New York Register, Volume 39, Issue 40, October 4, 2017

• Jurisdiction: New York
• Library: New York Register
• Published date: 04 October 2017
• Year: 2017

RULE MAKING

ACTIVITIES

Each rule making is identified by an I.D. No., which consists

of 13 characters. For example, the I.D. No. AAM-01-96-

00001-E indicates the following:

AAM -the abbreviation to identify the adopting agency

01 -the State Register issue number

96 -the year

00001 -the Department of State number, assigned upon

receipt of notice.

E -Emergency Rule Making—permanent action

not intended (This character could also be: A

for Adoption; P for Proposed Rule Making; RP

for Revised Rule Making; EP for a combined

Emergency and Proposed Rule Making; EA for

an Emergency Rule Making that is permanent

and does not expire 90 days after filing.)

Itali cs con tain ed in text denote new material. Brackets

indicate material to be deleted.

Office of Alcoholism and

Substance Abuse Services

REVISED RULE MAKING

NO HEARING(S) SCHEDULED

General Service Standards for Chemical Dependence Outpatient

(CD-OP) and Opioid Treatment Programs(OTP)

I.D. No. ASA-24-17-00017-RP

PURSUANT TO THE PROVISIONS OF THE State Administrative Pro-

cedure Act, NOTICE is hereby given of the following revised rule:

Proposed Action: Amendment of Part 822 of Title 14 NYCRR.

Statutory authority: Mental Hy giene Law, sections 19.07, 19.09, 19.16,

19.21, 19.40, 22.07, 32.01, 32.02, 32.05, 32.07, 32.09; Penal Law, section

220.78; Public Health Law, sections 2171, 2781 and 3309

Subject: Gener al service stan dards for chemi cal dependence o utpatient

(CD-OP) and opioid treatment programs (OTP).

Purpose: Conforms HIV and Hepatitis testing in accordance with the Pub-

lic Health Law; clarifies the services a peer may provide.

Substanc e of revised r ule (Full te xt is poste d at the follo wing State

website: www.oasas.ny.gov): This proposal makes amendments to the fol-

lowing sections in response to changes in the Public Health Law related to

testing for HIV and Hepatitis-C; to update the de finition of peer support

services; responding to comments received from the June 14, 2017 publi-

cation in the S tate Regist er; interna l review by the O ffice; and min or

technical amendments.

§ 822.2(o): Legal basis. Adds section 2781 of the Public Health Law re-

lated to HIV testing.

§ 822.5(n): Amends definition of “continuing care treatment” to clarify

requirements for OTP patients receiving continuing care services.

§ 822.5(t): Adopted comm on usage of the ter m “medicatio n assisted

treatment” (MAT)rather than “medication assisted recovery.”

§ 822.5(aa) and (ac): Makes technical amendments as needed; removes

the outdated definition of “outrea ch” and amends the definition of “pee r

support serv ice” for the pu rpose of engag ing patient s prior to prog ram

admission. Renumbering remaining subdivisions through (ah).

§ 822.7(a)(5) an d (l)(5): Amend s Policies an d Procedur es clarifyi ng

that providers m ust be in complia nce with local, s tate and federa l laws

pertaining to both H epatitis and HIV educa tion, prevention , testing and

counseling;adds a new paragraph to subdivision (l) to ensure clinical staff

be provided with documented training on crisis interventions, dealing with

speci al pop ulati ons, q uali ty impr ovem ents a nd agen cy pol icies a nd

procedures.

§ 822.8(a)(4)(i); ( 5)-(10): R equires all p atients be o ffered HIV and

hepatitis testing as well as other sexually transmitted diseases, which may

be conducted either on-site or by referral, as soon as possible after admis-

sion; conforms provisions related to offer of HIV/AIDS testing to current

Public Health Law; requires consultation with the prescribing provider of

a regimen of pre- or post-exposure prophylaxis prior to discontinuing the

regimen; clarifies that all programs must con duct an intradermal TB test

for patien ts with clin ical indic ations; p rograms mu st explain a ny test

results to patients as soon as possible after testing; clarifies that significant

medical issues w hich must be addre ssed in the treatm ent/recovery p lan

include risk for communicable diseases; renumbering paragraphs.

§ 822.8(e)(2): Requires, within one week of admission to an OTP, that

each patient be educated on HIV prophylaxis.

§ 822.9(g): Communicable disease. Adds a new subdivision requiri ng

communicable disease risk and treatment, or lack thereof, be documented

in the treatment recovery plan.

§ 822.12(b): Inc lude langu age regard ing prohibi tion again st sharing

any information pertaining to testing and treatment of sexually transmitted

diseases with a min or patient’s parent or gu ardian without t he patient’s

consent.

§ 822.14: Remove prohibition against OTPs having additional locations.

A copy of the full text of t he regulator y proposal is av ailable on the

OASAS website at: http://www.oasas.ny.gov/regs/index.cfm

Revised rule com pared with propo sed rule: Subst antial revisio ns were

made in sections 822.2(o), 82 2.5(n), (t), 822.7(a)(5) , 822.8(a)(4)(i), (5)-

(8), 822.9(g), 822.12(b) and 822.14(c).

Text of revised proposed rule and any required statements and analyses

may be obtained from Sara Osborne, Associate Attorney, NYS Office of

Alcoholism an d Substance Abuse Servi ces, 1450 Western Ave., Albany,

NY 12203, (518) 485-2312, email: Sara.Osborne@oasas.ny.gov

Data, views or arguments may be submitted to: Same as above.

Public comment will be received until: 30 days a fter publication of this

notice.

Revised Regulatory Impact Statement

1. Statutory Authority:

(a) Section 19.07(c) of the Mental Hygiene Law (MHL) charges the Of-

fice with the responsibility to ensure that persons who abuse or are depen-

dent on alcoho l and/or subs tances and the ir families a re provided w ith

care and treatment that is effective and of high quality.

(b) Section 19.07(e) of the MHL authorizes the commissioner to adopt

standards including necessary rules and regulations pertaining to chemical

dependence treatment services.

(c) Section 19.09(b) of the MHL authorizes the commissioner to adopt

regulations necessary and p roper to implement any matte r under his/her

jurisdiction.

(d) Section 19.16 of the MH L requires the commissione r to establish

and maintai n, either di rectly or th rough cont ract, a cent ral regist ry for

purposes of preventing multiple enrollments in opioid treatment programs

(OTPs) and provide medication dosage information during an emergency

situation, when displa ced patients may seek trea tment from an alternate

OTP.

1

(e) Section 19.21(b) of the MHL requires the commissioner to establish

and enforce regulations concerning the licensing, certification, and inspec-

tion of chemical dependence treatment services.

(f) Section 19.21(d) of the MHL requires the Office to establish reason-

able perf ormance s tandar ds for prov iders of s ervices c ertified b y the

Office.

(g) Sectio n 19.40 of the M HL authorize s the commis sioner to is sue

operating certificates for the provision of chemical dependence treatment

services.

(h) Section 22.07(c) o f the Mental Hygiene Law a uthorizes the com-

missioner to promulgate rules and regulations to ensure that the rights of

individuals who have re ceived, and are receivi ng, chemical dependen ce

services are protected.

(i) Section 32.01 of the MHL authorizes the commissioner to adopt any

regulation reasonably necessary to implement and effectively exercise the

powers and perform the duties conferred by Article 32 of the MHL.

(j) Section 32.05(b) o f the MHL provides that a contr olled substance

designate d by the commis sioner of th e New York State Departme nt of

Health (DOH) as appropriate for such use may be used by a physician to

treat a chemically dependent individual pursuant to section 32.09(b) of the

MHL.

(k) Section 32.07(a) of the MHL authorizes the commissioner to adopt

regulations to effectuate the provisions and purposes of Article 32 of the

MHL.

(l) Section 32.09(b) of the MHL provides that the commissi oner may,

once a controlled substance is approved by the commissioner of DOH as

appropriate for such use, authorize the use of such controlled substance in

treating a chemically dependent individual.

(m) Section 220.78 of the Penal Law affords limited prot ections from

prosecution for persons seeking medical attention for accidental overdose.

(n) Section 3309 of the Public Health Law authorizes the DOH to estab-

lish standards for approval of any opioid overdose prevention program.

(o) Section 32.02 of the Mental Hygiene Law author izes the commis-

sioner to adopt re gulations nec essary to ensur e high quality ser vices to

individuals suffering from problem gambling.

(p) Section 2781 of the Public Health Law defines the rules governing

HIV testing in New York.

2. Legislative Objectives: The Proposed Revised Rule Amends Part 822

to require all certified programs to offer all patients testing for HIV/AIDS,

sexually transmitted d iseases, and viral hepat itis in excess of the Publi c

Health Law; amends the definit ion of peer support service to c larify the

role of certifi ed peer advoca tes in pre-ad mission serv ices; remov es the

prohibition again st OTPs having additi onal locations; res ponds to com-

ments from June 14 , 2017 publicat ion in the State Re gister, and makes

technical a mendments . The state has a br oad public he alth intere st in

ensuring that individuals are tested for HIV and Hepatitis, especially those

individuals at increased risk and who routinely access addiction treatment

services. The role of peers in engaging people actively using substances is

extremely important and the definition of peer support service is amended

to provide cla rity on the role o f peers in engag ing individu als for the

purposes of entering treatment.

3. Needs and Benefits: This regulation responds to changes in the Pub-

lic Health Law which require the offer of an HIV test. The Public Health

Law also mandates the offer of a Hepatitis-C test for individuals born be-

tween 1945 -1965. Giv en the natu re of the serv ices provi ded to thos e

populations served by OASAS, the majority of individuals served are at-

risk and therefore an offer of HIV and hepatitis testing will be mandated

for all individuals admitted to treatment settings. Testing for both hepatitis

and HIV may be done on-site or by ref erral. The proposed amendme nts

are in accordance with OASAS outpatient and opioid treatment programs

providing integrated behavioral health and physical health service delivery

models of care. The role of peers in outreach and engagement of individu-

als to enter addiction treatment is clarified.

4. Costs: The Office anticipates no fiscal impact o n providers or local

governme nts, job cr eation or jo b loss, bec ause the pro visions m erely

require the offer of HIV and hepatitis testing an d clarify the services al-

ready provided by certified peer advocates that are reimbursable by third

party (insurance) payers.

5. Paperwork: The pr oposed regulat ory amendments w ill not require

additional paperwork be cause outpatient and opi oid treatment programs

would utiliz e existing tr eatment pla nning and dis charge admini strative

processes and certified peer advocates are already trained and operating in

the OASAS provider system.

6. Loca l Gover nment M anda tes: Thi s regul atio n impos es no new

mandates beyond those alrea dy existing in statute on loca l governments

operating certified OASAS outpatient and/or opioid treatment programs or

local governm ents whose jur isdiction alr eady includes a n outpatient o r

opioid treatment program.

7. Duplic ation: Th is propos ed rule doe s not dupl icate any s tate or

federal statute or rule.

8. Alternatives: No alternatives. HIV and hepatitis testing is in confor-

mity with the Public Health Law.

9. Federal Standard s: These amendments do no t conflict with feder al

standards.

10. Compl iance Sch edule: The se regula tions wil l be effecti ve upon

publication of a Notice of Adoption in the State Register.

Revised Regulatory Flexibility Analysis

OASAS has dete rmined that th e rule will not i mpose any adve rse eco-

nomic impact or re porting, reco rdkeeping or ot her compliance r equire-

ments on small bu sinesses or lo cal governme nts. This rulem aking pro-

posal has been reviewed and approved (April 24, 2017) by the Behavioral

Health Services Advisory Council consisting of affected OASAS provid-

ers of all sizes from diverse municipaliti es including local governments.

The proposal i s supported b y providers b ecause it con forms HIV and

Hepatitis testing with current public health law and also clarifies the role

of peers in pre-admission patient engagement. The proposal was published

in the June 14, 2017 State Register; the revised proposal incorporates re-

sponses to comments.

Revised Rural Area Flexibility Analysis

OASAS has determined that the rule will not impose any adverse impact

on rural areas or re porting, recor dkeeping or othe r compliance req uire-

ments on public or private entities in rural areas. This rulemaking proposal

has been reviewed and approved (April 24, 2017) by the Behavioral Health

Services Advisory Council consisting of affected OASAS providers of all

sizes from diverse municipaliti es, and including local governme nts. The

proposal is supported by providers because it conforms to or exceeds HIV

and Hepatitis testing with current public health law and also clarifies the

role of peers i n pre-admi ssion pati ent engage ment. The pro posal was

publi shed in t he June 1 4, 2017 S tate Re giste r; the r evise d propo sal

incorporates responses to comments.

Revised Job Impact Statement

OASAS is not su bmitting a Jo b Impact Stat ement for thi s rulemakin g.

OASAS does n ot anticip ate a subst antial adv erse impac t on jobs and

employment opportunities because the requirements for this service are al-

ready met by certain staff operating in certified outpatient and opioid treat-

ment programs. The p roposal was publ ished in the June 14, 2 017 State

Register; th e revised pro posal incorp orates resp onses to comm ents but

does not change the lack of job impact.

Assessment of Public Comment

Notice of Proposed Rule Making was published in the New YorkState

Register on June 14, 2017. The Office of Alcoholism and SubstanceAbuse

Services (OASAS) received three (3) sets of comments during the public

comment period associated wi th the revised rulemaking: fr om The New

York City Dept. of Health and Mental Hygiene, the NYS Dept. of Health

(AIDS Institute), and from one OASAS certified provider. Substantive is-

sues and concerns raised in these co mments with OASAS responses are

set forth below, grou ped according t o the section of t he revised rul e to

which they apply. Technical edits made by the Office with no substantive

effect are not summarized below.

822.2(o):

Issue/Concern: Request that OASAS exceed the requ irements of PHL

§ 2171 regarding offer of HCV testing for persons born between 1945 and

1965.

Response: The purpose of the rulemaking is to exceed to requirements

of PHL § 2127 and offer testing to all patients regardless of age. OASAS

removed the proposed refe rence in Legal Basis to PBH § 2171 to avoi d

further confusion.

822.5(n):

Issue/Concern: Internal review finds regulation is misleading about the

criteria for admission to continuing care in an OTP.

Response: Amended to clarify that a patient may be receiving continu-

ing care in an OTP after completing a taper or has completed the goals of

active treatment, but may still be receiving prescribed maintenance.

822.5(t):

Issue/Concern: Internal review determines return to use of “medication

assisted treatment” from “medication assisted recovery”; MATis the more

frequent usage.

Response: Amended.

822.7(a)(5):

Issue/Co ncern: Re quest for mo re detail t o clarify t hat polici es and

procedures governing the provision of clinical services must comply with

local laws, as well as state and federal, and that standards of care for HIV

preventio n and educat ion includ es condom us e, testing , pre- and post -

prophylaxis, and treatment.

Response: OASAS has included the suggested additional detail.

822.8(a)(4)(i):

Issue/Concern: Suggestion to change an “or” to an “and” to be inclusive

NYS Register/October 4, 2017Rule Making Activities

2