PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Amendment of Parts 700, 717, 793 and 794 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 4010(4)
Subject:
Hospice Operational Rules.
Purpose:
To implement hospice expansion.
Substance of proposed rule (Full text is posted at the following State website:www.health.ny.gov):
This rule amends Sections 700.2 and Parts 717 and repeals and replaces Part 793 and 794 of Title 10 (Health) of NYCRR, the operational rules for hospices approved to provide services in New York State under Article 40 of the Public Health Law. The changes will make state regulations consistent with the federal conditions of participation/rules, which were revised and implemented on December 3, 2008, as well as consistent with Article 40 of Public Health Law.
Section 700.2(a)(27) (Definitions) is amended to increase the maximum bed capacity from 8 to 16 beds in a hospice residence.
Section 700.2(c)(55) (Definitions) is amended to define hospice patient as a person certified as being terminally ill, who, alone or in conjunction with designated family member(s), has voluntarily requested admission and been accepted into a hospice for which the Department has issued a certificate of approval; and clarifies that nothing provided herein shall be construed to require provision of services to a patient that are not covered by the patient’s payment source.
Section 700.2(c)(58) (Definitions) is amended to clarify that palliative and supportive care is provided to a hospice patient for the reduction and abatement of pain and other symptoms and stresses associated with terminal illness and dying. This terminology (palliative and supportive care) is used in the definition of hospice found in 700.2(a)(23).
Section 700.2(c)(60) (Definitions) is added to include the definition of palliative care, as defined in Public Health Law Section 4012-b, provided to a person with advanced, life limiting illness.
Section 717.2 (Construction standards) is amended to increase the maximum bed capacity from 8 to 16 beds in a free standing hospice residence.
Section 717.3 (Patient and service areas in hospice inpatient facilities and units) is amended to reduce maximum room capacity from four to two patients as required by new federal rules.
Section 717.4 (Functional areas in hospice residences) is amended to allow a hospice to operate a maximum of twenty five percent of total residence beds as dually certified beds at any given time.
Section 793.1 (Governing authority) is repealed and replaced with a new section, entitled Patient Rights, which sets forth patient rights for hospice patients and requires alleged violations of mistreatment, neglect or abuse to be investigated and reported to the State, if verified.
Section 793.2 (Contracts) is repealed and replaced with a new section, entitled Eligibility, Election, Admission and Discharge, which sets forth provisions for determining eligibility for and admitting persons into a hospice program as well as requirements for discharging a hospice patient.
Section 793.3 (Administration) is repealed and replaced with a new section, entitled Initial and Comprehensive Assessment, which requires hospices to complete initial and comprehensive assessments and reassessments within specified time periods and identifies the information required in such assessments.
Section 793.4 (Staff Services) is repealed and replaced with a new section, entitled Patient Plan of Care, Interdisciplinary Group and Coordination of Care, which defines the interdisciplinary group members responsible for management of hospice care, identifies the responsibilities of the group, and lists the information required in the hospice plan of care.
Section 793.5 (Personnel) is repealed and replaced with a new section, entitled Quality Assessment and Performance Improvement, which sets forth requirements for the hospice quality assessment and performance improvement program. Hospices will be required to track performance indicators and conduct performance improvement projects.
Section 793.6 (Patient referral, admission and discharge) is repealed and replaced with a new section, entitled Infection Control, which sets forth requirements for management of an infection control program including policies and procedures for preventing and managing persons exposed to blood-borne pathogens and appropriate training of staff.
Section 793.7 (Records and reports) is repealed and replaced with a new section, entitled Staff and Services, which identifies the types of personnel a hospice is expected to employ and their responsibilities. This section also clarifies employment options (direct or contract), qualifications and supervision requirements strengthening the onsite supervision home health aide requirement.
Section 793.8 is repealed.
Section 794.1 (Patient/family rights) is repealed and replaced with a new section, entitled Governing Authority, which lists the responsibilities of the governing authority. It also sets forth requirements for a patient complaint investigation process and emergency plan. This section also requires hospices to obtain and maintain a Health Commerce System account as a communication link with the Department of Health.
Section 794.2 (Patient/family plan of care) is repealed and replaced with a new section, entitled Contracts, which sets forth contract requirements between the hospice and individual, facility or agency providers delivering services on behalf of the hospice. This section also specifies requirements for management contracts and explains those responsibilities that may not be delegated by the governing body.
Section 794.3 (Medical records systems and charts) is repealed and replaced with a new section, entitled Personnel, which sets forth personnel requirements including health requirements, identification and reference checks, maintenance and content of personnel records, job descriptions and orientation, performance appraisal and inservice education.
Section 794.4 (Hospice inpatient and residence services) is repealed and replaced with a new section, entitled Clinical Record, which sets forth requirements for maintenance and content of clinical records. Record retention standards are also included in this section.
Section 794.5 (Short Term Inpatient Service) is added and sets forth structural and operational standards for the provision of short-term inpatient service by the hospice. Physical plant, staffing, quality of life and patient comfort measures are addressed. This section also sets forth operational requirement for management and coordination of care.
Section 794.6 (Hospice Residence Service) is added and sets forth requirements for hospice residences, for those situations when a hospice chooses to offer a hospice operated home to a hospice patient without a suitable home in which to receive services, and increases maximum bed capacity from 8 to 16 beds.
Section 794.7 (Leases) is added and sets forth information which must be included in a lease agreement between a hospice and an inpatient setting or hospice residence.
Section 794.8 (Hospice Care Provided to Residents of a Skilled Nursing Facility (SNF) or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID)) is added and identifies responsibilities of the hospice and the facility when a resident elects the hospice benefit. Services expected to be provided by the hospice and the facility are clarified, and development and implementation of collaborative plans of care and care coordination between the two entities is required.
Section 794.9 (Records and Reports) is added and identifies those records which must be maintained by the hospice, and the retention timeframes. This section also specifies reports which must be submitted to the Department of Health.
Text of proposed rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
Statutory Authority:
Section 4010(4) of the Public Health Law authorizes the adoption and amendment of regulations for hospice providers approved pursuant to PHL Article 40 (Hospices). Section 4002 of the Public Health Law was amended by adding a new subdivision 5 to read as follows: “Terminally ill” means an individual has a medical prognosis that the individual’s life expectancy is approximately one year or less if the illness runs its normal course.
Legislative Objective:
PHL Article 40 provides that hospice care may offer persons with terminal illness an appropriate palliative care alternative to curative treatments and protects such vulnerable individuals through the imposition of care delivery standards for providers. It is the legislative intent that hospice’s interdisciplinary program and innovative approach to home and inpatient services be available statewide.
The proposed regulations attempt to achieve these legislative objectives by expanding the definition of terminal illness to conform with the statutory language as well as allow individuals the opportunity to receive hospice care earlier in their terminal illness – providing care to those who need it and reducing the need for emergency room visits and hospital stays.
Needs and Benefits:
The proposed rule making was necessitated by changes in the federal conditions of participation/rules for hospice providers and recent Medicaid Redesign Initiatives. State rules have been revised and reordered to be consistent with federal rules thereby facilitating provider compliance and surveillance activities. The intent of these revisions is to improve care delivery processes and support performance improvement activity at the provider level. Additionally, amendments were a result of changes made in Chapter 441 of the Laws of 2011 and Medicaid Redesign efforts to expand hospice benefits. Individuals could benefit from receiving hospice services earlier in their terminal illness and having their symptoms managed on an on-going basis, thereby reducing the need for emergency room visits and hospital stays.
Costs:
Costs to Regulated Parties:
Nominal costs may be incurred by hospice providers if coordination, management and documentation of care has not been effectively implemented by the hospice; or if data-driven, outcome-based quality assessment and performance improvement activities have not been taking place. These nominal costs are associated with federal quality assessment and performance improvement program requirements and would have to be incurred regardless of the proposed regulatory changes. There are currently 45 hospices in New York State.
Costs to the Agency and to the State and Local Governments Including this Agency:
The change in hospice patient eligibility which allows individuals with a 12-month life expectancy to elect the hospice benefit, has been estimated to have a net aggregate increase in gross Medicaid expenditures of $1,704,658. The aggregate NY State and Local Government share of the increase in Medicaid expenditures is approximately $400,000 for State government, and another $400,000 for local governments in the aggregate. Pursuant to 42 CFR Section 447.205, the Department gave public notice in December 2011 to amend the NYS Medicaid Plan for hospice services to expand access to the hospice benefit. No additional costs are anticipated for the Agency or for State and Local Governments.
Local Government Mandates:
There are no local mandates in this rule. However, 6 counties operate hospice programs and will be required to meet these rules in the same manner as will private entities, as there is no exemption authority for publicly sponsored programs.
Paperwork:
Under the proposed rules, providers will now be required to report verified incidences of mistreatment or abuse to the Department of Health and or state/local bodies having jurisdiction, as required by federal rules. All other reporting requirements are consistent with existing regulations.
Duplication:
Proposed rules will be duplicative of, but consistent with, federal rules. There are no known conflicts with federal rules; consistency should facilitate provider compliance and improve effectiveness of surveillance processes.
Alternatives:
The Department could choose to retain existing standards in which case federal rules would supersede State rules where gaps or inconsistency exist. This option was rejected as it would be confusing to both providers and surveyors. Furthermore, conforming state requirements to the federal requirements will facilitate the enforcement of both.
Federal Standards:
Section 418 of 42 CFR sets forth the federal rules for hospices. The proposed State rules are consistent with federal rules, but do exceed federal rules as follows:
• The quality assessment and performance improvement section includes the requirement to have a quality committee to assure comprehensive representation and involvement in quality activities and to assure a broader quality oversight process at the provider level. This is a state requirement that is not included in the federal rules.
• Infection control includes standards for prevention and management of HIV and other bloodborne pathogen infections, consistent with existing standards for all provider types in NYS. The standards exceed federal rules by including the required program specifications.
• The responsibilities of the governing body are more clearly delineated in the proposed rules than in the federal rules, including implementation of a complaint investigation procedure and requiring that the governing body obtain a Health Commerce System account for communication with the Department.
• The proposed rule specifically states the requirements for contracts, including management contracts, to ensure hospice and provider accountability and governing body responsibilities. Such requirements are not stated in the federal rules.
• Health requirements for personnel are specific and consistent with other provider types in NYS to assure adequate patient care protection. Job descriptions, employee identification and personnel records are also required as appropriate business practices. These requirements are not stated in the federal rules.
Compliance Schedule:
As the amendments ensure conformance with federal standards that were already in effect as of December 3, 2008, and any state requirements exceeding federal rules are already in effect, regulated parties should already be in compliance, and should readily be able to comply as of the effective date of these regulations.
Regulatory Flexibility Analysis
Effect of Rule:
Local governments will not be affected by this rule except to the extent that they are providers of hospice services. There are 6 county-based hospice providers. The small businesses which will be affected are hospice providers which employ fewer than 100 persons. There are approximately 36 small business hospices in NYS.
Compliance Requirements:
Regulated parties are expected to be in immediate compliance as these rules are consistent with federal standards already in effect as of Dec. 3, 2008, and rules that exceed the federal rules are already in place for existing hospice providers in NYS. The proposed regulations will create a new state reporting requirement, consistent with federal rules, for reporting verified instances of patient mistreatment, abuse or neglect to the Department or to other state and local authorities. The reporting will be done through existing complaint reporting mechanisms. The proposed regulations also require the hospice to report to the Department data on quality indicators and patient outcomes, which will be the basis for performance improvement activities. This may require additional staff training and electronic data systems at the hospice. The Department implemented a hospice quality initiative intended to assist hospices with meeting this requirement. All other reporting requirements mentioned in the proposed regulations currently exist for the hospice providers.
The Department does not intend to publish a small business regulation guide in connection with this regulation. Although a number of hospices are small businesses, the impact is not expected to be substantial. Additional guidance will be posted on the web as needed after the regulation is promulgated.
Professional Services:
No additional professional staff are expected to be needed as a result of the regulations. Quality assessment and performance improvement requirements could be handled by existing staff with appropriate training, unless staff shortages already exist at the hospice.
Compliance Costs:
There are no capital costs associated with these proposed rules. Additional costs may be associated with maintaining and analyzing data and carrying out performance improvement activities. The costs for small businesses and county sponsored hospices should not be significantly different from the costs to other affected providers.
Economic and Technological Feasibility:
The Department has considered feasibility and believes the rules can be met with minimal economic and technological impact. Departmental resources have been identified to assist hospices with quality indicators and performance improvement. Other regulations should not affect the routine cost of doing business.
Minimizing Adverse Impact:
While the Department has considered the options of State Administrative Procedure Act (SAPA) Section 202-b(1) in developing this rule, flexibility does not exist for any particular entity since the new requirements are consistent with new federal rules already in effect.
Small Business and Local Government Participations:
The Hospice and Palliative Care Association of NYS, which represents the majority of the hospices statewide, were included during the development of the proposed rulemaking. The Department will meet the requirements of SAPA Section 202-b(6) in part by publishing a notice of proposed rulemaking in the State Register with a comment period.
Rural Area Flexibility Analysis
Types and Estimated Numbers of Rural Areas:
All counties in NYS have rural areas with the exception of 7 downstate counties. Counties with rural areas are served by 34 of the existing 47 hospices in NYS.
Reporting, Recordkeeping and Other Compliance Requirements; and Professional Services:
Regulated parties are expected to be in immediate compliance as these rules are consistent with federal standards already in effect as of Dec. 3, 2008, and rules that exceed the federal rules are already in place for existing hospice providers in NYS.
The proposed regulations will create a new state reporting requirement, consistent with federal rules, for reporting verified instances of patient mistreatment, abuse or neglect to the Department or other state and local authorities. The reporting will be done through existing complaint reporting mechanisms. The proposed regulations also require the hospice to report to the Department data on quality indicators and patient outcomes, which will be the basis for performance improvement activities. This may require additional staff training and electronic data systems at the hospice. The Department implemented a hospice quality initiative intended to assist hospices with meeting this requirement. All other reporting requirements mentioned in the proposed regulations currently exist for the hospice providers.
Additional quality indicator and outcome data will need to be maintained in support of the reporting of the quality indicators and patient outcomes. This can be accomplished by existing clinical and/or administrative staff with appropriate training. Professional personnel required of the hospice is unchanged from existing requirements.
Costs:
There are no capital costs associated with these rules; any such costs would result from new federal rules, regardless of whether amendments were made to state regulation. Additional training of staff in quality assessment and performance improvement may be required to be in compliance with the requirements of the new federal rules.
Minimizing Adverse Impact:
While the Department has considered the options in State Administrative Procedure Act (SAPA) Section 202-bb(2)(b), the proposed regulatory changes are consistent with new federal requirements. Therefore, Department authority to minimize impact is limited. Adverse impact is expected to be minimal.
Rural Area Impact:
The Department will meet the requirements of SAPA Section 202-bb(7) in part by publishing a notice of proposed rulemaking in the State Register with a comment period.
Job Impact Statement
A Job Impact Statement is not required pursuant to Section 201-a(2)(a) of the State Administrative Procedure Act. The proposed regulations are intended to be consistent with current federal rules and also expand the definition of “terminal illness” to allow expanded access to hospice services and improve patient care. It is apparent, from the nature and purpose of the proposed rule, that it will not have a substantial adverse impact on jobs or employment opportunities.
