US State Reporting
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Connecticut Transparency Reporting
Key Dates
Report Due Date: July 1
Authority
Connecticut State Department of Consumer Protection as per Senate Bill 257 states, “An Act Concerning Reporting of Payments by Manufacturers to Independently-Practicing Advanced Practice Registered Nurses”
Who Must Report?
Pharmaceutical and medical device manufacturers
Pharmaceutical Companies and Medical Device Companies
Latest updated: 27 August 2022
Covered Recipients
Independently-practicing advanced practice registered nurses (APRNs) (Connecticut provides a list of applicable APRNs)
What is reported?
”Payment or other transfer of value” means a transfer of anything of value, except for the transfer of value that is made indirectly to an APRN through a third party where the applicable manufacturer is unaware of the APRN’s identity or meets the criteria for CMS Open Payments exclusions.
Data points to be disclosed:
Manufacturer’s name
Contact person’s name
Contact person’s email
Contact person’s phone number
Total value of the payment to APRN
.
Exemptions
- Manufacturers do not have to report transfers of value that fulfill the following criteria:
Indirect spending to a third party where the manufacturer is not aware of the recipient’s identity.
How to Report?
The report should be emailed to [email protected] with the subject “APRN Payment Report.” An auto-response will be generated to the submitter’s email address and will serve as a proof of submission.
Who Must Report?
Pharmaceutical and medical device manufacturers.
Resources
https://portal.ct.gov/DCP/Drug-Control-Division/Drug-Control/Expenditure-Disclosure-Form
Minnesota Transparency Reporting Requirement
Key Dates
Report Due Date: May 1
Authority
Minnesota Board of Pharmacy — Minnesota Statutes 151.461 and Minnesota Statutes 151.252, subd. 3
Who Must Report?
Pharmaceutical manufacturers
Pharmaceutical Companies and Medical Device Companies
Latest updated: 27 August 2022
Covered Recipients
Doctor
Dentist
Pharmacist
Nurse practitioner
Audiologist
Podiatrist
Physical therapist
What is reported?
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
Note: Entertainment/gifts are prohibited?? (Need to confirm from Umer or Ned)
Exemptions
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.
How to Report?
Submit the file as a comma-separated value (CSV) attachment via email to: [email protected]
The subject line should be “ Disclosure Report.” For example, if the reporting calendar year is 2022, the subject of the email is “2022 Disclosure Report”
If there are no disclosures to report, Send an email to [email protected].
In the body of the email, simply state “Company A has no reportable spend transactions to report for the 20XX calendar year.”
Who Must Report?
Any entity is classified as a Pharmaceutical or medical device manufacturer that:
(a) is directly or indirectly involved in producing, preparing, propagating, compounding, converting or processing 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.
Nevada Transparency Reporting Requirement
Key Dates
Report Due Date: March 1
Authority
Nevada Board of Pharmacy – Senate Bill 539
Who Must Report?
Pharmaceutical manufacturers / pharmaceutical manufacturer sales representatives
Pharmaceutical Companies
Latest updated: 27 August 2022
Covered Recipients
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
What is reported?
A list of HCPs to whom the pharmaceutical sales representative provided either:
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, along with the name of each person to whom a free sample was provided
Data points to be disclosed:
Manufacturer’s name
Representative’s State ID
Representative’s First and Last Name
Activity
Transaction Date
Recipient’s First and Last Name
Recipient’s Professional Designation (a list of applicable designations is 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
Exemptions
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 who produce drugs found on the current “List of Essential Drugs for Treating Diabetes” must report/notify the Department as outlined in SB539 Sec. 3.8 and 4.
How to Report?
Submit the template file as an attachment via email to: [email protected]
Who Must Report?
Pharmaceutical Manufacturer is 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 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, operators or employees of medical facilities, or persons licensed or certified under title 57 of NRS.
Note: Reporting for Pharmaceutical Representatives is both the individual’s responsibility as well as the manufacturer’s.
Vermont Transparency Reporting Requirement
Key Dates
Registration Due Date: January 1
Report Due Date: April 1
Authority
Vermont Attorney General’s Office – Prescribed Product Gift Ban and Disclosure Law
Who Must Report?
Pharmaceutical and medical device manufacturers
Pharmaceutical Companies and Medical Device Companies
Latest updated: 27 August 2022
Covered Recipients
Vermont healthcare providers (HCPs), including healthcare professionals; academic institutions located in or providing services in Vermont; non-profit hospital foundations located in or providing services in Vermont; professional, educational, and patient organizations representing or serving healthcare providers or consumers located in or providing services in Vermont; and members of the Green Mountain Care Board.
A Vermont “healthcare provider” (HCP) is a healthcare professional, a hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to dispense or purchase prescribed products in Vermont for distribution. A hospital foundation organized as a non-profit entity separate from a hospital is not an HCP.
A “healthcare professional” is any of the following:
A person who regularly practices in Vermont, authorized by law to prescribe or recommend prescribed products (such as a licensed clinical social worker or a licensed psychologist), is licensed or otherwise lawfully provides healthcare in Vermont.
A partnership or corporation made up of persons described in 1 above.
An officer, employee, agent, or contractor of a person described in 1 above, or a partnership or corporation made up of such persons, who is acting in the course and scope of employment providing healthcare to individuals, including nursing and front-office staff.
What is reported?
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
Recipient’s License number
Date of expenditure
Value of expenditure
Nature of expenditure
Purpose of expenditure
Product type and name
Exemptions
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 exempted 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.
How to Report?
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 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]
Who Must Report?
“Manufacturer” means a pharmaceutical, biological product, medical device manufacturer, or any other person engaged in the production, preparation, propagation, compounding, processing, marketing, packaging, repacking, distributing, or labeling of prescribed products.
District Of Columbia Transparency Reporting Requirement
Key Dates
Report Due Date: July 1
Authority
D.C. Department of Health – Prescription Drug Marketing Costs Guide
Who Must Report?
Pharmaceutical manufacturers
Pharmaceutical Companies
Latest updated: 27 August 2022
Covered Recipients
All licensed HCPs, including nurses, certified diabetes educators (CDEs), registered dieticians, licensed nutritionists, and radiology technicians.
Non-teaching hospitals/clinics, Universities, Patient advocacy associations, and Professional associations.
All licensed healthcare facilities, including hospice, long-term care, dialysis, etc.
What is reported?
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
The aggregate cost of employees or contractors directly or indirectly engaged in reportable activity
The required data to be disclosed will vary depending on whether the expense is attributable to gifts, advertising, or aggregate cost.
Exemptions
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 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, specialty medical, or other professional association if the association sponsoring the conference or seminar chooses the recipient for the scholarship.
How to Report?
Email the Excel workbook (in Excel format) containing the “Company Information,” “Gift Expenses,” and “Advertising Expenses” worksheets to [email protected]. 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, 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.”
The report must be submitted by July 1, and the signed statement and check must be received within 7 days of the report’s submission.
Mail signed “Company Information” worksheets and checks to:
Department of Health
Pharmaceutical Control – AccessRx
ATTN: Justin Ortique
899 N. Capitol Street, NE
Second Floor
Washington, D.C. 20002
Who Must Report?
All applicable manufacturers and labelers.
A “Manufacturer” is defined as a manufacturer of prescription drugs, including 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, which has a labeler code from the federal Food and Drug Administration under 21 C.F.R.§ 207.20.
Massachusetts Transparency Reporting Requirement
Key Dates
Report Due Date: July 1
Authority
Massachusetts Pharmaceutical Code of Conduct for Manufacturers
Who Must Report?
Pharmaceutical and medical device manufacturers
Pharmaceutical Companies and Medical Device Companies
Latest updated: 27 August 2022
Covered Recipients
Dentist
Pharmacist
Nurse practitioner
Audiologist
Podiatrist
Physical therapist
What is reported?
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
Note: Entertainment/gifts are prohibited
Exemptions
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.
How to Report?
The subject line should be “ Disclosure Report.” For example, if the reporting calendar year is 2022, the subject of the email is “2022 Disclosure Report”
If there are no disclosures to report, Send an email to [email protected].
In the body of the email, simply state “Company A has no reportable spend transactions to report for the 20XX calendar year.”
Who Must Report?
“Manufacturer” means a pharmaceutical, biological product, medical device manufacturer, or any other person engaged in the production, preparation, propagation, compounding, processing, marketing, packaging, repacking, distributing, or labeling of prescribed products.
Resources
https://www.mass.gov/pharmaceutical-code-of-conduct-for-manufacturers