FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
`NYSCEF DOC. NO. 1
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`INDEX NO. 908289-21
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`SUPREME COURT OF THE STATE OF NEW YORK
`ALBANY COUNTY
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`In the Matter of the Application of
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`NORTH SHORE HEMATOLOGY-ONCOLOGY
`ASSOCIATES, P.C. d/b/a NEW YORK CANCER &
`BLOOD SPECIALISTS,
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` Petitioner,
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`For a Judgment Under Article 78 of the CPLR,
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`
`
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`- against –
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`NEW YORK STATE DEPARTMENT OF HEALTH, and
`NEW YORK STATE EDUCATION DEPARTMENT,
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` Respondents.
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`
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`VERIFIED PETITION
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`ORAL ARGUMENT
`REQUESTED
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`
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`Index No.
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`
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`Plaintiffs, NORTH SHORE HEMATOLOGY-ONCOLOGY ASSOCIATES, P.C. d/b/a
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`
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`NEW YORK CANCER & BLOOD SPECIALISTS, LLC (“NYCBS” or “Petitioner”), for its
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`Verified Petition for judgment pursuant to Article 78 as against Respondents the NEW YORK
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`STATE DEPARTMENT OF HEALTH (“NYDOH”) and the NEW YORK STATE
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`EDUCATION DEPARTMENT (“NYSED”) (collectively, the “Respondents” or the “State”) states
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`as follows:
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`THE PARTIES
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`1. Petitioner is an independent, New York oncology practice that treats, among others, New
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`York Medicaid-enrolled cancer patients.
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`2. NYDOH is a New York state agency involved in the administration of New York State’s
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`Medicaid program.
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`3. NYSED is a New York state agency governed by and involved in the administration of the
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`New York Education Law, including New York Education Law § 6807, of relevance to this matter.
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`FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
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`JURISDICTION AND VENUE
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`4. This Court has jurisdiction over this controversy pursuant to, among other law, CPLR 7801
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`and 7803.
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`5. Venue is proper in this Court under CPLR 7804(b) and 506(b) because the Respondents are
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`both located in Albany, New York.
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`PRELIMINARY STATEMENT
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`6. In June of this year, the NYDOH and NYSED quietly slipped a de facto agency rule into a
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`New York State Medicaid Pharmacy Manual, which, without fanfare or legal authority, created out
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`of whole cloth a definition of the practice of oncology in New York State, and did so in such a narrow
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`and restrictive way as to interfere with New York oncologists’ ability to manage the care of their own
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`(Medicaid) patients. Constructing an entirely new legal definition of any medical specialty, let alone
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`oncology, without public notice and comment is a breathtakingly irresponsible abuse of agency
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`authority and one that must be corrected by the Court. The matter is all the more egregious given
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`that this new definition does not exist within Medicare and, thus, its adverse consequences are felt
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`only by New York’s highly vulnerable and “categorically needy” Medicaid population.1
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`7. Through this action, Petitioner seeks an Order nullifying this de facto rule as: an arbitrary and
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`capricious violation of (1) the New York State Administrative Procedure Act (“SAPA”) and (2)
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`Article IV, § 8 of the New York State Constitution for lack of public notice and comment; (3) and as
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`unconstitutionally vague.
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` 1
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` Roach v. Morse, 440 F.3d 53, 59 (2d Cir. 2006). (“The Medicaid program requires states that
`participate to cover the cost of care for the ‘categorically needy,’ which the statute defines as those
`individuals who are unable to cover the costs of their basic needs and already receive or are eligible
`for certain forms of public assistance.”) (internal citation omitted).
`2
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`FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
`NYSCEF DOC. NO. 1
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`INDEX NO. 908289-21
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`RECEIVED NYSCEF: 09/21/2021
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`BACKGROUND
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`A. Physician Dispensing In New York State and the “Oncological Protocol”.
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`8. Broadly, physician dispensing refers to the process through which a physician dispenses
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`medications to a patient at the point of care, rather than providing the patient a prescription to be
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`filled at a separate, third party pharmacy.2 It has obvious advantages – particularly in the oncology
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`context. The dispensing physician can coordinate all aspects of the patient’s medication management,
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`in addition to providing counseling to the patient upon dispensing, enhancing the effectiveness of a
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`drug regimen and a patient’s adherence to it.3 Under this model, sickly patients don’t have to try their
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`luck at random retail or mail-order pharmacies, where dispensing mistakes can occur, where wait
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`times can be extensive, and where administrative red-tape and confusion are often the rule rather
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`than the exception.4 Moreover, in the oncology setting, patients are often taking multiple
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`prescriptions at the same time, some of which cause severe side effects, and others of which mitigate
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`them. Receiving all cancer care – oncolytics and supportive medications – from the same source has
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`immense benefits for patients and caregivers alike.
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`9. New York generally limits physician dispensing by statute, with certain exceptions.
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`Specifically, New York Education Law § 6807, prohibits physicians and other New York prescribers
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`“who [are] not the owner[s] of a pharmacy” from “dispens[ing] more than . . . seventy-two hour
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`supply of drugs[.]” Id. at 6807(2)a. This prohibition is then followed by a finite list of exceptions,
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` 2
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` While, upon information and belief, there is nothing unlawful about a medical practice owning a
`pharmacy in the State of New York, as a practical matter, it is Petitioner’s understanding that this is
`generally disallowed by the State. This reality is reflected by the fact that, to Petitioner’s knowledge,
`neither the New York Board of Pharmacy nor the NYSED, Office of the Professions more broadly,
`grant pharmacy licenses to physician practices. Thus, for all intents and purposes, physician dispensing
`is a physician practice’s only option should it wish to dispense in-office to its patients.
`3 See, e.g., https://www.ncoda.org/wp-content/uploads/bp-
`attachments/7218/ajmcpan032016inofficedispensingcontinuityofcarebynancyegerton.pdf (last
`accessed 9/14/21) at S100-202.
`4 See Id. at S101.
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`3
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`among which, at § 6807(2)(a)(9), is the following: physicians may “dispens[e] . . . drugs pursuant to
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`an oncological or AIDS protocol.” This is the only mention of oncology in § 6807. See, generally, id.
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`10. The term “oncological protocol” or “oncologic protocol”5 is nowhere defined within the
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`New York Education Law or, per our research, anywhere else in New York law – be it statutory,
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`regulatory or the common law. And, as discussed below, no New York agency had ever issued
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`guidance on its meeting, until the de facto rule at issue in this matter was surreptitiously included in a
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`June 4, 2021 copy of the New York Medicaid Fee-For-Service Program Pharmacy Manual Policy
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`Guidelines (the “Medicaid Manual”).6
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`B. Publication of the June 4, 2021 New York State Fee-for-Service Program Pharmacy
`Policy Guidelines Without Notice and Comment.
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`11. On or about June 4, 2021, a link to the Medicaid Manual was published on the NYDOH
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`
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`website. See https://www.health.ny.gov/health_care/medicaid/program/pharmacy.htm
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`(last
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`accessed on 9/14/21).7
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`12. Page 20 of the Medicaid Manual provides a definition of the Oncologic Protocol, which, on
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`information and belief, was crafted by both the NYDOH and the NYSED (the latter of which is
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`charged with administration of the New York Education Law and associated regulations). The
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`definition provides:
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`“Policy
`Practitioners who choose to dispense outpatient drugs to a NYS Medicaid FFS
`or Managed Care member must:
`• be actively licensed as a practitioner authorized to prescribe and in good standing with
`NYS;
`• be actively enrolled as a practitioner;
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`
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` 5
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` For reasons unknown, the State appears to use the terms “oncologic protocol” and “oncological
`protocol” interchangeably. Compare Exhibit A at 20 with New York Education Law § 6807(a)(9).
`6 A true and accurate copy of the Medicaid Manual is attached hereto as Exhibit A.
`7 Note that clicking on the “NYS MMIS Pharmacy Provider Manual” hyperlink on this webpage
`redirects readers to https://www.emedny.org/providermanuals/ (last accessed 9/14/21), which
`contains a listing of “Provider Manuals,” among which is the Medicaid Manual.
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`• have software available to monitor for drug allergies or other complications;
`• dispense only to their own patients;
`•
`label, hand the drug to the patient directly (cannot be delegated to another person, must be
`completed by only the dispensing physician), and counsel patient according to NYS
`Education Department guidance;
`• maintain records of drugs dispensed and circumstances (i.e., emergency);
`•
`limit dispensing of drugs according to law including but not limited to:
`o An oncologic protocol is 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 or pain). [Education Law §6807]
`o An acquired immunodeficiency syndrome (AIDS) protocol is a written set of
`instructions to guide the administration antiretroviral drugs to patients for the
`treatment of HIV infections or AIDS. It does not include protocols that cover
`medications prescribed to provide relieve side effects of these therapies or
`distressing symptoms (such as nausea or pain). [Education Law §6807]”
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`[Id. (emphasis supplied) (hereafter, the “Oncologic Protocol” or the “de facto Rule”.]
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`13. Thus, as the bolded language suggests, the NYDOH and the NYSED, took it upon
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`themselves to define, in a highly restrictive fashion, the term “oncologic protocol,” decoupling from
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`it any medications prescribed by an oncologist to ease the often brutal pain, nausea or infections that
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`may arise as a result of therapies prescribed in the “treatment of cancer or tumors.” Indeed,
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`Respondents took it upon themselves to determine what the “treatment of cancer or tumors” means
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`and what it does not. Effectively, therefore, this so-called “[p]olicy”8 defines the practice of oncology.
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`14. Other than the citation to the New York Education Law § 6807, there is no authority, legal,
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`medical or otherwise, cited in support of the Oncologic Protocol’s newly-crafted definition.
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`15. There is, in fact, no statute, regulation or case that defines the Oncologic Protocol.
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`16. Respondents do not cite to any independent scientific or medical study supporting the
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`definition of the Oncologic Protocol.
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`17. Respondents do not cite to any study undertaken by either the NYDOH or the NYSED, or,
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`for that matter, to a study by any other New York State agency defining or attempting to define the
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` In fact, as discussed in greater detail below, the definition of the Oncologic Protocol is not a policy
`– it is a rule.
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`Oncologic Protocol.
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`18. Respondents provide no description or discussion of why the definition of the Oncologic
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`Protocol is necessary or helpful from a “[p]olicy” standpoint.
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`19. Upon information and belief, Respondents did not file a regulatory impact statement in
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`connection with the potential adverse effects of defining the Oncological Protocol as Respondents
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`have done.
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`20. Notwithstanding its utter lack of basis, legal or otherwise, this “[p]olicy,” which is actually a
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`poorly-veiled rule, directly and adversely impacts those members of New York’s deeply vulnerable
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`Medicaid population who are stricken with cancer, by precluding their oncologists’ ability to dispense
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`supportive medications while the patient is in-office, disruptively forcing these patients to search for
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`third party pharmacy alternatives.
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`21. Notably, federal law recognizes the value of physician dispensing, going so far as to create
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`safe harbors for the Stark Law and Federal Anti-Kickback Statute so that providers (under certain
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`circumstances) may bill Medicare for medications dispensed in-office without facing liability for what
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`might otherwise be deemed self-dealing. See 42 C.F.R. 431.55(b); 42 C.F.R. 1001.952(p)(4).
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`22. What’s more, the definition of the Oncologic Protocol (“DOP”) is plainly inconsistent with
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`the ordinary practice of oncology in that it attempts to decouple supportive care, such as the
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`dispensing of pain medication, anti-emetics or anti-biotics, from the “treatment of cancer or
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`tumors[,]” as though they were clinically unrelated.
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`23. The National Comprehensive Cancer Network (“NCC”) is an institution recognized as “an
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`expert body in the field of clinical oncology,” whose clinical care “Guidelines” are widely accepted
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`as “authoritative in the field.” See Zeneca Inc. v. Eli Lilly & Co., 1999 WL 509471, at *23 (SDNY
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`1999); see also Reimann v. Anthem Ins. Company, Inc., 2008 WL 4810543, at *6 (S.D.IN 2008)
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`(accord). Such acceptance extends to the Centers for Medicare and Medicaid Services (“CMS”), which
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`has recognized the NCCN Guidelines as an authoritative source for use in determination of medically
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`accepted indications for many aspects of the practice of oncology in connection with rendering
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`Medicare
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`coverage
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`decisions.
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`See,
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`e.g.,
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`www.cms.gov/Regulations-and-
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`Guidance/Guidance/Transmittals/Downloads/R96BP.pdf (last accessed 9/14/21).
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`24. The NCCN’s Guidelines contain a multitude of best practices for oncologists with respect to
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`oncology “Supportive Care,” including: “Adult Cancer Pain, Antiemesis, Cancer-Associated Venous
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`Thromboembolic Disease, Cancer-Related Fatigue, Distress Management, Management of
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`Immunotherapy-Related
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`Toxicities”
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`and
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`“Palliative Care,”
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`among
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`others.
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`See
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`https://www.nccn.org/guidelines/category_3 (last accessed 9/14/21). This is entirely inconsistent
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`with Respondents’ de facto Rule, which would excise from the Oncologic Protocol these recognized
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`categories of oncological care to the extent they call for the prescribing of medications not for the
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`“treatment of cancer or tumors,” such as, per Respondents, drugs falling within the “Antiemesis”
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`Supportive Care Guidelines.
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`25. In short, the DOP was issued without rationale, need or serious study. It is unsurprising,
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`then, that Respondents failed to file it with the Secretary of State for publication in the state register
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`or afford the public with an opportunity to submit comments to it as proposed rule, in violation of
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`SAPA and the New York State Constitution, among other laws.
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`C. Health Plans’ and PBMs’ Confused and Chaotic Implementation of the De Facto
`Rule.
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`26. In or around the time that the Medicaid Manual was published, NYCBS began receiving
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`
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`claims denials for “Supportive Care” medications, such as injectafer and venofer, from New York
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`Managed Medicaid plans (the “MCOs”), all of which were administered by the same Pharmacy
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`Benefits Manager (the “PBM”).9 The stated basis for the claims denials was that the “Practice [was]
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`Not Contracted With Plan On Date of Service[,]” despite the fact that NYCBS was, in fact, in
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`contract with both the MCOs and the PBM. Markedly, some of the MCOs denied claims for these
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`medications regularly and other did not, even though the stated reasons for the rejections remained
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`the same.
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`27. Counsel for NYCBS spoke with counsel for the PBM in an effort to determine the cause of
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`the denials. The PBM advised that the NYDOH had directed the MCOs to deny all claims for
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`medications that fell outside of the DOP and that the MCOs, in turn, had advised the PBM of the
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`new NYDOH-issued directive. This subsequently led to confusion on the MCOs’ part in terms of
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`what, in fact, fell within the ambit of the DOP and what did not, which, in turn led to disparate
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`determinations from individual MCOs – some finding that, for example, injectafer and venofer were
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`not within the DOP and others finding that they were.
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`28. Upon information and belief, to date, these claims denials have resulted in the denial of
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`hundreds of claims, valued at hundreds of thousands of dollars. More importantly however, this has
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`created a highly problematic and disruptive environment for NYCBS’ oncologists, who can no longer
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`dispense Supportive Care medications in-office to their New York Managed Medicaid patients with
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` For clarification on the relationship between these entities, note the following: “PBMs manage the
`pharmacy benefit of group health plan sponsors, such as HMO plans, self-insured employers,
`indemnity plans, labor union plans, and plans covering public employees. When an enrollee in one of
`these plans purchases a drug at a retail pharmacy, he or she presents a health plan card identifying the
`source of insurance coverage. The pharmacy will transmit the insurance coverage information to the
`PBM, which verifies coverage and determines if the plan covers the prescribed drug, what the plan
`owes as direct payment to the pharmacy, and what the enrollee's co-payment will be (if any). The PBM
`transmits this information back to the pharmacy, logs the payment information on its system, and
`transmits the billing information to health insurers. These insurers then remit payment to the PBM,
`which forwards payment to the retailer. This process, known as claims adjudication, is handled
`electronically. Ninety-five percent of patients with prescription drug insurance coverage receive their
`benefits through a PBM.” Improving Health Care: A Dose of Competition, A Report by the Federal
`Trade Commission and the Department of Justice, 2004 WL 1685795, at *136 (2004).
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`cancer.
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`29. To be clear, prior to the implementation of the DOP, NYCBS and many other New York
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`oncology practices regularly dispensed Supportive Care medications in-office to their cancer patients,
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`which claims were reimbursed without issue by all MCOs (assuming the claims were otherwise clean).
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`30. The DOP-based claims denials continue through the date of this writing, as does the disparate
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`treatment of those claims by various MCOs, all of which appear to be interpreting the meaning of
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`the DOP differently.
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`31. Additionally, by its own terms, the DOP affects physician dispensing both within the
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`“Managed Care” context, as described above, and within “NYS Medicaid F[ee-for-Service.]” This
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`means that the DOP will affect oncologists’ ability to dispense to patients directly enrolled in New
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`York’s Medicaid program, rather than through an intermediary MCO.
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`32. These are unacceptable results both for NYCBS and its Medicaid patients with cancer.
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`FIRST CAUSE OF ACTION AGAINST THE RESPONDENTS
`(The DOP Violates SAPA and the New York Constitution)
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`33. NYCBS incorporates the preceding paragraphs as if set forth herein.
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`34. While Respondents attempt to characterize the DOP as mere “[p]olicy[,]” it is, in fact, a rule
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`under New York law and, as such, Respondents’ failure to file a notice of proposed rule making with
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`the secretary of State for publication in the state register or to provide for a public notice and
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`comment period renders the rule unlawful and unenforceable under SAPA and the New York State
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`Constitution. It follows that the DOP was made in violation of lawful procedure, was arbitrary and
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`capricious, and was affected by an error of law under CPLR 7803(3).
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`35. Article IV, § 8 of the New York Constitution provides that “[n]o rule or regulation made by
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`any state department, board, bureau, officer, authority or commission, except such as relates to the
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`organization or internal management [thereof] . . . shall be effective until it is filed in the office of
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`the department of state.” Id. (emphasis supplied); see also New York Executive Law § 102(1).
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`36. The “SAPA requires submission of notice of a proposed rule making to the Secretary of State
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`for publication in the state register, followed by a public comment period, a public hearing (where
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`applicable), and the filing and publication of a notice of adoption of the rule. Only after the foregoing
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`is completed is the rule deemed effective.” Kahrmann v. Crime Victims Bd., 827 N.Y.S.2d 817, 820
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`(Alb. Cty. 2006) (citing to NY State Adm Pro §§ 202-203).
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`37. SAPA defines the term “Rule” to mean: “the whole or part of each agency statement,
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`regulation or code of general applicability that implements or applies law . . . or practices bearing on
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`any of the foregoing whether of general or particular applicability.” NY State Adm Pro § 102(2)(a).
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`38. Rules in the guise of agency guidance, policy or interpretation, are still rules under SAPA and
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`the New York Constitution if they “set standards that substantially alter or, in fact, can determine the
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`result of future adjudications.” In the Matter of Alca Industries, Inc. v. Peter W. Delaney,
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`Commissioner of the NY State Office of General Services, 686 N.Y.S.2d 356, 358 (Ct. App. 1999).
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`Stated another way, a “fixed, general principle to be applied by an administrative agency without
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`regard to other facts and circumstances relevant to the regulatory scheme of the statute it administers
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`constitutes a rule or regulation[.]” In the Matter of Pallette Stone Corporation v. State of New York
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`Office of General Services, 665 N.Y.S.2d 457, 459-460 (Ct. App. 1997).
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`39. Here, the DOP substantially alters or determines the result of whether New York Medicaid
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`(or, by extension, one of its contracted MCOs) will cover or not cover a particular medication
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`dispensed by an oncologist by applying the fixed inquiry of whether the medication is to be used for
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`“chemotherapy, immunotherapy, hormone therapy, [or] targeted therapy for the treatment of cancer
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`or tumors[,]” or, alternatively, whether medication is to be used “to relieve [the] side effects of these
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`therapies or to relieve distressing symptoms (such as nausea or pain).” See Exhibit A at 20. The State
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`has already implemented the application of this principle by directing its MCOs to comply with it
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`and, upon
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`information and belief, by applying
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`it to Medicaid fee-for-service coverage
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`determinations.10 Given the foregoing, the DOP is plainly a rule within the meaning of the New York
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`Constitution and SAPA.
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`40. Because the Respondents failed to file the DOP with the Secretary of State for publication in
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`the state register or provided for a public comment period or notice of adoption, the DOP was
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`promulgated in violation of New York law, namely, Article IV, § 8 of the New York Constitution,
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`and Sections 202 and 203 of the SAPA.
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`41. Respondents’ unlawful promulgation and implementation of the DOP proximately damaged
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`(and continues to damage) NYCBS financially, in addition to disrupting NYCBS’ ability to provide
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`its New York Medicaid patients with all of the benefits of in-office physician dispensing.
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`SECOND CAUSE OF ACTION AGAINST THE RESPONDENTS
`(The DOP is Arbitrary and Capricious Because Its Promulgation Lacked a Rational Basis)
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`42. NYCBS incorporates the preceding paragraphs as if set forth herein.
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`43. Respondents’ promulgation of the DOP lacks any rational basis and should be annulled as
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`such.
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`44. Notwithstanding any principles of agency deference that might ordinarily apply to a rule
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`making, a rule11 that lacks rationality and is marked by arbitrariness should be annulled as unlawful.
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`See Law Enforcement Officers Union, Dist. Council 82, AFSCME, AFL-CIO by Seide v. State, 647
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`N.Y.S.2d 916, 919-920 (Alb. Sup. Ct. 1996).
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`45. An agency rule lacks a sufficient rational basis where it is unreasonable and is unsupported
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`by any evidence, which may be discerned by the absence of “credible and more than insubstantial”
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`
`
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`10 Upon information and belief, the NYDOH has denied providers the ability to enroll with Medicaid
`fee-for-service as physician dispensers due to administrative delay and error. Notwithstanding, the
`DOP itself makes clear that it applies with equal force to both Medicaid Managed Care and fee-for-
`service Medicaid. See Exhibit A at 20. If Respondents have not yet implemented the de facto Rule with
`respect to fee-for-service coverage determinations, therefore, they will be doing so imminently.
`11 As discussed at length above, the DOP is a “rule” despite labeling itself a “[p]olicy.”
`11
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`FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
`NYSCEF DOC. NO. 1
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`INDEX NO. 908289-21
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`RECEIVED NYSCEF: 09/21/2021
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`evidence supportive thereof. Brodsky v. Zagata, 646 N.Y.S.2d 188, 190 (App. Div. 3rd Dep’t 1996).
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`46. The only evidence or authority cited in support of the DOP by Respondents is New York
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`Education Law § 6807. See Exhibit A at 20.
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`47. Section 6807 references oncology in only one subpart, namely, § 6807(2)(a)(9), which
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`provides that a physician may dispense medications “pursuant to an oncological or AIDS protocol.”
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`The statute says nothing further about an oncologic or oncological protocol.
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`48. In construing an enabling statute, courts should be mindful that “questions of pure legal
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`interpretation of statutory language do not warrant judicial deference to administrative expertise.”
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`Matter of Toys ‘R’ Us v. Silva, 89 N.Y.2d 411, 419 (Ct. App. 1996).
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`49. Here, the language of § 6807(2)(a)(9) – providing that physicians may dispense “pursuant to
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`an oncological or AIDS protocol[] – does not support the position, taken by Respondents, that the
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`Oncologic Protocol distinguishes between medications dispensed
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`for “chemotherapy,
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`immunotherapy, hormone therapy, [or] targeted therapy for the treatment of cancer or tumors[,]”
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`and those medications dispensed “to relieve [the] side effects of these therapies or to relieve
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`distressing symptoms (such as nausea or pain).” See Exhibit A at 20.
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`50. Further, in support of the DOP or as evidence for its lawful promulgation, Respondents fail
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`to cite or reference any independent scientific or medical study supporting the definition of the
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`Oncologic Protocol. Nor do Respondents reference or cite to any study undertaken by either
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`NYDOH or NYSED or any other New York State agency, which defines or attempts to define the
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`Oncologic Protocol. Nor have Respondents provided any discussion or indication as to why the
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`particular definition contained in the DOP is at all necessary or helpful from a “[p]olicy” perspective,
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`medical perspective or, indeed, a legal perspective.
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`51. Upon information and belief, there was no regulatory impact statement filed in connection
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`with the potential effects of publishing and implementing the DOP.
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`FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
`NYSCEF DOC. NO. 1
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`INDEX NO. 908289-21
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`RECEIVED NYSCEF: 09/21/2021
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`52. In fact, authoritative compendia on the practice of oncology, such as the NCCN Guidelines,
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`directly contravene the substance of the DOP in that they do not distinguish between the practice of
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`oncology (or the following of an oncological protocol) and the provision of supportive care, such as
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`the dispensing of anti-emetics, pain medications and/or antibiotics, among others.
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`53. In light of the above, it is plain that Respondents have not met even the relatively generous
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`“credible and more than insubstantial” evidence standard and, as a consequence, it is equally plain
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`that promulgation of the DOP lacked a rational basis.
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`54. The DOP is therefore arbitrary and capricious and affected by an error of law within the
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`meaning of CPLR 7803(3).
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`55. Respondents’ arbitrary and capricious promulgation of the DOP has proximately damaged
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`(and continues to damage) NYCBS financially, in addition to disrupting NYCBS’ ability to provide
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`its New York Medicaid patients with all of the benefits of in-office physician dispensing.
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`THIRD CAUSE OF ACTION AGAINST THE RESPONDENTS
`(The DOP is Unconstitutionally Vague)
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`56. NYCBS incorporates the preceding paragraphs as if set forth herein.
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`57. “The void-for-vagueness doctrine employs a rough idea of fairness, and applies to regulations
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`as well as statutes.” Matter of Gurnsey v. Sampson, 57 N.Y.S.3d 855, 865 (Ct. App. 2017).
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`58. A two-part test applies in evaluating a vagueness challenge. First, a court must determine
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`whether the regulation is “sufficiently definite so that individuals of ordinary intelligence are not forced
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`to guess at the meaning of [regulatory] terms” Matter of Kaur v. New York State Urban Dev. Corp.,
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`15 N.Y.3d 235, 256 (Ct. App. 2010), and have fair notice of the conduct is prohibited. See People v.
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`Nelson, 69 N.Y.2d 302, 307 (Ct. App. 187). Second, the court must determine whether the regulation
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`provides “clear standards for enforcement so as to avoid resolution on an ad hoc and subjective basis.”
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`People v. Stephens, 28 N.Y.3d 307, 312 (Ct. App. 2016). In sum, a regulation that “invites . . .
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`misunderstanding by a person of ordinary intelligence [and] . . . arbitrary enforcement by plaintiff[,]”
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`FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
`NYSCEF DOC. NO. 1
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`INDEX NO. 908289-21
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`RECEIVED NYSCEF: 09/21/2021
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`is unconstitutionally vague. Matter of Sullivan Farms IV, LLC v. Village of Wurtsboro, 21 N.Y.S.3d
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`450, 455 (App. Div, 3rd Dep’t 2015).
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`59. Here, the DOP purports to differentiate between medications to be used for “chemotherapy,
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`immunotherapy, hormone therapy, [or] targeted therapy for the treatment of cancer or tumors[,]” on
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`the one hand, and medications “to relieve [the] side effects of these therapies or to relieve distressing
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`symptoms (such as nausea or pain)[,]” on the other. See Exhibit A at 20. But it offers no guidance on
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`how a dispensing oncologist or the NYDOH is to make this determination – and a medication that
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`might have pain relieving, anti-emetic or anti-biotic effects may be necessary for the “treatment of
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`[the] cancer or tumors[,]” as such treatment may only proceed or succeed if the patient remains
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`reasonably healthy.
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`60. NCCN “Guidelines for Management of Immunotherapy-Related Toxicities,” for example, are
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`designed to “provide guidance on the management of immune-related adverse events (irAEs) resulting
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`from cancer immunotherapy.” https://jnccn.org/view/journals/jnccn/17/3/article-p255.xml (last
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`accessed 9/14/21). These Guidelines recommend various treatments to be used to maintain the health
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`of a patient undergoing immunotherapy for cancer, which can result in harmful toxicities such as
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`“dermatological toxicity” or “musculoskeletal toxicity[,]” conditions for which the Guidelines suggest
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`medications such as “oral antihistamines” or steroids such as “prednisone”. Are these medications
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`managing a potentially life-threatening “side effect[,]” in the words of the DOP, of immunotherapies
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`utilized to treat cancer or are they an integral part of it, and how is NYDOH to make this
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`determination in any given case? Similarly, can the use of antiemesis to manage Chemotherapy
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`Induced Nausea and Vomiting, which can cause “dehydration, malnutrition, electrolyte imbalances,
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`esophageal tears, fractures, wound dehiscence and deterioration of physical and metal status[,]”
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`legitimately be decoupled from the chemotherapy itself, if chemotherapy cannot be safely
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`administered in its absence? https://www.uspharmacist.com/article/chemotherapyinduced-nausea-
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`FILED: ALBANY COUNTY CLERK 09/21/2021 02:17 PM
`NYSCEF DOC. NO. 1
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`INDEX NO. 908289-21
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`RECEIVED NYSCEF: 09/21/2021
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`and-vomiting (last accessed 9/14/21). The DOP provid