Pursuant to the State Administrative Procedure Act Section 207 and 202-d, the Department of Health invites public comment on the continuation or modification of the following rules. Public comments will be accepted for 45 days from the date of publication in the State Register and should be submitted to Katherine Ceroalo, Bureau of House Counsel, Regulatory Affairs Unit, Corning Tower, Room 2438, Empire State Plaza, Albany, NY 12237 by email at [email protected].

Title 10 NYCRR - Three Year Review

Amendment of Section 2.59 of Title 10

(Prevention of Influenza Transmission by Healthcare and Residential Facility and Agency Personnel)

Statutory Authority:

Public Health Law sections 225, 2800, 2803, 3612 and 4010

Description of the regulation:

This regulation requires certain healthcare workers who are unvaccinated for influenza during the time when the Commissioner declares influenza to be prevalent to wear surgical or procedure masks. It also requires covered healthcare facilities and entities to report their personnel influenza vaccination rates.

The regulation should continue without modification.

Amendment of Section 12.3 of Title 10

(Administration of Vitamin K to Newborn Infants)

Statutory Authority:

Public Health Law section 225

Description of the regulation:

The amendment expanded the time window for the administration of vitamin K to newborn infants to within six hours of birth. This time frame is still consistent with the most recent 2012 American Academy of Pediatrics Policy Statement. Expanding the time frame for administration of vitamin K continues to promote and support early initiation and exclusive breastfeeding during the birth hospitalization. The regulation should continue without modification.

Repeal of Parts 39 & 40 and Addition of Part 40 of Title 10

(State Aid for Public Health Services: Counties and Cities)

Statutory Authority:

Public Health Law sections 201, 602, 603, 619, 2201, 2202, and 2276

Description of the regulation:

Title 10 NYCRR Subpart 39 “General Provisions Regarding the Payment of State Aid” was repealed in its entirety. To be consistent and in conjunction with amendments contained in the 2013-14 enacted State Budget which became effective on April 1, 2013, all of the relevant provisions of Part 39 were incorporated into the amended 10 NYCRR Subpart 40-1.

Title 10 NYCRR Subpart 40-1 “State Aid for Public Health Services: Counties and Cities” was repealed and replaced in its entirety to comply and maintain consistency with the Public Health Law Article 6 statute changes enacted as part of the 2013 New York State Budget. With the inclusion of the relevant provisions of the repealed 10 NYCRR Subpart 39, this Subpart describes the administrative processes involved in the State Aid Application and how the local health departments apply for and are reimbursed for State Aid.

Title 10 NYCRR Subpart 40-2 “Performance Standards for Basic Public Health Services and Minimum Requirements of Municipal Public Health Services Plans” was repealed and replaced in its entirety to comply and maintain consistency with Public Health Law Article 6 statute changes enacted as part of the 2013 New York State Budget. This Subpart was simplified and modernized. The Subpart describes the performance standards and requirements for core public health services provided by the local health departments to reflect current best practices and minimum program requirements for State Aid reimbursement. References to the Municipal Pubic Health Services Plan and the Fee and Revenue Plan were eliminated.

This regulation should continue without modification. It was developed jointly with considerable input from the New York State Association of County Officials and pertinent State programs to maintain consistency with the statute changes in Article 6 of the Public Health Law.

Amendment of Subpart 66-1 of Title 10

(School Immunization Requirements)

Statutory Authority:

Public Health Law sections 2164 and 2168

Description of the regulation:

Subpart 66-1 of Title 10 specifies dose- and grade-level school immunization requirements and Immunization Information System reporting requirements as authorized by Public Health Law Sections 2164 and 2168. The regulations were amended in 2014 to comply with current national immunization recommendations and medical and public health knowledge.

The regulations should be regularly updated to reflect changes in Advisory Committee on Immunization Practices (ACIP) recommendations and schedules. The ACIP meets three times a year to vote on updated immunization recommendations, and issues updated immunization schedules annually.

Amendment of Section 80.138 of Title 10

(Opioid Overdose Prevention Programs)

Statutory Authority:

Public Health Law section 3309

Description of the regulation:

Drug overdose is a serious public health concern and opioid-related overdose has increased as a health threat. A life-saving law took effect on April 1, 2006, making it legal in New York State for non-medical persons to administer Naloxone to another individual to prevent an opioid/heroin overdose from becoming fatal. All registered opioid overdose programs are furnished Naloxone by the NYSDOH. It is a prescription medicine that reverses an overdose by blocking heroin (or other opioids) in the brain for 30 to 90 minutes.

The regulation should continue without modification.

Amendment of Subpart 86-1 of Title 10

(Service Intensity Weights (SIWs) and Average Length-of-Stay (ALOS), Administrative Appeals and Out-of-State Providers)

Statutory Authority:

Public Health Law Section 2807-c(35)(c)

Description of the regulation:

Section 86-1.18: This regulation section requires modifications that are within the 7/1/2014 regulation package submitted for review and approval.

Section 86-1.32: The section of this regulation that was amended 7/9/14 remains the same, however, the regulation does require other modifications that are within the 7/1/2014 regulation package submitted for review and approval.

Section 86-1.33: This regulation section requires modifications that are within the 7/1/2014 regulation package submitted for review and approval.

The regulation requires modification.

Amendment of Section 86-1.16(c) of Subpart 86-1 of Title 10

(Reduction to Statewide Base Price)

Statutory Authority:

Public Health Law Section 2807-c(35)

Description of the regulation:

The section of this regulation that was amended 2/9/14 does not continue, however, the regulation does require other modifications that are within the 7/1/2014 regulation package submitted for review and approval.

The regulation requires modification.

Addition of Section 86-1.46 to Title 10

(Empire Clinical Research Investigator Program (ECRIP))

Statutory Authority:

Public Health Law Section 2807-m

Description of the regulation:

This regulation implemented a new statutory requirement relating to the Empire Clinical Research Investigator Program (ECRIP) under section 2807-m of the Public Health Law to: (1) maximize the impact of these funds; (2) make New York State teaching hospitals more competitive for large National Institutes of Health (NIH) center awards; and (3) stimulate collaboration within and among New York’s teaching institutions.

The regulation requires modification.

Addition of Section 86-1.47 to Title 10

(Hospital Indigent Care Pool Payment Methodology)

Statutory Authority:

Public Health Law Section 2807-k(5-d)

Description of the regulation:

Regulation 86-1.47 is effective for the period January 1, 2016 through December 31, 2018. Regulation 86-1.47 cites New York State’s statutory authority to administer the Disproportionate Share Hospital (DSH) Program and the methodology for calculating annual Indigent Care Pool payments to New York’s Article 28 hospitals. The DSH program reimburses hospitals that serve an unequal number of low-income Medicaid and uninsured patients with special needs. To be eligible for DSH, the Federal government requires an inpatient utilization rate for each hospital to be greater than 1%.

Because federal financial participation is available for aggregate ICP payments paid to the hospitals, the federal office of the Center for Medicare and Medicaid Services (CMS) requires an approved State Plan Amendment (SPA) that defines the methodology for calculating the rate of ICP distributions to New York State hospitals. Procedures for the State’s DSH process are then approved by CMS through the SPA.

Specific limits for the total DSH payments for both the State and the individual hospitals are contained in the legislation (Section 1923 of the Social Security Act and 42 USC 1396(r)). The statutory authority to make DSH payments pursuant to subdivision 5-d of section 2807-k of New York State’s Public Health Law are made in accordance with this section. For purposes within section 2807-k(5-d), each hospital’s relative uncompensated care need amount shall be determined in accordance with regulation 86-1.47.

The regulation requires modification. Regulation 86-1.47 is being updated to match State Plan Amendment 16-01 which is the Indigent Care Pool methodology extender.

Addition of New Section 86-2.40 to Subpart 86-2 of Title 10

(Statewide Pricing Methodology for Nursing Homes)

Statutory Authority:

Public Health Law Section 2808(2-c)

Description of the regulation:

This regulation sets for the pricing methodology as the basis for the reimbursement of operating costs for nursing homes. The regulation should continue without modification. However, beginning with 2018, this regulation will require modification.

Addition of Subpart 86-10 to Title 10

Rate Rationalization for Community Residences (CRs) / Individualized Residential Alternatives (IRAs) Habilitation and Day Habilitation

Statutory Authority:

Social Services Law, Section 363-a and Public Health Law Section 201(1)(v)

Description of the regulation:

Provides for updating the cost base of the rate calculation. This regulation requires modifications.

Addition of Subpart 86-11 to Title 10

Rate Rationalization for Intermediate Care Facilities for Persons with Developmental Disabilities (ICF/DDs)

Statutory Authority:

Social Services Law, Section 363-a and Public Health Law Section 201(1)(v)

Description of the regulation:

Provides for updating the cost base of the rate calculation. This regulation requires modifications.

Amendment of Section 400.18 of Title 10

(Statewide Planning and Research Cooperative System (SPARCS))

Statutory Authority:

Public Health Law section 2816

Description of the regulation:

This regulation governs the Statewide Planning and Research Cooperative System (SPARCS), the New York State Department of Health (NYSDOH) program that collects and maintains SPARCS data and discloses SPARCS and Patient Review Instrument (PRI) data. SPARCS data are inpatient and outpatient patient-level information collected from Article 28 hospitals, hospital extension clinics, and diagnostic and treatment centers. The regulation should continue without modification.

Amendment of Section 405.13, Repeal of Section 405.22 and Addition of new Sections 405.30 and 405.31 of Title 10

(Organ Transplant Provisions)

Statutory Authority:

Public Health Law Sections 2800 and 2803

Description of the regulation:

These amendments are still valid and current. They provide updated standards for transplant centers which are consistent with national requirements from the United Network for Organ Sharing (UNOS) and the Center for Medicare and Medicaid Services (CMS). No changes are necessary to this section.

Amendment of Part 425 of Title 10

(Adult Day Health Care Programs and Managed Long Term Care)

Statutory Authority:

Public Health Law Sections 201(1)(v) and 2803(2) and Social Services Law, Section 263-a

Description of the regulation:

10 NYCRR 425.1 through 425.23 sets forth regulatory requirements for ADHCPs related to non-residential, medically supervised services for individuals with physical or mental impairment.

ADHCP services include nursing, transportation, leisure activities, physical therapy, speech pathology, nutrition assessment, occupational therapy, medical social services, psychosocial assessment, rehabilitation and socialization, nursing evaluation and treatment, coordination of referrals for outpatient health, and dental services.

The regulation should continue without modification at this time. However, modification of 10 NYCRR 425.1 through 425.23 will be necessary in March 2019 to align with federal requirements of participation for Medicaid reimbursement.

The CMS final rule amended Medicaid regulations to provide home and community-based setting requirements related to section 2401 of the Affordable Care Act for section 1915(k) of the Act, the Community First Choice State plan option. This final rule included changes to the HCBS waiver provisions to convey expectations regarding person-centered plans of care, to provide characteristics of settings that are home and community-based as well as settings that may not be home and community-based. The final rule also included requirements for person-centered plans of care that document, among other things, an individual’s choice of a HCB setting from among options that meet the individual’s needs.

Addition of Part 1003 and Amendment of Subpart 98-1 of Title 10

(Accountable Care Organizations)

Statutory Authority:

Public Health Law Article 29-E and Section 4403(2)

Description of the regulation:

Part 1603 and Subpart 98-1 provides the regulatory framework for ACOs in New York. These regulations are still necessary to ensure compliance by ACO providers and to facilitate the approval of new ACO’s in New York. The regulation should continue without modification.

Title 18 NYCRR - Three Year Review

Repeal of Subparts 360-10, 360-11 and Sections 300.12 and 360-6.7 and Addition of a New Subpart 360-10 to Title 18

(Medicaid Managed Care Programs)

Statutory Authority:

Public Health Law Sections 201 and 206 & Social Services Law, Sections 363-a, 364-j, and 369-ee

Description of the regulation:

The regulation consolidates managed care regulations in one place and makes them consistent with the statutory Medicaid managed care program standards. It requires that Family Health Plus-eligible individuals receive health care services from a Medicaid managed care organization (MMCO), identifies the Medicaid populations required to enroll and those that are exempt or excluded from enrollment, defines good cause reasons for changing/disenrolling from an MMCO, or changing primary care providers, adds enrollee fair hearing rights, adds marketing/outreach and enrollment guidelines, and identifies unacceptable practices and the actions to be taken by the State when an MMCO commits an unacceptable practice.

Regulation changes to 360-10 will be required to bring into alignment with changes at 42 CFR 438.

Amendment of Section 505.5 of Title 18

(Expand Medicaid Coverage of Enteral Formula)

Statutory Authority:

Social Services Law, Sections 363-a and 365-a(2)(g) & Public Health Law Section 201(1)(v)

Description of the regulation:

This regulation expanded Medicaid coverage of enteral formula for individuals with HIV infection, AIDS or HIV-related illness or other diseases and conditions which can result in poor nutritional status.

The regulation should continue without modification.

Amendment of Section 505.31(h) of Title 18

(Hearing Aids)

Statutory Authority:

Social Services Law, Sections 363-a and 365-a(2) & Public Health Law Sections 201(1)(v) and 206

Description of the regulation:

This regulation improves administrative streamlining and billing efficiencies, and establish maximum reimbursable amounts (MRAs) based on an average cost of products representative of each type of hearing aid provided in the Medicaid Program.

The regulation should continue without modification.

Title 10 NYCRR - Five Year Review

Amendment of Part 40 of Title 10

(State Aid: Radioactive Materials and Radiation Producing Equipment; Individual Water and Sewage Systems; Calculation)

Statutory Authority:

Public Health Law sections 602 and 603

Description of the regulation:

The amendments clarified that, notwithstanding the repeal of State aid eligibility for certain optional general public health work (GPHW) programs, certain activities under the remaining “basic” GPHW programs remained eligible for State aid. Specifically, the regulations clarified that the following would remain eligible for State aid: technical assistance with maintenance and operation of individual water supplies and sewer systems; and for certain radioactive material licensing and inspection programs. The amendments also implemented technical and conforming edits.

The regulation should continue without modification.

Amendment of Part 63 of Title 10

(HIV/AIDS Testing, Reporting and Confidentiality of HIV Related Information)

Statutory Authority:

Public Health Law sections 2786 and 2139

Description of the regulation:

These regulations modified relevant sections of Title 10 NYCRR Part 63 (“HIV/AIDS Testing, Reporting and Confidentiality of HIV-Related Information”) to conform with Chapter 308 of the Laws of 2010.

The amendments included requiring HIV testing to be offered to persons of age 13 to 64; creating a standardized model for obtaining informed consent; requiring certain information be provided to patients concerning HIV testing; ensuring appropriate follow-up for patients who test positive for HIV; simplifying laboratory forms; and other provisions related to HIV testing and care.

The regulation was subsequently amended in 2017.

Amendment of Section 68.6 of Part 68 of Title 10

(Distributions from the Health Care Initiatives Pool for Poison Control Center Operations)

Statutory Authority:

Public Health Law Sections 2500-d, 2807-j and 2807-l, Section 40(e) of Part B of Chapter 109 of the Laws of 2010

Description of the regulation:

This regulation revised the methodology for distributing HCRA grant funding to Regional Poison Control Centers (RPCCs). Consolidation of PPC services into one upstate and one downstate RPCC rendered previous methodology obsolete.

The regulation should continue without modification.

Addition of Subdivision (c) to Section 86-1.16 of Subpart 86-1 of Title 10

(Reduction to Statewide Base Price)

Statutory Authority:

Public Health Law Section 2807-c(35)

Description of the regulation:

Reduces the Statewide Price by $24.2M for the inappropriate use of services. The section of this regulation that was added 2/22/12 does not continue, however, the regulation does require other modifications that are within the 7/1/2014 regulation package submitted for review and approval.

Amendment of Section 86-1.31 of Title 10

(Hospital Temporary Rate Adjustments)

Statutory Authority:

Public Health Law Section 2807-c(35)

Description of the regulation:

Provides for a temporary adjustment to the non-capital components of rates for eligible hospitals licensed under article 28 of the Public Health Law. This regulation needs to be modified. A regulation package is in process.

Addition of Section 86-1.41 to Subpart 86-1 of Title 10

(Hospital Quality Contribution)

Statutory Authority:

Public Health Law Section 2807-d-1

Description of the regulation:

The quality contribution is imposed on the inpatient revenue of each general hospital that is received for the provision of inpatient obstetrical care services, including services related to the care of newborns, but excluding neonatal intensive care services, as defined in PHL Section 2807-d(3)(a). The funds collected pursuant to this section shall be subject to and administered in accordance with the provisions of PHL Section 2807-d-1. The regulation should continue without modification.

Addition of New Section 86-1.42 to Subpart 86-1 of Title 10

(Potentially Preventable Negative Outcomes)

Statutory Authority:

Public Health Law Sections 2807-c(35)(b)(v)

Description of the regulation:

Provides for instances where payments will be denied for potentially preventable negative outcomes if they are acquired during a patient's inpatient stay at the hospital. The regulation should continue without modification.

Addition of Section 86-1.44 to Subpart 86-1 of Title 10

(Episodic Pricing for Certified Home Health Agencies)

Statutory Authority:

Public Health Law Section 3614.13

Description of the regulation:

This regulation changed the CHHA reimbursement to an episodic pricing system, paying per episode’ rather than a daily rate. The regulation should continue without modification.

Addition of New Section 86-2.39 to Subpart 86-2 of Title 10

(Temporary Rate Adjustment - Residential Health Care Facilities (Nursing Homes))

Statutory Authority:

Public Health Law Section 2808(2-c)(d)

Description of the regulation:

This regulation was put in place to recognize the changing environment in which nursing homes operate. Many closures, sales, and combinations of operations are occurring. The regulation should continue without modification.

Amendment of Subpart 86-8 of Title 10

(July 2011 Ambulatory Patient Groups (APGs) Payment Methodology)

Statutory Authority:

Section 2807(2-a)(e) of Public Health Law, Section 79(u) of Part C of Chapter 58 of Laws of 2008 and Section 129(1) of Part C of Chapter 58 of Laws of 2009

Description of the regulation:

To refine the APG payment methodology. The regulation should continue without modification.

Amendment of Subpart 86-8 of Title 10

(October 2011 Ambulatory Patient Groups (APGs) Payment Methodology)

Statutory Authority:

Section 2807(2-a)(e) of Public Health Law, Section 79(u) of Part C of Chapter 58 of Laws of 2008 and Section 129(1) of Part C of Chapter 58 of Laws of 2009

Description of the regulation:

To refine the APG payment methodology. The regulation should continue without modification.

Addition of New Section 86-8.15 to Subpart 86-8 of Title 10

(Temporary Rate Adjustment – Licensed Ambulatory Care Facilities)

Statutory Authority:

Public Health Law Section 2807(2-a)(e)

Description of the regulation:

Provides for a temporary adjustment to the non-capital components of rates for eligible ambulatory care facilities licensed under article 28 of the Public Health Law. The regulation should continue without modification.

Amendment of Section 98-1.11 of Title 10

(Managed Care Organizations)

Statutory Authority:

Public Health Law Section 4403(2)

Description of the regulation:

Section 98-1.11 provides the operational and financial requirements for MCO’s. This regulation is still necessary in order to ensure compliance with operational and financial statutes for Article 44 entities. The regulation should continue without modification.

Amendment of Section 401.2 of Part 401 of Title 10

(Amendment to Limitations of Operating Certificates)

Statutory Authority:

Public Health Law section 2803(2)(a)

Description of the regulation:

This regulation permits the Commissioner of the Department of Health to allow an operator of a facility licensed under Public Health Law Article 28 to operate at a site not designated on its operating certificate on a temporary basis due to an emergency.

The regulation should continue without modification.

Addition of New Part 403 to Title 10; Amendment of Sections 700.2, 763.13 and 766.11 of Title 10 and Amendment of Sections 505.14 and 505.23 of Title 18

(Home Care Services Worker Registry)

Statutory Authority:

Public Health Law section 3613

Description of the regulation:

The Department anticipates these regulations will require modifications pending legislation regarding advanced home health aides.

Amendment of Sections 405.1, 700.2, 720.1, and 755.2 of Title 10

(Accreditation of General Hospitals and Diagnostic and Treatment Centers)

Statutory Authority:

Public Health Law section 2803

Description of the regulation:

These provisions allow the Department to enter into collaborative agreements with accrediting agencies so that the agency’s accreditation survey may be used in lieu of a Departmental survey. This system has worked well and should be continued without modification.

The regulation should continue without modification.

Amendment of Section 405.19 of Part 405 of Title 10

(Observation Unit Operating Standards)

Statutory Authority:

Public Health Law section 2803

Description of the regulation:

These regulations concern the operation of observation beds in general hospitals. Subdivision (g) of this regulation was repealed (effective November 4, 2015) and a new section was added to Section 405.32 concerning observation services. These amendments reflect statutory changes to Article 28 (Chapters 5 and 397 of the Laws of 2013) and federal amendments to the conditions of participation, to alter how observation services are operated, including notice to consumers when they are assigned to observation services.

The regulation should continue without modification.

Title 18 NYCRR - Five Year Review

Amendment of Section 504.9 of Title 18

(Qualified Health Information Technology Entities)

Statutory Authority:

Public Health Law Sections 201 & 206 and Social Services Law, Section 363-a & 365-a(2)

Description of the regulation:

The regulation recognizes that Qualified Health Information Technology Entities, certified by the Department, may receive Medicaid claims information from the Department. The regulation allows Qualified Entities to make this information available to providers who, with the consent of their patients, can use the information to coordinate care, reduce costs and help increase the quality of care. All Qualified Entities that participate in the SHIN-NY go through a certification process to ensure they have the policies and procedures to process patient consent, manage identities and share information confidentially to ensure adherence to state and federal law.

The regulation should continue without modification.

Amendment of Sections 505.1, 505.5, 513.0, 513.1 and 513.6 of Title 18

(Medicaid Benefit Limits for Enteral Formula, Prescription Footwear, and Compression Stockings)

Statutory Authority:

Public Health Law Sections 201 and 206 & Social Services Law, Sections 363-a and 365-a(2)

Description of the regulation:

This regulation established Medicaid benefit limitations on coverage of enteral formula, prescription footwear, and compression stockings.

The regulation should continue without modification.

Title 10 NYCRR - Ten Year Review

Amendment of Sections 2.1(a) and 2.5 - Communicable Disease-Neonatal Herpes Infection Reporting and Laboratory Specimen Submission

Statutory Authority:

Public Health Law Sections 225(4) and 225(5)(a), (g), (h), and (i)

Description of the regulation:

Neonatal herpes, defined as herpes infection in infants aged 60 days or less, is a serious disease associated with neurological devastation of the infant and neonatal death. Neonatal herpes can result from infection with either herpes simplex virus (HSV) type 1 (HSV-1) or HSV type 2 (HSV-2). The disease can be localized to skin, eye and mouth (SEM disease), involve the central nervous system (CNS), or manifest as disseminated infection involving multiple organs. Most infants with CNS or disseminated disease have neurological sequelae, and the mortality rate in the absence of therapy is very high (80%) for these babies. Consequently, the Department believes it is essential to continue the reporting and laboratory submissions for testing for neonatal herpes.

The regulation should continue without modification.

Amendment of Subpart 6-1 - Swimming Pools

Statutory Authority:

Public Health Law Sections 225(5)(a) and 201(l) and (m)

Description of the regulation:

The amendments to the regulation (1) modified instructional swimming requirements; and (2) corrected an inconsistency between the requirements for supervision level IV use rules and the written statement/brochure requirements.

The regulation should continue without modification.

Addition of new Subpart 6-3 - Recreational Aquatic Spray Grounds

Statutory Authority:

Public Health Law Sections 225(5)(a) and 201(l) and (m)

Description of the regulation:

Prior to the adoption of Subpart 6-3, Recreational Aquatic Spray Grounds (Spray Grounds) were not regulated by the Department of Health. During the summer of 2005, approximately 3,000 patrons of the Seneca Lake State Park Spray Ground became ill with cryptosporidiosis as a result of exposure to the Spray Ground water. Spray Grounds, which collect and recirculate sprayed water, pose a significant risk of illness to the patrons. To prevent a similar illness outbreak at Spray Grounds, design and operation regulations are necessary.

The regulation should continue without modification.

Amendment of Section 52-1.1(r) and (aa)(2) and addition of new Subpart 52-11 to Part 52 of Title 10 - Minimum Technical Requirements for Nontransplant Anatomic Banks

Statutory Authority:

Public Health Law Article 43-B

Description of the regulation:

Nontransplant anatomic banks are licensed as tissue banks under 10 NYCRR Part 52. The amendments established technical standards for the operation of nontransplant anatomic banks, including whole body acquisition services and whole body users. These requirements have helped ensure that nontransplant anatomic parts recovered, processed, and used in New York State are obtained with documented informed consent, and handled respectfully and safely. The Department’s efforts must be maintained through continuation of Part 52.

The regulation should continue, but should be updated in the future as technology and practice standards change.

Amendment of Subpart 58-2 of Title 10 - Blood Banks

Statutory Authority:

Public Health Law Section 3121(5)

Description of the regulation:

This regulation amended provisions of Subpart 58-2 to reflect accepted nomenclature and advances in technology, update practice standards, eliminate obsolete requirements, clarify language, increase compliance flexibility, and permit blood donation by 16 year-olds, with parental permission.

The regulation should continue, but should be updated in the future as technology and practice standards change. It should be noted that this regulation has been updated, effective September 27, 2015.

Amendment of Sections 69-1.2 and 69-1.3 of Title 10 - Newborn Screening Panel-Krabbe Disease

Statutory Authority:

Public Health Law Sections 2500-a and 2500-f

Description of the regulation:

New York State Public Health Law Section 2500-a authorizes the Commissioner of Health to designate additional diseases or conditions for inclusion in the Newborn Screening Program test panel by regulation. The regulatory amendment added one condition-galactosylceramidase deficiency or Krabbe disease, a lipid disorder- to New York State's newborn screening test panel. Continued inclusion of this disorder to the list facilitates early identification and treatment.

The regulation should continue. Addition of other diseases or conditions may be required in the future and blood spot collection times and practices may be updated accordingly.

Addition of new 10 NYCRR Section 80.138 to Title 10 - Opioid Overdose Prevention Programs

Statutory Authority:

Public Health Law Section 3309(1)

Description of the regulation:

This regulation articulates the Commissioner’s standards for approval of opioid overdose prevention programs and include, but are not limited to, standards for program directors, appropriate clinical oversight, training, record keeping and reporting.

The need for standards continues; however, modification of the regulation is required with respect to language defining "person" in 10 NYCRR 80.138(a)(6), the responsibilities of the program director in 10 NYCRR 80.138(c)(1) and the supplies which must be maintained and provided by opioid overdose prevention programs in 10 NYCRR 80.138(c)(5).

The regulation should otherwise continue without modification.

Repeal 87.22 of Part 87 and add a new Sec. 400.24 to Part 400 of Title 10 - Increase DOH Fees for the Operational Period

Statutory Authority:

Public Health Law Sections 2868 and 2881; and Public Authorities Law Section 2976-a(3)

Description of the regulation:

Regarding the financing of hospital projects approved by the Commissioner for which reimbursement is provided pursuant to Article 28 of the Public Health Law, the regulation addresses the charge for the operational period of such financing which shall be from the occupancy date to the mortgage discharge at an annual charge of three-tenths of one percent of the mortgage loan, for inspection, regulation, supervision and audit. This is payable monthly to the State Department of Health by the mortgagor. Adjustments of charges for the operational period shall be made by adjusting future operational period payments.

The regulation should continue without modification.

Amendments to Part 96 of Title 10 - Licensure and Practice of Nursing Home Administration

Statutory authority:

Public Health Law Article 28-D and Section 2896-b.

Description of the regulation:

These regulations set forth the standards for licensure and practice of nursing home administration in New York State. They are necessary to protect public health and safety of residents.

The regulation should continue without modification.

Amendment of Section 400.18 of Title 10 - SPARCS Reporting Requirements for Ambulatory Surgery

Statutory Authority:

Public Health Law Section 2816

Description of the regulation:

Section 400.18 defined the reporting requirement for ambulatory surgery. It contained language to include the collection of data from free standing ambulatory surgeries. Ambulatory surgery services were defined by a range of Current Procedural Terminology (CPT) codes.

This regulation is being reviewed and revisions are expected.

Amendment of 405.9 and 405.19 of Part 405 and addition of a new Part 722 to Title 10 - Standards for Hospital-based Sexual Assault Forensic Examiners (SAFE) Programs

Statutory Authority:

Public Health Law Section 2805-i

Description of the regulation:

Sexual assault is an important public health issue. The regulations related to the Sexual Assault Forensic Examiners (SAFE) program set forth standards for hospitals and practitioners regarding capacity and expertise needed to ensure that victims of sexual assault are provided with competent, compassionate and prompt care.

Specifically, the regulation addressed requirements for hospitals related to provision of treatment for alleged victims of sexual offense, including collection and maintenance of sexual offense evidence, provision of support services for victims. The regulations authorized the Department of Health to designate hospitals as sites for 24-hour SAFE programs including use of qualified SAFE examiners.

These regulations are being reviewed and revisions to simplify and streamline regulations for this program are expected.

Amendment of Parts 700, 717, 790, 791 and 794 of Title 10 - Hospice Residence Dually Certified Beds

Statutory Authority:

Public Health Law Section 4004(4); Public Health Law Section 4010(4)

Description of the regulation:

Regulations addressed the approval, construction and operation of hospice residences, providing hospice access to individuals who may otherwise be denied such services due to the lack of an appropriate caregiver and/or suitable home environment. The dual certification of hospice residence beds for hospice inpatient level of care, as needed, allows for up to two patients residing in a hospice residence at any given time to receive the higher inpatient level of care, as necessitated by changes in their condition, without the need to transfer the patient out of the hospice residence into an alternate hospice inpatient bed setting.

The regulations should continue without modification.

Title 18 NYCRR - Ten Year Review

Repeal subdivision (j) of Section 360-3.2 and add a new subdivision (j) to Section 360-3.2 to Title 18 - Citizenship and Immigration Status - Conditions of Eligibility

Statutory Authority:

Social Services Law Section 363-a(2)

Description of the regulation:

The amendments revised the Department's regulations governing the Medicaid eligibility of aliens to be consistent with the Court of Appeals decision in Aliessa v. Novello. Under that decision, social services districts cannot deny Medicaid to otherwise eligible lawfully residing aliens, including qualified aliens and aliens who are permanently residing in the U.S. under color of law.

The regulations should continue without modification.

Title 10 NYCRR - Fifteen Year Review

Addition of new Subpart 7-5 Agricultural Fairgrounds

Statutory Authority:

Public Health Law Sections 225(5)(a), 201(l) and (m)

Description of the regulation:

Prior to the addition of Subpart 7-5, Agricultural Fairgrounds were not regulated. In August of 1999, an outbreak of gastrointestinal illness was associated with an agricultural fairground's on-site water supply resulting in two deaths and illness in more than 1,100 fair attendees. Regulations were adopted in 2002, and in 2006 were amended through the consensus regulation process to incorporate the Subpart 7-3 campground regulations into the Agricultural Fairground regulations and to modify the campsite size requirements.

The regulations should continue without modification.

Amendment of Subdivision 86-2.10(k) - Change in Ownership of Nursing Facilities – Medicaid Rates

Statutory Authority:

Public Health Law Sections 2803(2), 2807(3) and 2808

Description of the regulation:

The regulations allowed for the recalculation of nursing facility Medicaid reimbursement rates to be based upon an updated cost report once every ten years when transfers of ownership between a parent and a child occur.

The regulation is no longer relevant and the Department will consider its repeal.

Amendment of Subpart 86-6 - Hospice Residence Reimbursement

Statutory Authority:

Public Health Law Sections 4010(4) and 4012-a(4)

Chapter 532 of the Laws of 1995; Chapter 642 of the Laws of 1999;

Chapter 496 of the Laws of 2000

Description of the regulation:

Established a rate of payment for room and board services provided by hospice residences to Medicaid-eligible patients electing hospice care and residing in the hospice residence. The hospice residence will receive, in addition to the room and board rate, payment of the routine hospice rate for all other services provided.

The regulation should continue without modification.

Amendment of Sections 86-4.10, 405.3, 415.26, 444.23, 700.2, 751.6, 754.1, 754.2, 754.6 and 763.13 - Regulations Affecting Midwives

Statutory Authority:

Public Health Law Sections 2803(2)(a)(i) and (v), 2803-b(1), and 3612(5) and reflect practice provisions in Article 140 of the Education Law, amended by Chapter 327 of the Laws of 1992

Description of the regulation:

This regulation amended several provisions of Title 10 NYCRR to be consistent with Education Law Article 140, which defined and established licensure and practice standards for the practice of midwifery.

The regulation should continue without modification.

Amendment of Parts 700, 717, 790, 791, 793 and 794 of Title 10

Statutory Authority:

Public Health Law Section 4010(4)

Description of the regulation:

These regulations authorized the approval, construction and operation of hospice residences. The hospice residence program provides hospice access to individuals who may otherwise be denied such services due to the lack of an appropriate caregiver and/or safe environment. These patients are often transferred to more costly inpatient settings, such as hospitals or nursing homes.

This regulation should continue without modification.

Title 18 NYCRR - Fifteen Year Review

Amendment of Sections 360-4.3 and 360-4.6 - Allocation Provisions used in Medicaid Eligibility

Statutory Authority:

Social Services Law Section 366

Description of the regulation:

The regulatory amendment to 360-4.3 defined income to be used in determining Medicaid eligibility. The regulatory amendment to 360-4.6 defined the types and amounts of income and resources to be disregarded to determine the applicant's/recipient's net available income and resources. The regulatory amendment to 360-4.3 and 360-4.6 clarified that in determining the amount of income to be deemed available to an SSI-related applicant/recipient from his or her legally responsible relative, income of the legally responsible relative is first allocated to meet the needs of certain non-SSI-related relatives residing in the household.

The regulation should continue without modification.

Amendment of Parts 485, 486, 487, 488 and 490 - Adult Care Facilities

Statutory Authority:

Social Services Law Section 461-m

Description of the regulation:

The regulations required that the operator of an adult care facility (i.e., adult home, enriched housing program, and residence for adults) report all deaths to the Department within twenty-four hours of occurrence; and report to the State Commission on Quality of Care for the Mentally Disabled these deaths if they involved a resident who had at any time received services from a mental hygiene service provider.

This regulation was amended in 2016 and should continue without modification.

Amendment of Part 505 - OASAS Consolidation and Detoxification/Chemical Dependency

Statutory Authority:

Mental Hygiene Law Section 19.07

Description of the regulation:

The regulation addressed Medicaid billing methodology for drug and alcohol services. However, on July 1, 2011, OASAS began implementation of the Ambulatory Patient Group (APG) billing methodology for services provided in chemical dependence outpatient clinics and opioid treatment clinics. Accordingly, 505.27 will need to be revised to reflect this new billing methodology.

This regulation will be revised.

Amendment of Section 505.7 - Medicaid Payment for Laboratory Services

Statutory Authority:

Social Services Law Section 365 a(2)

Description of the regulation:

This regulation allowed practitioners ordering/initiating services for Medicaid recipients to designate to personnel/staff the authority to complete laboratory test form(s). The regulations allowed acceptance of electronic laboratory test ordering or signatures from authorized practitioners. Additionally, this amendment allowed Medicaid to accept “standing orders” for laboratory tests, for certain specific medical conditions, that are initiated by authorized practitioners.

This regulation should continue without modification.

Amendment of Section 515.9 and addition of new Part 520 – Monetary Penalties and Tax Intercepts to Determine Medicaid Fraud

Statutory Authority:

Public Health Law Section 206(17); Tax Law Section 171-f

Description of the regulation:

18 NYCRR Part 520 and Section 515.9 effectuated the statutory provisions that provide for an interception of a Medicaid provider’s State refund to repay identified Medicaid overpayments.

Part 520 of Title 18 provided for the administrative mechanism allowing the New York Medicaid program, and local Social Services districts in appropriate circumstances, to obtain State tax refunds belonging to current or former medical assistance providers as a recovery of identified Medicaid overpayments. The mechanism provided for access to the State tax refunds only in cases were the determination of liability for the Medicaid overpayments has been finally adjudicated through administrative and/or judicial review or where the time to contest the determination has passed. This regulation provided a simplified tool for the State to offset tax refunds against monies due the State while providing for significant administrative safeguards for the affected provider. The Section 515.9 amendment merely added the new Part 520 as an available mechanism for Medicaid overpayment recovery under Part 515.

This regulation should continue without modification.

Title 10 NYCRR - Twenty Year Review

Amendment to Part 53 of Title 10 (NYS Drinking Water State Revolving Fund (DWSRF))

Statutory Authority:

Public Health Law Sections 1161 and 1160

Description of the regulation:

This regulation provides rules and procedures for the Department of Health to provide financial assistance to public water systems from the New York State Drinking Water State Revolving Fund (DWSRF). In order to obtain federal participation in the fund, the State must provide assurances to the Environmental Protection Agency that it has the authority to establish and operate the DWSRF program in accordance with the provisions of the federal Safe Drinking Water Act.

The regulation should continue without modification.

Amendment to Part 54 of Title 10 (Requirements for Self-defense Spray Devices)

Statutory Authority:

Penal Law Section 265.20(a)

Description of the regulation:

Chapter 354 of the Laws of 1996 amended the Penal Law to allow, with certain restrictions, the purchase, possession and use of self-defense spray devices. The amendments required the Department of Health, with the cooperation of the Division of Criminal Justice Services and the Superintendent of State Police, to develop standards and promulgate regulations regarding the type of self-defense spray device which may lawfully be purchased, possessed or used. This rule establishes requirements that pertain to the active ingredient in self-defense spray devices, the concentration of the active ingredient and the size of the device. This rule also requires that self-defense spray devices have safety features designed to prevent accidental releases, that the devices be sold in sealed, tamper-proof packages, and that the devices not be camouflaged. A specific warning label and a specific package insert also are required. In the absence of this rule there would be no requirements or restrictions with respect to active ingredients, concentrations of those ingredients, size, safety features, appearance and warning labels for self-defense spray devices in New York State. This rule is necessary to protect public health by minimizing the health risks from exposure to the substances contained in self defense spray devices.

The regulation should continue without modification.

Amendment to Subpart 69-1 and addition of Subpart 69-6 of Title 10 (Comprehensive HIV Newborn Screening Program)

Statutory Authority:

Chapter 220 of the Laws of 1996 and Public Health Law Section 2500-f

Description of the regulation:

In the memorandum accompanying the bill (A.4413-c, S-7725), the Legislature indicated its purpose “to ensure that newborns who are born exposed to HIV receive prompt and immediate care and treatment that can enhance, prolong and possibly save their lives.” The amendments to 10 NYCRR Part 69 help to accomplish that purpose by adding HIV infection to the list of conditions included in New York’s newborn screening program. This measure placed the comprehensive newborn HIV testing program within the framework of a longstanding and successful public health initiative, the newborn screening program, which is a model for the nation. The newborn HIV testing program ensures communication of newborn HIV test results to all women giving birth in New York State hospitals and birthing centers. Therefore, mothers of newborns testing positive for HIV antibodies are able to make informed decisions regarding health care and social support for their infants and themselves. The newborn HIV testing program remains a “safety net” to identify HIV positive mothers and their newborns that have not been identified in prenatal, labor, delivery, or newborn nursery settings. These amendments also enable hospitals to report preliminary HIV test results on the newborn’s blood, or with consent, the mother’s blood to allow initiation of HIV therapy as early as possible.

The importance of the newborn screening program cannot be understated. From February 1997 and December 2005, approximately 7,300 HIV positive women have given birth in New York State. With information generated by the newborn HIV testing program, hospital and state staff have been able to follow HIV-exposed infants until they are connected to ongoing care.

The regulation should continue without modification.

Amendment to Subpart 69-4 of Title 10 (Early Intervention Program for Toddlers and Infants)

Statutory Authority:

Public Health Law, Article 25, Title II-A

Description of the regulation:

Subpart 69-4 sets forth the requirements upon all regulated parties, including Early Intervention Officials, primary referral sources, evaluators, service coordinators, service providers, and state agencies for implementation of the Early Intervention Program for Infants and Toddlers. Subpart 69-4 defines relevant terms and sets forth all program requirements and procedures, including: eligibility and child find requirements, qualifications for service coordinators, provider approval standards, responsibilities of initial service coordinators and evaluators, standards for the provision of services, service model options, requirements for individualized family service plans, standards for monitoring of providers, local early intervention coordinating council requirements, reporting requirements, procedural safeguards, respite services, transportation services, transition planning requirements, reimbursement of administrative costs, and third party payments.

The regulation requires modification.

Amendment to Section 69-4.30 of Title 10 (Early Intervention Reimbursement)

Statutory Authority:

Public Health Law Sections 2540, 2550 and 2559-b

Description of Regulation:

Based upon Chapter 428 of the Laws of 1992, the regulation established (17) regionally adjusted payment prices for early intervention services delivered to eligible children.

The regulation should continue without modification.

Addition of Subpart 69-7 (Medical Conditions Exempting Limits on Automobile Tinted Glass)

Statutory Authority:

Public Health Law Section 206(16)

Description of the regulation:

Prior to the regulation, any person who requested higher levels of window tinting was required to provide a general statement from a physician indicating that it was medically necessary. Law enforcement officers have been shot, injured or otherwise threatened by persons in vehicles with heavy window tinting. The tinted windows also conceal illegal behavior from law enforcement officers. Therefore, the law enforcement community requested that the regulation clarify the types of diseases that would require such heavy tinting to limit the number of vehicles on NYS highways with darkened windshields and reduce their risk of injury.

An addition to the regulation was promulgated in April 1997 to identify medical conditions that warrant higher tinted vehicle glass. DOH sought advice from experts, including the NYS Society of Dermatology and the NYS Ophthalmological Society. The Society of Dermatology identified the conditions in the revised regulation. These conditions are: porphyria, xeroderma pigmentosa, and severe drug photosensitivity.

The Ophthalmological Society stated that there were many ocular conditions that can change over time so that photosensitivity may be present as a symptom at some time during the illness/disease process, but not others. Ophthalmologists who the Society consulted were not able to identify chronic ocular conditions that would allow good enough vision to drive but nevertheless require heavy windshield tinting.

There are no costs associated with the regulation, nor are there any adverse impacts on small business, rural areas or the physician community. The NYS law enforcement community has cited benefits to their officers.

The regulation was amended in 2017 following a review of medical disorders and conditions that cause severe photosensitivity and were not addressed by the regulation. The regulation should continue without modification.

Amendment to Part 73 of Title 10 (Asbestos Safety Training Program Requirements)

Statutory Authority:

New York State Labor Law Section 905

Description of the regulation:

The regulation outlines administrative and technical requirements for all asbestos safety training courses and providers. NYSDOH approved training courses are required as a prerequisite to asbestos worker certification and licensure administered by the New York State Department of Labor.

The regulation should continue without modification at this time; however, it has been added to the Departments regulatory agenda to incorporate changes made by the New York State Department of Labor (12 NYCRR Part 56), as well as changes that have occurred in the industry.

Amendment to Sections 86-1.85 and 86-1.87 of Title 10 (Disproportionate Share Payments)

Statutory Authority:

Public Health Law Sections 2807-c(16)(d) and (21) as amended by section 35 of Chapter 731 of the Laws of 1993; and further amended by sections 37-39 of Chapter 81 of the Laws of 1995

Description of the regulation:

The rule implements the disproportionate share payment limitations that were enacted by The Omnibus Budget Reconciliation Act of 1993 (OBRA).

The regulation should continue without modification.

Amendment to Section 86-4.40 of Title 10 (Products of Ambulatory Surgery)

Statutory Authority:

Public Health Law Sections 2803(2) and 2807(2)(e)

Description of the regulation:

The rule (1) adds a new Products of Ambulatory Surgery (PAS) category for the surgical implant of a drug that treats CMV retinitis in patients with AIDS; and (2) corrects the name of an existing PAS category.

The Department no longer uses Products of Ambulatory Surgery for Medicaid payments. Ambulatory surgery is paid through Ambulatory Patient Groups (APGs).

This regulation can be discontinued.

Amendment to Section 405.3(b)(10) of Title 10 (Medical History and Physical Examination for Hospital Personnel)

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

Under the prior regulation, before assuming duties, all hospital personnel had to undergo a physical examination and recorded medical history sufficient in scope to ensure that he/she was free from a health impairment which was of potential risk to patients or which might interfere with the performance of his/her duties. The only exception was that volunteers in areas that did not expose them to patients (such as a gift shop) were exempt from such exam and medical history requirement. Under the amended regulation, any personnel, including volunteers, could be exempted if their activities are such that a health impairment would not pose a risk to patients or interfere with the performance of their duties (such as employees in the boiler room). Instead, all such exempted personnel are required to participate in a less rigorous and less costly "health status assessment".

The purpose of this regulation was to protect patients from potentially harmful consequences related to a health impairment of hospital personnel. As amended, the regulation continues to do this while relieving hospitals of the cost and workload of unnecessary physical examinations and recorded medical histories, thus allowing hospitals to reallocate these resources to other areas.

In the five years since adoption of this change, Department of Health hospital surveillance staff have not detected any negative impact on the quality or safety of hospital care and services. Nor has the Department received any complaints or objections from the public.

The regulation should continue without modification.

Amendments to Sections 405.19(d)(2)(ii), 405.19(d)(2)(iii) and 405.19(d)(3)(iii) of Part 405 of Title 10 NYCRR (ACLS and ATLS Training for Hospital Emergency Services Staff)

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

The prior regulation required that all physician assistants (PAs) and nurse practitioners (NPs) in a hospital's emergency service have training in Advanced Cardiac Life Support (ACLS) and Advanced Trauma Life Support (ATLS). As revised, the regulation requires that emergency rooms have ACLS and ATLS capability sufficient to meet patient needs but does not require that each and every PA and NP have such training. The prior requirement that, in some cases, could require hospitals to retain ACLS and ATLS capability in excess of patient needs was deemed unnecessary and potentially wasteful.

In the five years since adoption of this change, Department of Health hospital surveillance staff have not detected any negative impact on quality or safety of hospital care or services. Nor has the Department received any complaints or objections from the public.

The regulation should continue without modification.

These regulations were amended, effective, April 1, 2014 to require that training in Pediatric Advanced Life Support Training (PALS) also be included.

Amendments to Section 405.21 of Title 10 NYCRR (Footprinting of Newborns and Fingerprinting of Mothers)

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

This amendment repealed the requirement for footprinting of newborns and fingerprinting of mothers. Regulations continue to require that hospitals ensure the immediate and continuous identification of newborns throughout the hospitalization period. The change merely removes the requirement that such identification be done by footprinting newborns and fingerprinting mothers.

Experts in childbirth advised the Department that footprinting and fingerprinting often were carried out by staff untrained in these activities and that a worthless smudge sometimes resulted. By requiring positive identification of the newborn without prescribing the means of attaining this identification, the revised regulations focus on the desired outcome rather than the process, and give hospitals flexibility in determining how best to achieve that outcome.

Department hospital surveillance staff have not detected any negative impact on the quality or safety of hospital care and services. Nor has the Department received any complaints or objections from the public.

The regulation should continue without modification.

Amendment to Sections 405.21(c)(4) and 754.7(d)(5) of Title 10 (HIV Testing of Newborns)

Statutory Authority:

Public Health Law Sections 2803(2)(a)(v), 2500-f, 2781(6)(d)

Description of the regulation:

Chapter 220 of the Laws of 1996 amended the Public Health Law by adding a new section 2500-f, which requires the commissioner to promulgate regulations to establish and implement a comprehensive program for the testing of newborns for HIV and/or the presence of HIV antibodies. Chapter 220 also amended PHL Section 2781(6) by adding a new paragraph (d) that specifically excluded activities conducted pursuant to PHL section 2781.

To implement the commissioner’s newborn HIV testing plan, portions of regulations (10 NYCRR, 405.21(c)(4) and 754.7(d)(5)), which required hospitals and birthing centers to follow informed consent procedures, were repealed. The testing provisions of 10 NYCRR sections 405.21(c)(4) and 754.7(d)(5) were replaced by new amendments to 10 NYCRR Part 69, which reflect the statutory direction of PHL Section 2500-f.

Deletion of informed consent and counseling requirements to conform with section 2781.6(d) of the Public Health Law permitted flexible informed consent procedures to be carried out pursuant to amendments of Part 69.

In the memorandum accompanying the bill (A.4412-c, S-7725), the Legislature indicated its purpose “to ensure that newborns who are born exposed to HIV receive prompt and immediate care and treatment that can enhance, prolong and possibly save their lives.” Repeal of portions of 10 NYCRR section 405.21(c)(4) and section 754.7(d)(5) has facilitated communication of newborn test results to all women giving birth in New York State hospitals and birthing centers. With that knowledge, mothers of newborns testing positive for HIV antibodies are able to make informed decisions regarding health care and social support for their infants and themselves.

By allowing health care professionals to provide the newborns’ HIV test result directly to their mothers, this rule has allowed mothers to reduce the risk of HIV transmission that might occur through breastfeeding and has enabled them to seek appropriate care for their infants.

The regulation should continue without modification.

Amendment to Section 415.3(c)(2)(ii) of Title 10 (Nursing Home Residence Room Change)

Statutory Authority:

Public Health Law Section 2803(2)

Description of the regulation:

Both Federal and State regulations provide for notice to be given prior to a change in a resident's room. When the regulation was initially adopted in 1990, New York State allowed for a minimum of thirty days notice prior to a room change unless the resident agreed to an earlier change. The thirty days insured a waiting period prior to the move but required no additional action on the part of the facility to assist the resident. The amended regulation requiring facilities to make reasonable accommodation to a resident's needs and preferences was designed to eliminate the arbitrary 30 day waiting period and ensure that specific resident concerns are identified and addressed.

The regulatory changes mandated a process to be followed by the facility administration and staff for any change in a nursing home resident's room. The purpose of the mandated process is to ensure that a nursing home resident will receive prior notice of a room change, be provided with a meaningful opportunity to respond to the proposed room change, and have any concerns addressed and reasonably accommodated by the facility.

The concept of reasonable accommodation exists under the present regulations on both the State and Federal level. Under NYCRR 415.5(e) residents have the right to reasonable accommodation of needs and preferences. This would include taking into account the changing of a resident room and the timing of such a change.

Accompanying the regulation changes in 1997 were a set of guidelines developed by a work group consisting of nursing home industry representatives, consumer advocates, and representatives of the Department of Health and the State Office for Aging. These guidelines were part of DOHM 97-13 and distributed to all nursing homes in NYS. The guidelines provided instruction to nursing homes in order to facilitate compliance. The guidelines were not intended as a mandate but were seen as a recommended procedure for facilities to use. At the same time it was recognized that other measures exist and are utilized by facilities in room transfer that are acceptable and effective.

We are aware of no particular hardship experienced by either consumers or providers with regard to the regulation over the ten years that it has been in effect. We have frequent contact with nursing home advocacy groups and while they initially opposed the elimination of the 30 day notification requirement, we are not aware of situations, in which nursing homes have arbitrarily moved residents without preparation and notification. In analyzing data from ACO, the Federal database for deficiencies cited as a result of surveys, we note that for the last 5 year survey for all NYS nursing homes (655 on the Federal database) there were 14 deficiencies cited under F-tag 247 "receives notice before room or roommate change".

The regulation should continue without modification.

Amendment to Part 732 of Title 10 NYCRR (Workers’ Compensation Preferred Provider Organizations)

Statutory Authority:

Article 10-A of the Workers’ Compensation Law

Description of the regulation:

Rising costs, quality of care and timeliness of services associated with medical treatment of occupational diseases and accidental injury arising out of and in the course of employment are a concern to employees and employers in this State.

Concepts of managed care have proven to be a cost effective method of providing appropriate high quality, comprehensive health care to enrollees in many settings. The enabling legislation and corresponding regulations permit these benefits to accrue to employers and claimants through the establishment of PPOs specifically designed to provide workers’ compensation health care delivery. The regulations establish standards for certification to operate a PPO, as well as operating standards designed to ensure comprehensive and accessible care and services. These standards ensure comprehensive care to claimants provided on a cost effective basis for payors.

Under a preferred provider arrangement, an insurance carrier will contract with an employer for coverage of workers’ compensation services for all its employees. It also contracts with a certified preferred provider organization for the provision of all medical and health related services covered under the workers’ compensation program. The employee/claimant is provided with coordinated care and the law and regulations guarantees continuity of care, access to a second opinion, opt-out-provisions, quality assurance, utilization review, objective dispute resolution and other patient protections. Although freedom of choice in selecting a practitioner or a hospital is limited to providers participating in the PPO network, choice from among at least five accessible practitioners in each specialty (or an equivalent level of choice) and three accessible hospitals is mandated. In an emergency situation, a claimant is not limited to those three hospitals. PPOs generate cost savings for workers’ compensation as well as improve coordination of care for claimants, commensurate with the efficiencies and benefits inherent in managed medical care. Such cost savings has resulted in premium savings for employers, and improved coordination of care has led to better outcomes and a quicker return to work for claimants.

The regulation requires modification.

Amendment to Section 792.1(j) of Title 10 (Certificate of Approval for Hospice)

Statutory Authority:

Public Health Law Section 4004

Description of the regulation:

This rule repealed the requirement for biennial renewal of certificates of approval (operating certificates) for hospices. Certificates now remain in effect until revised, limited, annulled, revoked or suspended by the Commissioner or until surrendered by the operator. It was implemented in 1997 as part of the Department's regulatory reform effort.

This regulation should continue without modification.

Title 18 NYCRR - Twenty Year Review

Amendment to Section 360-3.2(f) of Title 18 (Organ Transplants for Undocumented Aliens)

Statutory Authority:

Social Services Law Sections 363(a)(2) and 365(a)(1) and (2) and Chapter 474 of the Laws of 1996

Description of the regulation:

This regulation conforms the Department’s regulation to the federal statute (42 U.S.C. Section 1396b(v)(2)(c)) which provides that Medicaid coverage of an emergency medical condition for undocumented aliens does not include care or services related to an organ transplant procedure.

The Medicaid Program paid approximately $4 million for organ transplants for undocumented aliens during the period August 1993 through June 1996 and has returned approximately $1.2 million in overpayments to the federal government as a result of the changes to the federal law which exempted such services from federal financial participation. The Department continues to project approximately $1 million savings annually ($500,000 State/$500,000 local share since there is no federal match), based on Medicaid costs associated with inpatient and physician claims for organ transplants for undocumented aliens with emergency coverage. This regulation imposes no new costs on State or local governments. Regulated parties incur no additional costs as a result of this regulation change unless they voluntarily choose to provide organ transplant services to undocumented aliens without charge.

This regulation should continue without modification.

Amendment to Section 360-4.10(a) of Title 18 (Medical Assistance for Institutionalized Spouses)

Statutory Authority:

Social Services Law Section 366-c(2)

Description of the regulation:

Chapter 81 of the Laws of 1995 amended Section 366-c(2) of the Social Services Law to set the State minimum community spouse resource standard for Medicaid eligibility at $74,820. Setting the State minimum community spouse resource standard at $74,820 provides that the community spouse is permitted to retain resources in an amount equal to the greater of the following amounts: (1) $74,820; (2) the spousal share up to $87,000 (the January 1, 2001 federal maximum community spouse resource allowance which is subject to the same percentage increase as the increase in the Federal consumer price index); or (3) the amount established for the support of the community spouse pursuant to a fair hearing or court order.

The regulation should continue without modification.

Amendment to Sections 505.14(f)(ii)(l), 505.14(f)(2)(ii)(m), 505.14(f)(2)(ii)(n), 505.14(g)(3)(xxiii), 505.14(g)(3)(xxiv) and 505.14(g)(3)(xxv) of Title 18 NYCRR (Personal Care Services – Advance Directives)

Statutory Authority:

Social Services Law Sections 363(a)(2) and 365(a)(2)(e) and Chapter 474 of the Laws of 1996

Description of the regulation:

Advance directives are written instructions, such as health care proxies, that are recognized under State law and relate to the provision of medical care to incapacitated individuals.

These regulatory amendments implemented the OBRA' 90 Federal Patient Self Determination Act, which imposed Advance Directive requirements upon states and Medicaid providers. In 1995, the Department of Health promulgated regulations imposing advance directive requirements upon those providers that the Department either licenses or certifies.

Certain providers of Medicaid personal care services are not subject to the licensure/certification regulations imposed at 10 NYCRR 700. These providers include New York City home care agencies that are exempt from licensure requirements and social services district employees or individual providers under contract to the district for the provision of personal care services.

The regulations at 18 NYCRR 505.14 will continue to extend advance directive requirements to the three groups of Title XIX personal care services providers not licensed or certified by the Department of Health: exempt home care agencies, individual providers and social services districts that employ staff to directly provide personal care services. They also continue to assure the State’s compliance with the Patient Self-Determination Act.

This regulation should continue without modification.

Amendment to Part 522 of Title 18 (Medicaid Billing for Pre-School Services)

Statutory Authority:

Section 177-a of Chapter 474 of the Laws of the 1996

Description of the regulation:

Medicaid reimburses Medicaid Preschool Supportive Health Service Program (PSHSP) providers for providing Medicaid eligible children related services listed on a child's Individualized Education Program (IEP). They contract with the State Education Department (SED) approved preschool programs to provide these services. These programs may also be a Medicaid approved Article 28 provider. Payment from the county to the SED approved preschool is in the form of a monthly tuition rate for a half or full day program. Payment is encounter based when only the related service is provided.

This regulation allowed Article 28 Medicaid providers to bill Medicaid directly for IEP services given in a full or half day SED program if the provider applied to do so.

Although instructions have been given as to which Medicaid providers are to bill under what circumstances there has been confusion. This problem was recently pointed out in the State Comptroller's draft audit #2001-S-11. The Comptroller identified possible duplicate payments between these types of providers for physical, speech and occupational therapies.

Fourteen Article 28 providers took advantage of the above regulation and are billing Medicaid directly for related services listed on a preschool child's (IEP). We have been informed by SED that 6 of these providers will no longer bill for the IEP services as an Article 28.

The Article 28 providers chose to bill Medicaid directly for the IEP services because they were concerned that their SED tuition payment would not be adjusted equitably to reflect the change. Also, there was concern their overall reimbursement between education and Medicaid programs would be reduced.

This regulation change was the result of an initiative from Article 28 providers that participate in the SED preschool program.

Today in 2016, there is only one Article 28 facility left who bills Medicaid directly for IEP services.

The regulation requires modification.

Amendment to Section 540.6 of Title 18 NYCRR (Billing to Medical Assistance Program)

Statutory Authority:

Social Services Law Sections 20(3)(d), 34(3)(f) and 363(a)(2) and section 37 of Chapter 938 of the Laws of 1990

Description of the regulation:

Section 540.6 of 18 NYCRR contains the requirements that a provider must follow when submitting a claim for payment for medical care, services or supplies which the provider has furnished under the Medicaid program. One of the requirements is that the provider must submit the claim to the Department or its fiscal agent within two years of the date on which the medical care, services or supplies were provided in order for the claim to be valid and enforceable. This regulation imposed an additional requirement for non-public providers. For such providers, the claim also would have to be payable within two years from the date of service. Some MA claims were paid more than two years after the service was provided. There are a variety of reasons why the Department is unable to pay a claim, which has been submitted by a provider within the two-year period. For example, the provider supplied incorrect or insufficient data on the claim form. Under the amendment, if a provider submitted a claim on the last day before the two year period expired, the Department would pay the claim only if it was payable when submitted. If a provider submitted a claim one day after the date of service which was not immediately payable for any reason, the provider would have sufficient time to correct any defect and submit the claim again within the two year period. Under the amendment, it is to the provider’s advantage to submit claims as soon as possible after service is rendered so that there is ample time to correct any problems. The regulatory amendment also clarifies how the two-year limit will be calculated for a public provider (school district). A public provider is permitted to submit a claim to the Department or its fiscal agent if the claim was submitted within two years of the date the care, services or supplies were furnished. The regulatory amendment also gives the Department discretion to extend the two-year timeframe if the public provider made payments under a program other than the MA program.

The Department estimates that the savings for State fiscal year 2000-01 associated with this regulation are as follows (in millions of dollars):

The Department determined this number by analyzing historical Medicaid Management Information System edit denials and valid resubmissions for claims which were over two years old.

The regulation should continue without modification.

Title 9 NYCRR - Twenty Year Review

Amendments to Sections 9700.1(b), 9710.1(c), 9750.2(a), 9850.10(k) and 9850.13(a) of Subtitle KK of Title 9 (EPIC Fair Hearing)

Statutory Authority:

Executive Law Sections 547-d(5), 547-f(2)

Description of the regulation:

These amendments conform EPIC regulations to an amendment to EPIC legislation (Article 19-K, Executive Law), which transferred administrative responsibility for conducting fair hearings from the Department of Social Services to the Department of Health. The change in legislation was effective August 1, 1996.

The regulation should continue without modification.

Amendment to Sections 9800.7(e) of Subtitle KK of Title 9 (EPIC Provider Biennial Recertification)

Statutory Authority:

Executive Law Section 547-d(5)

Description of the regulation:

This regulation requires pharmacy providers to submit to EPIC a biennial recertification of their level of participant services and previous year’s prescription volume, upon which their reimbursement for covered prescriptions is based. Previously the regulation required an annual recertification. This amendment reduces paperwork and unnecessary administrative costs for pharmacies and EPIC.

The regulation should continue without modification.