Section 505.14(a)(1) is amended to align the “personal care services” definition with statutory requirements that such services be ordered by a qualified and independent practitioner, and not the individual’s attending physician.

Section 505.14(a)(3)(iii) is amended to fully align the scope of services with local social services departments (LDSSs) and Medicaid Managed Care Organizations (MMCOs) evaluation responsibilities. Both LDSSs and MMCOs must evaluate the cost effectiveness of the provision of services relative to other services and supports available to the individual. Services may not be provided if they are not cost-effective in comparison to other appropriate alternatives.

Sections 505.14(a)(3)(iv), (a)(9) and 505.28(b)(1), (b)(14), (c)(8) are added to update the scope and needs requirements for PCS and CDPAS. Consistent with statutory requirements, recipients would need to demonstrate a minimum need for assistance with activities of daily living (ADL) before such services may be authorized. Specifically, individuals with dementia or Alzheimer’s must need at least supervision with more than one ADL, and all others must need at least limited assistance with physical maneuvering with more than two ADLs.

Subparagraph 505.14(a)(5)(iii) is added to clarify and codify existing Department of Health policy that supervision and cueing may be provided as a means of assisting an individual to perform nutritional and environmental support functions or personal care functions, but are not a standalone personal care service, and may not be authorized, paid for or reimbursed, except if they are provided to assist with one of the enumerated functions in section 505.14(a)(5)(ii).

Sections 505.14(a)(7) and 505.28(b)(12) are added to define the term “Medicaid Managed Care Organization (MMCO).” The proposed regulations add express references to MMCOs, in addition to existing references to LDSSs. Except where the amendments would implement new requirements and procedures, the addition of MMCOs acts to codify existing policies and practices with respect to MMCOs and the provision of PCS and CDPAS, such as those based on Federal regulations, the Department of Health’s model contract requirements, and Department guidance. The term MMCO does not include an entity approved to operate a Program of All-inclusive Care for the Elderly (PACE) organization.

Section 505.14(a)(8) is added to provide a definition for “medical assistance” or “Medicaid” or “MA” to clarify that these terms as used throughout the regulation refer to the same program.

Section 505.28(b)(4) is amended to align the definition of “consumer directed personal assistant” with State law.

Section 505.28(b)(5) is added to provide a definition for “consumer directed personal assistance program” or “consumer directed program” or “the program” to clarify that these terms as used throughout the regulation refer to the same program.

Section 505.28(b)(15) amends the definition for “self-directing consumer” to include the capability of performing the consumer responsibilities outlined in section 505.28(g).

Section 505.14(b)(1) and the opening paragraph of section 505.28(d) provide an overview of the assessment process, which include an independent assessment, a medical examination and practitioner order, an evaluation of the need and cost-effectiveness of services, the development of the plan of care, and, when required, an additional independent medical review for high needs cases. The paragraph further provides for how portions of the process may be conducted through telehealth modalities.

Sections 505.14(b)(2)(i) and 505.28(d)(1) describe the independent assessment which is performed by an independent assessor as opposed to the LDSS or MMCO. The independent assessment contains most of the elements of the current social and nursing assessments. Other portions of the current social and nursing assessments have either become unnecessary or remain the responsibility of the LDSS or MMCO to perform. For example, the nursing assessment requirements to review the practitioner order and document the primary diagnosis code have become moot because, under the proposed regulation, the medical examination that leads to a practitioner order will occur after the independent assessment.

Sections 505.14(b)(2)(ii) and 505.28(d)(2) describe the independent medical examination and practitioner order. Most of the examination and practitioner order requirements remain the same, such as the licensure, documentation, and practitioner signature requirements. However, the medical professionals who perform the examination and sign the practitioner order must be employed by or contracted with an entity designated by the Department of Health. Consequently, the 30-day deadline for the order to be provided after the examination has been eliminated. Also, as required by statute, the medical professionals who perform the examination and sign the practitioner order must be independent, meaning that they must not have a prior established provider-patient relationship with the individual.

Sections 505.14(b)(2)(iii) and 505.28(d)(3) describe the LDSS or MMCO responsibilities related to the assessment process. The LDSS or MMCO remain responsible for significant portions of the current assessment process requirements, including a) the review of other available services and supports to determine cost-effectiveness, b) determining frequency of nursing supervision, c) determining the individual’s preferences and social and cultural considerations for the receipt of care; d) heightened documentation requirements for 24-hour cases, and e) the development of the plan of care. In addition, before developing a plan of care or authorizing services, the LDSS or MMCO must review the independent assessment and practitioner order by the independent assessor and independent medical professional. Also, prior to authorizing more than 12 hours of services per day on average, the LDSS or MMCO must refer the case to the independent review panel, for an additional independent medical review of the individual and plan of care, and must consider the recommendation of the independent review panel when finalizing the plan of care and in its decision to authorize such services.

Sections 505.14(b)(2)(iv) and 505.28(d)(4) are added to require the LDSS or MMCO to coordinate with the entity or entities providing independent assessment and practitioner services. These sections also describe the process for resolving mistakes and clinical disagreements in the assessment process, as well as sanctions for failure to cooperate and abuse of the resolution process.

Sections 505.14(b)(2)(v) and 505.28(d)(5) describe the revised independent medical review process. Under the revised process, an independent medical review must be obtained when the LDSS or MMCO proposes to authorize more than 12 hours of services per day on average. The review is performed by an independent panel of medical professionals, and coordinated by a lead physician. The lead physician cannot be the practitioner who was involved in the initial examination or practitioner order. The lead physician, or another member of the panel, may evaluate the individual, consult with other providers and individuals, and obtain other medical records that may be relevant to the panel’s recommendation. When the independent medical review is complete, the lead physician shall produce a report to the LDSS or MMCO providing the panel’s recommendation on whether the plan of care is reasonable and appropriate to maintain the individual’s health and safety in his or her home. The recommendation may not include a specific amount or change in amount of services.

Sections 505.14(b)(3)(i) and 505.28(g)(1) require the independent assessment and practitioner order processes to be completed at least annually and in sufficient time to allow LDSSs and MMCOs to, when needed, comply with all applicable federal and state time frames for notice and determination of services.

Sections 505.14(b)(3)(ii) and 505.28(g)(2) require that all determinations by the LDSS must be made with reasonable promptness, not to exceed seven business days after receipt of both the independent assessment and practitioner order, or the independent review panel recommendation if applicable, except as provided under the immediate need process.

Sections 505.14(b)(3)(iii) and 505.28(g)(3) provide that MMCOs must make a determination and provide notice to current enrollees within the timeframes provided in their contract with the Department of Health, or as otherwise required by Federal or state statute or regulation.

Sections 505.14(b)(4)(i), (ii) and 505.28(e)(1)(i), (ii) are added to provide that an individual’s eligibility for services must be established prior to authorization, and that authorization must occur prior to the provision of services.

Sections 505.14(b)(4)(iii) and 505.28(e)(1)(iii) are added to provide that the authorization and reauthorization of services must be based on and reflect the assessment process and any exceptions to that process applicable to reauthorizations.

Section 505.28(e)(1)(v) is added to prohibit the authorization of services provided through more than one fiscal intermediary per consumer.

Sections 505.14(b)(4)(vi) and 505.28(e)(4) are added to require the LDSS or MMCO to consider the recommendation of the independent review panel prior to authorizing more than 12 hours of services.

Sections 505.14(b)(4)(viii)(b) and 505.28(i)(4) are amended to provide the Department of Health greater flexibility in determining when the LDSS or MMCO must use Department-developed forms in providing notice of service authorization, reauthorization, increase, decrease, discontinuance or denial.

Sections 505.14(b)(4)(viii)(c)(1) and 505.28(i)(4)(iii) are added to require LDSSs or MMCOs to document in the notice and plan of care the factors and clinical rationale specific to the client that went into the medical necessity determination that PCS or CDPAS should be denied, reduced, or discontinued.

Sections 505.14(b)(4)(viii)(c)(2)(vi) and (3)(iv) and 505.28(i)(4)(i)(e) and (ii)(d) are amended to clarify and provide examples of technological developments that may obviate the need for PCS or CDPAS.

Sections 505.14(b)(4)(viii)(c)(2)(i) and 505.28(i)(4)(ii)(a) are amended to clarify that a denial may be made if the clients health and safety cannot be “reasonably” assured with the provision of personal care services or consumer directed personal assistance.

Sections 505.14(b)(4)(viii)(c)(2)(vii) and 505.14(b)(4)(viii)(c)(3)(v) are amended to clarify that a denial may be made or services may be reduced or discontinued on the basis of residence in a facility if the client is not seeking to transition into a less restrictive setting or whose health and safety cannot be reasonably assured in such setting.

Sections 505.14(b)(4)(viii)(c)(3)(i) and 505.28(i)(4)(iii)(a) are amended to provide that services may be reduced or discontinued in cases where voluntary informal supports that are acceptable to the client have become available to meet some or all of the client’s needs.

Sections 505.14(b)(4)(viii)(c)(2)(ix) and (b)(4)(viii)(c)(3)(vii) and 505.28(i)(4)(i)(g), (i)(4)(i)(h), (i)(4)(ii)(g), and (i)(4)(ii)(h) are added to provide additional examples for denying, reducing, or discontinuing services. Section 505.28(i) is also amended to remove the requirement to notify those receiving other home care services about CDPAS in alignment with State law.

Sections 505.14(b)(4)(xi), (b)(4)(xii), and (b)(4)(vii) and 505.28(f)(1)(i), (f)(2), and (e)(5) are amended to clarify and align the required reassessment procedures when reauthorizing services under the new assessment process. In particular, an independent assessment and practitioner order are not needed to reauthorize services provided that they occur annually, rather than every six months, to maintain authorization or for another enumerated reason.

Sections 505.14(b)(4)(xiii) and 505.28(f)(3) are added to provide that the LDSS or MMCO shall document any changes in an individual’s need for services in the plan of care, and consider and make any necessary authorization changes.

Sections 505.14(b)(6) and (7) and 505.28(l) align the immediate need process with the new assessment process. An individual must first provide to the LDSS a statement of need for personal care services from a physician with direct knowledge of the applicant’s condition and an attestation of immediate need, before the individual is considered to have an immediate need.

Sections 505.14(b)(8) and 505.28(m) are added to allow the Department of Health to permit the current assessment process to continue until such time as the independent assessment and practitioner services are established at capacity or if the Department has not contracted with or designated an entity to provide independent assessment and practitioner services.

Section 505.14(c) is amended to remove the requirement for LDSSs to maintain contracts for the provision of nursing services.

Section 505.14(f)(3)(vi) is amended to remove references to the nursing assessment and clarify that the LDSS and MMCO are responsible for determining nursing supervision frequency.

Section 505.14(g) is amended to remove from case management responsibilities related to the coordination and performance of the practitioner order and the social and nursing assessments, and align requirements with the new assessment process.

Section 505.28(h)(2) requires consumer designated representatives to make themselves available to ensure that they can carry out the consumer responsibilities, and must be present at scheduled assessments or visits for nonself-directing consumers.

Section 505.28(h)(3) prohibits consumers from working with more than one fiscal intermediary at a time.

Statutory Authority:

Social Services Law (“SSL”) § 363-a and Public Health Law (“PHL”) §§ 201(1)(v) and 206(1)(f) provide that the Department of Health (“Department”) is the single state agency responsible for supervising the administration of the State’s medical assistance (“Medicaid”) program and for adopting such regulations, not inconsistent with law, as may be necessary to implement and enforce the standards of the Medicaid program. SSL § 365-a(2) authorizes Medicaid coverage for specified medical care, services and supplies, together with such medical care, services and supplies as authorized in the regulations of the Department. Under SSL § 365-a(2)(e) and § 365-f, respectively, the Medicaid program includes personal care services (“PCS”) and consumer directed personal assistance services (“CDPAS”). Finally, under SSL § 364-j and PHL Article 44, the Department may contract with Medicaid Managed Care Organizations (“MMCOs”) to provide Medicaid services to enrollees, which the Department has done for PCS and CDPAS.

Legislative Objectives:

SSL § 365-a(2) authorizes Medicaid coverage for specified medical care, services and supplies, together with such medical care, services and supplies as authorized in the regulations of the Department. Under SSL § 365-a(2)(e) and § 365-f, respectively, the Medicaid program includes PCS and CDPAS. Based upon recommendations of the Medicaid Redesign Team II (“MRT II”), the 2020-21 budget (Chapter 56 of the Laws of 2020, Part MM) amended SSL § 365-a, § 365-f and PHL Article 44 to improve the provision of Medicaid funded PCS and CDPAS. As amended, these provisions link the eligibility criteria for CDPAP and PCS to the performance of activities of daily living (“ADLs”) so services are authorized for those that need them the most, require the establishment of an independent assessor to take over the performance of assessments and reassessments required for determining individuals’ needs for such services, require an independent practitioner’s order to access PCS, ensure that such services are furnished to the extent medically necessary to maintain a member’s health and safety in his or her home, require that the standards established for the provision, management or assessment of such services meet that standards set forth in Olmstead v. LC by Zimring, 527 US 581 (1999), and provide relief for members who need access to such services by modifying the frequency in which assessments and authorizations for services are conducted.

Needs and Benefits:

The Department has promulgated regulations governing PCS at 18 NYCRR § 505.14 and CDPAS at 18 NYCRR § 505.28. Amendments to these regulations are essential to implementing requirements of the State Fiscal Year 2020-21 Enacted Budget (Chapter 56 of the Laws of 2020, Part MM) and MRT II long term care reform proposals, which include instituting new eligibility requirements, establishing an independent assessor, reducing the frequency of assessment from semi-annual to annual, centralizing practitioner orders and establishing an independent clinical review for high need cases to ensure that recipients receive the care they need to remain safely in the community. These amendments will help ensure Medicaid beneficiaries receive PCS and CDPAS that are required to appropriately meet their clinical needs as determined by the updated assessment and authorization process and documented in the plan of care.

By centralizing many of the functions of the assessment process and making them independent of the LDSS or MMCO responsible for authorizing services, the changes will bring efficiencies and consistency to the approval of PCS and CDPAS, and promote clinically appropriate outcomes. In particular, the review of high needs cases by an independent panel of medical professionals will help ensure that plans of care are reasonable and appropriate to safely service individuals in the community. Accordingly, this proposal will better facilitate access to PCS and CDPAS for people with disabilities who with the provision of such services are capable of safely remaining in the community in accordance with the standards set forth in Olmstead v. L.C., 527 U.S. 581 (1999).

The proposed regulations will further align the PCS and CDPAS regulations, which share many of the same or similar requirements, but historically have diverged in their drafting. This alignment will help to clarify the requirements for these benefits, which should lead to greater consistency in the assessment, authorization, and provision of services.

Proposed amendments to modernize the language are also included. Over the last decade, with the transition to mandatory enrollment into MMCOs, the majority of medical assistance recipients now receive most of their benefits through MMCOs, including community based long term care services. Although regulations in 18 NYCRR Part 505 are currently cast as requirements on LDSSs, contracts between the Department and MMCOs provide that services covered by MMCOs must comply with the terms of the New York State Medicaid Plan, established pursuant to SSL § 363-a, the Department’s regulations, and other applicable requirements. This contractual integration has meant that medical assistance service requirements, as outlined in 18 NYCRR Part 505 and throughout the Department’s regulations, generally apply to MMCOs even when MMCOs are not specifically referenced in the regulation.

By introducing references to MMCOs directly in 18 NYCRR §§ 505.14 and 505.28, the Department is dictating more directly how these regulatory provisions apply to MMCOs, and where there may be differences in application of the rules between LDSSs and MMCOs. However, nothing in these amendments necessitates a change in the nature of MMCOs’ contractual obligations under the model contracts. Requirements for the provision of covered services in 18 NYCRR Part 505 and throughout the Department’s regulations still apply to MMCOs through the model contracts, even when they are not specifically referenced.

The Department is also proposing to clarify and reinforce documentation requirements, to ensure that authorizations, and any proposed changes to such authorizations, are well documented and can be supported in the care plan and medical record. The Department also proposes to clarify and add appropriate reasons and notice language to be used when a LDSS or MMCO denies, reduces or discontinues PCS or CDPAS. Together, these proposed regulations should assist LDSSs and MMCOs, as well as Administrative Law Judges, evaluate the appropriateness of PCS and CDPAS authorizations and changes thereto. This proposal should increase consistency of authorizations as well as the outcomes of an appeal or fair hearing process.

Costs:

Costs to Private Regulated Parties:

These regulatory amendments governing PCS at 18 NYCRR § 505.14 and CDPAS at 18 NYCRR § 505.28 do not impose any additional costs to regulated parties. In fact, in centralizing the assessment and practitioners’ order process of authorizing PCS/CDPAS and reducing the assessment period to once a year absent any change in condition, the costs to private regulated parties is reduced. Furthermore, LDSS and MMCOs are already required to maintain and update plans of care and MMCOs are required to have an internal appeals process.

Costs to Local Government:

The proposed regulations require that social services districts refer Medicaid eligible individuals who may be eligible for long term care services and supports, including PCS and CDPAS, to the State’s contracted independent assessor to complete the long term care assessment tool and, if necessary, obtain a practitioner’s order for PCS or CDPAS. This relieves the LDSS from having to conduct initial and periodic reassessments and obtain a practitioners’ order from the potential recipients’ treating physician or other clinician. The proposed regulations do not impose any costs on local government.

Costs to the Department of Health:

The proposed regulations may result in minimal additional costs to the Department, which will be managed within existing resources.

Costs to Other State Agencies:

The proposed regulations will not result in any costs to other state agencies.

Local Government Mandates:

The proposed regulations do not impose any new programs, services, duties or responsibilities upon any county, city, town, village, school district, fire district or other special district.

Paperwork:

The proposed regulatory amendments include clarifying changes to existing forms, but regulated parties are familiar with and already use such forms. The amendments do not impose any new forms, paperwork or reporting requirements.

Duplication:

These regulatory amendments do not duplicate existing State or Federal requirements.

Alternatives:

Based on public comments received, many alternatives have been considered by the Department. A few of those follow, and the complete list of alternatives considered is included in the Assessment of Public Comment, which is located on the Department’s website.

The Department reviewed and rejected several proposed alternatives that would fail to implement the requirements of Chapter 56 of the Laws of 2020, Part MM, which establishes new minimum needs criteria for PCS and CDPAP and requires assessments to be performed by an independent assessor using an evidenced-based, validated assessment tool. Such suggestions included removal or modification to the minimum needs criteria and the maintenance of the assessment role with LDSS or MMCOs.

Many commenters suggested in various ways that the care planning process should reflect or include consumer preference. The Department agreed with these comments generally, and revised the LDSS and MMCO responsibilities to provide that consumer preferences must continue to be considered when developing the plan of care. However, the Department declined to duplicate the provisions of the federal regulations, as doing so is unnecessary because such requirements apply in their own right and because doing so may lead to unnecessary conflict and additional State administrative burden if and when federal requirements change.

The Department also considered and adopted suggestions to incorporate more specific procedures for coordination between the IA and the LDSS or MMCOs. The comments received on this point were many and varied. Some commenters were concerned that too much influence from LDSS or MMCOs would compromise the IA process, while others were concerned that a lack of feedback from the LDSS or MMCO could result in plans of care being developed that do not reflect the individual’s needs. The Department believes that there was validity to both of these concerns, and strived to balance them in the revised regulations. The addition of set procedures for coordination and sanction provisions for abuse of these procedures reflects the best balance for addressing these concerns in the Department’s view.

Another area of focus from commenters were the timeframes for the revised assessments and care planning processes. Comments were made about each step of the process, from the IA to the IRP. Some suggested that each step have its own specific timeframe, while others suggested that particular steps be waived in order to make timely service determinations. The Department has instead opted to require that the IA and Practitioner Order occur within sufficient time to allow the LDSS or MMCO to meet federal or State decision and notice timeframes. In addition, the Department has provided an exception to the prohibition on authorizing services for high needs cases prior to the IRP review and recommendation, to allow LDSS or MMCOs to meet federal and State timeframes, such as those for immediate need by providing a provisional authorization pending completion of the IRP report and final review by the LDSS or MMCO.

Federal Standards:

The proposed regulations do not duplicate or conflict with any Federal regulations.

Compliance Schedule:

The regulations will become effective on the 60th day following publication of a Notice of Adoption in the New York State Register.

Changes made to the last published rule do not necessitate revision to the previously published Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2024, which is no later than the 3rd year after the year in which this rule is being adopted.

A Notice of Proposed Rule Making was initially published in the State Register on July 15, 2020. A Notice of Revised Proposed Rule Making was later published in the State Register on January 27, 2021. During the public comment period for the Notice of Revised Proposed Rule Making, the Department of Health (the “Department”) received comments from consumers of and individual advocates for personal care services (“PCS”) or consumer directed personal assistance services (“CDPAS”); the Consumer Directed Personal Assistance Association of New York State; Center for Elder Law & Justice; Downstate New York ADAPT; Gurwin Certified Home Health Agency; the Home Care Association of New York State; LeadingAge New York; the Legal Aid Society; New York City Human Resources Administration; the New York Health Plan Association; New York Legal Assistance Group; New York State Association of Health Care Providers; New York State Bar Association; The Nurse Practitioner Association New York State; Onondaga County; Paraprofessional Healthcare Institute, Inc.; and Vesta Healthcare.

All comments received were reviewed and evaluated.

No substantive changes have been made to the regulations in light of the comments received. Other clarifications and technical, non-substantive changes have been made:

Section 505.14(a)(5)(iii) was amended to clarify that the language should not be construed as prohibiting the authorization of services for times between intermittent unpredictable tasks, such as may be needed and practical to ensure assistance with night-time toileting.

Sections 505.14(b)(2)(iv)(d)(1) and 505.28(d)(4)(iv)(a) are amended to clarify that LDSS and MMCOs are only required to notify the independent assessor when mistakes identified in the assessment are material such that they would affect the amount, type, or duration of services authorized. Amendments to these sections also clarify that the new assessment performed shall be performed in the same manner as new assessments performed as a result of a material disagreement.

Sections 505.14(b)(2)(iv)(d)(3) and 505.28(d)(4)(iv)(c) are amended to clarify that the requirements to schedule a new assessment as a result of a disagreement is only invoked when the disagreement is material.

Sections 505.14(b)(4)(viii)(c)(1) and 505.28(i)(4)(i) are amended to more clearly align with existing provisions at 505.14(b)(4)(viii)(a). The changes clarify that the requirement to identify and document factors that demonstrate when services are not medical necessity applies to denials and is not limited to reductions or discontinuances.

Sections 505.14(b)(4)(viii)(c)(2)(i), (c)(2)(vii), (c)(3)(i), (c)(3)(v) and 505.28(i)(4)(ii)(a) are amended to align and clarify existing provisions in light of Department guidance. See Guidelines for the Provision of Personal Care Services in Medicaid Managed Care, May 31, 2013, at p. 7 (denial appropriate if “health and safety cannot be reasonably assured”), available at https://www.health.ny.gov/health_care/medicaid/redesign/docs/final_personal_care_guidelines.pdf.

Sections 505.14(b)(4)(viii)(c)(3)(i) and 505.28(i)(4)(iii)(a) are amended to align the reduction reason language related to the identification of informal supports to clarify that such supports must be acceptable to the client, in line with existing requirements under 505.14(b)(2)(i)(b)(3)(v) and 505.28(d)(1)(ii)(c)(5).

Sections 505.14(b)(8) and 505.28(m) are amended to align with each other and to clarify that other subdivisions of such sections could be read as they were as of 1/1/21, such as those needed to reimburse LDSS for case management.

Section 505.28(i)(2) is amended to clarify that the language applies to MMCOs as well as LDSS.