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The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual

The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual

Final

Issued by: Office for Civil Rights (OCR)

The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual

Background

The Privacy Rule gives individuals important controls over whether and how their protected health information is used and disclosed for marketing purposes.  With limited exceptions, the Rule requires an individual’s written authorization before his or her protected health information can be used or disclosed to make a marketing communication to the individual.  In general, marketing means to make a communication to an individual about a product or service that encourages the individual to purchase or use that product or service.  Often, the lines between a marketing communication and a communication for a treatment or health care purpose unavoidably overlap, as a necessary part of providing treatment and health care services and benefits is to encourage or advise individuals to purchase or use certain health-related products or services.  For this reason, the Privacy Rule includes important exceptions to what is considered marketing to ensure essential healthcare communications are not impeded.  One important exception concerns communications about refill reminders and other communications about a drug or biologic currently being prescribed to the individual (“refill reminder exception”).

How the Refill Reminder Exception Works

The Privacy Rule expressly excludes from the definition of “marketing” refill reminders or other communications about a drug or biologic that is currently being prescribed for the individual, provided that financial remuneration received by the covered entity in exchange for making the communication, if any, is reasonably related to the covered entity’s cost of making the communication.  See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501.  Financial remuneration means payment to a covered entity (or business associate, if applicable) from or on behalf of a third party whose product or service is being described.  Financial remuneration does not include non-financial or in-kind benefits.

Thus, there are two components to determining whether a communication falls within the refill reminder exception to marketing.  The first is whether the communication is about a currently prescribed drug or biologic. The second is whether the communication involves financial remuneration and if it does, whether the financial remuneration is reasonably related to the covered entity’s cost of making the communication.  Below is guidance on each of these aspects of the exception.

1. Is the Communication about a Currently Prescribed Drug or Biologic?

WITHIN EXCEPTION

  • Refill reminders.
  • Communications about generic equivalents of a drug being prescribed.
  • Communications about a recently lapsed prescription (one that has lapsed within the last 90 calendar days).
  • Adherence communications encouraging individuals to take prescribed medicines as directed.
  • Where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system.

NOT WITHIN EXCEPTION

  • Communications about specific new formulations of a currently prescribed medicine.
  • Communications about specific adjunctive drugs related to the currently prescribed medicine.
  • Communications encouraging an individual to switch from a prescribed medicine to an alternative medicine.

2. Does the Communication Involve Financial Remuneration, and If So, Is It Reasonable?

WITHIN EXCEPTION

  • Communication does not involve remuneration.
  • Communication involves only non-financial or in-kind remuneration, such as supplies, computers, or other materials.
  • Communication involves only payment from a party other than the third party (or other than on behalf of the third party) whose product or service is being described in the communication, such as payment from a health plan.
  • Remuneration involves payments to the covered entity by a pharmaceutical manufacturer or other third party whose product is being described that cover the reasonable direct and indirect costs related to the refill reminder or medication adherence program, or other excepted communications, including labor, materials, and supplies, as well as capital and overhead costs.  
  • Remuneration involves payments to a business associate assisting a covered entity in carrying out a refill reminder or medication adherence program, or to make other excepted communications, up to the fair market value of the business associate’s services.  The payments may be made by a third party whose product is being described directly to the business associate or through the covered entity to the business associate.

NOT WITHIN EXCEPTION

  • Communication involves financial remuneration other than as described above.

Examples of Permitted Communications

  • A pharmacy administers a medication adherence program that involves mailing refill reminders and adherence communications to patients about their currently prescribed drugs even though the pharmacy receives financial remuneration from the pharmaceutical manufacturers, provided the financial remuneration covers only the pharmacy’s reasonable direct and indirect costs associated with the program.
  • A pharmacy mails its diabetic patients information concerning the diabetic pumps used to administer their insulin even though the pharmacy is paid by the manufacturer of the pumps, provided the payment covers only the reasonable direct and indirect costs associated with the communications.
  • A pharmacy hires a business associate to assist in administering a medication adherence program that involves mailing adherence communications to patients about their currently prescribed drugs, even though the business associate is paid by the pharmaceutical manufacturers, provided the payment does not exceed the fair market value of the business associate’s services.

Communications Not Falling Within the Refill Reminder Exception

Communications about drugs or biologics not falling within the refill reminder exception for one or more reasons described above are still permitted under the Privacy Rule if:

  • The communications are made face-to-face at the pharmacy or other setting.  Face-to-face communications do not include communications by telephone or sent by mail or e-mail.
  • Written authorization has been obtained from the individual to make the communications.
  • The communications fall within another exception to the definition of marketing and do not involve financial remuneration.


FAQs

Q: What types of communications fall within the “refill reminder” exception to marketing?

The refill reminder exception to the definition of “marketing” encompasses refill reminders and other communications about a drug or biologic that is currently being prescribed for the individual.  See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501.  In addition to refill reminders about currently prescribed drugs, the exception encompasses communications about generic equivalents of a drug being prescribed, adherence communications encouraging individuals to take prescribed medicines as directed, and communications about prescriptions that have lapsed within the last 90 calendar days.  Also, where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system fall within the refill reminder exception.  Thus, these types of communications are permitted without an individual’s authorization, provided any financial remuneration received from the pharmaceutical manufacturer in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

Q: Do communications about recently-lapsed prescriptions for a medicine fall within the “refill reminder” exception to marketing?

Yes, so long the prescription lapsed within the last 90 calendar days and any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.  Communications encouraging individuals to renew recently lapsed prescriptions are consistent with the purpose of refill reminder and medication adherence communications, which is to encourage individuals to continue to take their medication as directed.  However, once a prescription has lapsed for more than 90 calendar days, it is no longer reasonable to treat such communications as refill reminders or medication adherence communications for a currently prescribed drug or biologic.

Q: Do communications about drug delivery systems fall within the “refill reminder” exception to marketing?

Yes.  Where an individual is prescribed a self-administered drug or biologic, such as insulin, communications regarding all aspects of a drug delivery system, such as an insulin pump, fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501, provided any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

Q: Do communications about specific adjunctive drugs related to the currently prescribed drug fall within the “refill reminder” exception to marketing?

No, only communications about drugs or biologics currently prescribed to the individual fall within th

The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual

Background

The Privacy Rule gives individuals important controls over whether and how their protected health information is used and disclosed for marketing purposes.  With limited exceptions, the Rule requires an individual’s written authorization before his or her protected health information can be used or disclosed to make a marketing communication to the individual.  In general, marketing means to make a communication to an individual about a product or service that encourages the individual to purchase or use that product or service.  Often, the lines between a marketing communication and a communication for a treatment or health care purpose unavoidably overlap, as a necessary part of providing treatment and health care services and benefits is to encourage or advise individuals to purchase or use certain health-related products or services.  For this reason, the Privacy Rule includes important exceptions to what is considered marketing to ensure essential healthcare communications are not impeded.  One important exception concerns communications about refill reminders and other communications about a drug or biologic currently being prescribed to the individual (“refill reminder exception”).

How the Refill Reminder Exception Works

The Privacy Rule expressly excludes from the definition of “marketing” refill reminders or other communications about a drug or biologic that is currently being prescribed for the individual, provided that financial remuneration received by the covered entity in exchange for making the communication, if any, is reasonably related to the covered entity’s cost of making the communication.  See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501.  Financial remuneration means payment to a covered entity (or business associate, if applicable) from or on behalf of a third party whose product or service is being described.  Financial remuneration does not include non-financial or in-kind benefits.

Thus, there are two components to determining whether a communication falls within the refill reminder exception to marketing.  The first is whether the communication is about a currently prescribed drug or biologic. The second is whether the communication involves financial remuneration and if it does, whether the financial remuneration is reasonably related to the covered entity’s cost of making the communication.  Below is guidance on each of these aspects of the exception.

1. Is the Communication about a Currently Prescribed Drug or Biologic?

WITHIN EXCEPTION

  • Refill reminders.
  • Communications about generic equivalents of a drug being prescribed.
  • Communications about a recently lapsed prescription (one that has lapsed within the last 90 calendar days).
  • Adherence communications encouraging individuals to take prescribed medicines as directed.
  • Where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system.

NOT WITHIN EXCEPTION

  • Communications about specific new formulations of a currently prescribed medicine.
  • Communications about specific adjunctive drugs related to the currently prescribed medicine.
  • Communications encouraging an individual to switch from a prescribed medicine to an alternative medicine.

2. Does the Communication Involve Financial Remuneration, and If So, Is It Reasonable?

WITHIN EXCEPTION

  • Communication does not involve remuneration.
  • Communication involves only non-financial or in-kind remuneration, such as supplies, computers, or other materials.
  • Communication involves only payment from a party other than the third party (or other than on behalf of the third party) whose product or service is being described in the communication, such as payment from a health plan.
  • Remuneration involves payments to the covered entity by a pharmaceutical manufacturer or other third party whose product is being described that cover the reasonable direct and indirect costs related to the refill reminder or medication adherence program, or other excepted communications, including labor, materials, and supplies, as well as capital and overhead costs.  
  • Remuneration involves payments to a business associate assisting a covered entity in carrying out a refill reminder or medication adherence program, or to make other excepted communications, up to the fair market value of the business associate’s services.  The payments may be made by a third party whose product is being described directly to the business associate or through the covered entity to the business associate.

NOT WITHIN EXCEPTION

  • Communication involves financial remuneration other than as described above.

Examples of Permitted Communications

  • A pharmacy administers a medication adherence program that involves mailing refill reminders and adherence communications to patients about their currently prescribed drugs even though the pharmacy receives financial remuneration from the pharmaceutical manufacturers, provided the financial remuneration covers only the pharmacy’s reasonable direct and indirect costs associated with the program.
  • A pharmacy mails its diabetic patients information concerning the diabetic pumps used to administer their insulin even though the pharmacy is paid by the manufacturer of the pumps, provided the payment covers only the reasonable direct and indirect costs associated with the communications.
  • A pharmacy hires a business associate to assist in administering a medication adherence program that involves mailing adherence communications to patients about their currently prescribed drugs, even though the business associate is paid by the pharmaceutical manufacturers, provided the payment does not exceed the fair market value of the business associate’s services.

Communications Not Falling Within the Refill Reminder Exception

Communications about drugs or biologics not falling within the refill reminder exception for one or more reasons described above are still permitted under the Privacy Rule if:

  • The communications are made face-to-face at the pharmacy or other setting.  Face-to-face communications do not include communications by telephone or sent by mail or e-mail.
  • Written authorization has been obtained from the individual to make the communications.
  • The communications fall within another exception to the definition of marketing and do not involve financial remuneration.


FAQs

Q: What types of communications fall within the “refill reminder” exception to marketing?

The refill reminder exception to the definition of “marketing” encompasses refill reminders and other communications about a drug or biologic that is currently being prescribed for the individual.  See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501.  In addition to refill reminders about currently prescribed drugs, the exception encompasses communications about generic equivalents of a drug being prescribed, adherence communications encouraging individuals to take prescribed medicines as directed, and communications about prescriptions that have lapsed within the last 90 calendar days.  Also, where an individual is prescribed a self-administered drug, communications regarding all aspects of a drug delivery system fall within the refill reminder exception.  Thus, these types of communications are permitted without an individual’s authorization, provided any financial remuneration received from the pharmaceutical manufacturer in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

Q: Do communications about recently-lapsed prescriptions for a medicine fall within the “refill reminder” exception to marketing?

Yes, so long the prescription lapsed within the last 90 calendar days and any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.  Communications encouraging individuals to renew recently lapsed prescriptions are consistent with the purpose of refill reminder and medication adherence communications, which is to encourage individuals to continue to take their medication as directed.  However, once a prescription has lapsed for more than 90 calendar days, it is no longer reasonable to treat such communications as refill reminders or medication adherence communications for a currently prescribed drug or biologic.

Q: Do communications about drug delivery systems fall within the “refill reminder” exception to marketing?

Yes.  Where an individual is prescribed a self-administered drug or biologic, such as insulin, communications regarding all aspects of a drug delivery system, such as an insulin pump, fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501, provided any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

Q: Do communications about specific adjunctive drugs related to the currently prescribed drug fall within the “refill reminder” exception to marketing?

No, only communications about drugs or biologics currently prescribed to the individual fall within th

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