The 21st Century Cures Act, which was signed into law on December 13, 2016, called for the creation of a bundled payment for providers that supply home infusion therapy services to Medicare beneficiaries. A requirement of the Act stipulated that home infusion suppliers be accredited by an accrediting organization approved by the Centers for Medicare & Medicaid Services (CMS) in order to receive Medicare reimbursement.

Beginning January 1, 2021, all home infusion therapy suppliers must be accredited to receive Medicare reimbursement.

Yes, the Centers for Medicare & Medicaid Services (CMS) has recognized ACHC as a national accrediting organization for home infusion therapy suppliers. The decision gives ACHC deeming authority to conduct surveys that meet or exceed Medicare requirements, including new reimbursement rules mandated by the 21st Century Cures Act.

Any Home Health, Private Duty Nursing (PDN), or Infusion Nursing (IRN) organization accredited by ACHC before November 1, 2020, can seek to add Home Infusion Therapy Accreditation without an additional survey or charge. The new, separate accreditation would remain in effect until your Home Health, PDN, or IRN ACHC Accreditation cycle expires.

To apply, interested providers must complete the ACHC Program Addition form, which can be obtained from your Account Advisor. The completed form must be returned to your Account Advisor by 5 p.m. EST December 20, 2020.

Later, when applying to renew your Home Health, PDN, or IRN ACHC Accreditation, you will have an option to renew your Home Infusion Therapy Accreditation at the same time. An additional one-day survey would be conducted to maintain your Home Infusion Therapy Accreditation. Normal survey pricing rates would apply.

All organizations accredited for Home Health, PDN, or IRN after November 1, 2020, that want to bill Medicare Part B for home infusion therapy services will need an additional one-day survey to achieve Home Infusion Therapy Accreditation.

Each location will be required to have its own NPI and PTAN numbers. If home health and private duty nursing providers want to provide services and bill separately, they will need to apply for a Medicare Part B billing number in order to bill for the professional services provided in the client/patient’s home. This means that there will need to be individual accreditation for each location.

Beginning on or after November 1, 2020, accredited home infusion therapy organizations can submit their 855B application to their MAC. They need to submit the application fee and a copy of their Home Infusion Therapy Accreditation certificate.

Yes. To provide home infusion therapy services, a home health agency that is already billing Part B for flu shots would need to submit an 855B application.

If the supplier submits a web application via PECOS, they then would select “Home Infusion Therapy” as their supplier type.

Infusion Pharmacy (IRX) Accreditation centers around the pharmacy services of preparing and dispensing medication, equipment, and supplies to patients receiving home infusion therapy. Home Infusion Therapy Accreditation centers around the education, assessment, and medication review performed by a nurse during a home visit.

No. Standards for our Infusion Pharmacy Accreditation Service will remain the same.

For current customers renewing their ACHC Accreditation, and all organizations that ACHC accredits before January 1, 2021, ACHC will conduct both on-site surveys and off-site audits on a percentage of renewing locations. For new ACHC customers, CMS will require that all locations receive an on-site survey beginning January 1, 2021.

An off-site audit will be conducted on a percentage of an organization’s renewing locations based on a methodology that takes into consideration:

• History of complaints with client/patient-related deficiencies.
• Risk potential as identified by performance improvement data.
• Infusion volume.
• Previous survey results.

New home infusion therapy suppliers will need to have serviced three clients/patients and have one on service.  In rural areas, a new home infusion therapy supplier seeking accreditation will need to have serviced two clients/patients.

No, the supplier does not need to be a pharmacy. The supplier must be able to meet the provisions defined in the Social Security Act. The Social Security Act defines a supplier as:

Section 1861(iii)(3)(D)(i) of the Social Security Act defines a supplier as a pharmacy, physician, or other provider of services or supplier licensed by the State in which the pharmacy, physician, or provider of services or supplier furnishes items or services and that:

• Furnishes infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs;
• Ensures the safe and effective provision and administration of Home Infusion Therapy on a 7-day-a-week, 24-hour-a-day basis; and
• Is accredited by an organization designated by the Secretary pursuant to section 1834(u)(5).

A qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider of services, or another supplier to meet CMS requirements. The home infusion therapy supplier is responsible for negotiating appropriate contract terms in order to only assume responsibility for services related to home infusion therapy.

Payment for home infusion therapy services beginning in CY 2021 will be a bundled payment equivalent to five hours of infusion therapy administration services in a physician’s office for each day an infusion drug is administered. Therefore, even if the clinician is only in the home for three hours, the payment is still equivalent to five hours. However, the home infusion therapy services provider would still report the time spent on the claim in 15-minute increments.

Yes. If the patient meets the eligibility criteria for both programs, then the agency can receive both Medicare Part A and Part B reimbursement.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html

https://public-inspection.federalregister.gov/2020-24146.pdf