Guide Instructions for disclosure report creation

Learn how to create and properly format disclosure reports for submission to the Pharmaceutical Code of Conduct.

Table of Contents

Overview

A Pharmaceutical Manufacture must register with the Department of Public Health when the company first becomes subject to regulation (105 CMR 970.00). A $2,000.00 fee is required.

Manufacturers of pharmaceuticals and medical devices are required to disclose certain transactions with anyone who prescribes, dispenses, or purchases prescription drugs or medical devices in the Commonwealth. This includes any fee, payment, subsidy, or other economic benefit with a value of at least $50. The Department, as required by legislation, has created a database to provide the disclosed information to the public. 

Instructions

Follow the instructions below to prepare and send a Disclosure Report to the department. Please note: In accordance with the 2012 amendments to chapter 111N of the General Laws, the Department of Public Health may not require a pharmaceutical or medical device manufacturing company to disclose information that has been disclosed to a federal agency pursuant to federal law and that may be obtained by the department from such federal agency.  Do not include disclosures of payments to covered recipients reported to the federal government under Section 6002 of the Patient Protection and Affordable Care Act (Public Law No. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law No. 111-152).

Step 1

Download the 2018 Covered Recipient List (zip file).

Step 2

Identify each covered recipient on the Covered Recipient list who has received a payment in excess of $50 in calendar year 2018 from your company.

Step 3

Insert the missing information for each covered recipient under the appropriate columns. This includes:

  1. Company ID: Each company who submits an initial compliance form and fee to DPH will be assigned a unique company ID by MA DPH. This ID will start with a “CC” prefix, and be followed by 4 digits. Field length is 6 characters; data type is character.
  2. Category of Payment ID: There are several payment categories as defined by MA DPH. Each category has unique ID assigned to it. Field length is 4 characters; data type is numeric. These ID’s are listed here; they can also be found, along with their descriptions, on the department’s “Payment Category ID” spreadsheet detailed below.
    • 1000 – Compensation for Bona Fide Services
    • 2000 – CMEs, third-party Conferences, or Meetings
    • 3000 – Grants/Educational Gifts
    • 4000 – Food
    • 5000 – Education/Training
    • 6000 – Marketing Studies
    • 7000 – Charitable Donation
    • 8000 – Other
  3. Amount of Payment: Companies have to report the amount of payments in US dollars. All figures should be rounded to the nearest dollar using standard rounding guidelines. This figure represents the sum total of payments to a particular covered recipient within a particular payment category. Field length is 10 characters; data type is numeric (representing whole US dollars).
  4. Number of Events Reflected: This field represents the number of individual payment events that were provided to a particular covered entity for a particular payment category (for example: Company Y provides three lunches at $100 each to Dr. X – “amount of payment” = 300, “number of events reflected” = 3). If this field is left blank, it will be interpreted as “1.” Field length is 4 characters; data type is numeric.

Step 4

Copy the entire row for each covered recipient who received a payment and paste this information into a new CSV file.  Please do not alter the order of the columns from the Covered Recipient list.  The disclosure report must be sent in a comma-separated value format, or CSV. A CSV is a delimited text file that uses a comma to separate values, and can be viewed as a spreadsheet; many spreadsheet programs, such as Microsoft Excel, can create CSV files. Each row of this file will represent total payments to a particular covered recipient within a particular payment category.

Step 5

Attach the new CVS file to an email addressed to:  Pharmameddata@massmail.state.ma.us with the subject line 2018 Disclosure Report.

 

Downloads

Payment Disclosure Categories ID List

Unique ID Number MA Payment Category Name MA Payment Category Description
1000 Compensation for Bona Fide Services Consulting, Speaker's Bureaus, etc.
2000 CMEs, third-party Conferences, or Meetings Payments to CRs in Conjunction with CMEs, third-party conferences and meetings
3000 Grants/Educational Gifts Grants and Educational Gifts to CRs
4000 Food Meals Provided to CRs
5000 Education/Training Payments to CRs in Conjunction with education and training
6000 Marketing Studies Payments to CRs in conjunction with research other than genuine research
7000 Charitable Donation Donations other than donations of prescription drugs, biologics or medical devices
8000 Other Non-exempt payments to CRs of $50 or more

 Download: Payment Disclosure Categories ID List

If you cannot find a covered recipient on the Covered Recipient List

The Covered Recipient List CSV file is over 250,000 rows. Due to its size, some programs, such as older versions of Excel, will not display the full contents of this file. If you encounter this problem, you can open the file with a database program, such as Microsoft Access, or a simple text editor such as Notepad.

Only entities licensed in Massachusetts are covered recipients under the regulation; thus, only Massachusetts-licensed entities appear in the covered recipient list. If you cannot find a professional in the list, you should first verify that the person is licensed in Massachusetts. The best method of doing this to ask the person themselves about their license status. However, Massachusetts also provides two online resources to check the license status of most health professionals:

The definition of a covered recipient is very specific. In the past, we have received questions on several entities that are not considered covered recipients in regards to this regulation. Below is a list of entities that are not covered recipients (please note: simply being one of the below classifications does not preclude the entity from being a covered recipient for other reasons):

  • Academic Institutions
    Schools and universities are not covered recipients. However, teaching hospitals are covered recipients, as they are hospitals, which are considered covered recipients.
  • Trade Organizations, Conference Organizers, and Non-Profit Charitable Organizations
    Unless they are covered recipients for other reasons (such as a non-profit hospital, which is a covered recipient by virtue of being a hospital) these entities are not covered recipients.
  • Corporations and other business structures
    Corporations are not covered recipients; however, corporations may own an entity that is a covered recipient. For example, a corporation that owns a hospital; payments made to the hospital would need to be attributed to the hospital, and not the corporation. 

Additional Resources for If you cannot find a covered recipient on the Covered Recipient List

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