• Include in service definition: Outpatient services shall not include practitioners who hold a license issued by a health regulatory board of the Department of Health Professions or who are exempt from licensing pursuant to 54.1-2901, 54.1-3001, 54.13501, 54.1-3601 and 54.1-3701 of the code of Virginia.
• Remove general health care from SA OP (H). General health care is outside the scope of practice for a therapist. 
• 12VAC35-109-40 A.2 g.  Screenings should capture basic information about the person's risk, medication ,etc.  Remove "including recent increase, decrease, discontinuation, etc.  
• 12VAC35-109-50: Remove and possibly add to 109-40 all screening information shall be reviewed and updated as appropriate at the time of initial evaluation.  
• 12VAC35-109-110- recommend removing  #2.  as it limits who can provide direct supervision in many programs to  license or license eligible persons as guidelines says can approve assessments and ISPs. 
  • L1. expand to include General Physicians and Physician Extenders
  • M3. remove provide and replace with coordinate with .........
• 12VAC35-109-200 E.  Recommend that the entire section E ,aligns with Federal Guideline for OTP and addendums  to include the removal of :RN, program sponsor needing license or certified, regulating percentages of licensed, certified counselors, required security personal, etc. 
• F.  ( not clear as to the meaning or intent) 
• G ( remove change or loss of staff requires written notification and plan). Federal OTP guideline indicates the minimal staffing pattern.
• H ( remove)
• H4 ( remove caseload size for license and non licensed counselors).  Caseloads are determined by multiple factors to include but not limited to : client's level of intensity, centralized services,  type of service -primary,  follow-up, etc., client's time in treatment, etc. 
• 12 VAC35-109-280 A. remove 1 hour minimum. 
  • A1. Remove every week for the first 6 months.  Replace with Federal OTP guidelines  ( twice monthly) first year.  Second year at least once monthly. 
• 12VAC35-109-290 #2 remove weekly random drug screen- replace with Federal OTP guideline 8 per year and when clinically necessary
• 12VAC35-109-400 #3-Revised to say ensure clients have appropriate contact crisis information outside of clinic's normal hours. 
• 12VAC35-1090-440  services #4, 5,6 appears to be case management and care coordination functions. 

This requirement for PE and labwork prior to admission to MAT could delay starting clients on MAT when clients are not compliant with obtaining physical exams or labwork.  This could result in client death due to untreated opioid use disorder.  

It is often difficult to reach  private providers of MAT, and too often efforts to obtain records are futile or take a long time.   Attempts  to contact these providers seem reasonable once the client has been admitted into MAT program, but to delay services based on this requirement could result in increase numbers of overdoses of individuals with opioid use disorder

Current ARTS guidelines for OBATS state specifically that MAT should not be withheld based on an individual's failure to attend counseling sessions, because individuals with opioid use disorder are at different stages in their willingness to engage in counseling.

12VAC35-109-50. Secondary Screening

Section A States: In the event that an individual was placed on a waitlist prior to receiving services, a secondary screening shall be performed prior to admission to the service.

Recommend adding “for 90 days or more” after the word “waitlist”

• The concern without this specification is that if a patient is waiting just a few days, for example, this will still be required adding to unnecessary workload and creating a potential barrier to treatment.

12VAC35-109-180. Lighting

Section A Requires artificial lighting to be “by electricity”

Recommend removing this section

• In the event of an emergency or power outage, most artificial lighting will be by other means than electricity (e.g. solar power, battery, etc…).

12VAC35-109-200. Standards for the evaluation of new licenses for providers of services to individuals with opioid addiction.

Section E.3. States: The medical director shall be a physician. The medical director shall be a board-certified

addictionologist or have successfully completed or will complete within one year a course of

study in opiate addiction that is approved by the department, shall have completed an accredited

residency training program, and shall have at least one year of experience in addiction medicine

or addiction psychiatry.

Recommend removing the stipulation of having one year in addiction medicine or psychiatry

• Not enough providers in VA have this
• Not necessary for care or best practice
• There is a federal bill to try to allow physicians/OBATS to be able to prescribe methadone without these criteria and without the stricter regulations that OTPs have

Section E.5. States: A minimum of one registered nurse (RN) staffed with licensed practical nurses (LPNs), if

warranted to meet the needs and number of patients served. All LPNs hired shall be supervised by

a RN.

            Recommend removing the criteria of having an RN

• According to the Board of Nursing, LPNs can be supervised by other LPNs and are not required to be supervised by RNs
• This would further shrink the workforce making it more difficult to operate

Section E.6. States: Counselors shall be licensed or certified by the applicable Virginia health regulatory board eligible for this license or certification, and a minimum of two thirds (63%) of counselors working with individuals in an outpatient treatment program (OTP) program must be licensed or certified. No more than one third (33%) of counselors in a program can be eligible for license or certification.

Recommend removing “minimum of two thirds (63%) of counselors working with individuals in an outpatient treatment program (OTP) program must be licensed or certified. No more than one third (33%) of counselors in a program can be eligible for license or certification.”

• There is not enough supply of the credentials to meet that demand
• Those with licenses are aging out and there aren’t enough people coming in to replace them
• There are many individuals on the books that have active licenses, but many are not actively practicing
• This would also result in programs immediately being out of compliance as soon as a counselor leaves. It also significantly limits programs in how and who they are able to recruit, resulting in programs competing with each other to try to hire already credentialed individuals, which is even more limited in more rural areas.

Section E.7. States: Personnel to provide support services which shall include at least one security guard trained in accordance with 12VAC35-105-440, 12VAC35-105-450, and 12VAC35-105-460

            Recommend removing this section entirely as a requirement

• Security is not usually needed for startups and small clinics
• Unnecessary requirement that seems to be stigma motivated
• Programs already have safety measures and protocols in place (i.e., security cameras, alarms, panic buttons)

Section G States: If there is a change in or loss of any staff in the positions listed in subsection E, the department

requires written notification and a plan for immediate coverage within one week

            We agree with these criteria as it pertains to section E. 1-4.

            Recommend removing this requirement for all other subsections under E

• With high turnover rates with counselors, nurses, and front desk, this requirement would add significantly to the workload to both the program staff and the licensing specialist

Section H.3. States: The medical director shall be responsible for ensuring all medical, psychiatric, nursing, pharmacy, toxicology, and other services offered by the OTP are conducted in compliance with federal regulations at all times; and, shall be present at the program for a sufficient number of hours to ensure regulatory compliance and carry out those duties specifically assigned to the medical director by regulation. The medical director shall be present at a minimum one hour per every 50 patients

Recommend removing the last line stating the medical director shall be present at a minimum of one hour per every 50 patients

• Unsure of where this number comes from as it seems to be arbitrary
• Does not specify one hour per week, month, year, etc…
• Does not consider that there may be other physicians, NPs, etc… present in the program

Section H.4. States: Counselors shall meet the following caseload requirements: The caseload size for a licensed or certified counselor shall not exceed 45 patients. The caseload size for a nonlicensed or noncertified counselor shall be assigned from the licensed counselor's caseload and caseload size shall not exceed 30 patients.

            Recommend removing caseload limit

• Does not consider needs of individuals
  • Long term patients aren’t required to and often don’t need to meet as often
• Would double our clinical staff
  • This then causes problems with adequate space at the facility to house staff
• If we have to set a limit, a standard 60:1 is recommended, regardless of credential
  • While we do support a maximum limit for clinician caseload size, this ratio of 45:1 and 30:1 is small for an outpatient setting (outside of a group session). When compared to other types of outpatient treatment settings, the OTP is unique in that patients receive multiple contacts/touches throughout the week/month from both medical and clinical staff, which is as frequent as daily in early treatment. This provides better and more consistent support for the patient, which in turn also results in assisting counselors to better manage their caseloads.
  • The federal OTP regulations do not require a clinician ratio and a number of other states allow for a higher, but manageable ratio. For example, Ohio’s and Pennsylvania’s ratio is 1:65. VA OTP providers are currently operating in each of these other states and are successfully managing the higher clinician caseload sizes while continuing to provide quality treatment to our patients.
• Because someone is in process for a counselor credential does not necessarily mean they cannot handle a full caseload, as they are overseen by a licensing board and are receiving a required frequency and standard of supervision and their services and documentation are being reviewed.

Section I.4. States: Plans for on-site onsite security and services adequate to ensure the safety of patients, staff, and property

            Recommend removing “on-site security”

• As stated above, startups and small clinics don’t often need security personnel
• Safety policies and procedures, as approved by the licensing specialist, should suffice

Section J.7. States: All staff shall be certified in First Aid, CPR, and Naloxone administration

            Recommend changing the word “certified” to “trained”

• Nurses certified in CPR and First Aid are required to be on-site during patient hours
• While certification is available for CPR and First Aid, there is no formal certification for naloxone admin. There is educational training on overdose prevention, but training on how to administer naloxone is only a few minutes and can even be done via a handout or video since what is most available and used now is the nasal

12VAC35-109-250. Service operation schedule

Section B.2. States: The provider receives prior approval from the state opioid treatment authority (SOTA) for Sunday closings. Each program must have a policy that addresses medication for the newly inducted patients and those who are deemed at risk, i.e., still actively using illicit substances or medical issues that may warrant closer monitoring of medication. This policy must include openings on Sundays for the population described above

Recommend keeping the first sentence and eliminating the rest; or change the wording to state that programs will follow federal guidelines regarding Sunday closings.

• Programs already have to follow federal guidelines, and these are also overseen by the State Opioid Treatment Authority.

12VAC35-109-260. Initial and periodic assessment services

Section C States: Upon admission and annually, all individuals shall sign an authorization for disclosure of information to allow programs access to the Virginia Prescription Monitoring System (PMP). Failure to comply with this requirement shall be grounds for denial of admission to the program. Programs shall run a PMP report each month on every individual served. The program physician shall provide this report. The report shall be stored in the individual's file and must be marked "DO NOT DUPLICATE."

            Recommend removing the sentence, “Programs shall run a PMP report each month on every individual served.”

• Programs are already running PMPs at admission, every quarter, and as needed
• Some clinics have close to 1000 patients.  To run a PMP on every patient every month would overwhelm the system and the workforce

Section E States: Initial tests conducted by the provider shall include viral hepatitis, HIV and other sexually transmitted infections. On admission, all individuals shall be offered testing for AIDS/HIV. The individual may sign a notice of refusal without prejudice. The individual shall be certified as tuberculosis (TB) free upon admission and annually by a qualified licensed professional

            Recommend remove the requirement of the test being conducted at the facility.

Recommend programs provide patients with education about infectious diseases and offer referrals to places that can perform the testing

12VAC35-109-280. Counseling sessions

Section A.1. States: The provider shall conduct face-to-face counseling sessions (either individual, group, or family) of one hour minimum. The provider shall document details of each session including the length within the individual's service record. The counseling sessions shall occur:

1. Every week for the first six months of the first year of the individual's treatment.

Recommend keeping this regulation as it currently is stating counselors shall meet with individual 2x per month for the first year

• This draft version of the regulation does not consider all other duties that counselors have including weekly supervision, weekly meetings, trainings, documentation, etc…
• This regulation would be virtually impossible to meet

12VAC35-109-290. Drug screens

Section 2 States: Perform a random weekly drug screen whenever an individual's drug screen indicates

continued illicit drug use or when clinically and environmentally indicated

            Recommend removing this subsection

• Some drugs stay in the system longer than a week indicating that a weekly drug screen may not be clinically necessary as the result may likely be the same
• Providers should be allowed to use their clinical judgement as to the frequency of needed drug screens if it does not infringe on other federal or state regulations or patient’s rights

12VAC35-109-300. Take home medications

Section A-C Regarding criteria for and schedule of take home medications

            Recommend removing these sections

Recommend using the wording, “Medications used for the treatment of opioid use disorder to be dispensed to patients for unsupervised or “take home” use shall comply with the scheduling requirements set forth in 42 CFR Part 8 MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS

• Since COVID, SAMHSA has temporarily updated their take home requirement criteria
• The data gathered since the emergency take home exceptions were granted have shown improved compliance in treatment and successful outcomes.
• The federal regs are expected to be updated permanently in the next few months

Thank you for your support and willingness to work with providers as these regulations are amended. Please feel free to contact us with any questions or if we can be of assistance in any other way.

Respectfully,

David Cassise

David Cassise

VAMARP President

Regional Director

Pinnacle Treatment Centers

Cc:       Jodi Herndon, VAMARP Vice President

            Melissa Brown, VAMARP Treasurer

Stacie Shifflett, VAMARP Secretary

            VAMARP Member Programs

12VAC35-109-280. Counseling sessions

The initial requirements for weekly for 6 months ...  this is unrealistic in our current environment. Transportation is extremely problematic, child care becomes problematic and safety concerns increase. Patients new to recovery need to be met where they are in the treatment spectrum.

Many of the specific regulations in this proposal seem specifically designed to force existing opioid maintenance treatment programs out of business and to inhibit the ability of new programs offering new services to open. This is occurring in light of an ever increasing overdose epidemic, in which Virginia is seeing overdose rates above the national average. As most other regulatory authorities are begging treatment providers to find ways to reduce barriers to care, get more patients into treatment, and retain them, these regulations seem particular restrictive in preventing allowing programs to do just that.  Specifically:

12VAC35-109-40; 12VAC35-109-50: Regarding increased screening questions for patients.   Anytime that a patient calls interested in obtaining treatment a treatment program should be open to seeing that patient and evaluating them for possible admission. Additional screening questions before a patient can even be considered for admission serve no purpose other than to set up an additional barrier to treatment. A full evaluation of the patient will always be done before it is decided if the patient is appropriate for admission and treatment. There seems to be no purpose to mandate additional screening of patients, beyond questions such as “Are you using opiates and are you looking for help?” before providing them an opportunity for a full and comprehensive evaluation.

12VAC35-109-200: Staffing qualification requirements. While enhanced staffing training and certifications would always be desirable it is just not reasonable to require additional staffing restrictions during a time when there are marked staffing shortages everywhere. These regulations will have a significant effect on the ability of many treatment programs to operate. There are simply not enough board certified addition physicians, or even physicians well trained in addiction medicine to fill the required positions. As the nation faces a national physician shortage there are virtually no places where a physician can learn about addiction treatment, particularly about addiction treatment with methadone, outside of the OMT environment. Training on the job is the rule. Furthermore, to allow this necessary training on the job there must be the ability to allow other more appropriately trained and certified physicians to leverage their skills to multiple locations that require them. This will entail the ability to supervise multiple mid-level providers as well as other physicians that may not be well trained in addiction medicine. All of this supervision can be done remotely with currently available technology and EMR systems. An arbitrary requirement of onsite time per patient enrolled in the program makes no sense. Well trained physician time must be maximized and efficiently utilized. Travelling to multiple locations to meet an onsite time requirement is not an efficient use of this scarce resource.

The same work force situation exists with the proposed requirements for RNs as opposed to LPNs and the minimum counselor certifications and maximum counselor to patient restrictions. Many OTPs will simply not be able to find an adequate number of personnel to fill the needed positions.

There are multiple other proposed requirements in this draft document that are just not able to be done, or are extremely impractical to implement, due to staffing, facility, funding, time, and other limitations. Implementation of these regulations as proposed will result in a marked decrease in the amount of opioid maintenance treatment available to the citizens of Virginia and a subsequent increase in the number of opioid overdoses in addition to increases in other morbidity and mortality secondary to inadequately treated opiate use disorders. I would urge significant reconsideration of many of these proposals with more input from those on the ground who are diligently working to provide care to the most number of patients in the most efficient way possible.

Please also consider the very detailed comments previously posted by David Cassise, the President of VAMARP.  

The implementation of these proposals, unchanged, will significantly impair the ability to provide opioid maintenance treatment in the state of Virginia. These proposals set up multiple significant barriers to treatment that are directly contrary to the national movement being lead by SAMHSA and ASAM trying to make addiction treatment more focused on harm reduction and available to the most number of people possible. 

Thank you for your attention to these serious matters. Please let me know if I can provide you with any additional information.

In response to the proposed changes, I am in agreement with the responses made by Dr. Tannenbaum and David Cassise.  I would like to elaborate specifically regarding to the counseling ratio proposals. As a licensed clinical social worker who practices privately in addition to serving as the Director of Clinical Services for ARS for many years, I have seen many barriers implemented through regulations across states that hinder OTP's ability to provide quality care and/or serve as a reason for citations.  As others have stated, it is without a doubt desirable to have counselors who are certified and/or licensed.  With a requirement of 63% certified counselors with a maximum caseload of 45 and the remainder of uncertified counselors with a maximum caseload of 30, this will only further provide barriers to care.  An important aspect of this is having regular supervision where as a licensed supervisor works closely with the counseling staff.  Whether someone is certified or not, will not necessarily dictate their ability to provide quality care to those we serve. 

In addition to the ratio's and credentials mentioned above, requiring a minimum of one hour counseling per week for the first 6 months, is unrealistic. In order to provide patient centered care, the counselors are trained to meet clients where they are. For some, this is an unrealistic expectation and does not equate success and may further push our pre-contemplative clients; clients suffering with mental illness; and clients with unresolved trauma from attending treatment altogether.  Best practices will dictate if clinically indicated a patient will have additional counseling which may equate to weekly or more.  For some, weekly counseling may not be clinically indicated. 

I am in agreement if a ratio is needed, a 60:1 ratio is realistic and provides counselors with plenty of time throughout the month to meet the needs of the individuals served.  I would be more than happy to provide additional information for this if requested.  

Thank you for giving me the opportunity to make comments on the draft Center-Based Chapter. You will find my comments and recommendations below.

Throughout the entire document, I would like to recommend removing Substance Abuse and replacing it with Substance Use Disorder. I also recommend removing Mental Retardation with Developmental Disability/Intellectual Disability.

12VAC35-109-10

I would like to recommend adding a definition for Supported Decision Making to this section

12VAC35-109-40

Recommend changing Medical Symptoms to Medical Conditions.

12VAC35-109-40

Recommend changing Medical Symptoms to Medical Conditions.

12VAC35-109-60

D. Add “and available” after if applicable.

12VAC35-109-70

A.1 & 2 Recommend changing 24 hours after admission to 1 business day.

12VAC35-109-80

E. While I agree that employees should be knowledgeable about the contents of ISPs for individuals served, establishing expectations to train and test all employees involved with service delivery is an unrealistic expectation that will significantly detract from service delivery. Observations of competency and knowledge about providing services is part of the supervisory and evaluation process. Moving forward with this is likely to result in providers making fewer updates to ISPs, to avoid retraining and testing employees. There is no practical way to document this knowledge and competency without documentation of confidential information about individuals served, which should not be part of a Personnel File. This expectation places an undue burden on Human Resources who would have to maintain the documentation, as well as supervisors who would have to develop ways to test and train employees while maintaining their other responsibilities.

12VAC-109-90

C. Asking for clarification if quarterlies are required for this service.

12VAC35-109-100

B.5 This would be easier to identify for some services, such as outpatient, but not for a day program. This is an impractical expectation for daily service documentation..

B.6 Replace clinal staff with qualified staff. 

C Add informational notes along with communication logs and supervision notes.

12VAC35-109-120

A.3 & 4 Recommend to remove will provide as we cannot provide medical or dental services as we are not medical professionals.

12VAC35-109-130

B.2.b Remove as this pertains to residential services, not center-based services.

12VAC35-109-150

E Please make consistent throughout DBHDS regulations. The temperature range for center-based services is different than the temperature range for residential.

12VAC35-109-200

G This is an impractical expectation for programs due to the administrative burden. This is not required for any other DBHDS licensed service, request this requirement to be removed.

INITIAL DRAFT: NEW Center-Based Service Specific Chapter (109) for 12VAC35-105, Rules and Regulations for Licensing Providers by the Department of Behavioral Health and Developmental Services

1. Can you please consistently differentiate between the ISP (Individual Support Plan) and PFS (Plan for Supports)? Does the ISP reference what the Support Coordinator is responsible for?
2. Please add a definition for PFS (Plan for Supports)
3. 12VAC35-109-80. ISP requirements. B.14: Projected discharge plan and estimated length of stay within the service.
   1. Should this have “if applicable” after as we do not plan on discharging anyone from Center Based Day Support Services.
4. 12VAC35-109-80. ISP requirements. E. 2. After each training, providers shall test the employee’s or contractor’s knowledge, competency, or both, and retain documentation of the test of the employee’s or contractor’s knowledge, competency, or both within the employee or contractor’s personnel file.
   1. You are asking us to put program participant information into an employee/contractors personnel file. In addition, we are already documenting training of the plan, we review the notes to ensure understanding, all employees and contractors have competencies and other training related to services. Please consider removing this regulation as we should not be placing program participant specific info into personnel files and this adds an additional burden on an already cumbersome job for our managers.
5. 12VAC35-109-90. Reassessments and ISP reviews F.4.b.Individual’s progress towards discharge.
   1. Center Based Day Support does not routinely make plans for discharge, should this say “if applicable”?
6. 12VAC35-109-100 B.5. Describe needed follow-up care or note which objective within the ISP will receive focus the next time the individual receives services;
   1. Should this say “if applicable” as it does not appear to apply to center based day support?
7. 12VAC35-109-130. Emergency preparedness and response plan.
   1. Will you provide an example plan for all of section 130?
8. 12VAC35-109-130 B.1. Annexes dedicated to the highest-priority hazards as indicated by the vulnerability analysis which include documentation of specific plans, policies, and procedures to prevent, mitigate, prepare for, respond to, and recover from the hazards most likely to disrupt provider operations.
   1. Please define annexes.
   2. Who does the vulnerability analysis?
9. 12VAC35-109-130 B.2.a. Documented, current consideration of local and regional sites that could function as evacuation locations or stop-over points, including documentation of any arrangements the provider has made with such sites.
   1. In the event of an emergency or natural disaster we would listen to local news/radio to determine where to go. Gathering this information ahead of time is not helpful in the event of a true emergency as this is likely to change often and based on the type of emergency.
10. 12VAC35-109-130 B.2.b. Policy and procedure for executing an evacuation or individual relocation to include resident and staff tracking and preservation of all critical services (pharmacy, Feeding, etc.).
    1. Please clarify what type of tracking is expected.

12VAC35-109-80 ISP Requirements 

E.2 Provider shall test the employee or contractor's knowledge, competency, or both and retain documentation of test with in the employees file. 

• Please consider removing this regulation. Implementation of this regulation would require an persons served information to be kept in a staff members personnel file outside of the program. This regulation will also cause an undue hardship on providers with mangers having to create a test for every person served as well as HR departments having too track and log all test. The total amount of test that would need to be created and tracked could be in the hundreds annually. 

We appreciate the opportunity to review this section. In order to fully comment and understand the regulatory language, and the full context provided, it is helpful to have all the chapters to comment on at once.

12VAC35-109-80. ISP Requirements:

In Section A. regarding "Initial ISP", please consider revising language to include if the comprehensive ISP includes all elements of the initial ISP and is written in place of the initial ISP the "Initial ISP" is is not required.  Requiring an initial ISP separate from a comprehensive ISP could be burdensome to the client and provider.

In Section E, 1-3. regarding documented training surrounding each individual's ISP w/ a test is an administrative burden to the provider and may encourage less revising of the ISP when we want to encourage revising the ISP when this is needed (we want to be client centered).  Training surrounding ISP writing and implementation should be done at orientation and then at supervision level regularly.

12VAC35-120, 12VAC35-130, 12VAC35-180

Please consider revising language within these regulations as it appears to be heavily focused on residential treatment vs. "outpatient" center-based services. (i.e. 12 VAC35-120, Section A. 3 & 4, 12VAC35-130, Section 2b & 4c.)

Thank you for the opportunity to comment!

The Virginia Association of Community-Based Providers (VACBP) represents private-sector providers of behavioral health, substance use disorder and ABA services throughout the Commonwealth of Virginia. We appreciate the opportunity to share the following comments on the proposed regulations to the Center-Based Service chapter of the licensing regulations on behalf of our members. Below are some overarching comments that are reflected in the specific comments provided.

• The licensing regulations should use consistent and clear terminology that is well known and understood by providers.

• It’s important that the licensing regulations reflect the distinct differences between center-based services and residential or in-patient services, for example, hours of operation.

• Given the extensive requirements and oversight provided through the major accrediting bodies, flexibility in the licensing regulations should be allowed for agencies with proof of accreditation in good standing. This may include relief from initial and periodic licensing inspections, inspections of agency locations and client documentation requirements outlined in the regulations.

We propose the following specific changes in this section.

• Add definition for “approved accreditation bodies”

“Approved Accreditation Bodies”. The Department recognizes these accrediting bodies for licensed services. Agency proof of accreditation in good standing of the services under 12VAC35-109-20 substitutes for initial and periodic licensing inspections. Department inspection of agency locations as well as employee and client documentations requirements set forth in regulation is also not required for agencies with accredited services:

CARF International
6951 East Southpoint Road
Tucson, AZ 85756-9407

Council on Accreditation
45 Broadway, 29th Floor
New York, NY 10006

The Joint Commission
One Renaissance Boulevard
Oakbrook Terrace, IL 60181

• Change language to reflect that the “comprehensive assessment,” is the same as the “comprehensive needs assessment.”

• For initial ISP definition, recognize that center-based programs are often not 24/7 facilities, and as such, developing and implementing the initial ISP within, “24 hours of admission,” may not be feasible. We suggest the language change to, “by no later than the next business day."

• Add definition for program sponsor 

“Program sponsor” means the person(s) named in the application for licensing and shall have relevant training, experience, or both, in the treatment of individuals with opioid addiction.

• Add definition for QMHPP 

"Qualified Mental Health Paraprofessional” of “QMHPP" means a person who must meet at least one of the following criteria: (i) registered with the United States Psychiatric Association (USPRA) as an Associate Psychiatric Rehabilitation Provider (APRP); (ii) has an associate's degree in a related field (social work, psychology, psychiatric rehabilitation, sociology, counseling, vocational rehabilitation, human services counseling) and at least one year of experience providing direct services to individuals with a diagnosis of mental illness; (iii) licensed as an occupational therapy assistant, and supervised by a licensed occupational therapist, with at least one year of experience providing direct services to individuals with a diagnosis of mental illness; or (iv) has a minimum of 90 hours classroom training and 12 weeks of experience under the direct personal supervision of a QMHP-A providing services to individuals with mental illness and at least one year of experience (including the 12 weeks of supervised experience).

The following outlines our comments in this section:

• The term “screening” as described in this section is not a generally recognized term for providers.  The minimum elements outlined in this section are generally characterized as the “initial referral,” for providers and therefore, we suggest the regulations be changed to reflect this.
• In the minimum required elements for the screening or initial referral, we suggest changing (b) to read “legal and preferred name, date of birth, sex and gender.” This ensures providers know the individual’s legal name, which is likely how Medicaid recognizes them, but also allows providers to know their preferred name. In addition, we believe it would be more appropriate to remove the terms “biological” from sex, and “orientation” from gender.
• Also in the minimum required elements, we suggest changing (e) to read, “reported diagnosis,” because at this point in the process, a provider is likely relying on what the individual and/or person (people) who accompanies them is reporting to them.

The following provides our input in this section:

• This section provides another example where terms are used that are not generally understood and used by providers. The term “referral update,” better reflects what providers understand to be the documentation requirements outlined in the proposed regulations. For this reason, we recommend replacing the terms “secondary screening” with “referral update” throughout this section. The line-by-line comments reflect this suggested change.
• Also in this section, greater clarity is requested around whether the initial referral is acceptable in cases where a provider has no waitlist.
• Clarity is also requested with respect to how long a person must be on a waitlist to trigger the requirement for a secondary screening or referral update.

The following outlines our input in this section:

• As noted in the VACBP's comments in the definitions section, we believe it’s important that providers understand that this section is describing the “Comprehensive Needs Assessment,” as opposed to an additional or different assessment. For this reason, we suggest amending this section to replace the term, “assessment,” with as “Comprehensive Needs Assessment” or “CNA.”
• Within (F) of this section regarding the “initial assessment,” we propose including “as available” when directing providers to obtain information from other qualified providers, recognizing that it can be challenging to obtain this information.
• Also within (F) of this section, we propose adding (3) that states that, “An initial assessment shall not be required for Mental Health Outpatient services.” The rationale for this suggestion is that service authorizations are not required for mental health outpatient services, so the development of the described “initial assessment” may not be necessary.
• Within (G) of this section regarding the “comprehensive needs assessment,” we propose adding the words, “as available,” to (5), recognizing that previous assessments of an individual are not always available or easy to obtain.
• Also within (G) of this section, greater clarity regarding how “legal competency” is defined in this context is requested.

The following outlines our input in this section:

• Within (A.2) of this section, we propose revising the language regarding the timeline for developing and implementing the ISP to read, “no later than the next business day after admission,” recognizing that not all centers operate 24 hours/day, 7 days/week.
• Also within (A.2) of this section, we propose amending the last sentence to read, “The initial person-centered ISP shall be in effect for the first 30 days.”

The following outlines our input in this section:

• Consistent with our recommendation in our other comments, we propose replacing the term “assessment” throughout this section with “Comprehensive Needs Assessment,” or “CNA.”
• We recommend adding a (C) in this section that reads, “If a comprehensive ISP that includes all the required items outlined above is developed within one business day of admission, an initial ISP shall not be required.” Given all the required elements in the initial ISP are included in the comprehensive ISP, we don’t believe providers should have to develop both, again, so long as the comprehensive ISP is developed within one business day of admission.
• In the current (C) of this section, greater clarity is requested with respect to how frequently a provider must request a signature if the individual is not responding. While the regulations require a signature be requested at a minimum, each time the provider reviews the ISP, they don’t speak to how many times a provider needs to request a signature at any point in the process.

The following outlines our input in this section:

• Within (A) of this section, there is significant concern about the proposed requirement that the format of progress notes be consistent throughout all the services a provider offers. We propose the requirement for a consistent format in progress notes be by service. This will enable providers to utilize the most appropriate progress note format depending on the type of service.
• Within (B) of this section, we propose that the minimum progress notes requirements be amended as follows:
  • Remove the current (1) as this is clearly stated in (A).
  • In the current (3), remove, “including care provided and events relevant to diagnosis and treatment or care of the individual,” recognizing that the language prior to that, “record events of the individual’s interaction with the clinical staff writing the progress note,” is sufficient.
  • Remove current (4) (“have a narrative component”) which doesn’t seem necessary.
  • Amend the current (5) to read, “Note the ISP objectives being addressed.”
  • Add to the requirements a new (4) that reads, “Outline the plan for the next session.”

The following outlines our input in this section:

• In (3) of this section, we suggest removing the requirement that consultation in case of emergency be required, “by telephone 24 hours a day, 7 days a week when the treatment program is not in session,” given this is not a crisis-level service and being available in this way could be a significant challenge for providers. There are also liability and risk concerns related to this requirement among licensed mental health professionals.

The following outlines our input in this section:

For reasons consistent with our other comments, we suggest removing (2) of this section, which reads, “Ensure emergency services are available by telephone 24 hours a day, 7 days a week," given this is not a crisis-level service and being available in this way could be a significant challenge for providers. There are also liability and risk concerns related to this requirement among licensed mental health professionals. 

The following outlines our input in this section:

Consistent with our previous comments, we suggest removing (3) of this section, which reads, “Provide emergency assistance 24 hours a day, 7 days a week,” given this is not a crisis-level service and being available in this way could be a significant challenge for providers. There are also liability and risk concerns related to this requirement among licensed mental health professionals. 

Initial Draft NEW Center Based Service Chapter of the Licensing Regulations:

1. 12VAC35-109-10 Definitions: Please clarify if there is a definitional difference from DBHDS between “episodic” and “periodic” in the definition of Center-based respite care services. This language occurs later in the regulations in terms staff supervision and clarity is needed. If the DBHDS meaning of the two terms is the same, please eliminate one of them.
2. 12VAC35-109-40.A.2 Screening:  This language requires a policy/procedure regarding the identification, qualification, training and duties of employees responsible for screening.  Please reference what qualifications and training DBHDS requires (if they are specified) for employees who conduct screenings.
3. 12VAC35-109 -60.G.5:  Comprehensive assessment:  the language that the comprehensive assessment must “include unsuccessful interventions, and outcomes, and the provider shall ensure previous assessments are utilized to note these interventions as required” should be indicated as required “if applicable.”   Does this imply that new respite providers doing a comprehensive assessment must confer with other providers to gather information on unsuccessful interventions and outcomes? If so, that administrative and communication barrier is extremely high.
4. It would be extremely helpful if DBHDS clearly distinguished between an ISP developed with the support coordinator and a Plan of Care which is developed by a provider and submitted as Part V of the ISP in WAMS.  Using the term ISP for most of the regulatory provisions raises questions as to applicability for providers.  For example:12VAC35-109-80.A.5:  requires “identification of employees or contractors responsible for coordination and integration of services, including employees of other agencies.” It is reasonable for a support coordinator to manage “coordination and integration of services,” but it is not reasonable for a provider to do so.  This language appears again in 12VAC35-109-80.B.10.
5. 12VAC35-109-80.E.2. “After each training (on the ISP), providers shall test the employee’s or contractor’s knowledge, competency, or both and retain documentation of the test of the employee’s or contractor’s knowledge, competency, or both within the employee’s or contractor’s employment file.” This is an unworkable requirement.  As a center-based respite center serving individuals on a periodic basis, Jill’s House would be required to test and file test results in the employee file DSP knowledge of individual service plans on an almost weekly basis.
6. 12VAC35-109-90.F:  Quarterly Reports.  Please clarify that Quarterly Reports are not due to support coordinator for quarters during which the service was not provided.  Center-based respite is periodic in nature and may happen only 3 times a year.
7. 12VAC35-109-90.F.4.b.c.: requires that the quarterly review of the ISP shall note the individuals progress towards discharge and discharge planning;  Respite does not work toward discharge from services.  This should be “if applicable.”
8. 12VAC35-109-110.D:  Staffing “The supervisor shall have documented experience developing, conducting, and approving assessments and ISPs or treatment plans.”  This is an unnecessary requirement. Jill’s House floor/shift supervisors have experience reading, interpreting, and implementing services plans and are trained to supervise the DSPs providing the direct care in accordance with the ISP.  Our administrative staff and licensed QMHP’s develop and approve the ISP’s and treatment plans. Shift supervisors don’t need to know how to write the ISPs. They need to know how to read, understand, and implement it.

General statement: I agree with some previous comments about the clarification in these regulations regarding when ISP is referencing Parts I-V or just part V.

Definitions:

QDDP-  the addition of the following statement is not consistent with what has been allowable, therefore, it could cause some that are in supervisory positions, to no longer qualify.

….if the person has five years of paid experience in providing direction, development, and implementation, direct supervision, and monitoring to the service provided. QDDPs are responsible for approving assessments and individual service plans or treatment plans to ensure appropriate services are provided to meet the needs of individuals receiving services. The QDDP shall have documented experience developing, conducting, and approving assessments and individual service plans or treatment plans.

12VAC35-109-70. Individualized services plan (ISP); Individualized supports plan; Service

planning.

1. 1. Providers of developmental services shall develop and implement a plan for

supports, which is a component of the comprehensive individual support plan, 24

hours after admission.

This comment needs to be changed as we cannot submit this after 24 hours or there will be no payment.  It is noted that we need submission of an ISP to WaMS 30 days in advance of the start date, so this statement does not make sense.  In addition, the other regulations up for comment for Case Management notes the same, which has a large impact already on service providers being paid when case managers are given leeway in getting their documentation submitted timely as they are allowed to bill for services with other criteria, however, service providers cannot bill until the ISP is approved in WaMS causing us to lose payment when ISPs are not completed and pushed through for approval within WaMS prior to the start date of the ISP.

12VAC35-109-80. ISP Requirements

E.            2. After each training, providers shall test the employee’s or contractor’s knowledge,

competency, or both, and retain documentation of the test of the employee’s or

contractor’s knowledge, competency, or both within the employee or contractor’s

personnel file.

Please consider removing this requirement as this poses additional administrative burden and the DSP competency requirements already addresses having a working knowledge of the individuals for whom a DSP is working.  In addition, the employee files should not contain information pertaining to an individual receiving services.

12VAC35-109-90. Reassessments and ISP reviews.

F. The provider shall complete quarterly reviews of the ISP in writing at least every three months from

the date of the implementation of the comprehensive ISP or whenever there is a reassessment. The review of the ISP shall be conducted in a person-centered manner, to determine if services are being delivered as described within the ISP. The individual receiving services and the authorized representative, if applicable, shall be included in the ISP review, to determine if the individual is satisfied with the services provided.

4. A review of the ISP shall note the:

a. Individual’s family involvement, if any, in the individual’s treatment;

It should not be the individual service provider’s responsibility to indicate family involvement in someone’s treatment.  There is a review for satisfaction of service delivery that is reviewed quarterly when there is a Legal Guardian or Authorized Representative.  Please provide clarification on this statement.

This proposed regulation is an unwarranted hardship for providers.  Agencies will have to create a test for every individual served, test all staff members who work with that person, as well as having to track and file all the tests. 

This is an excessive requirement, especially during a time providers are experiencing a workforce crisis that will not end soon.  

The following outlines our input in this section:

• In (5) of this section, the extensive training requirements could be a challenge for some providers.

The following outlines our input in this section:

• (2) of this section, which reads, “Offer services between 9 and 19 hours a week, with programming to occur across a minimum of 3 days a week,” applies only to adults. Adolescent MH-IOP is 6-19 hours of programing per week.

The following outlines additional input in this section:

• (1) of this section, which reads, “Offer no more than 9 hours of programming a week,” greater clarity is requested regarding whether the regulations are capped at 9 hours because the next level of intensity in a minimum of 9 hours per week for adults. In addition, this refers to service for adults only. Adolescent IOP has a 6 hour per week minimum.

12VAC35-105-10 - recommendation to adding a definition for support decision making to this section

12VAC35-105-40 - recommendation changing medical condition to medical symptoms.

12VAC35-105-60 - add "and available" after if applicable

12VAC35-105-70 - A. #1 & #2 recommend changing 24 hour after admission to 1 business day

12VAC35-105-80 - While I agree employees should be knowledgeable about the contents of the ISP for individuals served, establishing expectations to train and test all employees involved in service delivery is an unrealistic expectation that will significantly distract from service delivery. Observations of knowledge and competency about providing the service is part of supervisory and performance evaluation. Moving forward with this is likely to reduce updates to ISPs. This places an undue burden on Human Resources and supervisors, who would have to develop ways to test and train employees while maintaining their other responsibilities.

12VAC35-105-90 - asking for clarification if quarterlies are required for this service. 

12VAC35-105-100 -

B5. Clarification on what services would be beneficial such as outpatient but not day support. This is an impractical expectation for daily service documentation.

B6 - replace clinical staff to qualified staff

C - add informational notes along with communication logs and supervisory notes.

12VAC35-105-120 - A #3 & #4 - recommend to remove will provide as we cannot provide medical or dental services as we are not medical professionals. 

12VAC35-105-130 - 2 b.  remove as this pertains to residential services not centered based services 

12VAC35-105-150 - recommendation to make consistent through DBHDS regulations. The temperature range is different for center based services than residential services. 

12VAC35-105-200 - G. This is an impractical expectation for programs due to the administrative burden. This is not required for any other DBHDS licensed service, request this be removed. 

The following outlines additional input in this section:

• (1) of this section, which reads, “Offer a minimum of 3 service hours per service day to achieve no fewer than 9 hours and no more than 19 hours of programming per week in a structured environment,” refers to adult IOP. Adolescent IOP is fewer than 6 hours and no more than 19 hours per week.

The following outlines input in this section:

• In (5) of this section, the extensive training requirements could be a challenge for some providers.

The following outlines additional input in this section:

• Within (D) of this section, further clarity around what would be characterized as “reasonable” is requested.
• Within (E) of this section, further clarity is requested regarding what “standardized state or federally sanction tools,” are.

Dear DBHDS:

BrightView Health would like to express our appreciation for considering feedback from providers and making amendments that will allow us to better provide appropriate substance use disorder treatment services. BrightView concurs with the comments submitted by the Virginia Association of Medication Assisted Recovery Programs. Please find that BrightView submits the following additional comments.

12VAC35-109-250 Service Operation Schedule

Section B.2. States, "The provider receives prior approval from the state opioid treatment authority (SOTA) for Sunday closings. Each program must have a policy that addresses medication for the newly inducted patients and those who are deemed at risk, i.e., still actively using illicit substances or medical issues that may warrant closer monitoring of medication. This policy must include openings on Sundays for the population described above."

BrightView recommends changing the wording of the first sentence to read, "Provider will follow federal guidelines for Sunday closings."

• The SOTA oversees and ensures the programs follow federal guidelines, and prior approval is not necessary.

12VAC35-109-280. Counseling sessions

Section A.1. States, "The provider shall conduct face-to-face counseling sessions (either individual, group, or family) of one hour minimum. The provider shall document details of each session including the length within the individual's service record. The counseling sessions shall occur:                                                                                                                     1. Every week for the first six months of the first year of the individual's treatment."

BrightView recommends the counseling sessions are only required to be offered to the individual twice per month for the first twelve months of treatment.                   

• The provider cannot control the frequency of the counseling sessions the patient chooses to attend. It is counterproductive to deem a patient ineligible for the program for noncompliance with inflexible therapy requirements.
• Federal regulations require counseling sessions to be provided to patients as clinically necessary (42 CFR 8.12(f)(5)(i)). The frequency of attendance that is clinically necessary should be left to the professional judgement of the provider.

Thank you for this opportunity to provide input on these proposed amendments. Please feel free to contact BrightView with any questions or if we can be of assistance in any way.

1. 12VAC35-109-10 Definitions. “Substance abuse intensive outpatient service” definition needs to include that services delivered to children/adolescents require a minimum of 2 hours of service per day to align with DMAS regulation 12VAC30-130-5090.

2. 12VAC35-109-10 Definition. The definition of “Initial assessment” includes “An assessment is not a service.”  Recommend that OL expand on this statement and provide more clarity on what OL is intending to convey as it relates to these regulations.

3. 12VAC35-109-40 Screening. All these “required elements” do not seem necessary for all levels or types of service to screen individuals for assessment for admission, or referral to more appropriate services or providers. Current OL regulations at 12VAC35-105-645 are sufficient and recommend leave as written. These proposed regulations seem to be confusing an initial contact/screening with an initial assessment to determine eligibility for admission.  Additionally,
   • Gender Identity should not be a required element for screening for services, only optional.  Should not have to collect this for every individual at screening; more appropriate for the intake/initial assessment.
   • Recommend changing “medical symptoms” to “current symptoms” to not exclude behavioral, emotional symptoms.
   • Current medications and these specific details are not necessary for an initial screening for all types of services or providers. 

4. 12VAC35-109-50 Secondary Screening.  All of the information required to be updated/collected in the Secondary Screening would be updated/collected at the initial intake/assessment prior to or at admission, so why would a Secondary Screening be necessary?  Just seems to be a redundant process.  A Secondary Screening only makes sense when an individual is on a wait list for an extended period of time without being assessed for admission.  Perhaps it should just be a “follow-up screening”, completed at defined timeframes while the individual remains on the waitlist to collect new/updated information and changes in symptoms and treatment needs that may move them to a priority list or immediate referral to another level of care.
   • Should define a timeframe in which a “secondary screening” (or follow-up) is needed.  On waitlist longer than 30 days, 45 days, 60 days? 
   • In A.2 – Providers should not be required to collect Emergency contact information at the initial screening; this is typically collected at the time of admission/intake to service (see current regulation 12VAC35-105-890, Individual Service Record for admitted individuals and -750 Emergency Medical Information).  Was also not a required element to be collected in the initial Screening in proposed section -40 above, so nothing to update.

5. 12VAC35-109-60.F(1)(g) Assessments. Remove “continue”.  Individuals have not started treatment at this phase of the admission process/initial assessment.

6. 12VAC35-109-70.D ISP. Need to clarify what this added language about case managers is attempting to convey and require.

7. 12VAC35-109-80 ISP Requirements. The requirements written here for an Initial ISP are almost  identical to the Comprehensive ISP.  The Initial ISP is based on the Initial Assessment and generally will not cover all assessed needs, only the initial service plan to address immediate health, safety, and treatment needs at the start of services.  The requirements listed here are much more comprehensive and require further assessment and planning than what can be defined and implemented with 24 hours from the initial assessment.  These elements of an ISP generally follow the completion of the comprehensive Assessment.

8. 12VAC35-109-80.E.2 ISP Requirements. The requirement to test a provider’s competency on each individual’s ISP AND to document the test within their personnel records is excessive and a huge documentation and labor burden on providers.  The general competency assessment requirement to determine and document a provider’s abilities and knowledge should just remain part of the General Chapter, Article 4 – Personnel. 

9. 12VAC35-109-90.F Reassessments and ISP Reviews. Recommend changing “to determine if the individual is satisfied with the services provided” to ”to determine if the individual’s treatment needs and preferences are being met” in keeping with the language used in the definition of an ISP in 109-10. “Satisfaction” has quality improvement implications, whereas the review of the ISP should remain clinically-focused.

10. 12VAC35-109-100.A Progress Notes or other documentation. Does the OL mean here that progress notes should be consistent across provider service “locations”?  To maintain a consistent format across different types of services can be challenging since different types of information are captured and documented depending on the service type and/or level of care the individual is receiving.

11. 12VAC35-109-100.B.6 Progress Notes or other documentation. Progress Notes should be signed and dated by the clinical staff who provided/rendered the service in keeping with DMAS and most payer requirements, not who entered the note, which may not necessarily be the same staff.

12. 12VAC35-109-200 through -350 only apply to OTPs.  Unlike the other service-specific sections at -360 through -500, the service name is not included in the section titles making it difficult to determine that these requirements are specific to MAT/OTP.  Recommended adding the service name to these section titles.

13. 12VAC35-190-400.1 Substance abuse intensive outpatient program criteria. The number of service hours per day should align with the DMAS regulations for this service.  See 12VAC30-130-5090. Services for children/adolescents only require a minimum of 2 service hours per day.

Thank you for considering these comments.

12VAC35-109-120. Health care policy. -

3. To what extent the provider will provide, arrange, or support the individual with the provision of medical and dental services identified at admission.

4. To what extent the provider will provide, arrange, or support the individual with the provision of routine ongoing and follow-up medical and dental services after admission.

5. How the provider will communicate the results of any physical examinations, medical assessments, and any diagnostic tests, treatments, or examinations to the individual and authorized representative, as appropriate.

6. How the provider will keep accessible to staff and contractors on duty the names, addresses, and phone numbers of the individual's medical and dental providers.

7. To what extent the provider will ensure a means for facilitating and arranging, as appropriate, transportation to medical and dental appointments and medical tests.

The overall policy is directed at Center Based services. Center based day support services will not likely have any control of nor should they for items 3 through 7. I recommend that these references be clarified as to what actual services they are required (IE opioid treatment centers, Center Based Respite, etc).