Plaintiffs bring this declaratory judgment action challenging: (1) the refusal of the defendant New York State Department of Health ("Department") to allow Medicaid coverage for medication administration in adult homes; (2) the Department's interpretations of the applicable regulations regarding medication management in adult homes as exceeding the scope of such regulations; as exceeding the Department's authority; and as being in violation of the Nurse Practice Act; and (3) the Department's interpretation of such regulations as being in violation of the State Administrative Procedure Act ("SAPA").

Plaintiffs request an order and judgment declaring that: (A) the plaintiff adult homes are not required to administer medications to residents who would not "ordinarily be capable" of the self-administration; (B) the defendant's policy of limiting Medicaid-funded nursing services in the adult home context to the application of sterile dressings and intravenous and subcutaneous injections is unlawful, ultra vires, in excess of defendant's statutory authority and arbitrary and capricious; and (C) the defendant's 2005 interpretative release, DAL HCBC 05-03, promulgated under the purported authority of 18 NYCRR § 487.7, is invalid for lack of statutory authority and failure to comply with SAPA; and also preliminary and permanently enjoining defendant from: (A) requiring the plaintiffs to administer medications to residents who would not "ordinarily be capable" of the self-administration of their medications; (B) enforcing the policy of limiting Medicaid-funded nursing services in the adult home context to the applications of sterile dressings and intravenous and subcutaneous injections; and (C) enforcing any provision in defendant's 2005 interpretative release (Complaint: pp, 29, 30).

Defendant Department has made a motion for an order dismissing portions of the complaint based upon: (A) the statute of limitations and (B) lack of standing; and (C) for an order granting summary judgment dismissing the complaint. Plaintiffs have cross-moved for an order granting summary judgment upon their claims.

Plaintiffs consist of an association formed to represent and protect the interests of adult home facilities, an association representing the interests of registered nurses, and several individually named adult homes. The plaintiff adult homes provide services to their residents, including: housekeeping, meal preparation, direction regarding and some assistance with personal care activities, assistance with the self-administration of medication, activities programming, and 24 hour supervision. Adult homes do not provide nursing services. Persons who are in need of continual medical care or nursing care supervision; persons who have a medical condition which is unstable and which requires continual skilled observation; and/or persons who refuse or are unable to comply with a prescribed treatment program, including but not limited to a prescribed medication regimen, should not be accepted by or retained by an adult home (see, 18 NYCRR § 487.4(b)).

Adult homes must provide assistance with the self-administration of medications to those residents who are capable of the self-administration of their medications. Such adult home resident's attending physician must certify that the resident is capable of self-administering his or her medications (see, 18 NYCRR § 487.7(f)(1)). A resident capable of the self-administration of [*2]medication must be able to perform the following tasks: (i) correctly read the label on the medication container; (ii) correctly interpret the label; (iii) correctly ingest, inject or apply the medication; (iv) correctly follow instructions as to the route, time dosage and frequency; (v) open the container; (vi) measure or prepare medications, including mixing, shaking, and filling syringes; and (vii) safely store the medication (see, 18 NYCRR § 487.7(f)(2)). A resident needing assistance with the self-administration of medication is one who needs assistance to properly carry out one or more of the activities listed in 18 NYCRR § 487.7(f)(2) (see, 18 NYCRR § 487.7(f)(3)). Assistance with self-administration shall include assistance with any activity the resident would ordinarily be capable of carrying out under 18 NYCRR § 487.7(f)(2) (see, 18 NYCRR § 487.7(f)(4)). However, assistance with self-administration may not include certain tasks such as administering injectable medications (see, 18 NYCRR § 487.7(f)(7)) or determining when a resident requires medication when it has been prescribed PRN ("as needed") (see, Adult Care Facility Directive No. 3-96 dated December 16, 1996).

On May 24, 2004, the Department issued a Dear Administrator Letter ("DAL") and a document entitled "Regulatory Interpretations for Medication Assistance in Adult Care Facilities" (designated as DAL-HCBC-04-06). The May 24, 2004 DAL clarified the regulations regarding providing assistance with the self-administration of medication and the record keeping duties relating thereto. The May 24, 2004 DAL raised issues of concern for various adult care facilities, and the Department engaged in discussions with the Empire State Association of Adult Homes and Assisted Living Facilities (the primary association of adult care facilities in the State) regarding the content of DAL-HCBC-04-06. As a result of these discussions, on January 25, 2005, the Department issued DAL-HCBC-05-03 with accompanying Regulatory Interpretations which modified the content of portions of the May 24, 2004 DAL. The Empire State Association of Adult Homes and Assisted Living Facilities advised its members of the modifications contained in DAL-HCBC-05-03 in its January 2005 newsletter. As a result of further questions regarding medication assistance, the Department on August 26, 2005 issued DAL-HCBC-05-07 including a document entitled "Medication Assistance Frequently Asked Questions".

Among other requirements, the interpretations of the regulations require the adult homes to: (1) request the pharmacy to refill all medications unless the legal representative makes other arrangements (Medicaid does not allow automatic refills); (2)

check medications against the physician's order and to validate any generic substitution (essentially confirming that the drug received matches the Medication Assistance Record); (3) have illegible medication orders interpreted by a licensed professional; (4) have a written policy regarding the tagging of medication containers to reflect physician ordered changes in dosage or schedule of a medication; (5) have a standardized time to assist with medications and that the medications be given within 1 ½ hours from that time; (6) consider whether medications may be taken with or without meals as indicated by the prescriber or pharmacist; and (7) use standardized abbreviations.

CPLR Article 78 Special Proceedings must be commenced within four months after the determination to be reviewed becomes "final and binding upon the petitioner" (CPLR § 217; [*3]Matter of Village of Westbury v. Dept of Transportation, 75 NY2d 62, 72 [1989]). A challenged determination becomes final and binding when it has its impact upon the petitioner who is thereby aggrieved (see, Matter of Biondo v. New York State Board of Parole, 60 NY2d 832 [1983]; Matter of Crest Mainstream, Inc. v. Mills, 262 AD2d 846 [3rd Dept. 1999]). Despite plaintiffs raising their claims in a declaratory judgment action, the four month statute of limitations for CPLR Article 78 proceedings still applies (see, Solnick v. Whalen, 49 NY2d 224 [1980]).

Defendant asserts a statute of limitations defense regarding the plaintiffs' challenge to the regulatory interpretations contained in DAL-HCBC-05-03. There is no dispute that such regulatory interpretations were mailed and that plaintiffs thereby received notification of such regulatory interpretations in January 2005. Furthermore, there is no dispute that the previous DAL-HCBC-04-06 was mailed on May 24, 2004. Plaintiffs contend that there was no actual concrete injury at the time the DAL was mailed because the adult homes were unclear as to how it would be enforced and were told that the DAL was merely interpretative and to be used as guidelines for compliance with the regulations. Interestingly, plaintiffs' papers also assert that the New York Coalition for Quality Assisted Living, Inc. did not challenge the interpretations in 2005 because such organization did not exist at that time. Plaintiffs commenced this declaratory judgment action on May 25, 2006.

Despite plaintiffs protestations to the contrary, this Court holds and determines that DAL-HCBC-05-03 clearly and unambiguously sets forth the Department's definitive position on its interpretations of the subject regulations—with no further procedural, administrative means for the plaintiffs to prevent or significantly ameliorate those interpretations—and therefore, became final and binding upon plaintiffs when such written interpretations were issued and plaintiffs received notice of them (see, Best Payphones, Inc. v. Dep't of Info. Tech. & Telecommunications, 5 NY3d 30 [2005]). Plaintiffs' exhibits attached to Marla Siegel's affidavit also demonstrate that adult homes were being cited for violations of the regulatory requirements at issue herein as early as January 25, 2005—although without direct reference to the DAL. Plaintiffs' challenges to the DAL-HCBC-05-03 interpretations commenced well over a year from their issuance are clearly untimely (see, Delta Kappa Epsilon (DKE) Alumni Corp. v. Colgate University, 38 AD3d 1041 [3rd Dept. 2007]). Accordingly, this Court holds and determines that plaintiffs' third and fourth causes of action should be and the same are hereby dismissed as time barred.

(B) Standing:

The issue of standing "presents some knotty conceptual issues and is litigated with regularity" (Borchers and Markell, New York State Administrative Procedure and Practice § 7.2, at 196 [2d ed]). "The harder cases involve persons who have a stake in the outcome of the administrative process, but whose injury is less direct or substantial" than those persons who are parties to the administrative process (id., § 7.3, at 196-197 [2d ed]).

"The standing of a party to seek judicial review of a particular claim or controversy is a threshold matter which, once questioned, should ordinarily be resolved by the court before the merits are reached" (Matter of Hoston v. New York State Dept. of Health, 203 AD2d 826, 827 [3d Dept 1994], citing Society of Plastics Indus. v. County of Suffolk, 77 NY2d 761, 769 [1991]; Matter of New York State Nurses Assn. v. Axelrod, 152 AD2d 888, 890 [3d Dept 1989]). "A [*4]party does not have standing to contest an administrative determination unless he or she has in fact been injured by the decision. Moreover, to confer standing, the injury must fall within the 'zone of interests' that the pertinent statute aims to protect or promote (see, Society of Plastics Indus. v. County of Suffolk, supra , at 772-773), and it must be different in degree or kind from that suffered by the general public (see, Matter of Sheehan v. Ambach, 136 AD2d 25, 28, lv denied 72 NY2d 804)" (Matter of Hoston v. New York State Dept. of Health, supra , at 827).

The plaintiff bears the burden of establishing standing (see, Society of Plastics Indus. v. County of Suffolk, supra , at 769). Where an association or organization seeks standing, it must establish, among other things, that one or more of its members would have standing to sue (supra , at 775). To establish standing, a "petitioner [plaintiff] need only show that the administrative action will in fact have a harmful effect on the petitioner [plaintiff] and that the interest asserted is arguably within the zone of interest to be protected by the statute" (Matter of Dairylea Coop. v. Walkley, 38 NY2d 6, 9 [1975]).

The issues of standing raised by defendant herein only address and apply to: (1) the plaintiff New York State Nurses Association's standing as a plaintiff herein; and (2) the standing of all plaintiffs to sue under the Medicaid Act. This Court for purely pragmatic reasons hereby declines to engage in any further discussion or determination of the issues of standing because such determinations—even if decided in favor of defendant—would not put an end to or finally determine this declaratory judgment action. Accordingly, this Court will simply assume, without deciding, that the plaintiff New York State Nurses Association has standing, and that all plaintiffs have standing to sue under the Medicaid Act, and this Court will address the merits of the complaint seeking a declaratory judgment (see, e.g. Defense Lawyers Assn. v. Kaye, 96 NY2d 512, at p 516 [2001]).

(C) Summary Judgment:

In the plaintiffs' first and second causes of action, plaintiffs seek a judgment declaring that the Department's medication assistance requirements are unlawful, ultra vires, in excess of the Department's statutory authority, arbitrary and capricious, in violation of the New York Medicaid statute, and in violation of the Nurse Practice Act. Plaintiffs contend that many of the present residents of adult home facilities are not capable of self-administering their medications and that defendant Department nevertheless forces the adult homes to administer such residents' medications.

As a preliminary matter, this Court specifically determines that the affidavit of Mary E. Hart does constitute competent evidence within this action based upon her 27 years of experience involving the oversight of adult care facilities and the interpretation of the Department's regulations.

A person requiring continual nursing care shall not be accepted or retained by an adult home (18 NYCRR § 487.4(b)(1, 6 & 7). The resident's physician must certify that the resident is capable of self-administering his or her medications (see, 18 NYCRR § 487.7(f)(1)). Such a certification necessarily implies that a physician (not a nurse) has determined that a resident is self-directing and capable of self-administration. Quite simply, this Court believes that if an adult home feels that a resident is not capable of self-administering his or her medications, the adult home should either contest the physician's certification or not retain the resident.

Rule 18 NYCRR § 487.7(f)(3) provides that a resident needing assistance with [*5]self-administration is one who needs assistance with one or more of the tasks listed in 478.7(f)(2), and Rule 18 NYCRR § 487.7(f)(4) specifically provides that an adult care facility may provide assistance with one or more of the seven activities listed in 478.7(f)(2). Assistance with self-administration shall include assistance with any activity the resident would ordinarily be capable of carrying out under 18 NYCRR § 487.7(f)(2) (see, 18 NYCRR § 487.7(f)(4)). Plaintiffs' contention that an adult home may on occasion provide medication assistance to a resident, when the resident is incapable of performing one of the tasks under 478.7(f)(2), without violating the Nurse Practice Act or the Medicaid Act—while at the same time contending that providing such assistance on a regular basis for a resident who would ordinarily be capable of performing the task or tasks does violate those same acts—defies both logic and common sense. An adult home may not assist with tasks that are typically performed by licensed professionals, such as administering injectable medications, applying sterile dressings, or determining when to administer a medication prescribed to be taken "as needed".

The Nurse Practice Act (Education Law § 6902(1)) provides that "executing medical regimens prescribed by a licensed physician, dentist or other licensed health care provider" is part of the practice of nursing. Certainly a part of a nurse's duties would include opening a medication container, reading the label, taking out the appropriate number of pills, and then storing the medication as directed on the label. However, these activities do not involve the exercise of any independent medical judgment. The Nurse Practice Act does not prohibit the provision of assistance with the self-administration of medication by family members or adult home staff. For this Court to interpret the Nurse Practice Act to include such a prohibition would burden the health care system with the unnecessary expense of providing nurses to perform such activities. Following a medication's instructions and measuring and storing the medication is no more complex than assisting a resident with managing his or her money—which the adult homes are capable of accomplishing. Based upon the very same logic—because the directed activities do not require a nurse to perform them, plaintiffs' claim that Defendant's regulations and its interpretation thereof violate the Medicaid Act must also fail. This Court holds and determines that the defendant's interpretation of the regulatory framework is reasonable and rational and not in excess of the defendant's authority (see, Matter of Elcor Health Services, Inc. v, Novello, 100 NY2d 273, 280 [2003]; Trump Equitable Corp. v. Gliedman, 62 NY2d 539 [1984]). Accordingly, this Court holds and determines that defendant's motion for an order granting summary judgment dismissing plaintiffs' first and second causes of action should be and the same is hereby granted, and the plaintiffs' first and second causes of action are hereby dismissed.

This Court holds and determines that plaintiffs' third and fourth causes of action should be and the same are hereby dismissed as "time barred" by the applicable four (4) month statute of limitations.

This Court further holds and determines that defendant's motion for an order granting summary judgment dismissing the plaintiffs' first and second causes of action should be and the same is hereby granted without costs, and the plaintiffs' first and second causes of action are hereby dismissed without costs.

This Court holds and determines that plaintiffs' cross-motion for an order granting partial summary judgment should be and the same is hereby denied without costs. [*6]

This memorandum shall constitute both the Decision and Judgment of the Court. All papers, including this Decision and Judgment, are being returned to the defendant's attorney. The signing of this Decision and Judgment shall not constitute entry or filing under CPLR § 2220. Legal counsel are not relieved from the applicable provisions of that section respecting filing, entry and notice of entry.

It is ADJUDGED that the complaint is dismissed.

Dated: Albany, New York

April 24, 2007

_____________________________________

DAN LAMONT, Acting J.S.C.

cc:

Jane Bello Burke, Esq.

Jeffrey J. Sherrin, Esq.

Jeffrey M. Dvorin, Esq.