Indiana Governor Signs Bill Supporting Tighter Regulations for Methadone Maintenance

[moda00]

Swim's methadone clinic has recently implemented some changes, and she's been doing some reading on the issues. She is one who believes that addiction and dependence are to be most effectively treated as social and medical issues and approached via harm reduction, and that professionals in treatment facilities such as methadone clinics should be able to have some flexibility to make individualized determinations (within reasonable guidelines). This new legislation in Indiana, sadly, seems to be a step back for harm reduction and making treatment accessible and reasonable..

April 03, 2008
Methadone clinics to get more oversight

Governor signs bill with tighter regulations
By MELISSA MOODY
Melissa.Moody@newsandtribune.com

A new Indiana law further regulating methadone-treatment clinics has appeased a Jeffersonville legislator and the clinic’s operator, but a county commissioner and resident say more needs to be done.

The bill has been championed by State Sen. Steve Stemler, D-Jeffersonville, as a much-needed to measure to help stop the steady flow of out-of-state residents coming into Southern Indiana to seek methadone treatment.

“This has been pretty high profile for (Clark) County, but it’s a state law and will affect the whole state as well,” Stemler said.

Southern Indiana Treatment Center’s Regional Director Tim Bohman — who oversees the local methadone clinic off Charlestown Pike — said the clinic’s operators are pleased with the outcome of the bill, and that it won’t affect the treatment provided to patients at the clinic.

“It basically set up regulations around good, quality treatment, and it didn’t affect access to care,” Bohman said. “We’re happy with the way the bill turned out.”

Indiana Gov. Mitch Daniels last week signed the bill that will increase the requirements regulating methadone clinics throughout the state, which are used to treat opioid addictions, such as from heroin. The measure received overwhelming support in the state House of Representatives and the Senate, “which is something (Daniels) always looks for when he signs a bill,” said Jane Jankowski, communications director for the governor’s office.

Previous laws governing Indiana methadone clinics were significantly less strict than laws in surrounding states, including Kentucky, Ohio and Illinois.

However, some residents and local leaders think the new bill doesn’t go far enough.

“There is more to do as far as protecting the citizens of Clark County rather than patients at the clinic. There was more emphasis on patients’ rights than residents’,” said Clark County Commissioner Mike Moore. “If the hospital won’t let you leave their grounds after receiving medication, then why in the world can the clinic.

“I don’t think kids should be on the grounds of the facility or a day care should be available. You don’t need to be walking kids into that facility or leaving kids in the car while parents are getting their dose.”

Moore and a resident living near the clinic visited the Senate in Indianapolis while the bill was being discussed by the General Assembly to advocate for the residents of Clark County. Of the three issues Moore raised, marijuana testing for patients was the only to make it into the final bill.

Moore said he also wanted to see the take-home dose given to patients decreased from 30 days to three, instead of from the 30 days to 14 which made it into law. He attributed the take-home dose — which is still larger with the more strict regulations than in surrounding states — to the high numbers of patients from out-of-state getting treatment at Indiana methadone clinics.

“Until we’re only dealing with Indiana patients, we’ll have the problems we’ve got,” he said. “I’m not satisfied, but I’m at least happy with they addressed marijuana testing.”

Many area residents pointed to the lack of marijuana-testing requirements as the reason so many people traveled here from out of state to seek treatment; marijuana testing is required in surrounding states.

Senate bill 157 will require methadone clinics to test all patients, both before receiving treatment and periodically throughout treatment, for drugs, including marijuana.

“It appears that legislation is moving in the right direction,” said Derrick Vogt, a county resident who lives near Southern Indiana Treatment Center. “I still would like to see tougher legislation concerning the patients and driving after their dosages.”

Another major component of the legislation is the creation of a central registry of patients receiving treatment at methadone clinics throughout the state. The registry will be established and maintained by the Indiana Family and Social Services Administration’s Division of Mental Health and Addiction.

It will be updated as information regarding patients is received from clinics, which are required to report patient information and progress on an at least monthly basis.

“We will be able to track the results and see how effective these clinics are,” Stemler said. “It is going to require (the state social services administration) to have greater oversight.

“We accomplished what we wanted and hopefully the results will prove successful.”

At a glance
Senate Bill 157, recently signed by Indiana Gov. Mitch Daniels, strengthens requirements for methadone clinics throughout the state. Here’s how:

• All methadone clinics must be approved and certified by the Indiana Family and Social Services Administration’s Division of Mental Health and Addiction, including each location operated by a clinic provider.

• All methadone-treatment programs must periodically and randomly test, including before receiving treatment, for drugs, including methadone, cocaine, opiates, amphetamines, barbiturates, marijuana, benzodiazepines and any other drug that may have been abused by the patient.

• Each methadone clinic operator must submit an annual report outlining the addiction-diversion program used, including the program’s drug testing procedure for testing a patient during treatment.

• The mental health division will conduct on-site visits of all methadone clinics annually.

• The mental health division will establish and maintain a central registry of all patients in the state being served by methadone-treatment programs, and all clinics must provide, at least monthly, information required by the department concerning patients in the addiction-treatment programs.

And the comments that the law "didn't go far enough" ??? Addicts should (obviously) be treated as human beings, and receiving a medication like methadone should be be treated as such- it is a prescription drug. One comment included states that if patients cannot leave the hospital after taking a medication, why should clinics let patients leave? They implied that this was a public health and safety issue. As if the addicts are a threat to society once they have ingested their methadone. And that kids shouldn't be exposed to that. Well, kids see their parents drink alcohol, or ingest food, or take prescription or over the counter meds. They are usually taught themselves to drink their cough syrup or take their antibiotics when ill as a child. Why couldn't they be with their parent when that parent drank a cup of medication? And in fact, if you want to encourage responsible parenting and treating substance abuse and dependence within the context of "protecting the kids," then best to facilitate that logically. If kids are banned in the clinics, do you want parents to leave them home alone? Or do you want this to become a barrier to treatment for individuals with children? As for the limit on take-home doses- every extra day you make that patient come to the clinic is a day they have to wake their kids up early, get them all ready, and haul them off to the clinic ("exposing" them far more often, which is apparently a problem in these folks' eyes. So either way, once a patient is stabilized, treat them like an adult, and minimize the intrusion upon their family and their life.

The new law minimized the take-home dosing period, from the usual 30 days (which takes over a year to attain anyways I believe) to 14 days, or two weeks. In fact, the gent quoted in the article said he thought three (3!) days should be the maximum- meaning patients, no matter how long they'd been sober or how functional they are, should need to come to the methadone clinic every three-four days. And the required testing for THC- if someone is smoking pot and able to stay off heroin, why penalize them? Most clinics test for pot anyways; it's standard in the "NIDA five." And most do penalize you for it to some extent- they won't allow you take-homes if you smoke, but they often won't kick you out completely- but with the feds stepping it up, they may not have any choice at some point. Why take it as far as to specify this requirement?

[moda00]

This is the committee report on the bill referenced above. They also changed the wording to opioid, but I'm unclear as to why,since methadone is still specified and it doesn't seem that this would apply to any other prescription opioid, like buprenorphine, or the more traditional opiate drugs like morphine, etc.

CONFERENCE COMMITTEE REPORT

MR. SPEAKER:
Your Conference Committee appointed to confer with a like committee from the Senate upon Engrossed House Amendments to Engrossed Senate Bill No. 157 respectfully reports that said two committees have conferred and agreed as follows to wit:

that the Senate recede from its dissent from all House amendments and that the Senate now concur in all House amendments to the bill and that the bill be further amended as follows:

Delete everything after the enacting clause and insert the following:
SOURCE: IC 12-7-2-135.6; (08)CC015701.1. --> SECTION 1. IC 12-7-2-135.6 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 135.6. "Opioid treatment program" means a program through which opioid agonist medication is dispensed to an individual in the treatment of opiate addiction and for which certification is required under 42 CFR Part 8.
SOURCE: IC 12-23-18-0.5; (08)CC015701.2. --> SECTION 2. IC 12-23-18-0.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 0.5. (a) An opioid treatment program shall not operate in Indiana unless:
(1) the opioid treatment program is specifically approved and the opiate treatment facility is certified by the division; and
(2) the opioid treatment program is in compliance with state and federal law.
(b) Separate specific approval and certification under this chapter is required for each location at which an opioid treatment program is operated.
SOURCE: IC 12-23-18-1; (08)CC015701.3. --> SECTION 3. IC 12-23-18-1 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 1. (a) Subject to federal law and consistent with standard medical practice in methadone opioid

treatment of drug abuse, the division shall adopt rules under IC 4-22-2 to establish and administer a methadone an opioid treatment diversion control and oversight program to identify individuals who divert controlled substances opioid treatment medications from legitimate treatment use and to terminate the methadone opioid treatment of those individuals.
(b) Rules adopted under subsection (a) must include provisions relating to the following matters concerning methadone providers opioid treatment programs and individuals patients who receive opioid treatment:
(1) Regular clinic attendance by the patient.
(2) Specific counseling requirements for the methadone provider opioid treatment program.
(3) Serious behavior problems of the patient.
(4) Stable home environment of the patient.
(5) Safe storage capacity of opioid treatment medications within the patient's home.
(6) Medically recognized testing protocols to determine legitimate opioid treatment medication use.
(7) The methadone provider's opioid treatment program's medical director and administrative staff responsibilities for preparing and implementing a diversion control plan.
SOURCE: IC 12-23-18-2; (08)CC015701.4. --> SECTION 4. IC 12-23-18-2 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 2. (a) Not later than February 28 of each year, each methadone provider opioid treatment program must submit to the division a diversion control plan required under that:
(1) meets the requirements of section 1(b)(7) 1 of this chapter; and
(2) includes in the opioid treatment program's diversion control plan the program's drug testing procedure for testing a patient during the patient's treatment by the program as required by section 2.5 of this chapter.
(b) Not later than May 1 of each year, the division shall review and approve plans a plan submitted under subsection (a).
(c) If the division denies a plan submitted under subsection (a), the methadone provider opioid treatment program must submit another plan not later than sixty (60) days after the denial of the plan.
SOURCE: IC 12-23-18-2.5; (08)CC015701.5. --> SECTION 5. IC 12-23-18-2.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 2.5. (a) An opioid treatment program must periodically and randomly test, including before receiving treatment, a patient for the following during the patient's treatment by the program:
(1) Methadone.
(2) Cocaine.
(3) Opiates.
(4) Amphetamines.
(5) Barbiturates.
(6) Tetrahydrocannabinol.
(7) Benzodiazepines. (8) Any other suspected or known drug that may have been abused by the patient.
(b) If a patient tests positive under a test described in subsection (a) for:
(1) a controlled substance other than a drug for which the patient has a prescription or that is part of the patient's treatment plan at the opioid treatment program; or
(2) an illegal drug other than the drug that is part of the patient's treatment plan at the opioid treatment program;
the opioid treatment program and the patient must comply with the requirements under subsection (c).
(c) If a patient tests positive under a test for a controlled substance or illegal drug that is not allowed under subsection (b), the following conditions must be met:
(1) The opioid treatment program must refer the patient to the onsite physician for a clinical evaluation that must be conducted not more than ten (10) days after the date of the patient's positive test. The physician shall consult with medical and behavioral staff to conduct the evaluation. The clinical evaluation must recommend a remedial action for the patient that may include discharge from the opioid treatment program or amending the treatment plan to require a higher level of supervision.
(2) The opioid treatment program may not allow the patient to take any opioid treatment medications from the treatment facility until the patient has completed a clinical assessment under subdivision (1) and has passed a random test. The patient must report to the treatment facility daily, except when the facility is closed, until the onsite physician, after consultation with the medical and behavioral staff, determines that daily treatment is no longer necessary.
(3) The patient must take a weekly random test until the patient passes a test under subsection (b).
(d) An opioid treatment program must conduct all tests required under this section in an observed manner to assure that a false sample is not provided by the patient.
SOURCE: IC 12-23-18-3; (08)CC015701.6. --> SECTION 6. IC 12-23-18-3 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 3. (a) By May 15 of each year, each methadone provider opioid treatment program shall submit to the division a fee of: twenty dollars ($20) for each nonresident; patient that is:
(1) an amount established by the division by rule under IC 4-22-2;
(2) not more than necessary to recover the costs of administering this chapter; and
(3) not more than seventy-five dollars ($75) for each opioid treatment program patient who was treated by the methadone provider opioid treatment program during the preceding calender calendar year.
(b) The fee collected under subsection (a) shall be deposited in the methadone diversion control and oversight program fund. established

under section 4 of this chapter.
SOURCE: IC 12-23-18-4; (08)CC015701.7. --> SECTION 7. IC 12-23-18-4 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 4. (a) As used in this section, "fund" means the methadone diversion control and oversight opioid treatment program fund established under subsection (b).
(b) The methadone diversion control and oversight opioid treatment program fund is established to administer and carry out the purposes of implement this chapter. The fund shall be administered by the division.
(c) The expenses of administering the fund shall be paid from money in the fund.
(d) The treasurer of state shall invest money in the fund in the same manner as other public money may be invested.
(e) Money in the fund at the end of the state fiscal year does not revert to the state general fund.
SOURCE: IC 12-23-18-5; (08)CC015701.8. --> SECTION 8. IC 12-23-18-5 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 5. (a) The division shall adopt rules under IC 4-22-2 to establish the following:
(1) Standards for operation of an opioid treatment program in Indiana, including the following requirements:
(A) An opioid treatment program shall obtain prior authorization from the division for any patient receiving more than fourteen (14) days of opioid treatment medications at one (1) time.
(B) Minimum requirements for a licensed physician's regular:
(i) physical presence in the opioid treatment facility; and
(ii) physical evaluation and progress evaluation of each opioid treatment program patient.
(C) Minimum staffing requirements by licensed and unlicensed personnel.
(D) Clinical standards for the appropriate tapering of a patient on and off of an opioid treatment medication.
(2) A requirement that, not later than February 28 of each year, a current diversion control plan that meets the requirements of 21 CFR Part 291 and 42 CFR Part 8 be submitted for each opioid treatment facility.
(3) Fees to be paid by an opioid treatment program for deposit in the fund for annual certification under this chapter as described in section 3 of this chapter.
The fees established under this subsection must be sufficient to pay the cost of implementing this chapter.
(b) The division shall conduct an annual onsite visit of each methadone provider opioid treatment program facility to assess compliance with the plan approved under this chapter.
SOURCE: IC 12-23-18-5.5; (08)CC015701.9. --> SECTION 9. IC 12-23-18-5.5, AS ADDED BY P.L.210-2007, SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 5.5. (a) The division may not grant specific approval to be a new opioid treatment program. This section does not apply to applications for new opioid treatment programs pending prior to March 1, 2007. (b) This section expires December 31, 2008.
SOURCE: IC 12-23-18-5.6; (08)CC015701.10. --> SECTION 10. IC 12-23-18-5.6 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 5.6. (a) The division shall establish a central registry to maintain information concerning each patient served by an opioid treatment program.
(b) An opioid treatment program shall, at least monthly, provide to the division information required by the division concerning patients currently served by the opioid treatment program.
(c) Information that could be used to identify an opioid treatment program patient and that is:
(1) contained in; or
(2) provided to the division and related to;
the central registry is confidential.
SOURCE: IC 12-23-18-5.7; (08)CC015701.11. --> SECTION 11. IC 12-23-18-5.7 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 5.7. (a) The division shall, as part of the biennial report required under IC 12-21-5-1.5(8), prepare and submit to the legislative council in an electronic format under IC 5-14-6, the state department of health, and the governor a report concerning treatment offered by opioid treatment programs. The report must contain the following information for each of the two (2) previous calendar years:
(1) The number of opioid treatment programs in Indiana.
(2) The number of patients receiving opioid treatment in Indiana.
(3) The length of time each patient received opioid treatment and the average length of time all patients received opioid treatment.
(4) The cost of each patient's opioid treatment and the average cost of opioid treatment.
(5) The number of patients who were determined to be no longer in need of services and are no longer receiving opioid treatment.
(6) The number of individuals, by geographic area, who are on a waiting list to receive opioid treatment.
(7) The patient information reported to the central registry established under section 5.6 of this chapter.
(8) Any other information that the division determines to be relevant to the success of a quality opioid treatment program.
(9) The number of patients who tested positive under a test for a controlled substance or illegal drug not allowed under section 2.5(b) of this chapter.
(b) Each opioid treatment program in Indiana shall provide information requested by the division for the report required by this section.
(c) Failure of an opioid treatment program to submit the information required under subsection (a) may result in suspension or termination of the opioid treatment program's specific approval to operate as an opioid treatment program or the opioid treatment facility's certification. (d) Information that could be used to identify an opioid treatment program patient and that is:
(1) contained in; or
(2) provided to the division related to;
the report required by this section is confidential.
SOURCE: IC 12-23-18-5.8; (08)CC015701.12. --> SECTION 12. IC 12-23-18-5.8 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2008]: Sec. 5.8. (a) The director of the division may take any of the following actions based on any grounds described in subsection (b):
(1) Issue a letter of correction.
(2) Reinspect an opioid treatment program facility.
(3) Deny renewal of, or revoke, any of the following:
(A) Specific approval to operate as an opioid treatment program.
(B) Certification of an opioid treatment facility.
(4) Impose a civil penalty in an amount not to exceed ten thousand dollars ($10,000).
(b) The director of the division may take action under subsection (a) based on any of the following grounds:
(1) Violation of this chapter or rules adopted under this chapter.
(2) Permitting, aiding, or abetting the commission of any illegal act in an opioid treatment program facility.
(3) Conduct or practice found by the director to be detrimental to the welfare of an opioid treatment program patient.
(c) IC 4-21.5 applies to an action under this section.
SOURCE: IC 12-23-18-6; (08)CC015701.13. --> SECTION 13. IC 12-23-18-6 IS REPEALED [EFFECTIVE JULY 1, 2008].
(Reference is to ESB 157 as reprinted February 27, 2008.)

Conference Committee Report
on
Engrossed Senate Bill 157

edit: I initially tried to save in the Law section of the Archive and was going to edit in a link to that page into my original post, but the link in the archive doesn't work. I couldn't get it to work as a pdf, and the direct link would have been to a government site- sorry! moda00