Why accreditation matters
by Sandra C. Canally

As a former oncology nurse, I can personally attest to the evolution of home infusion therapy (HIT) over the years.   

Back in the mid-1970s, I was the National Cancer Institute’s teaching liaison at Hahnemann University Hospital in my hometown of Philadelphia. A few years later, across town, I was nurse-in-charge at Thomas Jefferson University Hospital’s outpatient cancer clinic.

During those early years of my nursing career, infusion therapy was still very much considered a hospital or outpatient clinic procedure. It wasn’t until the 1980s, when hospitals were under pressure to reduce inpatient length of stays, that home infusion therapy became an option for patients and their families.

Fast forward to 1991. That’s when the Occupational Safety and Health Administration (OSHA) published its definitive bloodborne pathogen safety standards that identified the significant health risks associated with work-related exposure to blood and other potentially infectious materials.

OSHA concluded at the time that nearly 6 million health care workers in the United States faced possible exposure to bloodborne diseases. Included in that number were thousands of nurses who were performing patient infusions without protections. One could safely say that OSHA’s actions in the early ’90s ultimately led to the development of accreditation quality standards for home infusion therapy that help protect patients and their caregivers.

A History of HIT Accreditation

It is somewhat ironic that the Medicare Modernization Act of 2003 mandated accreditation for nonclinical, lower risk businesses selling infusion pumps and supplies to Part B Medicare beneficiaries. As a result, for many years equipment providers have been covered by Medicare mandated accreditation, but services for home infusion administration have not.

HIT accreditation in recent years has mainly been required of hospital-based and national infusion operations. Accreditation was voluntary for local and regional home infusion operations, even though home infusion was—and continues to be—subject to more risk.

Until recently, Medicare did not provide a benefit for home infusion services. The drug itself and the equipment were all covered under Medicare’s Part B durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) provisions. However, the actual infusion administration by a health care professional was not covered.

The 21st Century Cures Act of 2016 was meant to bring more patient centeredness to the development of new drugs, medical devices and services. It was intended to cover professional services and assessments, device and infusion administration education, monitoring, and coordination of care. The Centers for Medicare and Medicaid Services (CMS) HIT benefit took effect in 2019 as an interim program and became fully effective Jan. 1, 2021.

The Cures Act requires home infusion providers to be accredited by a CMS-approved accrediting organization (AO). Beyond being a CMS requirement, HIT accreditation is also the comprehensive measure of a home infusion company’s performance. It enables the organization to strive for a higher level of quality that reduces risk and keeps patients and providers safe.

Better documentation and business practices demonstrate continuous improvement while giving the organization an opportunity to evaluate the effectiveness of its operations and related services. HIT coverage not only removes certain barriers to care, but also allows providers to build around their business objectives and goals.

Independent HIT providers fall into several categories: home health agencies, community pharmacies, durable medical equipment providers, specialty home infusion therapy providers and physician practices.

You will need to attain HIT accreditation if your organization will be performing the infusion services.

3 Parts to Becoming a HIT Provider

There are at least three levels of home infusion services and coordination that the home infusion therapy provider should consider:

  • Medical equipment supply
  • Pharmacy services
  • Drug administration and services

Although some HIT providers have the knowledge, expertise and accreditation to provide all three, others choose to contract out some of the services.

Standards for Accreditation

Most accreditation organizations have standards that support the product- or service-specific standards directly related to the CMS program offered. Here are a few providers can expect:

  • Administrative documentation—Proper consents are in place and documented consistently, with patients knowing their rights and responsibilities as it relates to services provided.
  • Staff competency—Policies are in place for hiring, orienting and training and the supplier has a mechanism for assessing the knowledge and skill level of infusion procedures, such as site selection and medication administration.
  • Quality improvement—All accreditation programs typically include standards relating to patient satisfaction and dissatisfaction as well as an overall plan developed by key management personnel, that evaluate operational areas in need of improvement.
  • Assessment of environment—When care is given in the home, the environment and assessment of that environment as it relates to safety and hazards comes into play (see sidebar at left).
  • Pharmaceutical management & infection control practices—The HIT supplier follows infection control techniques that relate to the type of patient served, equipment provided and staff risk for exposure, as well as protecting the patient and staff from the spread of infection, because the handling, clean up and disposal of hazardous pharmaceutical and chemical waste are all important to address when delivering care in the home.
  • Policies & procedures—There are rules and processes in place to minimize drug errors and to actively identify potential and actual adverse drug events.
  • Patient/caregiver education—Patient/caregiver education is key to the success of the treatment. Knowing about risks and potential side effect influence who and when to reach out for medical intervention (see sidebar at right).

The home infusion therapy supplier must be in compliance with all local, state and federal regulatory agencies and have the legal authority to operate.

HIT Accreditation

The Cures Act requires home infusion providers to be accredited by a CMS-approved accrediting organization. To become federally authorized, an accreditation organization’s quality standards and validation process must meet and/or exceed CMS’s requirements. There are currently six: Accreditation Commission for Health Care, Community Health Accreditation Partner, National Association of Boards of Pharmacy, The Compliance Team, The Joint Commission and Utilization Review Accreditation Commission.

HIT accreditation is also the comprehensive measure of a home infusion company’s performance. It enables the organization to strive for a higher level of performance that reduces risk. Better documentation and business practices demonstrate continuous improvement, while giving the organization an opportunity to evaluate the effectiveness of its operations and related services.

Patient Assessment

The HIT supplier performs a patient assessment that includes but may not be limited to:

  • Physical status
  • Psychosocial
  • Nutritional
  • Caregiver support
  • Medications
  • Activities of daily living
  • Vital signs
  • Past medical history diagnosis
  • Home environment
  • Proper site selection
  • Equipment/device selection
  • Patient/caregiver learning ability
  • Need for community resources
  • Potential safety risks
  • Height and weight when applicable
  • Accurate history of allergies/adverse reactions
  • Other agencies/providers involved patient’s care

All patients/caregivers receiving infusion therapy are at a minimum educated on the following:

  • Care of the intravenous site and dressing changes
  • Treatment duration and expectations of outcome
  • Prevention of complications
  • Medications or enteral/parenteral nutrients preparation
  • Follow-up care
  • Potential safety risks and adverse drug reactions


The future of Medicare HIT is promising. As we review industry gains over the last year, such as the new administration allowable, elimination of homebound status to qualify for Part B HIT services, remote monitoring etc., there is still progress that needs to be accomplished and the industry will remain vigilant in advocating for adequate reimbursement, improved outcomes, and patient satisfaction. A wider drug selection, site of care, and medication management continue to be pressure points for our providers.

Sandra C. Canally, R.N., is the founder and CEO of The Compliance Team (TCT), a nationally recognized health care accreditation organization that is CMS deemed for HIT accreditation. TCT provides comprehensive accreditation and certification services to healthcare providers based in all fifty states, Puerto Rico and U.S. Virgin Islands. The Compliance Team’s proprietary accreditation status is known as Exemplary Provider Accreditation. Visit