ALERT FOR NEW YORK ONCOLOGY PRACTICES: The New York Department of Health and the New York State Education Department Have Substantially Redefined the Scope of What Oncologists Can Dispense Pursuant to an “Oncologic Protocol”

In an apparent unlawful exercise of authority, the New York Department of Health (“NYDOH”) and the New York State Education Department (“NYSED”) quietly slipped a de facto agency rule into the NYDOH’s Medicaid Pharmacy Manual Policy Guidelines without seeking public notice or comment. Broadly, the rule prevents oncologists from submitting Rx claims for supportive therapies designed to ease the side effects of traditional cancer medications, such as pain medication or anti-emetics, to New York fee-for-service Medicaid or New York managed Medicaid plans for reimbursement. By extension, this means that New York Medicaid and managed Medicaid cancer patients are now unable to receive these supportive medications from their own trusted oncologists and, instead, will need to find a third-party pharmacy to do it.

More specifically, through the de facto rule, NYDOH and NYSED defined a key legal term that previously had no definition under New York law – the “oncologic protocol.” The definition provides that: Physician dispensers “who choose to dispense outpatient drugs to a NYS Medicaid FFS or Managed Care member must . . . limit dispensing of drugs according to law including but not limited to [a]n oncologic protocol[, which is a] . . . written set of instructions to guide the administration chemotherapy, immunotherapy, hormone therapy, targeted therapy to patients for the treatment of cancer or tumors. It does not include protocols that cover drugs prescribed to relieve side effects of these therapies or to relieve distressing symptoms (such as nausea of pain).”

Importantly, this new definition is purportedly derived from New York Education Law § 6807, a statute which prohibits all physicians and other New York prescribers “who [are] not the owner[s] of a pharmacy” from “dispens[ing] more than . . . seventy-two hour supply of drugs,” unless a physician “dispens[es] . . . drugs pursuant to an oncological or AIDS protocol.” Id. at 6807(2)a(9). As noted, the term “oncologic protocol” is not defined anywhere within § 6807, and for many years, New York oncologists had dispensed the full range of oral oncolytics and supportive medications to their cancer Medicaid patients without issue.  This new interpretation thus represents a significant departure from longstanding practices and New York Medicaid payment polices.

What authority the NYSED and the NYDOH relied upon to craft the above language, is mysterious to say the least. More problematic still, neither the NYSED nor the NYDOH provided an opportunity for notice and comment, as they were legally required to do, before shoehorning this narrow and restrictive new definition of the practice of oncology into a New York Medicaid pharmacy manual. The real world effects of this de facto rule are serious – it means New York oncologists cannot dispense, administer and monitor supportive therapies such as anti-emetics or pain medication to their New York Medicaid cancer patients and, instead, must send them out into the cold to find a random pharmacy that will. Worse yet, several New York Medicaid managed care organizations are already directing their pharmacy benefits managers (like CVS Caremark) to begin denying claims for medications that are not deemed to be dispensed pursuant to an oncological protocol.  This is an unacceptable result, both for New York providers and, more importantly, their patients.

How Frier Levitt Can Help

Frier Levitt is currently working with practices and stakeholders who have been adversely affected by this de facto rule. If you are an oncologist or oncology practice in New York with concerns about this development, contact us today.