Testimony of Holly Catania, Drug Policy Alliance, Public Hearing On Methadone/LAAM Proposed Rule

I will begin with some general comments, then move on to specific sections in the proposed regulations addressing the issues of improving and expanding the delivery of methadone and LAAM.

The goals of the new proposed rule changes for the medical treatment of opiate addiction as stated in the Introduction

• to increase significantly the direct participation of the medical community in the oversight of addiction treatment
• to help mainstream the medical treatment of narcotic dependence
• to reduce the variability in the quality of opioid treatment services; and
• to reform the treatment system to provide for expanded treatment capacity

are much welcomed and long overdue. However, it is unclear how they will be accomplished in any substantial way by the proposed regulations that follow. While we applaud the innovations that will likely help mainstream the medical treatment of narcotic dependence such as the loosening of the restrictions regarding take-home medications and the lifting of the prohibition on take-home doses of LAAM, most of the restrictions that have historically blocked the expansion of methadone and prevented individual practitioners from treating their patieints' narcotics addictions are still in place.

The Introduction makes clear that the Secretary is considering increasing access to methadone/LAAM maintenance through office-based physician prescribing, but nothing in the proposed regulations reflects that stated desire. In fact, the regulations seem to further discourage individual practitioners, physicians as well as pharmacists, from treating addiction outside the limited clinic settings. By not including any specific provisions for treating addicted patients by physicians in their offices and by pharmacists in local pharmacies, the proposed rules continue to act as a bar to increasing access to legally prescribed and dispensed methadone and LAAM. Specifically, the exemption section of the new proposed rules, under which anyone who wishes to prescribe or dispense methadone outside the clinics must apply, is more vague and less instructive than the existing rules (more on this point later in the specific response section of my comments).

Why this change in language is necessary is unclear. Apparently, the existing regulations are a very effective bar to increasing access to opioid medication treatment. From our research, we have learned that no individual physician or pharmacist has received or even sought an exemption to prescribe or dispense methadone under the exemption section of the current regulations.

The regulations for office-based prescribing should be included in the same regulations that govern methadone and LAAM treatment in general. There should not be a two-tiered system of regulations.

Federal government leadership, as well as the cooperation of the states, addiction treatment professionals and primary care physicians, can effectively bring methadone maintenance treatment into mainstream medical practice. Expansion of maintenance treatment into private practice settings can be accomplished by giving physicians and pharmacists incentive to participate and by providing a focused training effort for generalists. The faculty for this effort could come from three national medical societies: The American Society of Addiction Medicine, The Association for Medical Education and Research in Substance Abuse, and The American Academy of Addiction Psychiatry. Combined, they have more than 5000 members. Many other countries that have successfully expanded methadone maintenance through physician prescribing, including Canada and Australia, have instituted similar training programs and training manuals.

In light of the AIDS and Hepatitis C epidemics, especially among injecting drug users, their partners and their children, it is critical that the federal government take the lead and implement policies and promulgate rules that will increase the availability of and access to opioid medications for the treatment of opiate addiction. This committee knows well the substantial body of evidence that shows that treating opiate addicts with methadone maintenance is good public health policy. The opportunity that the regulatory changes provides to enhance and improve the methadone/LAAM delivery systems must not be lost in the details of oversight. It is time to focus on reaching a lot more of the 85% of the people addicted to opiates who cannot be reached by the current system.

B. RESPONSES TO SPECIFIC SECTIONS OF THE PROPOSED RULES:

Amend Sec. 8.11(h).

If this is going to be the only provision by which methadone and LAAM can be prescribed and dispensed outside the clinic setting, then make this section stronger and clearer. Even the existing exemption sec. 291.505(F)(11) explicitly provides the example of to whom the exemption would likely apply: individual physicians and/or pharmacists in rural areas /areas where methadone is scarce or unavailable. The exemption section now gives no guidance as to whom it is intended to apply and, by comparison, is extremely vague and not encouraging. At the least, retain the language in the existing exemption section.

Repeal the section requiring physicians to justify any dose of more than 100 mgs. Sec. 8.12 (h) (3)(iii).This unnecessarily infringes on the practice of medicine. It is arbitrary, serves no medical purpose and perpetuates stigma against opioid maintenance treatment. Proper dosing should be determined by the individual practitioner based on examination and evaluation of the patient.

Amend the opioid treatment program certification section, Sec. 8.11(a), to explicitly include individual physicians, pharmacists and other medication units.

Repeal the 120-day time limit on interim maintenance, Sec. 8.12(g).
In many areas of the country, methadone is unavailable or scarce. People seeking treatment remain on some waiting lists for months at a time. Nationally, we are treating less than 20% of those addicted to opiates. Many states and localities have caps on the number of treatment places available at any one time. The research shows that most treatment programs operate at or near capacity. Many have waiting lists and, as we know, there are many areas where methadone is unavailable, including the eight states that have no methadone

In truth, interim methadone is not practiced in the U.S., except in a very few places on buses serving small numbers of addicted persons. As a matter of public health, the regulations should encourage greater use of interim methadone/LAAM or, at the least, not limit by bureaucratic decree the length of time one may receive treatment. If at the end of the 120 days, there is no room at the program, then providers will be forced to withdraw the medication, which is clinically contraindicated in the treatment of opiate addiction. This result can be avoided by amending the language to state that persons in interim maintenance shall be kept in treatment until such time as a position in the treatment program becomes available.

Repeal the restriction on take homes for detox and interim methadone Sec. 8.12 (i)(4).
If a patient otherwise meets the take-home requirements, why make them visit the clinic daily? This requirement is an unnecessary burden on the patient as well as on the treatment program.

Amend Sec. 8.11(g)(1) to require state approval where applicable.
Why is prior state approval needed if interim maintenance otherwise meets state requirements?
Se. 8.11(g)(2)(iii) implicitly recognizes that some states have capacity limits and puts the onus on the applying program to show that providing interim maintenance will not reduce the capacity of comprehensive maintenance treatment programs. This makes no sense: If a program has to first show that it is unable to place the person seeking treatment in a public or nonprofit private comprehensive program, then why require them to show it would not otherwise reduce capacity? Instead, why not require the state or local authority in whose jurisdiction there are no maintenance slots available to report to the federal government? Why is the onus on the applying program already operating under capacity restrictions? If done, this might serve to discourage states and localities from creating artificial treatment caps and could lead to expansion of methadone availability through interim maintenance.

Repeal Sec. 8.12(e)(3)
Eliminate the requirement of a minimum waiting period for treatment after detoxification treatment. This suggests a potentially dangerous assumption: That persons who have just completed treatment (detox or maintenance) are opiate free. Wouldn’t it be safer to assume that a person presenting for treatment is likely to be using opiates in an unsafe manner on the streets and admit him/her for evaluation and, if appropriate, treatment as soon as possible? As a matter of personal and public health, any one day that an addicted injecting drug user uses on the street is dangerous to his/her life as well as not serving the community’s interest. Best medical practice dictates that the decision to admit a person seeking treatment should be made by the examining physician/treatment provider.

Amend Sec. 8.12(e)(3) to state that admission to maintenance treatment requirements may be waived for any patient seeking treatment if clinically appropriate. To codify a few exceptions unnecessarily impedes good medical practice and second-guesses the judgment of the treating physicians. The categories of patients delineated in this section should be listed by way of example, not restriction.