Frequently Asked Questions

Frequently Asked Questions

General

What is an Opioid Treatment Program (OTP)?

What services are covered under the Opioid Treatment Program (OTP) benefit?

Where can I find more information about Medicare Administrative Contractors (MACs) and their role with CMS?

Enrollment

When can Opioid Treatment Programs (OTPs) start enrolling in Medicare?

My Opioid Treatment Program (OTP) has provisional certification from the Substance Abuse and Mental Health Administration (SAMHSA), can we enroll in Medicare now?

When and why did CMS implement fingerprint-based background checks for certain Medicare providers and suppliers?

Do the fingerprinting-based background checks apply to Outpatient Treatment Program (OTP) providers?

When must organizational providers applying to be OTP providers submit fingerprints?

How does CMS define an “owner”?

Do publicly traded company shareholders need to submit fingerprints?

Will every organization have an individual that meets the definition of “ownership or investment interest?”

Who evaluates whether an applicant is an individual who meets the definition of “ownership or investment interest?”

If I think that I or individuals in my organization meet the definition of an owner, when do I submit fingerprints? With my application?

How much does fingerprinting cost, and who pays for it?

Where can I find step-by-step fingerprinting instructions?

Where can I find additional fingerprinting information?

General

What is an Opioid Treatment Program (OTP)?

Opioid Treatment Programs (OTPs) provide medication-assisted treatment for people diagnosed with an OUD. OTPs must be certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) and accredited by an independent, SAMHSA-approved accrediting body. For SAMHSA certification, OTPs must comply with all pertinent state laws and regulations and all regulations enforced by the Drug Enforcement Administration.

 

What services are covered under the Opioid Treatment Program (OTP) benefit??

Under the new OTP benefit, Medicare covers:

  • U.S. Food and Drug Administration (FDA)-approved opioid agonist and antagonist medication-assisted treatment (MAT) medications
  • Dispensing and administration of MAT medications (if applicable)
  • Substance use counseling
  • Individual and group therapy
  • Toxicology testing
  • Intake activities
  • Periodic assessments

 

Where can I find more information about Medicare Administrative Contractors (MACs) and their role with CMS?

As a newly eligible Medicare provider, you should get to know your MAC. CMS contracts with MACs to process enrollment applications and Medicare Fee-For-Service (FFS) claims (also known as Medicare Part A and Part B claims). Each MAC processes FFS claims (including claims for OTP services) for certain areas of the country called jurisdictions. If you deliver OTP services in multiple jurisdictions, you might work with more than one Medicare A/B MAC. MACs also communicate information about the Medicare FFS Program to health care providers enrolled in the Medicare program. Learn more about MACs

 

Enrollment

When can Opioid Treatment Programs (OTPs) start enrolling in Medicare?

OTP providers should enroll in Medicare now to be able to bill Medicare for OTP services beginning January 1, 2020.

 

My Opioid Treatment Program (OTP) has provisional certification from the Substance Abuse and Mental Health Administration (SAMHSA), can we enroll in Medicare now?

No. To enroll in Medicare, OTPs must be fully certified by the SAMHSA and accredited by a SAMHSA-approved accrediting body. Medicare will not accept provisional SAMHSA certifications during the Medicare enrollment process. For more information on the accreditation process, visit SAMHSA’s Certification of Opioid Treatment Programs (OTPs) webpage.

 

When and why did CMS implement fingerprint-based background checks for certain Medicare providers and suppliers?

CMS began phasing in the fingerprint-based background check in 2014 as part of the enhanced enrollment screening provisions mandated by Section 6401 of the Affordable Care Act. CMS also published a final rule with comment period on February 2, 2011.

If you have a 5 percent or greater direct/indirect ownership interest in a Medicare-enrolled provider or supplier, CMS puts you in the high-risk screening category, which requires you to complete the fingerprint-based background check.

 

Do the fingerprinting-based background checks apply to Outpatient Treatment Program (OTP) providers?

Your MAC may ask you to submit fingerprints for individuals who have a 5% or greater direct/indirect ownership, even as a partner of an OTP provider when:

  • Initially enrolling
  • Substance Abuse and Mental Health Services Administration (SAMHSA) certified after October 23, 2018.

The CY 2020 Medicare Physician Fee Schedule final rule designates OTP providers as “high” categorical risk.

 

When must organizational providers applying to be OTP providers submit fingerprints?

After you submit your enrollment application, your MAC may ask you to submit fingerprints for individuals who have a 5% or greater direct/indirect ownership, even as a partner of an OTP provider when:

  • Initially enrolling

Substance Abuse and Mental Health Services Administration (SAMHSA) certified after October 23, 2018.

 

How does CMS define an “owner”?

According to 42 Code of Federal Regulations (C.F.R.) 424.502, an owner means any individual or entity that has any partnership interest in or that has 5 percent or more direct or indirect ownership of the provider or supplier as defined in the Social Security Act (SSA) § 1124 and § 1124A(A).

The Act defines the term “person with an ownership or control interest”, with respect to an entity, as a person who meets one or more criteria:

  • Has directly or indirectly an ownership interest of 5 per centum or more in the entity
  • Is the owner of a whole or part interest in any mortgage, deed of trust, note, or other obligation secured (in whole or in part) by the entity or any of the property or assets thereof, which whole or part interest is equal to or exceeds 5 per centum of the total property and assets of the entity
  • Is an officer or director of the entity if the entity is organized as a corporation
  • Is a partner in the entity if the entity is organized as a partnership

For more information on owners and ownership interest, refer to the Medicare Program Integrity Manual, Chapter 15, Sections 15.5.5 and 15.5.6 (PDF).

 

Do publicly traded company shareholders need to submit fingerprints?

Publicly traded company shareholders only submit fingerprints if they own 5 percent company shares or more.

 

Will every organization have an individual that meets the definition of “ownership or investment interest?”

No. Depending on your ownership structure, you may not have anyone who meets this definition. For example, non-profit organizations generally do not have owners and typically only have individuals with managing control.

 

Who evaluates whether an applicant is an individual who meets the definition of “ownership or investment interest?”

Your MAC will determine if you meet the definition of ownership or investment interest based on your OTP provider enrollment application and supporting documentation. For example, if you are a non-profit organization you must submit a copy of your 501(c)(3) forms to verify non-profit status.

 

If I think that I or individuals in my organization meet the definition of an owner, when do I submit fingerprints? With my application?

After you submit your application, your MAC may request you to submit fingerprints for individuals who have a 5% or greater direct/indirect ownership, even as a partner of an OTP provider when:

  • Initially enrolling
  • Substance Abuse and Mental Health Services Administration (SAMHSA) certified after October 23, 2018.

 

How much does fingerprinting cost, and who pays for it?

Cost may vary by location. You must pay to get your fingerprints; however, CMS pays for the background check on your fingerprints.

 

Where can I find step-by-step fingerprinting instructions?

The CMS Fingerprinting Instruction website allows you to:

  • Download forms and view fingerprinting instructions
  • Find a fingerprint collection site
  • Track the status of your submission to CMS
  •  

Where can I find additional fingerprinting information?

For more information, refer to MLN Matters® Article SE1417 (PDF) or contact your MAC.

 

Page Last Modified:
11/04/2019 03:16 PM