HLT-14-10-00005-P Expedited Partner Therapy to Treat Chlamydia Trachomatis

4/7/10 N.Y. St. Reg. HLT-14-10-00005-P

NEW YORK STATE REGISTER

VOLUME XXXII, ISSUE 14

April 07, 2010

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-14-10-00005-P

Expedited Partner Therapy to Treat Chlamydia Trachomatis

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

Proposed Action:

Addition of section 23.4 to Title 10 NYCRR.

Statutory authority:

Public Health Law, section 2312

Subject:

Expedited Partner Therapy to Treat Chlamydia Trachomatis.

Purpose:

Use of expedited partner therapy to treat the partner of persons infected with Chlamydia Trachomatis.

Text of proposed rule:

Pursuant to the authority vested in the Commissioner of Health by Section 2312 of the Public Health Law, Part 23 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is hereby amended, by adding a new Section 23.4, to read as follows:

Section 23.4 Expedited Partner Therapy for Chlamydia trachomatis Infection

(a) Definitions. As used in this section:

(1) "Expedited Partner Therapy" or "EPT" means a practice whereby a health care practitioner chooses to provide a patient with either antibiotics intended for the patient's sexual partner or partners or a written prescription for antibiotics for the sexual partner or partners to be delivered by the patient to the sexual partner or partners for treatment of exposure to Chlamydia trachomatis.

(2) "Health care practitioner" means a physician, midwife, nurse practitioner, physician assistant, or other person who is authorized under Title 8 of the Education Law to diagnose and prescribe drugs for Chlamydia trachomatis, acting within his or her lawful scope of practice.

(b) Liability. A health care practitioner who reasonably and in good faith renders expedited partner therapy in accordance with section 2312 of the Public Health Law and this section, and a pharmacist who reasonably and in good faith dispenses drugs pursuant to a prescription written in accordance with section 2312 of the Public Health Law and this section, shall not be subject to civil or criminal liability or be deemed to have engaged in unprofessional conduct.

(c) Eligibility criteria for EPT. EPT shall:

(1) be provided only for the partner or partners of a patient diagnosed with Chlamydia trachomatis infection; and

(2) not be provided for any partner or partners, when the patient with Chlamydia trachomatis infection seen by the health care practitioner is found to be concurrently infected with gonorrhea or syphilis.

(d) Educational material requirements for patients provided with EPT. Each patient provided with antibiotics or a prescription in accordance with this section must be given informational materials for the patient to give to his or her sexual partner or partners. Each patient shall be counseled by his or her health care practitioner to inform his or her partner or partners that it is important to read the information contained in the materials prior to the partner or partners taking the medication.

The materials shall:

(1) encourage the partner to consult a health care practitioner for a complete sexually transmitted infection evaluation as a preferred alternative to EPT and regardless of whether they take the medication;

(2) disclose the risk of potential adverse drug reactions, including allergic reactions, and the possibility of dangerous interactions between the patient-delivered therapy and other medications that the partner may be taking;

(3) inform the partner that he or she may be affected by other sexually transmitted infections that may be left untreated by the delivered medicine;

(4) inform the partner that if symptoms of a more serious infection are present (such as abdominal, pelvic, or testicular pain, fever, nausea or vomiting) he or she should seek medical care as soon as possible;

(5) recommend that a partner who is or could be pregnant should consult a health care practitioner as soon as possible;

(6) instruct the patient and the partner to abstain from sexual activity for at least seven days after treatment of both the patient and the partner in order to decrease the risk of recurrent infection;

(7) inform a partner who is at high risk of co-morbidity with HIV infection that he or she should consult a health care practitioner for a complete medical evaluation including testing for HIV and other sexually transmitted infections; and

(8) inform the patient and the partner how to prevent repeated chlamydia infection.

(e) Prescription format. Whenever a health care practitioner provides EPT through the use of a prescription:

(1) the designation "EPT" must be written in the body of the prescription form above the name of the medication and dosage for all prescriptions issued;

(2) if the name, address, and date of birth of the sexual partner are available, this should be written in the designated area of the prescription form; and

(3) if the sexual partner's name, address, and date of birth are not available, the written designation "EPT" shall be sufficient for the pharmacist to fill the prescription.

(f) Reporting of cases of Chlamydia trachomatis by health care providers.

(1) This section shall not affect the obligation to report individual cases and suspected cases of Chlamydia trachomatis imposed by Part 2 of this Chapter.

(2) Reports of cases of Chlamydia trachomatis who are provided with EPT shall include the added designation of "EPT" plus the number of sexual partners for whom a prescription or medication was provided.

Text of 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:

45 days after publication of this notice.

Regulatory Impact Statement

Statutory Authority:

Section 2312 of the Public Health Law (PHL) requires the Commissioner to promulgate rules and regulations concerning the implementation of the statute. The proposed regulation represents a consensus of interested parties and reflects the recommendations of the Centers for Disease Control and Prevention (CDC) regarding strategies to control Chlamydia trachomatis.

Legislative Objectives:

The proposed regulation meets the legislative objective of putting into effect rules and regulations concerning the implementation of PHL section 2312, which permits the use of expedited partner therapy (EPT) to treat the partners of persons infected with Chlamydia trachomatis. The regulation defines EPT and provides that practitioners who use EPT for their patients' sexual contacts, and pharmacists who fill EPT prescriptions, in good faith and consistent with section 2312 and the regulation would not be subject to criminal or civil liability. In addition, the regulation provides a detailed outline of the educational steps that are required of health care practitioners employing EPT, describes the permissible manner of writing a prescription for EPT when partner identifying information is not known, and clarifies provider reporting requirements when EPT is used. The proposed regulation provides the guidance and clarity necessary to fulfill the legislative intent, which is to make EPT an available intervention to control the spread and reduce the complications of Chlamydia trachomatis.

Needs and Benefits:

The proposed addition of section 23.4 to 10 NYCRR Part 23 will provide an intervention option to health care providers and local health departments for responding to the increasing number of chlamydia cases being reported in New York State. In 2001 there were 46,391 cases of chlamydia reported in New York State, and by 2006, 68,725 cases were reported, nearly a 50 percent increase. Data from 2008 indicate that over 88,000 cases of chlamydia were reported. This increase has strained existing resources for controlling sexually transmitted diseases and has prompted consideration of alternative methods for addressing highly prevalent infections such as Chlamydia trachomatis.

The most recent sexually transmitted disease treatment guidelines for chlamydia issued by the CDC in 2006 states that "delivery of antibiotic therapy (either a prescription or medication) by heterosexual male or female patients to their partners might be an option." Based on the evidence from three published randomly controlled trials of EPT, the CDC found that the practice has the potential for preventing re-infection of the index case and providing a slightly higher likelihood of partner treatment as compared with unassisted patient self-referral of partners. EPT provides a relatively safe and simple way to address the high chlamydia morbidity burden at a time when existing infrastructure is inadequate to provide services for exposed partners. The CDC recommendation for use of EPT has been actively supported by organizations such as the American College of Obstetrics and Gynecology, Family Planning Advocates, and the American Academy of Pediatrics.

Patients who are co-infected with chlamydia and either gonorrhea or syphilis are deemed ineligible for EPT because one gram of azithromycin provided as treatment for chlamydia could result in partial treatment of gonorrhea or syphilis, if present in the partner. Partial treatment of these infections could lead to later development of complications from inadequate initial treatment or of drug resistance.

To date, 16 states have adopted EPT as a strategy for controlling the spread of Chlamydia trachomatis and its associated complications. However, since reporting is not required in the states that have implemented the practice in the Western United States, no data is available to predict how often providers will utilize EPT in New York State. Proposed 10 NYCRR section 23.4 will require providers to indicate use of EPT when reporting cases of Chlamydia trachomatis, which may allow the Department of Health to track its use prospectively.

Costs:

Costs to Regulated Parties:

There is no mandated requirement that health care providers use EPT. There may be an increased cost to health care providers who choose to use EPT by directly providing the index case with medication to give their partners. The cost to treat uncomplicated Chlamydia trachomatis using the recommended dosage of Azithromycin (one gram single oral dose) ranges from approximately $12.00 (public health price) to $25.00 (retail pharmacy cost). This regulation also permits the use of a prescription for EPT, an option which, if chosen, would remove any cost to providers.

If the index case or his or her partner or partners do not have health insurance, they will be personally responsible for the cost of the drugs prescribed for EPT. Medicaid also places limitations on the use of EPT, as current rules do not allow prescribing medications for persons other than the patient seen by the provider.

Cost to Local and State Government:

There may be an increased cost incurred by local health departments by adding the proposed section 23.4 to 10 NYCRR Part 23; if local sexually transmitted disease care facilities voluntarily decided to provide the index case with medication to give their partners they will incur an increased cost. However, since this regulation permits the use of a prescription for EPT, any cost to local government can be avoided. Again, there is no mandate that local governments must utilize EPT.

Cost to the Department of Health:

There would be no increase in costs to the Department of Health as a result of this regulatory change, since the Department does not offer clinical care for Chlamydia trachomatis. The cost of developing the educational materials referred to in the proposed regulation will be absorbed into the operating budget of the Department's Bureau of STD Control. These materials will then be posted on the Department's website so that providers can download them as needed for distribution to patients when EPT is used.

Paperwork:

There will be no new paperwork associated with these changes, except for the writing of "EPT" on relevant prescriptions and case report forms.

Local Government Mandates:

There are no new mandates associated with this regulatory change. The use of EPT is optional.

Duplication:

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

Alternatives:

There is no alternative to adding this regulation as the change in PHL section 2312 requires the promulgation of this regulation.

Federal Standards:

The proposed regulations are consistent with federal guidelines promulgated by the CDC.

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.

Regulatory Flexibility Analysis

Effect of Rule:

The regulatory changes apply to the treatment of partners to persons infected with Chlamydia trachomatis. There will he no effect on small business or local governments since the proposed regulation is permissive and does not require the use of EPT.

Compliance Requirements:

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

Professional Services:

No additional professional services will he required.

Compliance Costs:

No additional costs will be incurred by this revision to the Sanitary Code.

Minimizing Adverse Impact:

There will be no adverse impact to any of the parties affected by this regulatory change. PHL section 2312 specifically provides that providers who use EPT in good faith and in a manner consistent with the proposed regulation will not be subject to criminal or civil liability.

Economic and Technological Feasibility:

There will be no increased workload associated with these revisions.

Small Business and Local Government Participation:

The Department consulted with multiple stakeholders when crafting this regulation, including:

American Academy of Pediatrics;

Academy of Family Practitioners;

Medical Society of New York State;

Office of the Professions, State Education Department;

Association of Nurse Midwives;

Family Planning Advocates;

American College of Obstetricians and Gynecologists;

Association of Independent Pharmacies;

Association of Chain Pharmacies;

New York City Department of Health and Mental Hygiene;

Dutchess County Department of Health;

Erie County Department of Health; and

New York State Association of County Health Officials.

Suggestions were incorporated regarding eligibility and education/counseling messages. While the State Sanitary Code requires reporting of "suspect" cases of communicable diseases, some advocates resisted including a reporting requirement of partners receiving EPT with names and demographic information as suspect Chlamydia trachomatis cases. Negotiations resulted in a compromise for providers to indicate the use of EPT when reporting cases along with the numbers of partners provided medication or prescriptions.

Rural Area Flexibility Analysis

Effect in Rural Areas:

The proposed regulation will apply statewide. The proposed regulation is permissive, not mandatory, and therefore will not have any undue affect on rural local health departments.

Compliance Requirements:

There are no compliance requirements associated with this proposed regulation.

Professional Services:

No additional professional services will be required.

Compliance Costs:

No additional costs will be incurred as a result of this addition to the Sanitary Code.

Minimizing Adverse Impact:

No adverse impacts are expected as a result of adding this proposed regulation to the Sanitary Code.

Economic and Technological Feasibility:

There will be no increased workload with these revisions.

Rural Area Participation:

The Department consulted with multiple stakeholders when crafting this regulation; including:

American Academy of Pediatrics;

Academy of Family Practitioners;

Medical Society of New York State;

Office of the Professions, State Education Department;

Association of Nurse Midwives;

Family Planning Advocate;

American College of Obstetricians and Gynecologists;

Association of Independent Pharmacies;

Association of Chain Pharmacies;

New York City Department of Health and Mental Hygiene;

Dutchess County Department of Health;

Erie County Department of Health; and

New York State Association of County Health Officials.

Suggestions were incorporated regarding eligibility and education/counseling messages. While the State Sanitary Code requires reporting of "suspect" cases of communicable diseases, some advocates resisted including a reporting requirement of partners receiving EPT with names and demographic information as suspect Chlamydia trachomatis cases. Negotiations resulted in a compromise for providers to indicate the use of EPT when reporting cases along with the numbers of partners provided medication or prescriptions.

Job Impact Statement

The proposed regulatory change will not increase demands on existing staff or increase the need to hire additional staff for providers or local health departments, and therefore will not have an adverse impact on jobs and employment.