Via Electronic Submission to: Telehealth.RFI@mail.house.gov
April 1, 2019
Congressional Telehealth Caucus
Re: RFI – Revised Telehealth Package
To Whom it May Concern:
On behalf of PursueCare LLC (https://www.pursuecare.com) and its affiliated Medication Assisted Treatment (“MAT”) health care providers, its Chief Medical Officer Steven Powell, MD, MPH, CPE, FAPA, as well as its addiction treatment pharmacy, CompreCare (https://www.comprecarerx.com) (collectively referred to herein as “PursueCare”), I am pleased to submit comments for the Congressional Telehealth Caucus’ RFI Revised Telehealth Package.
PursueCare supports the use of health IT and telehealth by its practitioners and pharmacy in order to make Opioid Use Disorder (“OUD”) treatment more accessible to patients wherever they are located, particularly those in rural areas and those who encounter barriers such as work, childcare, stigma, and lack of providers/treatment availability. MAT assessing and prescribing physicians, nurse practitioners, and physician assistants treating OUD, certified addiction counselors providing therapy to OUD patients, and pharmacists are ideal users of health IT and telehealth that is tailored toward direct-to-patient care via secure synchronous video conferencing. Additionally, health IT and telehealth technologies aid in collaboration, transitions of care, after-care, clinical decision support services, e-prescribing, and data reporting.
As an attorney, behavioral health executive and health care management professional, I have been involved with and consulted with the American Health Lawyers Association (“AHLA”), the American Pharmacists’ Association (“APhA”), and other organizations supporting and developing the national health information technology framework. Approximately 75% of counties in America are considered Mental Health Professional Shortage Areas. Additionally, evidence shows that many traditional addiction treatment models have not proven successful at reducing overdose deaths, instances of relapse, and access to care, particularly in rural regions.
I, along with our stakeholders, launched PursueCare with the mission and purpose to help solve the opioid epidemic that is perpetuated by lack of convenient and readily available access to MAT, addiction pharmacy services, and mental health care professionals. We intend to do this by “digitizing” the OUD addiction care continuum and bringing it directly to patients through telehealth and Health IT tools accessible via any web browser, and smart phone native applications.
Public policy professes to assert that addiction is not a moral failing, yet our current system serves to treat many patients as if they cannot be trusted. Our recommendations would lower barriers to successful recovery, support improved access and patient care availability, and lower overall costs of care for this at-risk population.
PursueCare’s comments are as follows:
REMOVE U.S. ATTORNEY GENERAL MANDATE TO PROMULGATE FINAL REGULATIONS SPECIFYING A LIMITING SPECIAL REGISTRATION REQUIRED FOR PRESCRIBING ACCEPTED MAT MEDICATIONS CLASSIFIED AS CONTROLLED SUBSTANCES; ALTERNATIVELY MANDATE IMMEDIATE PROMULGATION OF INTERIM RULES DEFINING PROCEDURES FOR OBTAINING SUCH A SPECIAL REGISTRATION IN ORDER TO ALLOW SUCH PRESCRIBING.
The SUPPORT for Patients and Communities Act (the “SUPPORT Act”) mandates that the U.S. Attorney General promulgate final regulations that specify (1) “the limited circumstances in which a special registration under this subsection may be issued” and (2) “the procedure for obtaining a special registration.” Under 21 U.S.C. 831(h), as amended by The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”), this special registration would allow health care providers to prescribe controlled substances via telehealth when legitimately necessary, including when an in-person evaluation is not possible. Despite the statutory mandate in the Ryan Haight Act passed more than eight years ago, the Attorney General has not yet issued any such regulations or guidance on how to obtain this special registration.
The Drug Enforcement Administration (“DEA”), which is delegated authority to promulgate such regulations by the Attorney General, has also failed to promulgate any regulation or other guidance addressing special registration.
While the SUPPORT Act gives the Attorney General until October 24, 2019, to promulgate its final regulations on this matter, it is our position that this measure represents an impediment on providing life-saving and critical OUD MAT to vulnerable populations in communities severely impacted by the opioid epidemic and in need of immediate care. Further, the delay in promulgating such guidance likely has a chilling effect on similar amendments to state legislature that tracks federal acts like the SUPPORT Act.
Although there may be some statutory restrictions for Medicare telehealth services related to assessment and prescribing of controlled substances, we respectfully ask the Telehealth Caucus to remove all requirements for special registration by practitioners to prescribe accepted and effective MAT medications classified as controlled substances such as Buprenorphine and Suboxone, where prescribing practitioners would otherwise be qualified to prescribe such medications in-person.
Alternatively, we respectfully request that the U.S. Attorney General and the DEA promulgate specific regulations and guidance addressing special registration with immediate effect or allow such prescribing via telehealth as described in this Section during the interim period as a matter of health policy crisis.
REMOVE AMBIGUITY AND UNNECESSARY RESTRICTIONS ON CARE PERTAINING TO THE “LEGITIMATE NECESSITY” AND “IN-PERSON AVAILABILITY” QUALIFYING CONDITIONS PRESENT IN THE SUPPORT ACT.
In the event that the requirement for special registration in the SUPPORT Act and/or Ryan Haight is not removed as proposed above, the requirement that health care providers prescribing MAT controlled substances via telehealth must prove that using telehealth is legitimately necessary, including that in-person evaluation is not possible, is arbitrary and ambiguous.
Non-metropolitan regions have greater or similar rates of substance use disorder as metropolitan areas in individuals ages 12 and up.1 Drug overdoses in rural areas are higher than in urban areas. While access to waivered physicians has increased since 2012, approximately 60% of rural counties still lack a physician with a DEA waiver to prescribe buprenorphine and similar MAT medications.2 Counties with waivered providers may not have such providers who are working in or with Opioid Treatment Programs (“OTP”), reducing the likelihood that they accept new patients specifically for treating OUD, as stigma attributable to accepting and treating this patient population in-person is prevalent.
The U.S. Attorney General and the DEA have not defined legitimate necessity so as to take into account the mental health professional shortage and lack of qualified MAT prescribing practitioners across large non-metropolitan areas of the country. We respectfully request that the requirement for showing legitimate necessity, including but not limited to proving lack of in- person availability, be stricken from the SUPPORT ACT and all subsequent regulations related to special registration. Alternatively, we ask that such a requirement be defined sufficiently rationally and broadly (such as by percentage of OUD patients within census in relation to qualified OTP that may treat them within their geographic area) so as to allow unfettered provision of telehealth services in areas described in this Section.
EXPAND ACCESS TO TELEHEALTH FOR OUD TREATMENT DIRECTLY TO PATIENTS WHEREVER THEY ARE LOCATED
The Bipartisan Budget Act of 2018 and The SUPPORT Act modified and removed limitations relating to geography and patient setting for certain telehealth services, including services for OUD addiction treatment. Patients are capable of making decisions regarding their own healthcare, including in what setting they receive it. Restrictions related to defining a qualifying Originating Site serve to decrease the likelihood that physicians and other qualified providers will consult and treat their patients without first confirming the location meets the definition of an Originating Site for billing purposes. It also makes it less likely that patients at risk of life-threatening overdose scenarios will be able to obtain emergent consultation and treatment prior to using dangerous narcotics which might serve to otherwise reduce such risk and save lives. Thus such a restriction is not rationally tailored to serve the patient’s right to make choices regarding their own healthcare, including when and where it is received.
Although there may be some statutory restrictions for Medicare telehealth services, and restrictions rationally tailored toward obtaining consent from patients and ensuring their need for privacy under HIPAA is met, we respectfully ask the Telehealth Caucus to remove all Originating Site-related restrictions to providing eligible addiction treatment telehealth services in order to allow Medicare patients to fully control where and when they access MAT via telehealth, provided that they orally consent to such care in whatever setting they have chosen.
EXPAND TYPES OF PROVIDERS QUALIFIED TO ASSESS FOR OUD AND PRESCRIBE COMMON MAT MEDICATIONS VIA TELEHEALTH.
In conjunction with the Pharmacy Health Information Technology Collaborative’s submission to the RFI-Revised Telehealth Package, PursueCare also supports the use of telehealth for delivering clinical health and person-centered care, particularly in rural health areas, and including telehealth benefits in any health coverage plan, including Medicare Advantage plans. PursueCare also supports the current proposed changes under consideration by CMS from telehealth being a supplemental benefit to making it a basic benefit; however, there is a concern with the Bipartisan Budget Act of 2018 requirements for Medicare plans offering additional telehealth benefits that we ask the caucus to review and address in any proposed legislation.
Although Medicare routinely pays physicians and other health care providers and practitioners (e.g., social workers, dieticians; see 42 C.F.R. §410.73 and §410.134 respectively) for several kinds of services provided via interactive communication technology (including telehealth), Medicare does not reimburse pharmacists for telehealth services provided. The reason for this is because pharmacists are not recognized as practitioners (providers) under the Medicare Telehealth Benefit of the Social Security Act, Section 1834(m) [42 C.F.R. § 410.78], and therefore, there are no Medicare payment codes for these services. Pharmacists should be included as practitioners.
Pharmacists are a part of the health care management teams providing health care and Medicare services, and are telehealth providers. Telehealth enables pharmacists to connect with established health care management teams and patients, particularly when questions arise concerning medications prescribed or changes to medications, independent of geography. In many instances, especially in rural and underserved areas where telehealth would be invaluable, pharmacists are the first point of contact by patients. This lack of access represents yet another barrier to recovery for those patients seeking care.
The role of pharmacists in telehealth is expanding. Among the types of telehealth services pharmacists can provide, which are clinically appropriate, and should be included in any telehealth benefit are: assessing for substance use disorder and prescribing (via collaborative practice agreement) appropriate medication to treat the physiological symptoms of withdrawal, medication therapy management, chronic care management, medication reconciliation, transitions of care, pharmacogenomics, interpretation of diagnostic tests and providing test results, consultations with patients and health care providers beyond merely the time of dispensing, and ambulatory care services.
Telehealth is a cost-saving solution that can expand pharmacy-provided health care services to patients outside retail pharmacy practice settings while complementing existing pharmacy services. Telehealth and telepharmacy could also provide cost-savings for hospitals, particularly rural hospitals.3
We ask the Telehealth Caucus to include pharmacists as practitioners (providers) for not only the Medicare Telehealth Benefit but for any other telehealth proposal that may be considered, as well as adding payment codes for those telehealth services related to assessing and prescribing MAT, and that pharmacists provide to Medicare patients and their health care management teams.
This request is consistent with the Department of Health and Human Services (HHS) report, “Reforming America’s Healthcare System Through Choice and Competition,” which states that the federal government should consider legislative and administrative proposals to allow non-physician providers (e.g., pharmacists) to be paid directly for their services. Section 1834(m) grants the secretary the authority to add to the list of allowable telehealth services. This would appear to include telehealth services provided by pharmacists, which are clinically appropriate to be provided through electronic exchange for additional telehealth benefits.
PursueCare (https://www.pursuecare.com), a technology-enabled health services startup aiming to help solve the nation’s growing opioid epidemic, is launching a first-of-its-kind telehealth opioid addiction treatment network available to patients through an iOS/Android mobile app, tablet, or computer.
PursueCare partners with addiction treatment providers and programs to increase access, enhance service offerings, and create efficiencies and cost-savings in the process. The organization leverages telehealth technology together with management services supporting the partnering providers, including transition of care coordination, scheduling, advancing evidence- based protocols, and reporting population health data. The platform connects providers with remote patients needing enhanced and more convenient recovery resources. PursueCare is also partnering with rural hospitals, emergency departments and inpatient facilities to initiate MAT post-discharge, where in-person care would otherwise be unavailable or unlikely to be attended by the patient.
The app allows users to input insurance information or choose payment options and select providers that fit their needs and schedule. Users can also request “on-demand” sessions with certified addiction counselors through secure video conferencing technology to intervene when patients are at risk of self-harm or overdose. The integrated pharmacy is joint-commission accredited and can fill and mail medications like suboxone and naloxone with a prescription.
PursueCare’s vision is to put a full continuum of addiction recovery resources in the patient’s hand, wherever they are and whenever they need them. Many communities don’t have sufficient care options, and evidence suggests that traditional care models are not sufficiently increasing access or reducing overdose deaths and instances of relapse. PursueCare’s stigma-free and convenient resources are a needed innovation in health care to give patients more options, more control, and promote lasting recovery.
1Source: Substance Abuse and Mental Health Services Administration (SAMHSA), Results from the 2016 National Survey on Drug Use and Health: Detailed Tables.
2Andrilla CHA, Coulthard C, Larson EH. Changes in the Supply of Physicians with a DEA DATA Waiver to Prescribe Buprenorphine for Opioid Use Disorder. Data Brief #162. Seattle, WA: WWAMI Rural Health Research Center, University of Washington, May 2017.
On behalf of PursueCare, thank you again for the opportunity to comment on the Congressional Telehealth Caucus’ RFI: Revised Telehealth Package.
For more information please contact me at the email address or phone number below.
Nicholas J. Mercadante, Esq.
Co-founder and Chief Executive Officer