HLT-14-10-00006-RP Sexually Transmitted Disease (STD) Reporting and Treatment Requirements

4/6/11 N.Y. St. Reg. HLT-14-10-00006-RP

NEW YORK STATE REGISTER

VOLUME XXXIII, ISSUE 14

April 06, 2011

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

REVISED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-14-10-00006-RP

Sexually Transmitted Disease (STD) Reporting and Treatment Requirements

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

Proposed Action:

Amendment of section 2.10 and Part 23 of Title 10 NYCRR.

Statutory authority:

Public Health Law, sections 206(1), 225 and 2311

Subject:

Sexually Transmitted Disease (STD) Reporting and Treatment Requirements.

Purpose:

Reporting of cases or suspected cases or outbreaks of communicable disease by physicians, list and reporting of STDs.

Text of revised rule:

Section 2.10 is amended as follows:

Section 2.10 Reporting cases or suspected cases or outbreaks of communicable disease by physicians.

It shall be the duty of every physician to report to the city, county or district health officer, within whose jurisdiction such patient [is] resides, the full name, age and address of every person with a suspected or confirmed case of a communicable disease, any outbreak of communicable disease, any unusual disease or unusual disease outbreak and as otherwise authorized in section 2.1 of this Part, together with the name of the disease if known, and any additional information requested by the health officer in the course of an investigation pursuant to this Part, within 24 hours from the time the case is first seen by him, and such report shall be by telephone, facsimile transmission or other electronic communication if indicated, and shall also be made in writing, except that the written notice may be omitted with the approval of the State Commissioner of Health. [(a) Cases in State institutions and facilities licensed under article 28 of the Public Health Law.] When a case which is required to be reported under section 2.1 of this Part occurs in a State institution or a facility licensed under Article 28 of the Public Health Law, the person in charge of the institution or facility shall report the case to the State Department of Health and to the city, county or district health officer, in whose jurisdiction such institution is located.

[(b) Cases of sexually transmitted diseases. Provided further that cases of gonorrhea, chlamydia trachomatis infection and syphilis shall be reported in writing, and that the patient's initials may be given in lieu of the patient's name. The physician shall keep a record of each case reported by initials and the corresponding name of the patient together with his address. The name and address of the patient shall be reported to the local or State health official to whom the attending physician is required to report such case, upon the special request of such official.]

Section 23.1 is amended as follows:

Section 23.1 List of sexually transmissible diseases.

The following [is a list] are groups of sexually transmissible diseases [(STD)] (STDs) and shall constitute the definition of sexually transmissible diseases for the purposes of this Part:

[Chlamydia trachomatis infection*

Gonorrhea*

Syphilis*

Non-gonococcal Urethritis (NGU)*

Non-gonococcal (mucopurulent) Cervicitis*

Trichomoniasis*

Genital Herpes Simplex*

PID Gonococcal/Non-gonococcal

Lymphogranuloma Venereum*

Chancroid*

Ano-genital warts

Granuloma Inguinale*

Yeast Vaginitis

Gardnerella Vaginitis

Pediulosis Pubis

Scabies

*Treatment facilities referred to in section 23.2 of this part must provide diagnosis and treatment for those STD designated by*.]

Group A

Treatment facilities referred to in section 23.2 of this part must provide diagnosis and treatment free of charge as provided in subdivision (c) of section 23.2 of this Part for the following STDs:

Chlamydia trachomatis infection

Gonorrhea

Syphilis

Non-gonococcal Urethritis (NGU)

Non-gonococcal (mucopurulent) Cervicitis

Trichomoniasis

Lymphogranuloma Venereum

Chancroid

Granuloma Inguinale

Group B

Treatment facilities referred to in section 23.2 of this Part must provide diagnosis free of charge and must provide treatment as provided in subdivision (d) of section 23.2 of this Part for the following STDs:

Ano-genital warts

Human Papilloma Virus (HPV)

Genital Herpes Simplex

Group C

Treatment facilities referred to in section 23.2 of this Part must provide diagnosis free of charge and must provide treatment as provided in subdivision (e) of section 23.2 of this Part for the following STD:

Pelvic Inflammatory Disease (PID) Gonococcal/Non-gonococcal

Group D

Treatment facilities referred to in section 23.2 of this Part must provide diagnosis free of charge and must provide treatment as provided in subdivision (f) of section 23.2 of this Part for the following STDs:

Yeast (Candida) Vaginitis

Bacterial Vaginosis

Pediculosis Pubis

Scabies

Section 23.2 is amended as follows:

23.2 Treatment facilities.

Each health district shall provide adequate facilities[, without charge,] for the diagnosis and treatment of persons living within its jurisdiction who are infected or are suspected of being infected with STD as specified in section 23.1.

(a) Such persons shall be examined and shall have appropriate laboratory specimens taken and laboratory tests performed for those diseases designated in this Part as [sexually transmissible diseases] STDs for which such person exhibits symptoms or is otherwise suspected of being infected.

(b) The examinations and laboratory tests shall be conducted in accordance with accepted medical procedures as described in the most recent STD clinical guidelines and laboratory guidelines distributed by the New York State Department of Health.

(c) Any persons diagnosed as having [syphilis or gonorrhea, or those who have been exposed to syphilis or gonorrhea,] any of the STDs in Group A in section 23.1 of this Part shall be treated with appropriate medication in accordance with accepted medical procedures as described in the most recent treatment [schedule] guidelines distributed by the department [of health].

[(d) Because antiviral therapy is rapidly evolving, the choice of therapy for persons having herpes (hominis) infection shall be in accordance with established medical procedure as described in the STD clinical guidelines distributed by the New York State Department of Health.

(e) Any person diagnosed as having the other sexually transmissible diseases (Non-gonococcal Urethritis, Non-gonococcal (mucopurulent) Cervicitis, Trichomoniasis, Lymphogranuloma Venereum, Chancroid, and Granuloma Inguinale) designated for the purposes of this section shall be treated by means of a written prescription issued in accordance with accepted medical procedure as described in the STD clinic guidelines distributed by the New York State Department of Health.]

(d) Any persons diagnosed as having any of the STDs in Group B in section 23.1 of this Part must be provided treatment either directly in the clinic or through a written or electronic prescription or referral. If treatment is provided directly, it must be provided free of charge.

(e) Any person diagnosed as having the STD in Group C in section 23.1 of this Part may be managed by immediate referral. If outpatient treatment is appropriate as indicated by accepted clinical guidelines and is provided directly, it must be provided free of charge.

(f) Any person diagnosed as having any of the STDs in Group D in section 23.1 of this Part may be provided treatment directly within the clinic or through a written or electronic prescription. If treatment is provided directly, it must be provided free of charge.

Section 23.3 is deleted:

[23.3 STD reporting.

(a) The reporting obligations of this section shall not affect the obligation to report individual cases of syphilis and gonorrhea imposed by section 2.10(b) of this Chapter.

(b) Cases of STD diagnosed in public health clinics operated by, and for, a health district must be reported by mail to the New York State Department of Health, Empire State Plaza, Tower Building, Albany, N.Y. 12237, by the 15th of the month following the month in which the case is diagnosed. Such reports shall be made on a standard form provided by the Department of Health.

(c) Cases of STD diagnosed by health providers other than those specified in subdivision (b) of this section may be tabulated and reported as described in that subdivision.]

Section 23.4 is renumbered as section 23.3, and a new Section 23.3 is added as follows:

[23.4] 23.3 Cases treated by other providers.

(a) Every physician, licensed midwife or nurse practitioner providing (as authorized by their scope of practice) gynecological, obstetrical, genito-urological, contraceptive, sterilization, or termination of pregnancy services or treatment, shall offer to administer to every patient treated by such physician, licensed midwife[,] or nurse practitioner, appropriate examinations or tests for STD as defined in this Part.

(b) The administrative officer or other person in charge of a clinic or other facility providing gynecological, obstetrical, genito-urological, contraceptive, sterilization or termination of pregnancy services or treatment shall require the staff of such clinic or facility to offer to administer to every resident of the State of New York coming to such clinic or facility for such services or treatment, appropriate examinations or tests for the detection of sexually transmissible diseases.

Revised rule compared with proposed rule:

Substantial revisions were made in sections 2.10, 23.1 and 23.2.

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

Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

30 days after publication of this notice.

Revised Regulatory Impact Statement

Statutory Authority:

Sections 225(4) and 225(5) (a), (h), and (i) of the Public Health Law (PHL) authorize the Public Health and Health Planning Council to establish and amend State Sanitary Code provisions relating to the designation of communicable diseases dangerous to public health, and the nature of information required to be furnished by physicians in each case of communicable disease. PHL Section 206(1) (d) authorizes the commissioner to "investigate the causes of disease, epidemics, the sources of mortality, and the effect of localities, employments and other conditions, upon the public health." PHL Section 206(1) (e) permits the commissioner to "obtain, collect and preserve such information relating to marriage, birth, mortality, disease and health as may be useful in the discharge of his duties or may contribute to the promotion of health or the security of life in the state. . ."

Article 23 of the PHL provides the authority for the control of sexually transmissible diseases (STDs) by local health officers. Section 2304 outlines the responsibility of each board of health of a health district "to provide adequate facilities for the free diagnosis and treatment of persons living within its jurisdiction who are suspected of being infected or are infected with" an STD; that the health officer "shall administer these facilities and shall promptly examine or arrange for the examination of persons suspected of being infected…"; and that these facilities "shall comply with the requirements of the commissioner" of the New York State Department of Health (NYSDOH).

Section 2.10 of the State Sanitary Code codified in Title 10 (Health) of the Codes, Rules, and Regulations of the State of New York requires the reporting of cases or suspected cases or outbreaks of communicable disease, including chancroid, chlamydia, gonorrhea, lymphogranuloma venereum, hepatitis B virus and syphilis, as outlined in Section 2.1, by physicians.

The part of the State Sanitary Code codified in Sections 23.1 through 23.4 of Title 10 outlines the list of STDs, the rules for the examination by the health department of persons infected or suspected of being infected with STD; the reporting obligations for STD, and the requirement that either physicians or clinics providing gynecological, obstetrical, genito-urinary, contraceptive, sterilization, or termination of pregnancy shall offer every patient appropriate examination or tests for STD.

Legislative Objectives:

The following are proposed changes to Sections 2.10, 23.1, 23.2, 23.3 and 23.4 that deal with the reporting of cases or suspected cases or outbreaks of communicable disease by physicians, list of sexually transmitted diseases, treatment facilities, and STD reporting. These regulations meet the legislative objective of protecting the public health by removing archaic language, which requires the filing of written reports. In addition, language allowing reporting using patient's initials is equally archaic and is being removed. HIPAA regulations (45 CFR Parts 160 and 164) as well as other confidentiality protections currently make reporting by initials unnecessary. Further, the proposed legislation updates the list and the terminology used for conditions in Section 23.1 designated as requiring free diagnosis and treatment in Section 23.2 (c): specifically chlamydia, gonorrhea, syphilis, non-gonococcal urethritis, mucopurulent cervicitis, trichomoniasis, lymphogranuloma venereum, chancroid and granuloma Inguinale.

The syndromal condition, pelvic inflammatory disease (PID) is being added to the list of STDs requiring free diagnosis, but free treatment is not required for PID. The NYSDOH will promulgate diagnostic criteria for PID. Outpatient treatment may be offered by local health department STD clinics or a managed referral to another health care provider must take place. Local health departments must be able to confirm the follow-up of PID patients if requested by the NYSDOH. Confirmation includes facilitating the referral to another medical provider, ensuring that the patient attended the referral appointment, and verifying that treatment was provided. Facilities described in Part 23.2 (local health department clinics) must provide treatment for genital herpes simplex, ano-genital warts, and human papilloma virus on-site or by means of a written or electronic prescription or by referral to another provider. Yeast (candida) vaginitis, bacterial vaginosis, pediculosis pubis and scabies may be treated on site by the Part 23.2 facility or by means of a written or electronic prescription.

The proposed changes are consistent with the current guidance from the Centers for Disease Control and Prevention (CDC) as to what conditions constitute sexually transmitted diseases. The changes also clarify disease reporting requirements for medical providers and medical management requirements for local health departments.

Needs and Benefits:

A. Background

Proposed changes to Section 23.1 clarify and update the official list of STDs in NYS including NYC based on current medical technology and understanding. Proposed changes to Sections 23.1 and 23.2 also clarify and simplify local health department service responsibilities relating to STD control.

The CDC's Program Operations Guidelines for STD Prevention states "Medical services at the public STD clinic should be low or no cost, confidential, and convenient to avoid creation of barriers between the patient and the accessibility of services." Recommendations regarding the range of services include at a minimum that clinics should have the capacity to: accurately diagnose and treat bacterial STDs and to distribute medications for diseases diagnosed in the clinic. Medications "must be available for locally prevalent STDs, with prescriptions available for diagnosed diseases not prevalent in the community." The proposed regulations are consistent with these federal guidelines.

Modification of the treatment requirements for pelvic inflammatory disease in Section 23.2(e) will permit the local health department to either treat the patient on site free of charge OR immediately refer the individual for out-patient management to another medical facility.

The list of conditions in Sections 23.2 (d) and 23.2 (f) designated as requiring free diagnosis, permits the local health department to either treat the patient on site free of charge OR to treat with either prescription or referral. This list includes: genital herpes, ano-genital warts, human papilloma virus, yeast (candida) vaginitis, bacterial vaginosis, pediculosis pubis, and scabies. For genital herpes, free diagnosis would not include a requirement for providing antibody serologic testing as this is not considered a diagnostic test for acute or recurrent infection, but rather a screening test for past exposure that is useful for counseling purposes. Language relating to therapy for herpes infection is being updated since the preferred therapy is now firmly established. Part 23.2 facilities will have a choice of providing on-site treatment for herpes or providing a prescription.

If the local health department selects to treat with either prescription or referral for conditions listed in 23.2(d) or (f), or chooses the referral option for conditions listed in 23.2(e), they are absolved of the cost for treatment and will not be responsible for any residual costs of treatment that are not covered by the patient or insurance carriers.

In addition, for the purpose of these regulations, the cervical Papanicolaou (Pap) test, while an indirect indicator of human papilloma virus infection, is a screening test for cervical cancer rather than an STD. Thus, local health departments would not be required to offer cervical Pap tests free of charge. These changes are recommended based on the positive fiscal impact they will have on the local health department's provision of STD clinical services.

Section 23.3 has been eliminated since it is inconsistent with the reporting requirements of communicable diseases as written in Section 2.10. In addition, laboratories currently report test results electronically to the health departments. The counties are required to complete a case investigation and report morbidity to the state using the Communicable Disease Electronic Surveillance System (CDESS).

COSTS:

Costs to Regulated Parties:

The deletion of Sections 2.10(b) and 23.3 updates the Sanitary Code to reflect accepted practice, reporting by name only. There will be no increased costs to physicians as a result of this change.

Costs to Local and State Governments:

There would be no increased costs incurred from the changes to Part 23 to local health department facilities. Changes in the official list of STDs will have minimal cost impact on local health departments as most have already adopted the updated STD nomenclature. Clearly identifying those STDs that must be diagnosed and treated on site at local health departments, diseases diagnosed and referred for treatment, and diseases treated by prescription, will clarify vagaries of the regulations as currently written. These clarifications have been requested by local health department officials.

Local health departments are already required to provide free diagnosis of all the listed STD conditions. In fact, the proposed changes would actually serve to lessen the burden of costs to local health departments associated with the treatment of some selected conditions by permitting either referral or use of a written or electronic prescription. In addition, the local health departments may realize some increased revenues by having the ability to bill third parties for selected screening services which are considered "non-diagnostic" tests for the purposes of this section (i.e., herpes simplex antibody serology, and cervical Pap smears), a practice which is currently permitted for HIV antibody serologic testing.

Increased costs for services under Public Health Law section 602(3)(b) - disease control and 10 NYCRR sections 40-2.80 and 2.81 are expected to be negligible, in the $25,000 - $50,000 annual range statewide, as county health departments already have the diagnostic capability required in the proposed changes. Treatment costs are expected to remain stable since the medications recommended are inexpensive and more conditions can now be treated through prescription. In addition, clarifying which STDs can be treated by prescription or by referral may reduce overall costs thereby potentially lessening Article 6 costs to the state.

Costs to the Department of Health:

There would be no increased costs to the Department of Health as a result of these regulatory changes. The infrastructure of the state DOH to manage the proposed changes is in place. Medicaid costs for STDs are typically associated with care for complications of untreated disease. The proposed changes should decrease Medicaid costs by encouraging patients to visit local health departments for free diagnosis and treatment, thereby reducing complications which would normally require hospitalization. The Department of Health will maintain its commitment to assist counties with disease intervention activities including interviewing patients and partner notification.

Paperwork:

There will be no new paperwork associated with these changes. The proposed changes will result in decreased paperwork since written reporting is no longer required.

Local Government Mandates:

There are no new mandates associated with these regulatory changes. Current mandates are clarified, simplified, and worded in such a way as to eliminate additional financial burden on local governments.

Duplication:

There is no duplication of these regulatory changes in existing State or federal law.

Alternatives:

The Department considered no action to update these regulations, but determined that the proposed revisions would be more prudent.

The deletion of Section 2.10(b) and Section 23.3 removes archaic language in order to make the regulations consistent with current reporting practices.

The proposed changes to Part 23 clarify existing responsibilities of the local health department in providing diagnostic and treatment services for STD. Variations in the nomenclature of STDs and the diagnosis and treatment requirements reflect the most recent Program Operations Guidelines promulgated by CDC. For the most part, these changes are in place in local health departments and clarify vague language that has previously existed.

Federal Standards:

The proposed regulations are consistent with federal guidelines. The regulatory changes recommended are consistent with federal standards as promulgated in the CDC Program Operations Guidelines.

Compliance Schedule:

Compliance with these revisions of the Sanitary Code will be mandated upon filing of a Notice of Adoption of this regulation in the New York State Register.

Revised Regulatory Flexibility Analysis

Changes made to the last published rule do not necessitate revision to the previously published RFA.

Revised Rural Area Flexibility Analysis

Effect on Rural Areas:

The proposed regulatory changes will apply statewide and will affect reporting of STD by health care providers in the same manner across the state. The effect on rural health departments in the provision of services for the diagnosis and treatment of persons with STD or suspected STD infection within their jurisdiction will also be similar to the rest of the state. Analysis of STD data statewide shows that rural areas do not have a disproportionate number of STD cases.

Compliance Requirements:

There are no new compliance requirements associated with these proposed changes.

Professional Services:

No additional professional services will be required. Any additional needed training on reporting will be provided by the New York State Department of Health in multi-county meetings or on an individual basis as necessary or as requested. Clinical training will be made available by the Montefiore Medical Center STD Center for Excellence, a contractor for the Bureau of STD Prevention and Epidemiology.

Compliance Costs:

No additional costs will be incurred as a result of these revisions to the Sanitary Code.

Due to rising costs and decreased revenues, local health departments are struggling to maintain services as required by the Public Health Law and Sanitary Code. These proposed revisions should actually lessen the burden of costs associated with treatment for some conditions by allowing the use of prescriptions to meet the "treatment" requirement.

Minimizing Adverse Impact:

There will be no adverse impacts on reporting or clinical services as a result of these changes. The changes will likely enhance screening and have the potential for actually enhancing the scope of services for county residents who receive STD care through the local health department.

Feasibility Assessment:

There will be no increased workload associated with these revisions.

Rural Area Participation:

Local governments have been consulted in the process through communication with local health departments and the New York State Association of County Health Officers.

Revised Job Impact Statement

Changes made to the last published rule do not necessitate revision to the previously published JIS.

Assessment of Public Comment

The NYS Department of Health (NYSDOH) received written comments on the proposed amendments to Parts 2.1 and Part 23 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York from the New York City Department of Health and Mental Hygiene, (NYCDOHMH) and an anonymous entity. Each noted concerns with the proposed amendments which are summarized below, followed by the NYSDOH response.

Comment #1

The proposed regulations for Section 2.10 place reporting requirements solely on physicians which is overly restrictive. The provision should be revised to permit other licensed health care professionals who may provide care for a patient to report cases. In addition, the provision should clarify the meaning of the phrase "report to the health officer within whose jurisdiction such patient is." Finally, it is suggested that local health departments have the authority to waive the requirement to report in writing instead of limiting this authority to the State Commissioner of Health.

Response:

These comments are not commenting on the Department's proposed amendments; rather, these comments are proposing that the Department make additional amendments to a part of the regulation that the Department was not proposing to amend. Nevertheless, NYSDOH now proposes to modify the regulatory language in Section 2.10 to state "It shall be the duty of every physician to report to the city, county or district health officer, within whose jurisdiction such patient resides. . ."

Other licensed health care professionals who may provide care for a patient are permitted to report cases; nothing in these regulations prohibits them from doing so. Furthermore, it is permissible for a physician to designate another person, including another health care professional, to report cases on behalf of the physician.

The statutory authority to mandate reporting of cases is limited to the State Commissioner of Health and consequently, only the commissioner can approve requests to omit written reports.

Comment #2

The proposed § 23.1 presents the list or groups of sexually transmitted diseases that local health departments have responsibility for diagnosing and treating. However, the Regulatory Impact Statement states that the proposed changes to § 23.1 clarify and update the official reportable STDs in NYS including NYC. It is requested that NYSDOH change the relevant statement in the Regulatory Impact Statement to reflect that the proposed group of conditions in § 23.1 should be interpreted to apply to local health department responsibility for care and treatment and not to those STDs which are reportable.

Response:

NYSDOH agrees with the comment that the group of conditions listed in Section 23.1 represent those conditions for which the local health department is required to provide diagnosis and treatment. NYSDOH has amended the Regulatory Impact Statement for Part 23 in "Needs and Benefits: A. Background. Proposed changes to Section 23.1 clarify and update the official list of STDs in NYS including NYC based on current medical technology and understanding." The list of communicable diseases which must be reported is established in Section 2.1 and includes chancroid, chlamydia, gonorrhea, lymphogranuloma venereum, and syphilis.

Comment #3

The proposed regulation does not appear to permit direct treatment of Group B conditions by local health departments; the proposed language should be further revised to permit direct treatment and furthermore, health departments should also be permitted to bill for such treatment.

The proposed regulations that permit treatment by written prescription should be aligned with NYCRR 63.6(a)(7) and 8 NYCRR Part 29 which authorizes the use of electronic prescriptions in addition to written prescriptions.

Response:

NYSDOH agrees that local health departments should have the opportunity to provide care directly in the clinic for those conditions in Group B. Furthermore, NYSDOH agrees to reconcile § 23.1 with NYCRR 63.6(a)(7) and 8 NYCRR Part 29. However, NYSDOH does not agree that local health departments that choose to provide treatment directly for Group B conditions be authorized to bill for such treatment. PHL § 2304 is the basis for the proposed regulation and specifically states that diagnosis and treatment must be free. The revised regulations specify how such diagnosis and treatment may be offered but does not change section 2304 which requires that diagnosis and treatment must be free.

NYSDOH amended § 23.2 paragraph (d) to state "Any persons diagnosed as having any of the STDs in Group B in section 23.1 of this Part must be provided treatment either directly in the clinic or through a written or electronic prescription or referral. If treatment is provided directly, it must be provided free of charge." Article 6 funding permits local health departments to recover some of the costs of treatment for Group B conditions.

Comment #4

The proposed regulation does not clearly state that treatment for Group D conditions must be provided free of charge if local health departments choose to treat directly. The proposed regulations should be revised to permit local health departments to bill for Group D conditions that are treated directly.

Yeast should not be included in Group D as it is not always transmitted sexually. Furthermore, local health departments may not treat yeast infections as over the counter medication is available.

References to Pediulosis should be changed to Pediculosis.

Response:

NYSDOH does not agree that the local health department should have the authority to bill for conditions in Group D should it provide such treatment directly in the clinic. As stated in the NYSDOH response to the comment #3 regarding Group B conditions, PHL § 2304 is the basis for the proposed regulation and specifically states that diagnosis and treatment must be free. The revised regulations specify how such diagnosis and treatment may be offered but does not change § 2304 which requires that diagnosis and treatment must be free.

To clarify the financial responsibility of the local health department as regards treatment for Group D conditions, NYSDOH proposes to amend § 23.2 paragraph (f): "Any person diagnosed as having any of the STDs in Group D in § 23.1 of this Part may be provided treatment directly within the clinic or through a written or electronic prescription. If treatment is provided directly, it must be free of charge."

With respect to yeast, sexual transmission of yeast does occur. As it is not possible to distinguish between those cases which are sexually transmitted and those that are not, NYSDOH proposes to keep yeast in the list of Group D conditions to assure that those persons in need of diagnosis and treatment for this prevalent infection receive appropriate care without obstacle.

NYSDOH will also make technical correction to references to "Pediulosis" in the regulations and Regulatory Impact Statement.

Comment #5

In section 23.2, references are made to the use of clinical, laboratory or treatment guidelines for the diagnosis and treatment of persons infected with STDs as defined by 23.1. Requiring the use of such guidelines, which do not go through a regulatory approval process, limits health department flexibility in determining the best course of care. The language should be modified to permit health departments this flexibility.

Response:

NYSDOH distributes currently published CDC treatment and laboratory guidelines that are developed by a national panel of experts and are subject to a federal review and approval process. The CDC treatment guidelines provide recommendations based on current scientific evidence published in the literature. Furthermore, these guidelines provide options for treatment thereby establishing flexibility for providers. While federal guidelines are considered best practice, they do not prevent local health departments from using clinical judgment for management and treatment of persons diagnosed with an STD. NYSDOH intends to maintain the language in section 23.2 as written in order to ensure that patients can receive diagnosis and treatment consistent with federal recommendations.

Comment #6

The Regulatory Impact Statement states that NYSDOH will issue diagnostic criteria for PID and will require local health departments to confirm follow-up of patients with PID. Additional guidance is being sought on the requirements of local health department confirmation.

The Regulatory Impact Statement indicates that serologic testing for genital herpes antibody and pap smears for human papilloma virus do not need to be provided for free as these tests are not considered diagnostic. It would be useful to include these specifications in the regulations themselves. Furthermore, these regulations should be reconciled with proposed regulations for APG (10 NYCRR Subpart 86-8) to enable local health departments to bill for pap smears on a fee-for-service basis.

Response:

NYSDOH will establish criteria for PID that is based on federal guidelines as published by the CDC in its current STD Treatment Guidelines. The Regulatory Impact Statement provides that treatment of patients diagnosed with PID in local health departments may be via a "managed referral." The intent is to ensure that patients attend referral appointments and receive recommended treatment for this potentially serious syndrome. Follow-up confirmation by the local health department would include making the appointment for the client at the referral medical facility, confirming that the patient attended the appointment and verifying therapy for the patient's PID diagnosis.

NYSDOH has elected not to specifically identify in the proposed regulations which laboratory tests may or may not be used for diagnostic purposes and will not revise the language for Group B conditions to further elucidate those specific tests that are excluded. The current information in the Regulatory Impact Statement on pap smears and serologic testing for herpes antibody provides guidance for interpreting the regulations and will remain unchanged.

APG rate setting methodology and Medicaid reimbursement of pap smears is a separate issue and will not be addressed through these proposed regulations.

Comment #7

Guidance is sought on local health department reimbursement under Article 6 for treatment of Group C and D conditions for which it is not obligated to treat.

Response:

The STD policy statement which was jointly developed by NYSDOH and NYSACHO specifically establishes those conditions for which local health departments may recover Article 6 funding.

Comment #8

The statement that genital herpes serologic testing "is not considered a diagnostic test for acute or recurrent infection, but rather a screening test for past exposure that is useful for counseling purposes" is untrue. The diagnosis of recurrent genital herpes is challenging because viral culture is relatively insensitive in the absence of intact vesicles, and these vesicles may be absent or present for only a few hours in many patients with recurrent genital herpes. Polymerase chain reaction assays for herpes simplex virus are not a practical option for diagnostic purposes because of their high cost. In such settings, serologic testing is the preferred diagnostic option.

Response:

The comment is clinically inaccurate; serologic testing for genital herpes is not a diagnostic test.

Comment #9

Local health department clinics do not have the capacity or resources to establish billing systems for selected STD treatment services. Revenue generated through billing would be offset by the costs of establishing and operating such a system. There is concern that billing patients would create a disparity in the quality of services provided to those patients who can afford to pay compared to those who cannot.

Response:

These regulations do not require local health departments to bill patients or insurance carriers. For the conditions listed, local health department are either required to treat for free or have the option to treat by prescription or referral.

Comment #10

NYSDOH should have consulted with more local health districts in drafting this regulation.

Response:

NYSDOH broadly solicited comments on the proposed regulations. As stated in the regulatory impact statement, NYSDOH consulted with a number of professional organizations, including the New York State Association of County Health Officers, as well as local governments to seek input during the drafting of these regulations.

Comment #11

It is recommended that NYSDOH post all comments in real-time in order to permit greater transparency in NYS governmental operations, reduce potential for duplicate comments, and improve the quality of the regulations.

Response:

NYSDOH consulted widely in the development of these regulations in order to ensure representation of those consumers and stakeholders who would be impacted by the proposed rules. This consultation process promoted transparency, discussion, and quality of the regulations. Finally, this Assessment of Public Comment serves to inform all parties of the comments that were submitted in response to these regulations and the NYSDOH response.

Comment #12

If local health departments choose to treat STDs through prescription or referral, it would be helpful to clarify that the local health department is not be responsible for any residual costs of treatment that are not covered by the patient or third-party insurance.

Response:

NYSDOH does not intend for local health departments to accrue any cost burden associated with those conditions which may be treated through prescription or referral and will include additional language to this effect in the Regulatory Impact Statement.