MRD-12-10-00010-P Procedures for the Control of Tuberculosis (TB)

3/24/10 N.Y. St. Reg. MRD-12-10-00010-P

NEW YORK STATE REGISTER

VOLUME XXXII, ISSUE 12

March 24, 2010

RULE MAKING ACTIVITIES

OFFICE OF MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. MRD-12-10-00010-P

Procedures for the Control of Tuberculosis (TB)

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Repeal of Subpart 635-8 and addition of section 633.14 to Title 14 NYCRR.

Statutory authority:

Mental Hygiene Law, sections 13.07, 13.09(b) and 16.00

Subject:

Procedures for the control of tuberculosis (TB).

Purpose:

To conform OMRDD requirements related to the control of TB to current national recommended practices.

Substance of proposed rule (Full text is posted at the following State website:www.omr.state.ny.us):

• The proposed regulation repeals existing out-of-date OMRDD requirements on the control of tuberculosis (TB) in 14 NYCRR Subpart 635-8 and adds a new Section 633.14 containing updated requirements.

• TB testing. The existing regulation requires most service recipients, employees, volunteers and independent contractors to be tested for TB annually. The proposed regulation would require service recipients, employees, volunteers and independent contractors (excluding those who reside, work or volunteer in a developmental center) to have an initial TB test with a follow-up TB test only if the person is exposed to TB or the person exhibits TB symptoms. For those who live, work or volunteer in a development center, an annual TB test continues to be required.

• Testing technology. The existing regulation only allows for testing with the purified protein derivative (PPD) Mantoux skin test. The proposed rule allows for new TB testing techniques.

• Treatment of TB. Subpart 635-8 contains requirements, including isolation rooms at developmental centers, for the treatment of someone with active TB. The proposed regulations require people who have active TB be treated by their own healthcare provider in conjunction with the local health department.

• Applicability to non-certified services. The existing regulation applies to developmental centers, certified facilities and non-certified services. The proposed regulation would only apply to developmental centers and certified facilities. Non-certified services would no longer be required to comply.

Text of proposed rule and any required statements and analyses may be obtained from:

Barbara Brundage, Director of Regulatory Affairs, OMRDD, 44 Holland Avenue, Albany, New York 12229, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Additional matter required by statute:

Pursuant to the requirements of SEQRA and 14 NYCRR Part 602, OMRDD has determined that the action described herein will have no effect on the environment, and an E.I.S is not needed.

Regulatory Impact Statement

1. Statutory Authority:

a. Section 13.07 of the New York State Mental Hygiene Law establishes that OMRDD shall have responsibility for seeing that persons with developmental disabilities receiving care and treatment have their personal and civil rights protected.

b. Section 13.09(b) of the New York State Mental Hygiene Law establishes OMRDD's authority to adopt rules and regulations necessary and proper to implement any matter under its jurisdiction.

c. Section 16.00 of the New York State Mental Hygiene Law enables the commissioner of OMRDD to regulate and assure the quality of services provided to persons with developmental disabilities.

2. Legislative Objectives: The proposed amendments further the legislative objectives embodied in sections 13.07, 13.09(b) and 16.00 of the New York State Mental Hygiene Law by conforming OMRDD requirements related to the control of tuberculosis (TB) to current recommended national practices. This furthers OMRDD's responsibility to assure the consistent high quality of services for persons with developmental disabilities by fostering healthy environments.

3. Needs and Benefits: OMRDD promulgated regulations related to the control of tuberculosis over 15 years ago. The recommendations of the Centers for Disease Control (CDC), the Association for Professionals in Infection Control (APIC) and the New York State Department of Health (NYSDOH) concerning the screening for and control of tuberculosis have changed substantially since the current regulation was written. The OMRDD system of residential facilities has also changed substantially from primarily large institutions and campuses to small community based residences. Implementation of many of the provisions of the current regulation (e.g. isolation procedures) is not feasible in the newer settings. New screening and treatment methods have also been developed which the current regulation does not permit.

OMRDD is proposing that the current regulations be repealed in their entirety and that new regulations be added that are consistent with current recommendations and reflective of the current OMRDD service delivery system.

A key difference between the current regulations and the proposed regulations is in the requirement for annual testing. The current regulations require an annual Mantoux Skin Test (a.k.a. PPD) for all individuals receiving services, employees, and others throughout the OMRDD system. The proposed regulation maintains the requirement for annual testing only in Developmental Centers. The new regulations continue the requirement for initial testing (e.g. when an individual begins to receive services or an employee is hired).

An annual testing requirement in non-institutional settings is not consistent with current recommended practices and is not necessary for the effective control of tuberculosis.

The elimination of annual testing will have many benefits for individuals receiving services, employees and agencies providing services. The administration of unnecessary tests can be detrimental for individuals receiving services. For some individuals, the administration of the PPD may cause anxiety and agitation. Sometimes the person needs to be restrained, sedated or placed under general anesthesia to accomplish the test. Other individuals and employees may be inconvenienced by the yearly ordeal of TB testing and sometimes incur personal expenses associated with the tests. Staff time and effort involved in testing can be more productively used. The volume of required annual tests can tax limited nursing resources, which can detract from the provision of more important nursing services. The administrative burden of documenting the annual testing and maintaining records can be eliminated. Finally, agencies can save the substantial cost incurred for the administration of these unnecessary tests.

The regulation also excludes non-certified programs and services, in conformance with federal recommendations.

Several additional considerations prompted this initiative by OMRDD:

• the need to modify language regarding testing methods to accommodate new techniques

• the need to revise out-of-date information

• the need to modify testing requirements for children based on the American Academy of Pediatrics newest recommendations

• the need to clarify testing requirements for individuals in residential settings given State Department of Health (NYSDOH) guidance document issued in 2006

• the need to clarify exemptions for testing

The proposed regulations integrate changes based on the most current tuberculosis recommendations and included a thorough evaluation of current requirements conducted in collaboration with the DDSO Infection Control Nurses, DDSO Nursing Management Teams, DDSO Medical Directors, and the Family Care Community of Practice. The proposed changes were also reviewed and the key changes were found "reasonable and appropriate" by Margaret J. Oxtoby, M.D., Director, Bureau of Tuberculosis Control, New York State Department of Health.

4. Costs: Except in developmental centers, routine annual TB testing of individuals receiving services and employees, volunteers and others is eliminated. This will result in annual cost savings in several ways.

The vast majority of individuals receiving services are Medicaid recipients. For individuals accessing the required TB testing through a private physician's office or clinic, Medicaid will save at a minimum the cost of the TB test itself. This savings will be realized 50% by the state and 50% by the federal government.

Generally, providers (including OMRDD as a provider) assume the cost of testing employees, volunteers, etc., and sometimes the provider assumes the cost of testing individuals receiving services. When the provider pays for the testing, the savings generated will accrue 100% to the provider (either OMRDD or the voluntary provider). The following accounts for the cost of the TB test itself. However, associated savings will also be realized which are difficult to quantify due to the avoidance of various costs of TB testing. This includes the cost of testing volunteers and others besides employees, the cost of the clinician's time to administer and read the test, travel time and expense, lost work time, savings associated with documentation, etc. There may be additional Medicaid costs that are avoided which are associated with the administration of the TB test to some individuals, such as the cost of anesthesia or sedation.

Methodology:

OMRDD estimates that there are 9425 individuals living in State operated residences (except for developmental centers). About 70% of TB tests to these individuals are administered by the state directly (generating savings to OMRDD), and about 30% are administered at Medicaid cost. For the additional 5356 individuals in state-operated day programs who do not live in certified residences, it is assumed the tests are administered at Medicaid cost. An estimated 41,969 individuals live in voluntary operated residences or attend voluntary operated day programs. The cost of these individual's tests are generally paid by Medicaid. OMRDD estimates that there are 16,500 employees in state-operated programs (excepting Developmental Centers). OMRDD also estimates 56,000 employees in voluntary operated programs. OMRDD estimates that the rate of attrition is 8% per year. New employees must have a TB test so the number of employee tests that are avoided are correspondingly reduced. TB testing is estimated to cost $21.90 per test.

Additional savings will result from the exclusion of non-certified programs from the proposed regulation. These are difficult to quantify.

a. Costs to the Agency and to the State and its local governments:

Annual Federal share of Medicaid savings: $549,169

Annual State share of Medicaid savings: $549,169

OMRDD's anticipated annual direct savings as a provider: $343,950 is saved in the cost of the actual test. Associated savings cannot be quantified.

Local governments: There is no effect on local government. While a local Medicaid share exists for some individuals, there is an overall cap on Medicaid costs for local governments. Therefore, the Medicaid savings will be realized by the state and federal governments and not the localities.

b. Costs to private regulated parties:

OMRDD estimates that the current regulation requires annual testing for 56,000 employees of voluntary providers at a cost of $21.90 per test. Again, OMRDD assumes 8% attrition, which reduces the number of tests avoided. This is expected to result in direct annual savings of $1,128,288 for voluntary providers. Providers will also save in associated costs as noted above, which cannot be quantified.

5. Local Government Mandates: There are no new mandates on local governmental units or any other special districts.

6. Paperwork: OMRDD and voluntary agencies will reduce the amount of paperwork because of the elimination of the requirement for annual testing. Documentation of these tests and retention of these records will be eliminated.

7. Duplication: None.

8. Alternatives: OMRDD had considered deletion of the requirement for annual tests for children receiving services in accordance with the recommendation of the American Academy of Pediatrics. However, after analysis of other national recommendations and deliberation, OMRDD decided to extend the deletion of the annual testing requirement for all individuals and staff, except in institutional settings.

9. Federal Standards: The proposed amendments do not exceed any minimum standards of the Federal government.

10. Compliance Schedule: It is OMRDD's intent to finalize the proposed amendments as quickly as allowed by the requirements of the State Administrative Procedure Act.

Regulatory Flexibility Analysis

1. Effect on small businesses: These proposed amendments apply to organizations that operate facilities under the auspices of OMRDD.

While most of the organizations employ more than 100 people overall, many of the facilities operated by the organizations at discrete sites (e.g. small residences) employ fewer than 100 employees at each site, and each site (if viewed independently would therefore be classified as a small business. Some smaller organizations which employ fewer than 100 employees would themselves be classified as small businesses.

The proposed amendments have been reviewed by OMRDD in light of their impact on these small businesses and on local governments. OMRDD has determined that the proposed amendments will not cause undue hardship to small business providers due to increased costs or increased compliance requirements. In fact, OMRDD has determined that with the elimination of annual testing for tuberculosis (TB) for the majority of those who are employed or receive services from the small businesses, the business will experience savings.

The proposed amendments result in no new costs for local government.

2. Compliance requirements: Existing facilities with current operating certificates will need to develop new policies and procedures for the control of TB to be compliant with the proposed amendments. The proposed amendments contain no compliance requirements for local government.

3. Professional services: No additional professional services are required as a result of these proposed amendments. Regulated parties will be able to use the existing professional services more effectively with the elimination of the outdated requirements as proposed in the amendments. The proposed amendments will have no impact on the professional service needs of the local government.

4. Compliance costs: There are no compliance costs to local governments. Small business will experience a savings in compliance costs.

5. Economic and technological feasibility: The proposed amendments do not impose on regulated parties the use of any technological processes.

6. Minimizing adverse economic impact: These proposed amendments impose no adverse economic impact on local governments or small businesses.

7. Small business and local government participation: Draft copies of the proposed amendments were distributed to each of the 9 provider associations at a Provider Association meeting for distribution to their membership.

Rural Area Flexibility Analysis

A Rural Area Flexibility Analysis for the proposed amendments has not been submitted. OMRDD has determined that the amendments will not impose any adverse impact, reporting, recordkeeping, or other compliance requirements on public or private entities in rural areas. The rulemaking proposes to conform OMRDD requirements related to the control of tuberculosis to current national recommended practices.

Job Impact Statement

A Job Impact Statement is not submitted because the amendment will not present an adverse impact on existing jobs or employment opportunities. The rulemaking proposes to conform OMRDD requirements related to the control of tuberculosis to current national recommended practices.