a manufacturer and ADR both have records regarding the same drug sample request or distribution, only one of the two entities should submit the required drug sample information to FDA.
- Sign up for Electronic Submissions Gateway account:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm - Submit reports made in XML format to FDA via Gateway. XML schema can be downloaded via
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm
Dates
Submission: 1st May
Authority
Minnesota Board of Pharmacy
Who must report?
Pharmaceutical manufacturers
- Advanced practice registered nurses (APRNs)
- Physician assistants (PAs)
- Veterinarians
- Dental therapists
Payments, reimbursement or other compensation paid to HCPs registered and practicing in Minnesota during the calendar year in which the transfer of value is $100 or more, to a particular covered recipient.
Data points to be disclosed:
- Name of practitioner
- Professional designation
- Address of practitioner
- Value of payment
- Specific reason for payment
Any entity engaged in manufacturing, wholesale distribution, or selling of drugs and/or medical device, medicines, chemicals, or poisons for medicinal purposes other than to the consuming public or patient, licensed by the state.
- A medical device manufacturer distributing drugs as an incidental part of its device business shall not be considered a manufacturer, a wholesale drug distributor, or agent under this section and hence exempted from reporting Transfers of Value made in association with those drugs only.
- Professional samples of a drug provided to a prescriber for free distribution to patients are not considered as reportable transfers of value.
- Transfers of value with a total combined retail value, in any calendar year, of not more than $50 are also not reportable.
- A payment to the sponsor of a medical conference, professional meeting, or other educational program, provided the payment is not made directly to a practitioner and is used solely for bona fide educational purposes is also exempted from disclosure.
- Reasonable honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting, less than $100 value annually. Any honoraria or payment to practitioner exceeding $100 annually must be reported.
- Compensation for the substantial professional or consulting services of a practitioner in connection with a genuine research project, less than $100 annually. Transfers of value exceeding $100 annually in this category is reportable.
- Publications and educational materials; or
- Salaries or other benefits paid to employees.
Reports must be filed in an electronic format. Applicable manufacturers are required to fill out the spreadsheet available on Minnesota Board of Pharmacy website and return it to the Board either attached to an e-mail ([email protected]) or copied onto a CD-ROM.
Dates
Submission: 1st July
Authority
D.C. Department of Health
Who must report?
Pharmaceuticals – Manufacturers and labelers
- All licensed HCPs including nurses, certified diabetes educators (CDEs), registered dieticians, licensed nutritionists, radiology technicians.
- Non-teaching hospitals/clinics, Universities, Patient advocacy associations, Professional associations.
- All licensed healthcare facilities, including hospice, long-term care, dialysis, etc.
- All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications to D.C. residents
- Any expenditure for consulting and honoraria fees, charitable grants, educational programs, gifts, meals or entertainment over $25 in value, and travel reimbursement for District healthcare professionals
- Aggregate cost of employees or contractors who directly or indirectly engage in reportable activity
The required data to be disclosed will vary depending on whether the expense is attributable to gifts, advertising or aggregate cost.
- All applicable manufacturers and labelers.
- A “Manufacturer” is defined as a manufacturer of prescription drugs and inclusive of a subsidiary or affiliate of a manufacturer.
- A “Labeler” refers to an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R.§ 207.20.
- Expenses of $25 or less.
- Compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy, or treatment that is of modest value.
- Scholarships and reimbursement of expenses for certain recipients attending a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the association sponsoring the conference or seminar chooses the recipient of the scholarship.
- Submit the Excel workbook (in Excel format) containing the “Company Information,” “Gift Expenses,” and “Advertising Expenses” worksheets via email to [email protected]
Note: Although you are required to utilize the “Aggregate Cost” worksheet to perform your calculations, you are not required to submit the worksheet itself. You may elect instead to submit only the total based on your calculations using the “Aggregate Cost” worksheet. In addition, print out the “Company Information” worksheet only, provide wet signature certification, and mail it to the Department of Health accompanied by a check for $5,000 made payable to “D.C. Treasurer.” - Mail signed “Company Information” worksheets and checks to:
Department of Health
Pharmaceutical Control – AccessRx ATTN: Shauna White
899 N. Capitol Street, NE
Second Floor
Washington, D.C. 20002
Reports must be submitted by July 1, and the signed statement along with the check must be received no later than 7 days after the report’s submission.
Dates
Submission: 1st April
Authority
Oregon Department of Consumer and Business Services
Who must report?
Pharmaceutical Company Representatives
An individual authorized, certified, and licensed under the laws of Oregon to prescribe, dispense or provide pharmaceutical products, i.e., drugs, to patients for treatment, diagnosis, injury, congenital or disease prevention is a covered recipient.
The interactions that healthcare professionals (HCPs) have with pharmaceutical representatives include but are not limited to video conference, email exchange, telephonic conversation, meeting in person, leveraging other communication channels, or leaving material, i.e., drugs samples for the specific HPC without communicating personally is termed as reported.
Data to be disclosed:
- HCP’s License Type, Name, Address, NPI or Oregon State License Number
- Representatives License Number and Name
- Date, location, and the duration of interaction
- Name, Number of Drugs Promoted During the Interaction, Monetary Value of Samples, Value of Pharmaceutical Related Materials
- Gifts Given, and Description of Compensation.
Pharmaceutical Company Representatives
Exemption
No Exemptions.
A disclosure log can be prepared and maintained by license holders/representatives. This log should contain all pharmaceutical representatives’ interactions with healthcare providers. This disclosure log must be turned into a program via the iReg Portal before April 1st, 2023.
The reporting spreadsheet is available on this web page. A registration email, with instructions, for the iReg portal is sent to the license holder once a license application is approved.
Important Links:
https://dfr.oregon.gov/business/licensing/pharmaceutical-rep/pages/pharmaceutical-rep.aspx
Dates
Submission: 1st July
Authority
Massachusetts Department of Public Health
Who must report?
Applicable Pharmaceuticals and medical device manufacturers
- Doctor
- Dentist
- Pharmacist
- Nurse practitioner
- Audiologist
- Podiatrist
- Physical therapist
- Product education and training
- Modest meals in conjunction with product education and training
- Honoraria, consultant, speaker fees and related out-of-pocket expenses
- Reasonable travel and lodging necessary for training
- Demonstration or evaluation units
- Educational gifts (journal articles, anatomical models, textbooks)
- Charitable donations
- Any entity is classified as Pharmaceutical or medical device manufacturer that:
- (a) is directly or indirectly involved in producing, preparing, propagating, compounding, converting or processing of prescription drugs, biologics, or medical devices, either by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis; or
- (b) is involved directly in the packaging, repackaging, labeling, relabeling or distributing
- prescription drugs, biologics, or medical devices.
Companies do not have to report transfers of value made to:
- Full time employees and board members of a pharmaceutical or medical device manufacturer acting in that capacity.
- Consumers who purchase prescription drugs or medical devices for themselves or for a family member.
- Schools, universities and trade organizations.
- Manufacturers of pharmaceuticals and medical devices are required to register with Department of Public Health and renew registration annually by paying a yearly fee of $2000.
- Email the file as a comma-separated value (CSV) attachment to: [email protected]
- Add subject line as “
Disclosure Report.” E.g if the reporting calendar year is 2021, the subject of the email is “2021 Disclosure Report”
Note: If there are no reportable transactions, email to [email protected] stating “Company
Dates
Registration Due Date: 1st Jan
Report Due Date: 1st April
Authority
Vermont Attorney General’s Office
Who must report?
Pharmaceutical and medical device manufacturers
- Healthcare professionals,
- Academic institutions,
- Non-profit hospital foundations,
- Educational, and patient organizations located in or providing services in Vermont; and
- Members of the Green Mountain Care Board
- Samples (separate disclosure template)
- Device loaners (allowed for up to 120 days)
- Clinical and research payments
- Compensation for bona fide services
- Sponsorship and fellowship payments
- Educational materials
- Demo/evaluation units
- Coupons, vouchers and discount cards
- Charitable contributions
Data points to be disclosed:
- Manufacturer’s name
- Recipient’s name
- License number of recipients
- Date of expenditure
- Value of expenditure
- Nature of expenditure
- Purpose of expenditure
- Product type and name
“Manufacturer” means a pharmaceutical, biological product, or medical device manufacturer or any other person who is engaged in the production, preparation, propagation, compounding, processing, marketing, packaging, repacking, distributing, or labeling of prescribed products.
- The term “Manufacturer” does not include a wholesale distributor of biological products, a retailer, or a pharmacist licensed under 26 V.S.A. chapter 36.
- The term also does not include a manufacturer whose only prescribed products are classified as Class I by the U.S. Food and Drug Administration, are exempt from pre-market notification under Section 510(k) of the federal Food, Drug and Cosmetic Act, and are sold over-the-counter without a prescription.
- The Compliance Officer Form must be completed and submitted by the first day of each reporting period – e.g. by January 1, 2021, by manufacturers with expenditures in 2020 with a registration fees of $500.
- The AGO provides Excel spreadsheets for both Expenditure and Sample disclosures, once completed the spreadsheets should be emailed to [email protected]
Our EU Reporting services utilize a combination of advanced compliance technology and the expertise of local SMEs. These experts bring an in-depth understanding of regional compliance landscapes, which, when combined with our technology, offers a customized service that adapts to each country’s unique requirements resulting in detailed compliance reports and insights.
We cover data collection, validation, and reporting processes across all the European countries, ensuring that all disclosures of payments made to Health Care Professionals (HCPs) and Health Care Organizations (HCOs) comply with local legal requirements.
Initial Consultation
Understanding the client’s needs and the local compliance landscape
Local SME Involvement
Engaging local SMEs for region-specific expertise and guidance
Compliance Reporting
Utilizing our SME insights to validate and report data
Final Submission
Ensuring accurate and timely submissions of compliance reports
Ongoing Support
Offering continuous support and updates on local compliance changes
Europe Transparency Reporting Requirements
On 29 December 2011, the French Public Health Code (PHC) introduced the French Sunshine Act to establish transparency in a broad section of the France life sciences industry. The act ensures that life sciences companies provide transparent information about any existing contract with the health care providers.
Your company produces or markets products for health purposes (products for human use, health products (medicines and medical devices) or cosmetics, veterinary products) or provides services related to these products.
And your company maintains links (agreements, remuneration, benefits) with players in the health field.
Companies subject to Transparency-Health are required to declare twice a year the links they have with the beneficiaries (agreements, remuneration and/or benefits) covered by the system:
- For the first half of year n, before September 1 of year n,
- For the second half of year n, before March 1 of year n+1.
Companies are required to report any kind of agreement made with health care providers of any category.
- Companies are required to submit the following information for any agreement made with the health care providers:
- Name and address, along with the registration number and qualification (in case of medical students), of the individual HCPs
- Contract date
- Purpose of the contract
- Amount of the contract need not be disclosed
- Companies that provide benefits to the HCPs are required to submit the following information:
- Name and address, along with the registration number and qualification (in case of medical students), of the individual HCPs
- Value and nature of the benefits along with the date on which the benefits were granted
- Duration throughout which benefits were provided
For further information, please refer to this website:
Disclosure UK is part of a Europe-wide initiative to increase transparency between pharmaceutical companies and the doctors, nurses, pharmacists and other health professionals and organizations it works with.
The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry to operate the ABPI Code of Practice for the Pharmaceutical Industry.
As part of wider commitments to transparency, pharmaceutical companies are required by the ABPI Code of Practice for the pharmaceutical industry to publicly disclose the data annually, via Disclosure UK.
Disclosure UK is updated at the end of June every year and can be found at www.disclosureuk.org.uk. It is managed by ABPI, on behalf of the companies disclosing data. It covers the key areas of partnership between industry and HCPs/HCOs, including:
- Participation in advisory boards
- Speaking at or chairing meetings
- Working with and advising doctors and scientists in pharmaceutical companies
- Speaking at conferences and symposia
- Attending and contributing to national and international conferences
- Provision of grants and donations (HCOs only)
- Sponsorship of events for the provision of medical education to HCPs (HCOs only)
https://www.pmcpa.org.uk/media/3406/2021-abpi-code-of-practice.pdf
Here is the list of ABPI members:
https://www.abpi.org.uk/membership2/abpi-members-list/
Further requirements on what to report are mentioned in this document:
https://www.pmcpa.org.uk/media/3292/2021-abpi-code-of-practice-technical-release.pdf
Countries Covered
