Making the Grade: New Standards Coming Out of the Woodwork

Dawn Holcombe, MBA, FACMPE, ACHE
President, DGH Consulting, South Windsor, CT

With the increased complexity in oncology practices come additional standards—new standards for improving value-based market positioning and financial return, dispensing oral oncology drugs, and handling hazardous oncology drugs—that mirror a full-service healthcare facility more than a physician’s office.

Will these standards help the practice of oncology to create a firm platform for the specialty of oncology, or will they push the practice of oncology into more diverse settings and change the shape of care delivery forever?

Currently, these new standards affect the ability of practices to serve patients, and may also affect their financial future, and their competitive market positioning. In addition, they may affect the selection and implementation of cancer treatments. Furthermore, these new standards are changing how practices operate, document, and create their policies and procedures, and may also change how providers consider the treatment path of individual patients and of patient populations.

Standards to Improve Value-Based Market Positioning and Financial Return

Under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), 2 new payment systems were created, including the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Let us review how these payment systems have changed the standards for practice operation.

To meet the performance and quality criteria of the MIPS program, oncology practices must achieve detailed measures, including new standards for practice operation, tracking, reporting, and treatment decision-making.

Similarly, to qualify for the APM program, including advanced APMs, specific certifications must be met to be recognized as a specialty patient-centered medical home, in addition to the quality, practice transformations, and advancing care information components of the MACRA program that are being met through the APM activity or the MIPS reporting.

Participation in the Oncology Care Model (OCM) means that nearly 200 oncology practices must follow an additional, all-encompassing set of changes in how they staff, operate, handle workflow and patient communications, manage patient interactions inside and outside of the office, utilize technology, and meet expected technology infrastructure obligations. The OCM-related documents provide hundreds of pages of guidance on the expected levels of care management, communication, work interaction, and patient management. These are all new checklists that oncology practices did not have to deal with historically.

Standards for Dispensing Oncology Drugs

Physicians have historically dispensed oral oncology and supportive care drugs under their medical license in the states where they are permitted to do so. Now, however, market demands are practically mandating that physician practices that dispense oral oncology drugs obtain specialty pharmacy accreditation, with an additional Distinction in Oncology. The Accreditation Commission for Health Care worked with the Community Oncology Pharmacy Association to create an oncology accreditation set of standards specific to pharmacies that dispense oral oncolytics.

Furthermore, some Pharmacy Benefit Managers (PBMs) are now notifying oncology practices that they (the practices) must be credentialed and/or accredited to continue dispensing oral oncology drugs covered through the PBM network, as well as to submit fees to the PBM for that privilege. These new expectations and standards are beyond the normal quality and care parameters that are followed as part of the practice of medicine for drug management.

Standards for Handling Hazardous Drugs and Compounding Sterile Preparations

In New Jersey, California, and Maryland, several bills have been passed through the state legislatures requiring oncology practices to comply with the standards for handling hazardous drugs. These standards are usually aligned with those set forth in the US Pharmacopeia (USP) Convention Chapter 800 (USP 800) but often have enforcement deadlines that are much earlier than the July 2018 date when USP 800 itself becomes enforceable by any entity that chooses to comply with it.

In addition, academic clinical research networks and regional hospital networks in New England are limiting the availability of clinical research drugs from facilities that are not compliant with the USP standards for compounding sterile preparations set forth in USP Chapter 797 (USP 797). The US Food and Drug Administration (FDA) has cited oncology practices and hospital cancer centers for failure to meet the USP 797 standards.

Activity is being monitored across the country for local, state, and federal attention to USP 797 and USP 800 standards, which affect facilities; staff training and evaluation; policies and procedures; and daily operations, cleaning, and inventory management.

For example, the Centers for Disease Control and Prevention has been tracking adverse events stemming from outpatient oncology centers, which resulted in the FDA shutting down a New York–based outpatient oncology practice, in which several patients became infected because of contaminated port flush solution.1

In addition, lawyers have approached oncology practice staff who work with hazardous drugs after suffering medical issues.

One challenge for oncology practices is market positioning: pharmacies have been held to standards, including USP 797 standards, for more than a decade; should oncology practices not be held to the same facility, operational, staff competency, and quality standards that pharmacies must meet? Will this involve a risk in terms of public opinion even in areas where there are no enforcement activities related to USP 797 and USP 800 if compliance (or lack thereof) of medical practices, with drug-handling standards that are common in pharmacy, were challenged in the press?

Prepare for New Standards

The existence of these new standards and the complexity of decision-making around their selection and implementation moves practice administration to a whole new level. Someone has to be watching and planning for these changes to allow physicians to continue to focus on their patients. These new skill sets were never covered in formal healthcare administrative coursework or even in the school of hard knocks and past experience.

But they are on the horizon, and more significant than ever before. We will continue to cover late-breaking information on these new standards through Oncology Practice Management and bring together the national network of practice administrators to prepare them for these changes. Together, we will meet these challenges head on.


  1. Vasquez AM, Lake J, Ngai S, et al. Notes from the field: fungal bloodstream infections associated with a compounded intravenous medication at an outpatient oncology clinic—New York City, 2016. MMWR Morb Mortal Wkly Rep. 2016;65:1274-1275.

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