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 The leading web portal for pharmacy resources, news, education and careers April 26, 2018
Pharmacy Choice - Pharmaceutical News - House Energy & Commerce Subcommittee Issues Testimony From Utah County Department of Drug & Alcohol Prevention & Treatment - April 26, 2018

Pharmacy News Article

 2/28/18 - House Energy & Commerce Subcommittee Issues Testimony From Utah County Department of Drug & Alcohol Prevention & Treatment

WASHINGTON, Feb. 28 The House Energy and Commerce subcommittee on Health issued the following testimony by Richard Nance, director of the Utah County Department of Drug and Alcohol Prevention and Treatment, at a hearing entitled "Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety":

"Chairman Burgess, Ranking Member Green, and Members of the Health Subcommittee, thank you for the opportunity to testify on an issue that is impacting community addiction and mental health treatment centers' ability to provide patients speedy and safe treatments for substance use disorder (SUD) and mental health conditions by utilizing telemedicine. Medically appropriate treatment for SUD and mental health conditions sometimes involves controlled substances. Unfortunately, today thousands of community addiction and mental health treatment centers across the country are unable to use telemedicine that results in the issuance of a prescription for a controlled substance due to the DEA's narrow interpretation of the Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act).

"I appreciate the opportunity to speak for the 2,900 National Council for Behavioral Health member organizations that provide front-line addiction and mental health treatment across the country. We deeply appreciate Congress's interest in creating a pathway to enable legitimate community addiction and mental health treatment centers to register with DEA such that they may provide treatment for Americans in need.

About the National Council for Behavioral Health

"The National Council for Behavioral Health is the unifying voice of America's health care organizations that deliver mental health and addictions treatment and services. Together with our 2,900 member organizations serving over 10 million adults, children and families living with mental illnesses and addictions, the National Council is committed to all Americans having access to comprehensive, high-quality care that affords every opportunity for recovery.

"I am a Licensed Clinical Social Worker in Utah, and have been Director of Utah County's Department of Drug and Alcohol Prevention and Treatment (UCaDDAPT) since 1998. UCaDDAPT provides a comprehensive range of drug and alcohol prevention and treatment services, including medication-assisted treatment for substance use disorders (SUD), such as opiate addiction and abuse, as well as for co-occurring SUD and mental health disorders. UCaDDAPT also contracts for methadone treatment services. Utah County has a population of over 600,000, and UCaDDAPT serves over 2,000 people per year. Over 40% of these are now being seen for opiate use disorders, and at any given time about 30% of those are receiving MAT in addition to counseling services.

"LEGISLATION IS NEEDED TO ENABLE COMMUNITY ADDICTION AND MENTAL HEALTH TREATMENT CENTERS TO USE TELEMEDICINE TO PROVIDE TREATMENT INVOLVING CONTROLLED SUBSTANCES

The Problem

"Thanks to ever-expanding technological advances, telemedicine has the potential to improve access to care, while reducing costs and increasing patient and provider convenience. Unfortunately, today my center and many other legitimate community addiction and mental health treatment centers are unable use telemedicine to connect patients in our center with DEA-registered doctors. Here is why:

"The Controlled Substances Act, as amended by the Ryan Haight Act, allows for the issuance of a prescription for a controlled substance without a prior in-person patient medical evaluation in limited circumstances, known as telemedicine exceptions. The most common way for such telemedicine to be permitted is when the patient being treated is located in a DEA-registered hospital or clinic and is being treated by a DEA-registered provider located off-site. See 21 U.S.C. 829(e)(3)(A). In order to register, DEA requires that hospitals or clinics be licensed by a state. See Appendix A, DEA Registration Form 224, Section 4. The state licensure requirement is not in statute, rather is a result of DEA's administrative application of the Act. The problem is, many community addiction and mental health treatment centers are unable to use telemedicine that results in a prescription for a controlled substance because they are not "state-licensed" according to DEA's interpretation. Many community addiction and mental health centers are licensed, certified, or otherwise formally overseen and recognized by their state, county, or municipality but do not meet the DEA's narrow interpretation.

"The National Council believes community mental health or addiction treatment facilities that are licensed, operated, authorized, or otherwise recognized by a state, county or municipality should be able to register with DEA for purposes of complying with the Ryan Haight Act.

"Especially given the opioid epidemic, the National Council continues to believe remote prescribing of controlled substances without a prior in-person medical evaluation should be limited to patients located in a DEA-registered facility, including community addiction and mental health treatment centers registered under the two draft bills sponsored by Representatives Harper and Matsui and by Representatives Carter and Bustos. Our concerns with removing the registration requirement and/or allowing patients to receive prescriptions for controlled substances via telemedicine while at their home or otherwise not in a care setting as currently permitted under the Act are outlined later in this statement.

About Community Addiction and Mental Health Treatment Centers

"In general, community addiction and mental health treatment centers are facilities that treat patients for mental health, substance use disorder, and other behavioral health needs. These centers, for the most part, do not dispense controlled substances.1

"There is no federal definition of a community mental health center or of an addiction treatment center applicable in all 50 states to clinics that serve patients from all payer sources. Rather, states, counties, and in some cases municipalities determine what qualifies as a legitimate center and how to regulate them. Sometimes centers are required to have state licenses; sometimes states establish and run the centers themselves as parts of the government; in other cases, centers are regulated by county or municipal governments. For example:

- In Utah: Community mental health and addiction treatment (MH/SUD) centers are overseen by the State Department of Human Services Office of Licensing. Utah has a county government-based addiction and mental health system, which means addiction and mental health services are services are delivered directly by county government, or are contracted out to one or more MH/SUD providers that are also under the purview of the state licensing department and are overseen by governing boards comprised of elected county government officials.

- In Texas - Community mental health centers (known as Community Centers) are governmental entities authorized in Texas statute and required by Texas law to treat individuals with severe and persistent mental illness throughout Texas. In their capacity as units of Texas government they do not require any additional state license to perform their state-mandated tasks. These centers are a critical component of the Texas health care system and already meet the intent of registration by virtue of their statutory authorization to perform the functions of Community Mental Health Centers with regard to psychiatric medications. The Texas Council of Community Centers represents 39 centers across Texas that were established by Texas statute and has spent multiple years working with DEA on behalf of its membership to secure DEA registration, with no resolution to date. See Appendix B for a discussion of these efforts.

- In Georgia - Community mental health centers (known as Community Service Boards) are quasi-governmental entities authorized in Georgia statute and required by Georgia law to treat individuals with severe and persistent mental illness. In their capacity as instrumentalities of Georgia government, they do not require any additional state license to perform their state-mandated tasks. These centers are a critical component of the Georgia health care system and they are already registered under Georgia law with regard to controlled substances. The CSBs of the Georgia Association of Community Service Boards are concerned about access to vital psychiatric services in schools (as delivered by school-based clinics in partnership with Community Service Boards) and rural areas.

- In Missouri - Community mental health centers operate across 25 service areas reaching the entire state. These providers are non-profit entities serving in a quasi-governmental role as administrative agents of the state responsible for a comprehensive array of mental health and addiction services in their catchment area. Though these centers do not have a state licensure number, they are certified and monitored by the state, are subject to detailed administrative rules outlining their certification criteria and obligations, and are closely overseen by a system of regional managers.

"The authorizing governmental body (e.g. states, counties) can determine the scope of services that are able to be provided in these centers and the professional qualification requirements of the centers' on-site staff.

1. Types of Providers On-Site in Centers: Community addiction and mental health treatment centers may not always have doctors or psychiatrists on-site at all times. In these cases, it is common for centers to be staffed by social workers, nurses, counselors and other state-licensed mental health or addiction professionals that do not have prescribing authority. Staff at community addiction and mental health treatment facilities are regulated by state and local laws, including any requirements for licensure (e.g. state nursing licenses, social worker licenses), education, and professional conduct.

2. Scope of Services Provided in Centers: The types of services provided by community addiction and mental health treatment centers vary, but we do know that roughly 75% of the National Council's 2,900 member organizations offer addiction treatment services. The number of organizations that strictly provide mental health treatment services without any addiction services is very slim. For example, Hill Country MHDD Centers serve 19 Texas counties and provide mental health, individual developmental disability, substance use disorder, and early childhood intervention services. These centers need the ability to register with DEA such they can bring in an addictionologist, addiction psychiatrist or child psychiatrist via telemedicine to prescribe to a patient on-site, when medically appropriate.

The Impact on Patients During the Opioid Epidemic and Beyond

"The inability of legitimate community addiction and mental health treatment centers to use telemedicine has a direct impact on the lives of Americans. As this Committee understands, the demand for addiction and mental health services far exceeds current system capacity to serve patients. Telemedicine is a vital opportunity to extend both addiction and mental health treatment services to more patients, particularly those living in rural and frontier areas that lack qualified providers.

"There are only four medications commonly used to treat opiate use disorders. One of these - naloxone - is only used for emergency reversal of opiate overdoses. Naltrexone - in oral or long acting injection form works well for some patients, but not for all. The other two - methadone and buprenorphine (also delivered as Suboxone, a formulation that includes buprenorphine combined with naloxone) - are controlled substances and a form of opiate medication themselves. Methadone is the longstanding gold standard for opiate addiction treatment, but methadone treatment programs are subject to tight licensing, accreditation, and DEA oversight standards. These standards make the establishment of methadone treatment programs in rural and frontier areas economically non-viable. Buprenorphine/Suboxone can be prescribed by DATA 2000 certified physicians, but for several reasons, there are few Suboxone prescribers in rural and frontier areas. In Utah, there are over 400 Suboxone prescribers on the DEA's list, however, many of these are not actively prescribing Suboxone. Of the remainder, many choose not to solicit new Suboxone patients, but only use their certification to prescribe to existing patients in their own practices. There are 506 registered buprenorphine prescribers in Utah and 28 American Board of Addiction Medicine (ABAM)-certified physicians in practice (however, some of these only do pain management). Only 72 Suboxone prescribers can be found on the Suboxone.com website for Utah.

"Here is a real-world example from my practice in Utah: A patient at one of our rural county-licensed community mental health or addiction treatment centers is in crisis and needs addiction treatment involving a prescription for a controlled substance as part of his/her medication-assisted treatment (MAT). MAT is a highly effective, evidence-based treatment for opioid addiction that combines the use of medication with counseling and mental therapies.

"As common with community addiction and mental health treatment centers, my center is staffed with social workers, nurses, counselors and other mental health professionals, including a full time ABAM certified addictionologist. Due to shortages of providers and the rural and frontier nature of most of the rest of the state, many other community addiction and mental health centers do not regularly have DEA-registered doctors or psychiatrists on site who are certified, competent, or willing to prescribe MAT for opiate use disorders.

"But thanks to advances in technology, we do have the technical ability to connect the patient to a DEA-registered psychiatrist via telemedicine. The problem is that because my center is county-licensed (not state-licensed, as DEA requires), we are unable to register with DEA such that the Ryan Haight Act's telemedicine exception for "treatment in a hospital or clinic" would apply.

"As such, we cannot provide the patient his/her needed care; rather we must wait for a DEA-registered doctor to "go on the road." If we take Bluff, Utah, as an example, it can take up to ten hours round-trip including an overnight stay - to do the required face-to-face physical evaluation of the patient prior to writing the prescription. If Suboxone treatment is indicated, this requires the patient to fill the prescription then return to the office for a medically supervised induction process that takes up to 4 hours. For Dr. Elina Chernyak in my office to provide this service, she must forego seeing up to 48 - 60 of our own patients to see one in the rural setting - if the patient actually keeps the appointment. People in active opiate addiction are often disorganized, physically ill, and cognitively impaired to the point that they may be unable to keep or even remember their appointment.

"In the context of the opioid epidemic, the costs of this inefficiency can tragically be measured in lives lost from speedy access to MAT. We can also measure the cost in terms of dollars, as just for my Utah center alone we estimate it costs $490 in travel, lodging, and per diem and $1,400 in physician time to have Dr. Chernyak drive out to the center to do an in-person patient medical evaluation, prescribing, and Suboxone induction. In the winter in Utah, this could easily double or even have to be cancelled for safety reasons depending on road conditions. This is to see perhaps one patient, versus the 48 - 60 that she could see if she stayed in her office in Provo. Continuing care could be conducted via telemedicine procedures.

"If the law were changed to permit our clinics to register with DEA, instead of this inefficient and high-cost workaround, we could provide consumers with more responsive, timely access to care. Currently, to evaluate and initiate Suboxone treatment, Dr. Chernyak must drive often quite lengthy distances for the first face-to-face visit, with continuing patient care and consulting with the clinical staff being done via a secure HIPAA-compliant telehealth platform called Zoom.

"In contrast, when Suboxone is prescribed via telemedicine, we would follow a version of Vermont's hub and spoke model. The hub would be our office in Provo where our DEA-certified addiction medicine doctor - Dr. Chernyak - has her full-time office. The spokes could be one or more rural or frontier community MH/SUD health center(s) or federally qualified health center sites. At present we have contracts with Northeastern Counseling Center and Mountainlands Community Health Center in Vernal and Roosevelt, Utah that could serve as the spokes in this model. In addition to counselors and therapists, both these centers employ nursing staff who can monitor patients' first use of the medication (known as "induction") and immediately address any adverse reactions in partnership with the prescribing physician via telemedicine. Having a medical professional in the room with the patient is the standard practice for first-time use, or induction, of Suboxone and is in accordance with national best practices and guidelines established by ASAM. This is the only way we would consider practicing addiction medicine using Suboxone. We would never consider it advisable to see a patient over a non-secure platform such as Facetime when the patient was using the Wi-Fi at Starbucks, for instance.

National Council Support for Federal Legislation

"The National Council appreciates the efforts this Committee, including Representatives Carter, Harper and Matsui, for putting forward draft legislation that would support the ability of legitimate clinics to register with DEA for purposes of complying with the Ryan Haight Act. Benefits of this approach include:

1. Giving DEA transparency into and jurisdiction over the practices of health care locations not otherwise registered with the DEA under Section 303(f) but which nonetheless have patients on-site that need treatment via telemedicine involving the issuance of a prescription for a controlled substance.

2. Balancing the burden that is placed on the health care provider with a corresponding onus on the center where the patient is located. Providers already must be registered with DEA in order to prescribe controlled substances.

3. Continuing DEA jurisdiction over both parts of the treatment - the provider and the center - which both benefits the Agency's enforcement abilities and is consistent with the Ryan Haight Act's "belt and suspenders" approach of allowing telemedicine treatment in a hospital or clinic registered with the DEA.

"As for how to accomplish this goal, we defer to Congressional leaders on the best approach but share some considerations:

1. Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f) does not capture what community addiction and mental health treatment centers do. These centers typically do not dispense controlled substances and do not conduct research. Accordingly, we fear that the addition of community addiction and mental health treatment centers to Section 303(f) will not solve our problem.

2. As an alternative, Paragraph (54) of section 102 of the Controlled Substances Act (21 U.S.C. 102) could be amended to make clear that legitimate community addiction and mental health treatment centers shall be eligible to register with DEA just like state licensed hospitals and clinics currently can. For example:

(i) while the patient is being treated by, and physically located in

(I) a hospital or clinic registered under section 303(f); or

(II) a community mental health or addiction treatment center registered for purposes of this subparagraph."

"Plus at the end:

""The Attorney General shall register community mental health or addiction treatment facilities that are licensed, operated, authorized, or otherwise recognized by a State, county, or municipal government for purposes of treatment via the practice of telemedicine as described in subparagraph (A)"

3. We appreciate the draft Harper/Matsui bill allows centers to use telemedicine to treat patients for all types of addiction and mental health conditions, not just SUD. While the opioid epidemic is the nation's most pressing public health issue and the subject of this hearing, the National Council wishes to emphasize the importance of allowing community addiction and mental health treatment centers to use telemedicine to treat other mental health conditions too, not just SUD. There are two reasons for this:

- There is a legitimate public health need to improve access to mental health services generally. According to federal health authorities, there are roughly 4,000 areas nationwide where there is only one psychiatrist for every 30,000 patients. Further, the American Academy of Child and Adolescent Psychiatrists, (AACAP) reports there are approximately 8,300 practicing child and adolescent psychiatrists in the U.S. and over 15 million youths in need of one. Telemedicine can be part of the solution to this provided shortage, but currently the Ryan Haight Act limits mental health providers' ability to treat mental illness because of restrictions on stimulants that are commonly used in psychiatric treatment for both children and adults.

- Many treatment centers provide both addiction and mental health services, and not all states certify, recognize or otherwise authorize addiction and mental health treatment centers in the same way. In some states there are two separate certifications (one for mental health treatment services and another for addiction treatment services), while other states provide a single certification for community providers offering both types of services. Therefore, to be inclusive of the full universe of community providers who offer addiction treatment services, the legislation cannot narrow the scope to simply "addiction" providers as this would exclude many of the organizations who currently provide both addiction and mental health care.

4. We also support the approach outlined in the Carter/Bustos draft, which requires DEA to act swiftly to implement a "special registration" and note that we continue to believe that the patient who is being treated by telemedicine should be located in a DEA-registered facility. It is our hope that such a special process would be inclusive enough to apply to community addiction and mental health treatment clinics, though we fear that if the registration process is implemented too narrowly it could continue to exclude these treatment providers. It is possible that DEA could implement the "special registration" it in a way to still require "state licensure" of hospitals and clinics, or to otherwise draft regulations that would continue to exclude legitimate community addiction and mental health treatment centers from being able to use telemedicine for controlled substance treatment. If that were to occur, centers that are licensed, operated, authorized, or otherwise recognized by a State, county, or municipal government would still be shut out from being able to provide effective health care options to patients in need. The Carter/Bustos draft bill will have the most impact if enacted in conjunction with the Harper/Matsui draft bill that clearly specifies community mental health and addiction providers as a category of centers eligible to register with DEA.

5. We support requiring patients to be treated via telemedicine while located in a DEA-registered location (hospital, clinic, center). The draft Harper-Matsui bill simply makes clear that legitimate community addiction and mental health treatment centers shall be eligible to register with DEA just like hospitals and clinics.

"Allowing patients to receive prescriptions for controlled substances via telemedicine outside of a legitimate care setting would erode the Ryan Haight Act and invite rogue online pharmacies posing as telemedicine providers into the market. The National Council worries rogue actors would see this as a market opportunity to offer controlled substances based on a prescription issued via "telemedicine," but instead of providing real patient care, rogue sites would simply sell prescriptions on demand for controlled substances. Such a result is opposite of Congress's intent, of course, and contrary to the Ryan Haight Act itself, but a foreseeable consequence of allowing online prescribing of controlled substances to patients outside of legitimate care settings. As true when the Ryan Haight Act was passed in 2008, illegal online dispensing/prescribing of controlled substances is still a problem today:

- In February 2018 the National Association of Boards of Pharmacy (NABP) reported that 54% of the online pharmacy websites they surveyed were selling controlled substances. This is a substantial jump from the 13% of all sites NABP has reviewed and listed as "Not Recommended" in the past nine years that were selling controlled substances.

- The Alliance for Safe Online Pharmacies estimates that there are roughly 30,000 active online drug sellers operating at any one time. If NABP's finding that 54% of sites sell controlled substances holds true for the full online pharmacy market, that would mean more than 15,000 sites offer controlled substances at any one time.

- The U.S. Senate Permanent Subcommittee on Investigations January 2018 report evidences how easy it is to buy illicit, mail-order opioids online. Investigators for the Subcommittee posed as would-be online buyers, entering terms like "fentanyl for sale" into Google and used payment information to track more than 500 US-linked transactions from these illegal sites.

- Just last week a group of Senators led by Ryan Haight Act sponsor Senator Feinstein and Judiciary Chairman Senator Grassley sent a letter to Google, Microsoft, Pinterest and Yahoo discuss the rise illegal online sale of controlled substances.

"Therefore, the National Council urges Congress to not authorize online prescribing of controlled substances to patients not located in a DEA-registered facilitywhether an existing DEA-registered facility or a center registered pursuant to the Harper/Matsui or Carter/Bustos billsas such risks making the opioid epidemic worse.

Conclusion

"Thank you again for considering my testimony in support of the draft Harper/Matsui and Carter/Bustos bills that would enable legitimate community addiction and mental health treatment centers to register with DEA to be able to use telemedicine that involves issuance of a prescription for a controlled substance. Changing this law will have immediate and measurable impact on the lives of countless Americans seeking treatment options for mental health conditions and substance use disorder. I appreciate your time and attention to this important public health issue."

* * *

Footnote:

1 While rare, we are aware of at least one center that does dispense: the Josephine County, Oregon Health Department is the local behavioral health authority, and they operate a licensed methadone program - thus dispense controlled substances.



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