RULES AND REGULATIONS
Title 4--ADMINISTRATION
Title 28--HEALTH AND SAFETY
DEPARTMENT OF HEALTH
[4 PA. CODE CH. 263]
[28 PA. CODE CHS. 701 AND 715]
Drug and Alcohol Facilities and Services
[32 Pa.B. 5638] The Department of Health (Department) amends the standards for approval of narcotic treatment programs by deleting 4 Pa. Code Chapter 263 (relating to methadone), amending 28 Pa. Code Chapter 701 (relating to general provisions) and adding 28 Pa. Code Chapter 715 (relating to standards for approval of narcotic treatment programs) to read as set forth in Annex A.
A. Purpose of the Final-Form Rulemaking
The purpose of this final-form rulemaking is to revise and update current narcotic treatment standards for the approval of narcotic treatment programs to conform with updated Federal regulations and requirements. The Federal regulations were revised in 1994, and again several years ago, and treatment of the narcotic addict has changed over the past 25 years. Therefore, the need exists to amend the State methadone regulations to more closely align with the Federal regulations, as well as to incorporate current treatment practices for narcotic addicts.
The Department's Division of Drug and Alcohol Program Licensure (Division) inspects narcotic treatment programs on an annual basis.
Chapter 715 replaces the deleted methadone treatment regulations in 4 Pa. Code Chapter 263. Those regulations, as applied, were not consistent with current health practices or Federal requirements. They were more burdensome than Federal regulations.
B. Comments
Chapter 701. General Provisions
Subchapter A. Definitions Section 701.1. General definitions.
This section defines terms used in Part V (relating to drug and alcohol facilities and services).
Comment
The definition of the term ''agent'' should not contain within its parameters the term being defined, rather, the word ''agent'' should be replaced with a more appropriate term such as ''controlled substance.''
Response
The Department agrees. The word ''agent'' has been removed from the definition and replaced with the word ''substance.''
Comment
The proposed definition of ''controlled substance'' includes the phrase ''or as added, deleted or rescheduled by regulation.'' This phrase renders the definition inconsistent with this statutory definition and should be removed from the definition.
Response
The Department agrees. The phrase ''or as added, deleted or rescheduled by regulation'' has been deleted.
Comment
The lengthy phrase ''Commonwealth approved opioid pharmacotherapy agent'' included in the proposed term and definition of ''detoxification of a narcotic dependent person utilizing a Commonwealth approved opioid pharmacotherapy agent'' should be changed to the single word ''agent'' which is already defined in this subchapter.
Response
The Department agrees. The phrase ''Commonwealth approved opioid pharmacotherapy agent'' has been replaced with the term ''agent'' to provide clarity. The Department has made this substitution throughout the final-form rulemaking.
Comment
According to the proposed definition of ''maintenance treatment,'' the goal of maintenance is to achieve stabilization or prevent withdrawal symptoms for treatment of an individual with opiate dependency rather than to assist the client in permanently discontinuing the use of dependency producing substances. The Department should explain the rationale behind the change in the goal of the Commonwealth's maintenance program. Further, the proposed definition is inconsistent with the Federal regulations at 42 CFR 8.2 (relating to definitions), which provide two types of treatment: comprehensive maintenance treatment and interim maintenance treatment. The definition should be consistent with the Federal definition of ''maintenance treatment.''
Response
According to research by Alan Leshner, Ph.D., Director of the National Institute on Drug and Abuse, National Institute of Mental Health Addiction and the Brain, addiction is a disease of the brain requiring long-term maintenance for many individuals, and possibly permanent maintenance for some. In addition, the Department has decided to limit the definition as proposed to only provide for comprehensive maintenance treatment. The Department does not believe that it is in the best interest of patients to receive ''interim maintenance treatment'' because that would allow for medicating patients without counseling or treatment. Accordingly, the Department does not believe its definition of ''maintenance treatment'' is inconsistent with Federal regulations.
Other Changes
The Department has added a definition for the term ''medication unit'' since § 715.25 (relating to prohibition of medication units) prohibits the use of medication units and the term had not been defined in the proposed rulemaking. This definition is in line with the Federal definition of ''medication unit.''
The Department has added the words ''narcotic treatment'' before the words ''physician'' and ''program'' for clarity and consistency throughout the regulations. The Department has also added a definition for ''psychotherapy'' since that term has been added in § 715.19 (relating to psychotherapy services). The Department has also deleted the definition of and reference to ''Federal Food and Drug Administration (FDA)'' and added a definition for the ''Center For Substance Abuse Treatment (CSAT)'' since the functions previously performed by the FDA are now performed by CSAT.
Chapter 715. Standards for Approval of Narcotic Treatment Program Section 715.1. General provisions.
This section requires approval from the Department to operate a narcotic treatment program and approval is contingent upon compliance with all applicable State and Federal laws and regulations. The Department received no comment on this section. It made a minor revision to clarify that the section relates to narcotic treatment programs.
Section 715.2. Relationship of Federal and State regulations.
This section provides that a narcotic treatment program must comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.
Comment
Subsection (b) of the proposed rulemaking should be amended to delete the last sentence. If the Department is or becomes aware of conflicts with Federal requirement, the Department should amend its regulations to address the conflicts rather than state, ''when there is a conflict between this chapter and the Federal regulations, the stricter standard shall apply.'' Also, the term ''complement'' in subsection (b) should be replaced with ''supplement'' or ''supersede'' to provide clarity as to what the Department is intending to convey by the phrase ''this chapter is intended to complement the Federal regulations. . . .''
Response
The Department agrees. The phrase ''when there is a conflict between this chapter and the Federal regulation, the stricter standard shall apply'' has been deleted from subsection (b) of the regulation. The word ''supplement'' in subsection (b) has replaced the word ''complement.''
Section 715.3. Approval of narcotic treatment programs.
This section sets forth the process by which a narcotic treatment program shall obtain and maintain licensure and approval for operation within this Commonwealth.
Comment
The Department should define and explain its intent in using the term ''designee'' in the phrase ''an entity shall apply for and receive approval as required by the Department, the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA) or designee'' in subsection (a). It is not clear from the regulation who a ''designee'' may be under the proposed rulemaking.
Response
The Department agrees. The term ''designee'' has been replaced by the phrase ''an organization designated by the Substance Abuse and Mental Health Services Administration under the authority of 21 U.S.C.A. § 823; 42 U.S.C.A. §§ 257a, 290aa(d), 290dd-2, 300x-23, 300x-27(a) and 300y-11.''
Comment
Proposed subsection (d) provides that the Department may inspect the narcotic treatment program without notice whereas the existing regulation at 4 Pa. Code § 263.3(e) states that ''inspections will occur without notice to the methadone project.'' The Department should explain the rationale behind removing mandatory no-notice inspections from the regulation. Subsection (d) does not articulate what standards will be used by the Department to determine which narcotic treatment programs will be inspected without notice and with notice.
Response
The Department has not revised the proposed rulemaking. The section provides that inspections may occur without notice to the narcotic treatment program and shall occur during any regular business hours of the narcotic treatment program. The general standards for all drug and alcohol treatment facilities is that notice is provided for annual renewal inspections. The Department is being consistent in this section. The Department may still conduct inspections without notice when it investigates complaints or conducts a plan of correction follow-up, for example.
Comment
The phrase ''within the provisions of State and Federal confidentiality regulations'' contained in subsection (e) of the proposed rulemaking is a vague reference which does not afford notice of the specific requirements which must be satisfied under State and Federal regulations.
Response
The Department agrees. The specific citations 42 CFR Part 2.53 (relating to audit and evaluation activities) and 28 Pa. Code §§ 709.15 and 711.15 (both relating to right to enter and inspect) are referenced in subsection (e).
Comment
Proposed subsection (g) removes the 60-day time limit for programs to correct deficiencies. The Department should explain its rationale and the benefits to be derived from the removal of the maximum time limit.
Response
The Department does not wish to be bound by a specific time frame, rather, it wishes to examine each case on a deficiency-by-deficiency basis. Adopting the language of subsection (g)(2) permits flexibility in the time in which deficiencies must be corrected. Also, the word ''conditional'' has been removed. There is no provision for, or definition of, ''conditional'' approval. The Department will either approve or not approve under this section.
Comment
Proposed subsection (h)(2) is not clear as to when the Department would require the submittal of plans of correction: within 15 working days after onsite inspection or within 15 working days after the program receives the results of the onsite inspection. Also, the exact meaning of ''working days'' is unclear in the proposed rulemaking.
Response
The Department agrees and has changed the regulation. Results of site inspections are distributed to a program on the last day of the inspection. The narcotic treatment program will have 21 days from the last day of the site inspection to submit its plan of correction to the Department.
Other Changes
The Department has added a reference to 28 Pa. Code Chapter 705 (relating to physical plant standards) in subsection (b). Chapter 705 became effective on March 2, 2002, and also applies to narcotic treatment programs.
Section 715.4. Denial, revocation or suspension of approval.
This section outlines when approval will be denied, revoked or suspended due to noncompliance by an applicant or a program.
Comment
Proposed subsection (a) does not allow any opportunity for providers to appeal issues related to noncompliance, expansion or capacity. The proposed rulemaking only addresses denial or revocation of approval. The Department should preserve an option for approval comparable to that in the existing standard. Also, providers should have the opportunity to appeal to another entity rather than resubmitting their appeal to the same entity that initially gave a negative response.
Response
The Department has not changed the section in response to this comment. An appeal mechanism currently exists for narcotic treatment programs to appeal overall Department approval decisions. See § 715.3 (relating to approval of narcotic treatment programs). A formal appeal process on issues relating to matters of noncompliance where the Department requests a plan of correction is inappropriate because a request for a plan of correction is not a final agency decision. If a program does not comply with a request for a plan of correction, the Department will take administrative action. If that administrative action is adverse to the facility, it may appeal from that decision.
Section 715.5. Patient capacity.
This section sets out the criteria to be used by the Department in reviewing a request by a program for an increase in patient capacity.
Comment
The phrase ''may limit'' in the first sentence is too broad. The Department should clarify whether it intends to use this section for another purpose such as lowering the permitted patient capacity of the program and, if so, amend the first sentence accordingly. The Department should also examine whether this section can supercede the staffing ratios in proposed § 715.7 (relating to dispensing or administering staffing). This section would require written approval of the Department to be ''based upon periodic monitoring and review.'' It is unclear as to the exact time frame intended by the term ''periodic.'' Lastly, criteria for the evaluation of the factors in proposed paragraphs (1)--(4) should be established.
Response
The Department agrees with these recommendations. The phrase ''may limit'' in the first sentence of this section has been replaced with the phrase ''may increase or decrease.'' This section does not supersede § 715.7. The Department would not approve an increase in capacity that would conflict with the required ratios.
The following criteria will be used by the Department in evaluating the factors in paragraphs (1)--(5): (1) Safety--considerations include dispensing time, internal patient flow and external traffic patterns; (2) Physical facility--considerations include number and size of counseling office, waiting area, restrooms, and dispensing and nursing windows; (3) Staff size and composition--considerations include the number of physician, dispensing and counseling staff; (4) Ability to provide required services--considerations include compliance with licensing and narcotic treatment program regulations as determined during licensing, monitoring and special visits to the program; and (5) Availability and accessibility of service--considerations include the location of the narcotic treatment program and the hours of operation. These criteria are reflected in the final amendments.
Section 715.6. Physician staffing.
This section establishes the staffing ratios and requirements for narcotic treatment physicians providing treatment to patients in methadone treatment programs.
Comment
Proposed subsection (a)(2) provides that ''the interim medical director shall meet the qualifications within 24 months of being hired.'' The 24-month time limit is unreasonable and should be amended. Examinations by the American Society of Addiction Medicine are held roughly every 2 years. To sit for an exam, a physician must document 1-year full time equivalent (FTE) experience in addiction medicine. Further, for many narcotic treatment programs, physicians are recruited from the community. They may not have sufficient time dedicated in a field to be able to comply with this regulation and sit for the exam within 24 months after being hired. A training program documenting specific education in addiction and narcotic treatment should suffice to guarantee that the narcotic treatment program has a current and up-to-date practitioner.
Response
The Department accepts this recommendation in part. The Department has changed the 24-month time limit to a more reasonable 36-month time period for the narcotic treatment program physician to meet all the qualification requirements contained in the regulation. However, the Department will not accept training in lieu of compliance with the regulations.
Comment
Proposed subsection (a)(3)(i) requires a medical director to supervise ''program physicians.'' Proposed subsection (b) states that programs may employ ''narcotic treatment physicians to assist the medical director.'' The section is unclear as to whether the two positions are interchangeable or serve separate functions. The Department should use either of the terms consistently throughout the regulations and amend the definitions in § 701.1 (relating to general definitions) accordingly.
Response
The Department agrees that the use of ''physicians'' and ''narcotic treatment physician'' in proposed subsection (a)(3)(i) and (b) was unclear and inconsistent. Additionally, there were many other places in the proposed regulations where there was inconsistent use of these terms. The Department now uses the term ''narcotic treatment physician'' consistently throughout the regulations. Also, there was inconsistent use of the terms ''narcotic treatment program,'' ''treatment program'' and ''program.'' The term ''narcotic treatment program'' is now used consistently throughout.
Comments
Proposed subsections (d) and (e) contain the staffing ratios for physicians and other licensed and certified health care professionals providing treatment to patients in narcotic treatment programs. The 1:10 physician-hour per week per patient ratio in subsection (d) is excessive, unnecessary, costly and unreasonable. The economics of narcotics addiction treatment for smaller clinics simply does not allow for a large and unnecessary allocation to physician services. Further, other states impose no physician-patient requirements on narcotic treatment programs. The Department should consider amending the ratio to a maximum of 1:25 or a minimum of 1:15. If the Department elects not to amend its ratios, at a minimum, the Department should explain how the ratios were developed and whether each ratio is the most reasonable and appropriate to protect public health, safety and welfare.
The staffing ratios in proposed subsection (e) would require that ''one-third of all required physician time shall be provided by a physician'' and ''time provided by other licensed certified health care professionals may not exceed two-thirds of the required physician time.'' The proposed rulemaking would exceed the regulations of advance practice nurses and physician assistants. The Department should explain how the ratios were developed and whether each ratio is the most reasonable and appropriate ratio for the protection of public health, safety and welfare.
Response
The Department has developed the ratios in subsections (d) and (e) through extensive research. The Department recognizes that physician time is costly but finds the arguments for maintaining the current ratio persuasive. Accordingly, it prefers to maintain the requirement of 1 hour per week of onsite physician time for every ten patients, as proposed. This guideline for physician coverage was established by the Federal government in 1990. Methadone treatment is a medically directed service. Many patients who are currently enrolled in narcotic treatment programs exhibit complex and multiple medical disorders, both physically and emotionally. Patients are concurrently taking medication for TB, HIV, hepatitis B and hepatitis C, all of which interact with methadone and require ongoing physician monitoring. Further, the nature of methadone treatment requires physician presence for supervision of patient care to maintain the credibility of methadone treatment in the medical and clinical community.
In response to cost concerns, the Department has reduced physician involvement by permitting the use of physician assistants and certified registered nurse practitioners in the ratio. Only 1/3 of the time must be physician time. In response to the comment that other states impose no physician-patient ratios, the Department agrees that it is true that some states impose no requirements. However, several states do require physician hours and several other states are considering readoption of the requirements for physician hours due to problems experienced as a result of insufficient physician coverage. The Department is allowing for up to 2/3 of physician time to be met through the use of physician assistants or certified registered nurse practitioners. Accordingly, the Department has not changed the section.
Comment
Proposed subsection (f), which provides that ''two hours of physician assistant or certified registered nurse practitioner time shall be equivalent to one hour of physician time,'' is both unnecessary and restrictive. One hour of service from these licensed health care providers should be fully considered as it is in physician offices, emergency rooms and other medical facilities. The Department should explain how the ratios were developed and whether each ratio is the most reasonable and appropriate to protect public health, safety and welfare.
Response
The Department has reconsidered this requirement and agrees. The revisions in subsection (e) render subsection (f) unnecessary and it has been deleted.
Section 715.7. Dispensing or administering staffing.
This section provides the requirements of both automatic dispensing systems and manual dispensing systems.
Comment
The requirement of one full-time licensed nurse or other person authorized to dispense controlled substances for every 200 patients for automated dispensing systems in proposed subsection (a)(1) should be increased to 300 patients because lesser ratios do not result in full utilization of staff and are a waste of resources.
Response
The Department proposed the 1,200 ratio based on findings from onsite inspections. The Department found that 90% of all the facilities within this Commonwealth utilize an automated dispensing system. Automated dispensing systems provide efficiency in dispensing controlled substances and the Department believes that the dispensing or administering staff ratio of 1 to every 200 patients is essential to meet the need of the patients. The Department has not revised the proposed regulation in response to this comment.
Comment
Proposed subsection (a)(2), requiring a 1 to 100 ratio for manual dispensing systems, does not result in full utilization of staff, and would be a waste of resources. The ratio for dispensing or administering staff in a manual dispensing systems should be increased to 1 to 150 patients.
Response
The Department agrees with the recommendation. The ratio has been amended to provide for one full-time nurse or other person authorized to administer or dispense a controlled substance for every 150 patients in an manual or nonautomated dispensing system.
Comment
The phrase ''timely and orderly manner'' contained in proposed subsection (b) is vague. The Department should amend the regulation to provide clarity on what constitutes a timely and orderly manner for the dispensing of medication.
Response
The Department agrees that the phrase ''timely and orderly manner'' is vague. The Department has revised the entire provision to state: ''Dispensing time shall be prorated for patient census. There shall be sufficient dispensing staff to ensure that all patients are medicated within fifteen minutes of arrival at the dispensing area.'' The original rationale for including the phrase ''timely and orderly manner'' was to provide for the safety of patients during the dispensing process and has been moved to § 715.17 (relating to medication control).
Section 715.8. Psychosocial staffing.
This section requires narcotic treatment programs to comply with staffing ratios in Chapter 704 (relating to staffing requirements for drug and alcohol treatment activities).
Comment
This proposed section simply references the staffing ratios in Chapter 704, but does not specify which ratios are applicable to psychosocial staffing, the counselor or primary care staff ratios. The Department should reference the specific staffing ratio that applies to psychosocial staffing.
Response
The Department agrees. The Department has revised this section to incorporate the staffing ratios from § 704.12 (relating to full-time equivalent (FTE) maximum client/staff and client/counselor ratios). In subsection (a), narcotic treatment programs are required to comply with the client/staff and client/counselor ratios in paragraphs (1)--(6) during primary care hours. These ratios refer to the total number of clients being treated, including clients with diagnoses other than drug and alcohol addiction served in other facets of the project. Family units may be counted as one client. For inpatient nonhospital detoxification (residential detoxification), one FTE primary care staff person is required for every seven clients during primary care hours and a physician is to be on-call at all times. For inpatient hospital detoxification, one FTE primary care staff person is required for every five clients during primary care hours. For inpatient nonhospital treatment and rehabilitation (residential treatment and rehabilitation), serving adult clients, one FTE counselor is required for every eight clients. In projects for adolescent clients, one FTE counselor is required for every six clients. For inpatient hospital treatment and rehabilitation (general, psychiatric or specialty hospital) serving adult clients, one FTE counselor is required for every five clients. For partial hospitalization, one FTE counselor is required for every ten clients. For outpatients, FTE counselor caseload for counseling in outpatient narcotic treatment programs may not exceed 35 active clients. In subsection (b) (regarding counselor assistants), counselor assistants may be included in determining FTE ratios when the counselor assistant is eligible for a caseload.
Section 715.9. Intake.
This section requires screening of narcotic treatment program applicants prior to admission.
Comment
Under proposed subsection (a)(1), a program is required to ''verify that the individual has reached the age of majority.'' To avoid confusion, the Department should replace ''age of majority'' with the more specific ''age of 18.''
Response
The Department notes that in this Commonwealth, for most purposes, the age of majority is 21. In this case, however, the Department adopts the recommendation and replaces ''the age of majority'' with the phrase ''the age of 18.''
Comment
Proposed subsection (a)(4) should be clarified. The subsection states that before a narcotic treatment physician prescribes methadone there must be ''a determination by the physician that the individual is currently physiologically dependent.'' The most appropriate care and diagnosis is achieved through an initial face-to-face determination between a physician and patient; however, ''determination'' is not clearly defined. A third party consultation between a physician assistant, nurse practitioner or other health care person and the physician without the physician ever physically seeing the patient could be construed as sufficient for ''determination'' of dependency. The term ''determination'' should be further clarified to ensure correct diagnosis and appropriate care.
Response
The Department agrees. Proposed subsection (a)(4) has been revised to require that a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been psysiologically dependent for at least 1 year prior to admission for maintenance treatment.
Comment
The proposed language of subsection (b)(3) does not satisfactorily address readmission of persons formerly in treatment. Regardless of voluntary versus involuntary detoxification or number of years out of treatment, readmission should be left entirely to the discretion of the narcotic treatment program as long as current dependence is demonstrated.
Response
The Department agrees in part with the recommendation regarding voluntary versus involuntary detoxification, specifically that consideration be given to any person who has been detoxified, whether voluntarily or involuntarily. The distinction is eliminated. Patients who have been either voluntarily or involuntarily detoxified from comprehensive maintenance treatment may be readmitted to maintenance treatment, without evidence to support findings of current physiologic dependence, up to 2 years after discharge. Readmission is conditioned upon the program being able to document prior narcotic drug comprehensive maintenance treatment of 6 months or more, and the admitting program physician, exercising reasonable clinical judgment, finding readmission to comprehensive maintenance treatment to be medically justified.
Section 715.10. Pregnant patients.
This section establishes requirements for the admission and treatment of pregnant patients. This section is included because of the increasing rate of heroin addiction among pregnant women.
Comment
This proposed section does not reference the Federal regulation, which states that a pregnant woman is to be informed of the risks of continued illicit drug use to her and her unborn child. The Department should cross reference 21 CFR 291.505(d)(1)(iii)(B)(5) (relating to pregnant patients).
Response
The Department has added § 715.10(f) (relating to pregnant patients) to address this comment.
Other Changes
Subsection (e) has been removed. It merely stated the general standard of practice in treatment and it is not necessary to state it as part of the regulation here.
Section 715.11. Confidentiality of patient records.
This section reiterates that narcotic treatment programs shall comply with Federal and State confidentiality requirements regarding patient records.
Comments
The phrase ''within the provisions of State and Federal confidentiality regulations'' contained in this section of the proposed regulation is a vague reference which does not afford notice of the specific requirements which must be satisfied under State and Federal regulations.
Response
The Department agrees. The specific citations 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality) are referenced in the final-form rulemaking.
Section 715.12. Informed patient consent.
This section requires the program to secure an informed, voluntary consent from the patient prior to the administering of an agent for detoxification or maintenance treatment.
Comment
This proposed section requires that a narcotic treatment program obtain an ''informed, voluntary consent'' before an agent can be administered to a patient. The proposed rulemaking does not clearly state the specific information that the narcotic treatment program must provide to the patient and whether the consent must be written.
Response
The Department has amended the regulation to require a written consent and to require a list of specific items that must appear in writing on the consent. The following information must be included in the consent: (1) that methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision; (2) that methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results; (3) that alternative methods of treatment exist; (4) that the possible risks and complications of treatment have been explained to the patient; and (5) that methadone is transmitted to the unborn child and will cause physical dependence.
Section 715.13. Patient identification.
This section requires a narcotic treatment program to develop a system for patient identification to ensure that the drug is being administered to the appropriate patient and for security and patient care reasons.
Comment
In proposed subsection (a), the term ''develop'' should be replaced with the term ''use.''
Response
The Department agrees and has substituted the term ''use'' in place of ''develop.''
Section 715.14. Urine testing.
This section updates the urine testing procedures to conform with Federal standards and current practices. It requires testing for certain specific substances.
Comment
Neither this proposed section, nor proposed § 715.21 (relating to patient termination), identify the consequence of failing a urine test for a patient in the narcotic treatment program. The Department should explain the consequences when a patient's urine test detects and continues to detect any of the drugs in proposed subsection (a) of this section.
Response
The Department believes that if a patient's urine test detects and continues to detect any of the drugs identified in subsection (a), it would indicate the need for an intervention from the facility that could include an increase in dose, an increase in counseling services offered, a change in type of counseling services offered or eventual discharge from the program. Accordingly, it is not appropriate for the Department to regulate consequences. The testing must be performed. What the facility does with the results will vary on a case by case basis, according to each individuals treatment needs and in conjunction with facility policy. The Department has made no change to the section based on this comment.
Comment
Proposed subsection (a) reduces the testing requirement to monthly for all tested substances. The existing regulation requires weekly urine testing for opiates and synthetic narcotics and monthly testing for other controlled substances. Urine testing for the first 2 years of narcotic addiction treatment should be conducted at a minimum of once per week because these patients need to be monitored more closely for relapse. The current requirement of weekly urine testing should be retained for more stable patients. The Department should explain its rationale behind requiring only monthly testing for all patients.
Response
The Department does not believe that requiring weekly urinalysis is appropriate for the patients that are treated in narcotic treatment programs. The testing is very costly, and is unnecessary for every patient. Further, facilities can require weekly testing for specific clients, if necessary.
Comment
Proposed subsection (b) requires the program ''to ensure that urine collected from patients is unadulterated'' and ''that a random observation . . . be conducted professionally, ethically and in a manner that protects patient privacy.'' The proposed language does not specify whether the observer is required to be a licensed health care professional. Also, the proposed language does not specify the methods to be used to ensure the sample is unadulterated and that the observation be conducted in a manner that protects patient privacy.
Response
The Department has not changed the proposed regulation. The Department is not requiring the observer of the urinalysis testing to be a licensed health care professional. The Department is requiring that the program establish procedures to ensure that the urine sample is unadulterated and the investigation is conducted in a manner which respects patient privacy. These procedures are left to the discretion of the program.
Comment
Proposed subsection (c) requires a narcotic treatment program to implement policies and procedures addressing the chain of custody of a urine specimen to ensure that the specimen can be traced to the donor. ''Chain of custody'' is different from ordinary procedures to safeguard identifications of urine screens. It implies a specific set of procedures intended to meet forensic standards. This requirement is unnecessary, expensive and unduly burdensome. Implementing ''chain of custody'' procedures would increase testing costs by about 400% (or $25,000 per year). The Department should explain the need for a chain of custody and how the benefits outweigh the costs. Additionally, the Department should consider replacing the phrase ''traced to the person whom it belongs'' with the phrase ''traced to the donor.''
Response
The Department agrees with the recommendations and adopts the following revision: ''A narcotic treatment program shall develop and implement policies and procedures to minimize misidentifications of urine specimens and to ensure that the tested specimens can be traced to the donor.''
Section 715.15. Medication dosage.
This section requires narcotic treatment programs to meet various Federal standards relating to narcotic treatment medication dosage.
Comment
The phrase ''a narcotic treatment program may not administer an agent'' in proposed subsections (a), (e) and (f) is inconsistent with the language of proposed subsection (c), which allows methadone to be ''administered or dispensed.'' For clarity, the Department should add the term ''dispense'' to proposed subsections (a), (e) and (f). Also, the wording of the language of proposed subsection (c) which states ''although tablets, syrup concentrate or other formulations may be distributed by the program, all oral medication is required to be administered or dispensed in liquid form'' is not grammatically correct. An appropriate construct of the phrase would state ''or other formulations may be distributed to the program . . . .'' The program receives the medications and then dispenses them to its patients. Further, the language ''tablets, syrup concentrate or'' should be omitted from the regulation if narcotic treatment programs do not dispense there formulations.
Response
The Department accepts this recommendation in part. The Department has added the term ''dispense'' to the phrase ''administer or dispense'' in subsections (a) and (e), to provide consistency throughout the section. In concert with Federal regulations, the Department will substitute the following language for proposed subsection (c): ''Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral abuse.'' Subsection (f) has been combined with subsection (e) and modified to be consistent with subsection (c). In addition, subsection (a) was rewritten for clarification.
Section 715.16. Take-home privileges.
This section establishes eligibility requirements for patients who may take medication out of the facility and self-administer outside the supervision of the program.
Comment
The current standard for giving patients take-home privileges does not respond to trends toward ''medical maintenance.'' Programs should respond to the changes by permitting ''senior patients,'' those patients who have substantial ''clean time'' with 5 or more years in treatment, to remain in programs and be able to receive up to a 30-day supply of medication. The proposed regulations seem to grant an exception for these patients, permitting them to attend a clinic twice a month where they receive a 2-week supply of medication. There is no clear procedure for how the requests for exception in this section will be approved and by whom. Also, the language of subsection (a) includes a sentence which states: ''The physician shall make this determination after consultation with appropriate staff.'' It is unclear who are ''appropriate staff within the program'' with whom the physician must consult. The Department should expand the regulation to specifically state who are ''appropriate staff.''
Response
The Department agrees in part. The Department agrees that the phrase ''appropriate staff'' needs clarity. Therefore, the Department has revised proposed subsection (a) to state that ''the narcotic treatment physician shall make this determination after a consultations with staff involved in the patient's care.'' Medical maintenance as a treatment modality has not been tested effectively, and thus far has only been approved under Federal research pilot studies. The Department, therefore, declines to include medical maintenance in its regulation. The Department wishes to ensure that all take home methadone medication is utilized responsibly with minimal opportunities for diversion. The Department will continue to examine take-home privileges for longer than 6 days on a request for exception basis. Patient specific exceptions may be requested under § 715.29 (relating to exceptions).
Comment
The phrase ''exceptional circumstance'' in proposed subsection (d)(3) should be amended to make specific reference to the fact that ''travel'' is considered to be an ''exceptional circumstance'' under this regulation.
Response
The Department agrees that the phrase ''exceptional circumstance'' needs refinement. It has revised the regulation to provide that a patient has an exceptional circumstance if the patient confronts circumstances such as illness, personal or family crisis or travel that interfere with the ability to conform to the applicable mandatory attendance schedules.
Section 715.17. Medication control.
This section provides that programs develop and implement policies and procedures relating to pharmaceutical services, verbal medication orders and medications.
Comment
Proposed subsection (c)(1)(iii) permits only patients to be present in the dispensing area. If the intent of this regulation is to restrict persons other than employees of the narcotic treatment programs and patients from entering the dispensing area, the subsection should be clarified to reflect that authorized employees are also permitted to enter into the dispensing area.
Response
The Department agrees. The Department's intent is to have subsection (c)(1)(iii) restrict the dispensing area to only patients and authorized staff. Therefore, the Department has revised the subsection to state ''only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.''
Comment
Proposed subsection (c)(2) states ''a narcotic treatment program shall develop and implement written policies and procedures regarding where and how medications are stored . . . . Agents shall be stored in a locked safe that has been approved by the DEA.'' However, § 715.26 (relating to security) requires that ''a narcotic treatment program shall meet the security standards for the distribution and storage of controlled substances as required by Federal and State statutes and regulations.'' There is a lack of clarity and consistency throughout the regulation on the requirements for storage areas, specifically, in the storage of a small amount of an agent in a secure area. For clarity, the Department should consider incorporating by reference 21 CFR 1301.72 and 1301.74 (relating physical security controls; and other security controls) in both this section and § 715.26.
Response
The Department agrees that its regulation should be consistent with Federal regulation requirements for storage and security of controlled substances. Accordingly, the Department has specifically referred to 21 CFR 1301.72 and 1301.74 in subsection (c)(2) and in § 715.26.
Comment
The phrase ''adequately documented'' in proposed subsection (c)(3)(iv) is unclear. The Department should clarify this phrase.
Response
The Department adopts this recommendation. It has deleted the term ''adequately'' from the regulation, leaving only the requirement of documentation.
Other Changes
Subsection (a) was revised by deleting the phrase ''which provide pharmaceutical services.'' This phrase added nothing to this subsection since compliance is required by all narcotic treatment programs. Subsection (c)(1)(vi) has been added to assist in controlling the administering and dispensing of medication.
In addition, various nonsubstantive changes were made for clarification.
Section 715.18. Rehabilitation services.
This section revises the requirements for rehabilitative services to accurately reflect current practices of narcotic treatment programs.
Comment
This proposed section requires a narcotic treatment program to provide a full range of rehabilitative services, including legal services, employment services, HIV education services, public health services, adult educational services and behavioral health services. The Federal regulations, specifically 21 CFR 291.505(d)(4)(i)(C), require that each narcotic treatment program provide ''medical and rehabilitative services and programs'' and ''counseling on HIV disease.'' However, 21 CFR 291.505(d)(4)(iv) requires narcotic treatment programs to ''provide opportunities'' for vocational rehabilitation, education and employment. For consistency with Federal regulations, the Department should state that, while programs are required to provide HIV services and public health services, a program shall also provide opportunities for patients to access legal services, employment services, adult educational services and behavioral health services.
Response
The Department agrees and adopts the recommendation which makes the regulation more consistent with Federal regulations.
Section 715.19. Psychotherapy services.
This section establishes the requirements for psychotherapy services to be provided to patients.
Comment
The counselor staffing ratios defined in the proposed rulemaking need to be refined. There is a demand for a different treatment approach for long-term rehabilitated patients which facilitates deviations from the current client-ratio requirements, required physician hours and rehabilitative and psychotherapy services. To mandate these services would cause unnecessary hardship, time and money on the part of both the client and provider. The Department should amend the regulation to adopt a standard more suitable to meet the needs of the patient at each level of the narcotic treatment program.
Response
The Department agrees in part. Proposed paragraph (1) has been amended to include a requirement that additional psychotherapy shall be provided as dictated by the ongoing assessment of the patient. Proposed paragraph (2) has been revised to require a narcotic treatment program to provide each patient at least 1 hour per month of group or individual psychotherapy during the third and fourth year of treatment. Additional psychotherapy shall also be provided as dictated by the ongoing assessment of the patient. Proposed paragraph (3) has been deleted in its entirety. The Department has substituted the following language:
After 4 years of treatment, a narcotic treatment program shall provide each patient with at least 1 hour of group or individual psychotherapy every 2 months. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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