EXPEDITED PARTNER THERAPY H.B. 4736 (H-2):
SUMMARY OF HOUSE-PASSED BILL
IN COMMITTEE
House Bill 4736 (Substitute H-2 as passed by the House)
Sponsor: Representative George Darany
House Committee: Health Policy
Senate Committee: Health Policy
CONTENT
The bill would amend the Public Health Code to do the following:
-- Authorize a health professional, under specific circumstances, to provide expedited partner therapy (EPT), i.e., dispense or prescribe a drug or treatment for the partner of a patient diagnosed with a sexually transmitted infection (STI) without directly examining the partner.
-- Require the Department of Community Health (DCH) to maintain a list of STIs for which EPT was appropriate.
-- Require a health professional to dispense or prescribe therapy in the name of "expedited partner therapy" if the partner's name were unknown.
-- Require the DCH to develop and distribute an information sheet that included information regarding EPT, antibiotic treatment for STIs, and other information.
-- Provide that a health professional would not be liable for damages in a civil action or subject to administrative action in connection with the provision of EPT, unless his or her action was grossly negligent.
-- Provide exceptions to certain requirements regarding documentation of a patient's personal information related to prescription drugs in the case of EPT.
The bill specifies an effective date of January 1, 2014.
Prevention & Control of Diseases & Disabilities
The bill would authorize EPT to protect and promote the public health of individuals in Michigan. The bill states, "Expedited partner therapy is authorized to protect individuals in this state from the spread of sexually transmitted infections, which can cause infertility and ectopic pregnancies".
"Expedited partner therapy" would mean the indirect treatment of a partner of a patient who has been diagnosed as having an STI through the dispensing or prescribing of antibiotic drug or other treatment that is the standard of care for STIs in accordance with guidelines established by the Federal Centers for Disease Control and Prevention (CDC) for the treatment of the partner without the physical examination of the partner by a health professional. "Health professional" would mean either of the following:
-- An individual licensed or otherwise authorized to engage in a health profession under Article 15 (Occupations) and whose scope of practice included the diagnosis and treatment of STIs.
-- For the purpose of dispensing therapy under the bill, a pharmacist who was licensed or otherwise authorized to engage in the practice of pharmacy under Article 15.
"Sexually transmitted infection" would mean one of the following:
-- Until the DCH established a list, an STI for which the CDC recommended the use of EPT.
-- On and after that date, an STI included in the DCH's list.
The DCH could promulgate rules that it determined necessary to implement and administer the bill's requirements.
The Code requires the DCH to maintain a list of reportable diseases, infections, and disabilities that designates and classifies them as communicable, serious communicable, chronic, or noncommunicable; and review and revise the list at least annually. Under the bill, the DCH would have to include in this list a separate list of STIs for which EPT as authorized by the bill was appropriate. In developing the list, the DCH would have to consult with the CDC and health professionals in Michigan.
In addition to treating his or her patient, a health professional could provide EPT if the patient met all of the following requirements:
-- Had a laboratory-confirmed or suspected clinical diagnosis of an STI.
-- Indicated that he or she had a partner with whom he or she had engaged in sexual activity within the 60-day period immediately before the diagnosis.
-- Indicated that his or her partner was unable or unlikely to seek clinical services in a timely manner.
A health professional who provided EPT would have to dispense or prescribe the therapy in the name of the partner, if known, without physically examining the partner. Notwithstanding any provision of the Code or rules to the contrary, if the partner's name were not known, the health professional would have to dispense or prescribe the therapy in the name of "expedited partner therapy". Additionally, the health professional would have to do the following:
-- Convey to the patient that it was important to notify his or her partner of his or her diagnosis and that it was important for the partner to obtain medical care for a complete evaluation, testing for STIs, counseling, and treatment.
-- Distribute to the patient an information sheet developed by the DCH.
The DCH would have to develop and distribute to local health departments and, upon request, to health professionals subject to the bill an information sheet that included all of the following information:
-- A description of EPT and its purpose.
-- A statement that a common therapy for certain STIs is antibiotic therapy.
-- Important warnings and information of which the reader should be aware, if the EPT dispensed or prescribed for the reader included antibiotic therapy.
-- A warning about the dangers of administering certain antibiotic therapies to a pregnant individual.
-- Information about antibiotics dispensed or prescribed in antibiotic therapy and dosages of those antibiotics dispensed or prescribed.
-- A warning about the risk of allergies to and drug interactions with such antibiotics.
-- Information about STIs, as well as diagnosis and treatment.
-- A notice that the partner should be tested for STIs.
-- A notice of the risk to the patient, his or her partner, and others, including the public health, if an STI were not treated completely.
-- A notice of the patient's responsibility to notify his or her sexual partners of the risk of STIs and the importance of examination and treatment for STIs.
-- A statement advising any individual who had any questions regarding anything in the information sheet to contact his or her health professional or local health department.
-- A statement that the cost of drugs dispensed pursuant to a prescription issued in the name of EPT had to be paid by the individual filling the prescription if he or she did not have prescription drug coverage under a health benefit plan or third-party reimbursement arrangement.
These requirements would not require a health benefit plan or third-party reimbursement arrangement to pay for or provide reimbursement for authorized EPT unless the partner who received it were listed as a member, subscriber, contract holder, or beneficiary under the plan or arrangement.
Except as otherwise provided, a health professional who provided expedited partner therapy as authorized would not be liable for damages in a civil action or subject to administrative action under Sections 16221 and 16226 for personal injury, death, or other consequences arising from or related in any way to the provision of EPT by the health professional. This provision would not apply if the health professional's action in providing EPT were gross negligence.
(Under Section 16221, the Department of Licensing and Regulatory Affairs may investigate activities related to the practice of a health profession by a licensee, a registrant, or an applicant for licensure or registration, and report its findings to the appropriate disciplinary subcommittee. If it finds that certain grounds exist, the disciplinary subcommittee must proceed under Section 16626, which prescribes sanctions a subcommittee must impose for specific violations.)
Pharmacy Practice & Drug Control
Dispensing Prescriber. The Code authorizes a dispensing prescriber to dispense prescription drugs only to his or her own patients. Under the bill, this provision would apply except as otherwise authorized for EPT.
A dispensing prescriber must include in a patient's chart or clinical record a complete record, including prescription drug names, dosages, and quantities, of all prescription drugs dispensed directly by the prescriber or indirectly under his or her delegatory authority. Under the bill, this provision would include authorized EPT. In a patient's chart or clinical record, a dispensing prescriber must distinguish between prescription drugs dispensed to the patient and those prescribed for the patient. The bill would include prescription drugs dispensed or prescribed for EPT among those between which the prescriber must distinguish. (A dispensing prescriber must maintain this information for at least five years after it is entered in the chart or record.)
The Code requires a dispensing prescriber to dispense a drug in a container that bears a label containing certain information, including the patient's name and record number. Under the bill, this requirement would apply except as otherwise authorized for EPT.
Out-of-State Prescription. Under the Code, a pharmacist may dispense a prescription written by a physician or dentist prescriber in another state only if the pharmacist determines, in the exercise of his or her professional judgment, that the prescription was issued pursuant to an existing physician-patient or dentist-patient relationship. Under the bill, this would apply except as otherwise authorized for EPT.
Electronic Prescription. The Code provides for the electronic transmission of a prescription if certain conditions are met. The prescription must contain specific information, including the
full name of the patient for whom the prescription is issued. Under the bill, this requirement would apply except as otherwise authorized for EPT.
Prescription Receipt. A pharmacist must furnish to a prescription drug purchaser a receipt evidencing the transaction. The receipt must contain specific information, including the name of the patient for whom the drug was prescribed. Under the bill, this requirement would apply except as otherwise authorized for EPT.
MCL 324.17745 et al. Legislative Analyst: Julie Cassidy
FISCAL IMPACT
The bill would have a net positive fiscal impact on State and local government by decreasing costs related to the treatment of sexually transmitted diseases. By allowing expedited partner therapy, the bill would lead to a decrease in control program costs related to reinfection and untreated sexually transmitted disease. The same cost decreases also would be reflected in health care costs for governmental employees. This positive impact would outweigh the minor negative fiscal impact on the State of creating informational materials and the optional promulgation of rules related to EPT. The DCH estimates a cost of less than $5,000 for the creation of informational material, all of which could be covered through existing Federal grant funding.
For FY 2013-14, the DCH budget includes funding of $6.2 million Gross ($795,600 GF/GP) for the sexually transmitted disease control program.
Fiscal Analyst: Ellyn Ackerman
This analysis was prepared by nonpartisan Senate staff for use by the Senate in its deliberations and does not constitute an official statement of legislative intent.