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