Medi-Cal News: REMS Certification and Provider Training Required to Administer Nexplanon

On July 24, 2026, the article titled “REMS Certification and Provider Training Required to Administer Nexplanon” was posted to the Medi-Cal News area on the Medi-Cal Provider website.

Summary: 

Effective January 16, 2026, the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for Nexplanon® (68 mg etonogestrel implant), extending its approved use from three years to up to five years for pregnancy prevention.

All providers performing Nexplanon® insertions or removals must complete the FDA-required Risk Evaluation and Mitigation Strategy (REMS) certification. Providers should note the following:

  • All Nexplanon-trained providers must complete REMS enrollment by August 23, 2026, to continue procuring and inserting Nexplanon®.
  • Providers who have not been previously trained by Organon, or those who did not complete the 2018 re-training, can visit the Nexplanon® REMS website to enroll in the REMS program and receive information on the required training.
  • All health care providers must receive instruction and training prior to performing insertion and/or removal of Nexplanon®.

To obtain additional information from the manufacturer and enroll in the REMS, visit the Nexplanon REMS website.

The FDA Highlights of Prescribing Information for clinicians and FDA-Approved Patient Labeling documents have been updated.

Additionally, the following provider manual sections have been updated:

Planned Family PACT Portal Production Outage: July 26-27, 2026

The Department of Health Care Services (DHCS) will perform a system update to the Family PACT Portal beginning at 12:00 a.m. on Sunday, July 26 through Monday, July 27, 2026, at 6 a.m. During this time, the Family PACT Portal will be unavailable to clients, providers, and DHCS staff.

Providers affected by this outage should continue determining eligibility using the Client Eligibility Certification (CEC) Form (DHCS 4461).

To ensure uninterrupted service during the outage, Family PACT providers will need to initiate downtime procedures:

  • Complete the CEC Form to determine eligibility.
  • If eligible, proceed with the visit under the Family PACT program.
  • Once the Family PACT Portal is available, enroll the client in the Family PACT Portal and use the NEW Override Eligibility Date Request function.
    • Note: Providers can use the Override Eligibility Date Request Function for existing clients (e.g., reporting a change, recertification).

For detailed instructions on how to submit an Override Eligibility Date Request, review the Override Eligibility Date Request Job Aid.

Please note that providers should periodically check the Family PACT Portal in case the outage ends early. For any questions or assistance, please contact providerservices@dhcs.ca.gov or via phone at 916-650-0414.

Family PACT Policy Updates and Clarifications

As announced in the July 2026 DHCS Bulletin, effective July 1, 2026, the Office of Family Planning (OFP) has updated the Family PACT Policies, Procedures, and Billing Instructions (PPBI) Manual regarding required trainings, contraceptive requirements, and non-physician medical practitioners.

Required Training Update

  • Clinicians and all other clinic staff are now required to complete Family PACT trainings every five (5) years, instead of every two (2) years.
  • Site Certifier training requirements remain unchanged:
    • Required trainings must be completed every two (2) years and
    • Provider Orientation must be attended every two (2) years.
  • Refer to the Provider Enrollment and Responsibilities section of the PPBI.

Course Catalog Updates

  • The Back Office training has been archived and removed from the course catalog.
  • The U.S. Medical Eligibility Criteria for Contraceptive Use and U.S. Selected Practice Recommendations for Contraceptive Use courses, which were required, are now optional.
  • Additional training catalog updates will be released Fall 2026.
  • For more information on trainings, visit the Family PACT Online Training Center.

Contraceptive Requirement Clarifications

  • OFP has updated Provider Enrollment and Responsibilities to clarify that Family PACT providers must offer, at minimum, the contraceptive implant and at least one type of hormonal IUD and non-hormonal IUD onsite.
  • Program Standards has a new “Availability of Covered Services (Contraceptives)” table clarifying which contraceptive methods are required to be offered onsite, by prescription, or by referral.

Non-Physician Medical Practitioners (NMPs) Update

  • NMPs are authorized to deliver the full scope of Family PACT family planning and family planning-related services, including sterilization services, within their scope of practice and to the extent permitted by applicable professional licensing statues and regulations as set forth in the physician/practitioner interface document.
  • Refer to the Provider Enrollment and Responsibilities section of the PPBI.

Family PACT Telehealth Policy Update

The Department of Health Care Services (DHCS) published revisions to the telehealth policy for the Family PACT Program.

The policy has been updated to include:

  • Patient Choice of Telehealth Modality; and
  • Right to In-Person Services

Providers who offer Family PACT covered benefits and services via telehealth modalities must offer Family PACT clients the choice between telehealth modalities and the ability to opt for in-person services, if desired or clinically appropriate. These options ensure that Family PACT clients can select the most suitable modality for accessing their Family PACT benefits and services based upon individualized preferences, needs and circumstances. For more information, please review the Family PACT Program’s Policies, Procedures and Billing Instructions (PPBI) manual, Benefits: Clinical Services Overview section.

FDA Approves Updated Nexplanon Label and Launches New REMS

Effective January 16, 2026, the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for Nexplanon (68 mg etonogestrel implant), extending its approved use from 3 years to up to 5 years for pregnancy prevention.

  • Full Prescribing Information (for clinicians) and Patient Labeling have been updated accordingly.
  • Clinical trial data (NCT04626596) showed zero pregnancies during years 4–5 and no new safety concerns across BMI ranges of 17.2 to 64.3 kg/m², including 38% with BMI ≥30 kg/m².

All clinicians performing Nexplanon insertions or removals must now complete FDA-required Risk Evaluation and Mitigation Strategy (REMS) certification.

Clinical Note:

  • In 2018, the insertion location changed from the sulcus between the biceps and the triceps muscles to the current insertion site, which is 3-5 cm posterior to (below) the sulcus. This decreases the risk of migration and neurovascular injury. This 2026 label change does not change the recommended insertion location. [See “Insertion Procedure” on page 5 of the Full Prescribing Information.]

Requirements of the Nexplanon REMS program include:

  • Healthcare providers must certify with the program by enrolling and completing training on the proper insertion and removal of Nexplanon prior to first use.
  • Wholesalers and distributors must be registered with the program and must only distribute to certified pharmacies and certified healthcare providers.

Instructions for providers to enroll and certify in the REMS program:

  • Visit: nexplanonrems.com
  • Following review of the updated Prescribing Information and Healthcare Provider Guide, providers are to create a Nexplanon REMS account, take a Knowledge Assessment, and complete an Enrollment Form to obtain REMS certification.
  • The REMS enrollment period is February 23, 2026 through August, 23, 2026.
    • Providers who do not enroll during this time period will not be able to purchase Nexplanon after the end of this 6-month certification period.
  • Providers who have not been previously trained by Organon – or those who did not complete the 2018 re-training – can visit the Nexplanon REMS website to enroll in the REMS program and receive information on the required training.
    •  All health care providers must receive instruction and training prior to performing insertion and/or removal of Nexplanon.
     Resources:Nexplanon REMS: nexplanonrems.comUpdated FDA Full Prescribing InformationNexplanon Healthcare Provider REMS Flashcard

IMPORTANT: Office of Family Planning Reminder

Family PACT Providers are required to offer the Nexplanon contraceptive implant onsite. Each site enrolled in the Family PACT Program must identify, at a minimum, one practitioner trained to provide Long-Acting Reversible Contraception (LARC) services – including insertion and removal of the contraceptive implant – onsite. See Family PACT Policies, Procedures and Billing Instructions Manual (PPBI), Section Provider Enrollment and Responsibilities page 5.

DHCS 4475 Update

On February 10, 2026, the Department of Health Care Services (DHCS) Office of Family Planning published the updated version of the Site Certifier for Multiple Service Locations Declaration (DHCS 4475). This form is used to request DHCS approval for one site certifier to oversee up to 10 service locations for designated clinic types specified in the Provider Enrollment and Responsibilities section of the Policies, Procedures and Billing Instructions Manual.

What Has Changed:

  • Each DHCS 4475 allows the site certifier to designate one additional service location – in addition to their main location – per form.
  • Provider must submit a DHCS 4475 for each additional service location.
  • Additional supporting documentation is now required with each submission.
  • The form has been updated with new instructions explaining how to complete and submit the request for multiple locations (up to 10).

Providers planning to designate one certifier to oversee multiple service locations (up to 10) must:

The updated DHCS 4475 is available for download on the Family PACT website and the Medi-Cal Provider Forms web page.

Previous versions of the DHCS 4475 will no longer be accepted after March 1, 2026.

One Site Certifier for Multiple Service Locations Update

On October 16, 2025, the Department of Health Care Services published updated policy to the Family Planning, Access, Care, and Treatment (Family PACT) program implementing Senate Bill 1131, allowing one site certifier to oversee up to ten service locations for the designated clinic types specified in Family PACT Policies, Procedures, and Billing Instructions ManualProvider Enrollment and Responsibilities section

Additional manual updates include:

  • clarification that Family PACT providers must ensure client access to comprehensive family planning services on the same day eligibility is determined,
  • clarification that Family PACT providers must inform clients that their Health Access Program Identification Numbers are valid at any Family PACT provider location, and
  • minor edits throughout to clarify language and correct general terminology.

Providers planning to appoint one site certifier to oversee multiple locations must sign the updated Family PACT Program Provider Agreement (DHCS 4469) and submit a Site Certifier for Multiple Service Locations Declaration (DHCS 4475), which DHCS will review for approval.

The Family PACT Portal will be updated to reflect these changes. These updates serve as user functionality enhancements, focusing on expanding Site Certifier and Provider Staff site location limitations while adding more flexibility when editing or changing accounts.

These enhancements:

  • Site Certifiers will be able to navigate and switch to multiple site locations that they are associated with on the Access Management Dashboard.
  • Site Certifiers and Provider Staff can be associated with multiple site locations that can be viewed when creating an account or in account settings.
  • Site Certifiers will be able to edit, resend, revoke, disassociate, and deactivate other Privileged Staff and Provider Staff accounts.
  • Site Certifiers capabilities can be granted to Provider Staff at the same site location making them Privileged Provider Staff.
  • Notifications will be sent to active Site Certifiers when site locations are associated/disassociated and to Provider Staff when entitlements are granted/removed.
  • Site Certifiers and Provider Staff will be able to designate the site location they’re working from.

Additional information about Provider Enrollment and Responsibilities is available on the Family PACT Provider Enrollment webpage and Family PACT Policies, Procedures, and Billing Instructions ManualProvider Enrollment and Responsibilities section.