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Prescription Drug Marketing Costs
A Guide for Pharmaceutical Manufacturers and Labelers
Published by the District of Columbia Department ofHealth
Calendar Year 2021
Description of Requirements
Pursuant to the requirements of Chapter 18 of Title 22 of the District of Columbia Municipal Regulations
(DCMR), entitled “Prescription Drug Marketing Costs,” and Title III of the AccessRx Act of 2004,
manufactures and labelers of prescription drugs dispensed in the District of Columbia (“District”) who
engage in marketing in the District must report to the Department of Health (“Department”) their costs
for pharmaceutical drug marketing in each calendar year by July 1st of the following year.
Submission Procedures
Fill out the “Company Information,” “Gift Expenses,” “Advertising Expenses,” and “Aggregate Cost”
worksheets of the workbook titled “2021_Prescription_Drug_Marketing_Costs.xls,” and email the Excel
workbook containing the “Company Information,” “Gift Expenses,” and “Advertising Expenses”
worksheets to DC.Accessrx@dc.gov. 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
only submit the total based on your calculations using the “Aggregate Cost” worksheet. The other three
worksheets must be completed using the accepted values and submitted in Excel format, not as a PDF.
In addition, print out the “Company Information” worksheet only, provide wet signature certification, and
mail it to the Department accompanied by a $5,000* check made payable to “D.C. Treasurer.”
The report must be submitted by July 1st, and the signed statement and check must be received within
seven (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
*With passage of the “Fiscal Year 2010 Balanced Budget Support Emergency Act of 2010,” the fee for the program is
$5,000.
Spreadsheet Instructions
The “2021_Prescription_Drug_Marketing_Costs.xls” document contains four worksheets in which
information should be entered: Company Information, Gift Expenses, Advertising Expenses, and Aggregate Cost.
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(The fifth worksheet, Instructions, is for reference purposes.) Please make sure to fill out all four
required worksheets.
Worksheet 1: Company Information
The Company Information worksheet includes fields for the company’s contact information and the
contact information of the individual responsible for the company’s compliance. Pursuant to 22 DCMR
1801.5, the responsible individual “shall be a member of senior management or senior level company
official within the manufacturer's or labeler's company or corporate structure.”
The “2021 Marketing Expenses” section of this worksheet should contain the relevant totals from the
Gift Expenses, Advertising Expenses, and Aggregate Cost worksheets. PLEASE DOUBLE CHECK
that the totals listed on this worksheet match the totals on the three following worksheets (i.e.,
that the Gift Expense figure on Worksheet 1 matches the Gift Expense total on Worksheet 2, etc.). Add
the Gift Expenses, Advertising Expenses, and Aggregate Cost figures to get the Total Marketing
Expenses. Please confirm that the sum of the three figures is correct.
Worksheet 2: Gift Expenses
The Gift Expenses worksheet collects the following information, as described in §48-833.03 of the
AccessRx Act of 2004:
With regard to all persons and entities licensed to provide health care in the
District, including health care professionals and persons employed by them in the
District, carriers licensed under Title 31, health plans and benefits managers, pharmacies, hospitals,
nursing facilities, clinics, and other entities licensed to provide health care in the District, the
following information:
(A) All expenses associated with educational or informational programs, materials, and seminars,
and remuneration for promoting or participating in educational or informational sessions,
regardless of whether the manufacturer or labeler provides the educational or informational
sessions or materials;
(B) All expenses associated with food, entertainment, gifts valued at more than $25, and anything
provided to a health care professional for less than market value;
(C) All expenses associated with trips and travel; and
(D) All expenses associated with product samples, except for samples that will be distributed free
of charge to patients.
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The following expenses are not subject to reporting requirements:
(1) Marketing expenses of twenty-five dollars ($25) or less per day and per health care
provider or entity
(2) Reasonable compensation and reimbursement for expenses in connection with a bona fide
clinical trial of a new vaccine, therapy, or treatment;
(3) Scholarships and reimbursement of expenses for attending a significant educational,
scientific, or policy-making conference or seminar of a national, regional, or specialty medical or
other professional association if the recipient of the scholarship is chosen by the association
sponsoring the conference or seminar; and
(4) Expenses associated with advertising and promotional activities purchased for a regional or
national market that includes advertising in the District if the portion of the costs pertaining to or
directed at the District or cannot be reasonably allocated, distinguished, determined or otherwise
separated out.
Using one line per payment, fill in the information required for each of the columns. Gifts must be
classified as either individual or non-individual. Individuals are persons licensed to provide health care in
the District who receive gifts or payments, including cash, food, or in-kind items. Non-individuals are
entities such as hospitals, clinics, nursing facilities, pharmacies, and health organizations.
Gifts given to physicians and teaching hospitals must be reported to the Open Payments system. A
physician is a doctor of medicine or osteopathy, a doctor of dental surgery or medicine, a doctor of
podiatric medicine, a doctor of optometry, or a chiropractor. See, 42 U.S.C.A. § 1395x(r). Additionally, to
reduce “double counting” of payments, gifts to physicians or teaching hospitals should not be included
or “rolled up” in reported payments to practices or other non-individual recipients. Payments reported
to Open Payments should not be reported to the AccessRx.
IMPORTANT: Gifts to staff of physician offices or medical practices should be attributed to named
individuals, whenever possible. If a gift cannot be reasonably allocated to a specific individual or
individuals, it may be reported as a non-individual gift but this is not preferred. Any non-individual gifts
must not include the physician’s share, as it is reported to Open Payments.
IMPORTANT: Note that if you enter “Other” in the column for Credentials, Recipient Type, Nature of
Payment, Form of Payment, Primary Purpose, or Secondary Purpose, you must enter details in the next
column. For instance, if your company provided lunch to the receptionist at a clinic, you would enter
“Other” in the Recipient Type column and “Receptionist” in the Other Type column.
IMPORTANT: Columns which have listed Accepted Values must be filled with one of the Accepted
Values. Do not enter a value that is not listed as an option. Detailed instructions about the information
required for each column appear in the “Column Instructions: Gift Expenses” section on page 5 of this
document
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Worksheet 3: Advertising Expenses
§48-833.03 of the AccessRx Act of 2004 describes these expenses as:
All expenses associated with advertising, marketing, and direct promotion of prescription drugs
through radio, television, magazines, newspapers, direct mail, and telephone communications as
they pertain to District residents.
22 DCMR 1802.3 provides the following examples:
Advertising, marketing, direct promotion, market research survey, patient education including
materials such as disease management information; materials/consulting to promote new uses of
drugs.
Using one line per payment, fill in the information required for each of the columns. Please note that for
some columns, there is a limited set of accepted values. Detailed instructions about the information
required for each column appear in the “Column Instructions: Advertising Expenses” section on page 8 of
this document.
Worksheet 4: Aggregate Cost
The Aggregate Cost worksheet collects the following information, as described in 22 DCMR 1801.1:
The aggregate cost of, including all forms of payment to, all employees or contractors of the
manufacturer or labeler who directly or indirectly engage in the advertising and promotional
activities ... limited to that portion of payment to the employees or contractors that pertains to
activities within the district or to recipients of the advertising or promotional activities who are
residents of or are employed in the District.
Using one line per employee or contractor, enter the position title for each employee or contractor who
directly or indirectly engages in advertising and promotional activities and devotes any time to activities
pertaining to the District. If the employer or contractor was a registered detailer in the District of
Columbia during the past calendar year, provide that person’s license number. In the corresponding
columns, enter the salary, benefits, and commission amounts for each of these employees or contractors.
Multiply the sum of those figures by the percentage of time that individual spent on activities conducted
within the District or directed to recipients who are residents of or are employed in the District. 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 only submit the total based on your
calculations using the worksheet.
Detailed instructions about the information required for each column appear in the “Column Instructions:
Aggregate Cost” section on page 10 of this document.
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Column Instructions: Gift Expenses
If you have no gift expenses to report, enter “None” in the first available cell.
A. Payment Date
Enter the date on which the payment was made, in MM/DD/YY format (the “Short Date” Excel
format).
B. Non-Individual Recipient
If the recipient is not an individual – e.g., if the payment was made to an organization, hospital, or
department – enter the name of the entity here. If the recipient is an individual, leave this cell
blank.
C. Recipient Last Name
If the recipient of the payment is an individual, enter his or her last name here. If the recipient is
not an individual, leave this cell blank.
D. Recipient First Name
If the recipient of the payment is an individual, enter his or her first name here. If the recipient is
not an individual, leave this cell blank.
E. Recipient Middle Initial
If the recipient of the payment is an individual, enter his or her middle initial here. If the recipient
is not an individual, leave this cell blank.
F. Recipient Credentials
Accepted values: APN/NP, RN/LPN, PharmD, RPH, ND, PA, DDS*, DO*, DPM*, MD*, OD*,
DVM, Other
If the recipient of the payment is an individual, enter his or her credentials here. If the recipient is
not an individual, leave this cell blank. Use the above abbreviations (e.g., do not spell out “nurse”
if the credentials are NP or RN). If the recipient is not an individual, leave this cell blank. *Note
that gifts to physicians given after July 31, 2013 are not required to be reported to the District.
A physician is a doctor of medicine or osteopathy, a doctor of dental surgery or medicine, a doctor
of podiatric medicine, a doctor of optometry, or a chiropractor. See, 42 U.S.C.A. § 1395x(r). Gifts
to physicians should only be reported to AccessRx under special circumstances, when a gift is not
reported to Open Payments.
G. Other Credentials
If “Other” is entered in the “Recipient Credentials” cell, enter the recipient’s credentials here.
Otherwise, leave this cell blank.
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H. Recipient Affiliated Facility
Enter the name of the facility (e.g., George Washington University Medical Center, American
Heart Association DC Office) with which the recipient is affiliated.
I. Recipient Type
Accepted values: Clinic, Dentist*, Hospital*, Medical Education or Communication Company, Medical Staff,
Nonprofit Organization, Nurse, Nurse Practitioner/Advanced Practice Nurse, University, Pharmacist,
Physician*, Physician Assistant, Psychologist, Social Worker, Technician, Clinical Nurse Specialist, Certified
Registered Nurse Anesthetists & Anesthesiologist Assistants and Certified Nurse-Midwives, Other
Enter the above term that best describes the type of recipient.
*Note that gifts to physicians and teaching hospitals given after July 31, 2013 are not required to be
reported to the District. The list of teaching hospitals is available at:
http://www.cms.gov/OpenPayments/About/Resources.html. Gifts to physicians should only be
reported to AccessRx under special circumstances, when a gift is not reported to Open Payments.
J. Other Type
If “Other” is entered in the “Recipient Type” cell, enter the type of recipient here. Otherwise, leave
this cell blank.
K. Nature of Payment
Accepted values: Consulting Fee, Compensation for services other than consulting, including serving as faculty
or as a speaker at a venue other than a continuing education program, Honoraria, Gift, Entertainment, Food and
Beverage, Travel and Lodging, Education, Charitable Contribution, Royalty or License, Current or prospective
ownership or investment interest, Compensation for serving as faculty or as a speaker for a non-accredited and
noncertified continuing education program or Compensation for serving as faculty or as a speaker for an accredited
or certified continuing education program are combined into one, Grant, Space Rental or Facility Fees, Debt
Forgiveness, Long term medical supply or device loan, Acquisitions Other Enter
Note: The changes to the Nature of Payment categories will be available within the Open Payments
System when submitting records dated on or after January 1, 2021. The Natures of Payment updates are
not applicable to Program Year 2020 data submission.
L. Other Nature
If “Other” is entered in the “Nature of Payment” cell, enter the nature of payment here.
Otherwise, leave this cell blank.
M. Form of Payment
Accepted values: Cash or Cash Equivalent, In-kind Items and Services; Stock, stock options, or any other
ownership interest; Dividend, profit or other return on investment, Other
Enter the above term that best describes the form of payment.
N. Other Form
If “Other” is entered in the “Form of Payment” cell, enter the form of payment here. Otherwise,
leave this cell blank.
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O.
Primary Purpose accepted values: Consulting, Education, Marketing, Donation, Other
Enter the above term that best describes the primary purpose of the payment.
P. Other Primary Purpose
If “Other” is entered in the “Primary Purpose” cell, enter the primary purpose of the payment
here. Otherwise, leave this cell blank.
Q. Secondary Purpose
Accepted values: None, Consulting, Education, Marketing, Donation, Other
Enter the above term that best describes the secondary purpose of the payment. (If the payment
had no secondary purpose, enter “None.”)
R. Other Secondary Purpose
If “Other” is entered in the “Secondary Purpose” cell, enter the secondary purpose of the payment
here. Otherwise, leave this cell blank.
S. Value
Enter the dollar value of the payment in $X,XXX.XX format (the “Currency” Excel format).
T. Trade Secret?
If the company has designated this payment a trade secret, enter “Yes” in this cell; if it has not
designated the payment a trade secret, enter “No.”
22 DCMR 1899.1 defines a Trade Secret as follows: “Information, including a formula, pattern,
compilation, program, device, method, technique, or process, that:
(A) Derives actual or potential independent economic value, from not being generally known to,
and not being readily ascertainable by, proper means by another who can obtain economic
value from its disclosure or use; and
(B) Is the subject of reasonable efforts to maintain its secrecy.”
U. Trade Secret Explanation
If you answered “Yes” to the question “Is this payment a Trade Secret?” explain the justification
for the trade secret designation. Otherwise, leave this cell blank.
V. Resubmission?
If this submission is a resubmission of data (i.e., an addition or correction to an earlier submission),
enter “Yes.” If this is the first time you are submitting this information, enter “No.
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W. Original Submission Date
If you answered “Yes” to the question “Is this a resubmission of data?” enter the date of the
original submission that this submission is amending or replacing. Otherwise, leave this cell blank.
If applicable, the date should be listed as MM/DD/YY (the “Short Date” Excel format).
X. Resubmission Description
If you answered “Yes” to the question “Is this a resubmission of data?” enter details about how
this submission amends or replaces the submission whose date is entered in the “Original
Submission Date” field. Otherwise, leave this cell blank.
Column Instructions: Advertising Expenses
If you have no advertising expenses to report, enter “None” in the first available cell.
A. Activity Date
Enter a single date for the activity, in MM/DD/YY format (the “Short Date” Excel format). If the
activity took place over a date range, enter the date when the activity began.
B. Type of Activity
Accepted values: Direct-to-Consumer Advertisement Production, Direct-to-Consumer Advertisement
Placement, Other Advertisement Production, Other Advertisement Placement, Market Research, Other
Promotional Activity
Enter the type of activity (e.g., advertising, direct promotion, patient education).
C. Medium Type
Accepted values: Conference or Other Event, Direct Mail, Internet/Email, Medical Journal,
Newspaper/Magazine, Patient Materials, Radio, TV/Video, Other Printed Material, Other
Enter the type of medium used in the activity (e.g., radio, television, magazines,
newspapers, direct mail, telephone).
D. Medium Name
If applicable, enter the name of the medium used (e.g., newspaper name, name of television
or radio station). If no medium name applies, leave this cell blank.
E. Product Marketed
Enter the name of the prescription drug being advertised; if no specific drug was advertised,
enter “general.”
F. Target Audience
Enter the name of the audience to whom the advertising was directed (e.g., general public,
prescribers).
G. Cost of Activity
Enter the cost of the activity, in $X,XXX.XX format (the “Currency” Excel format).
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H. Trade Secret
If the company has designated this payment a trade secret, enter “Yes” in this cell; if it has not
designated the payment a trade secret, enter “No.”
22 DCMR 1899.1 defines a Trade Secret as follows: “Information, including a formula, pattern,
compilation, program, device, method, technique, or process, that:
(A) Derives actual or potential independent economic value, from not being generally known to,
and not being readily ascertainable by, proper means by another who can obtain economic
value from its disclosure or use; and
(B) Is the subject of reasonable efforts to maintain its secrecy.”
I. Trade Secret Explanation
If you answered “Yes” to the question “Is this payment a Trade Secret?” explain the justification
for the trade secret designation. Otherwise, leave this cell blank.
J. Resubmission?
If this submission is a resubmission of data (i.e., an addition or correction to an earlier submission),
enter “Yes.” If this is the first time you are submitting this information, enter “No.”
K. Original Submission Date
If you answered “Yes” to the question “Is this a resubmission of data?” enter the date of the
original submission that this submission is amending or replacing. Otherwise, leave this cell blank.
If applicable, the date should be listed as MM/DD/YY (the “Short Date” Excel format).
L. Resubmission Description
If you answered “Yes” to the question “Is this a resubmission of data?” enter details about
how this submission amends or replaces the submission whose date is entered in the
“Original Submission Date” field. Otherwise, leave this cell blank.
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Column Instructions: Aggregate Cost
If you have no aggregate cost to report, enter "None" in the first available cell.
A. Position Title
Enter the position title for each employee or contractor who directly or indirectly engages in
advertising and promotional activities and devotes any time to activities pertaining to the District.
B. License # (DC Detailers)
If the position was filled by a detailer licensed in the District during the past calendar year,
enter the detailer’s license number. If it was not filled by a detailer licensed in the District,
leave this field blank.
C. Salary
Enter the salary paid to the employee or contractor during the past calendar year, in $XX,XXX.XX
format (the “Currency” Excel format).
D. Benefits
Enter the dollar value of the benefits paid to the employee or contractor during the past calendar
year, in $XX,XXX.XX format (the “Currency” Excel format).
E. Commission
Enter the amount of commission payments made to the employee or contractor during the past
calendar year, in $XX,XXX.XX format (the “Currency” Excel format). If no commissions were
paid to the employee or contractor, leave this field blank.
F. Total Compensation
Enter the sum of the Salary, Benefits, and Commission, in $XX,XXX.XX format (the “Currency”
Excel format).
G. Time Percentage
Enter the percentage of the employee or contractor’s time spent during the past calendar year on
activities conducted within the District or directed to recipients who are residents of or are
employed in the District.
H. DC Position Total
Multiply Total Compensation by the Time Percentage and enter the result here, in $XX,XXX.XX
format (the “Currency” Excel format).
