Introduction and Background
The calendar year (CY) 2020 Medicare Physician Fee Schedule Proposed Rule with comment was published in the Federal Register on July 29, 2019.1 This proposed rule updated payment policies, payment rates and other provisions for services furnished under the Medicare Physician Fee Schedule (PFS). It added services to the telehealth list and included a proposal to implement Section 2005 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act),2 creating a new Medicare Part B benefit for Opioid Treatment Programs. The Centers for Medicare & Medicaid Services (CMS) accepted comments through September 27, 2019.
Introduction and Background
Following close of the comment period and review of public comments, CMS provided its response with the CY 2020 Medical Fee Schedule Final Rule, placed on display in the Federal Register on November 15, 2019.3 This final rule updated payment policies, payment rates and other provisions for services furnished under the Medicare PFS on or after January 1, 2020. For items related to telehealth, CMS finalized its proposal to add three new codes for a bundled episode of care for treatment of opioid use disorder to the list of services eligible for telehealth reimbursement. CMS further finalized a bundled payment structure for opioid use disorder (OUD) treatment by opioid treatment programs (OTPs) allowing counseling and therapy (face-to-face) components to be delivered by live interactive video.4
Adding Services to the List of Medicare Telehealth Services
Medicare Part B coverage for telehealth covers office visits and consultations using an interactive two-way telecommunications system (with real-time audio and video) by a doctor or certain other healthcare providers5 at a distinct location.6 In the CY 2003 PFS final rule CMS established a process for adding services to the list of telehealth services in accordance with Section 1834(m)(4)(F)(ii)7 of the Social Security Act. This process provides the public with an opportunity to submit requests for adding new services. Under this process, CMS assigns any submitted request to add to the list of services to one of two categories for consideration.
Category 1 involves services that are similar to professional consultations, office visits and office psychiatry services that are currently on the list of telehealth services.8 In reviewing these requests, CMS looks for similarities between the requested and existing telehealth services for the roles of and interactions among the beneficiary, the physician or other practitioner at the distant site9 and, if necessary, the tele-practitioner who is present with the beneficiary in the originating site.10
Category 2 involves services that are not similar to those on the current list of telehealth services. Review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient.11
CMS accepts requests to add services to the list of telehealth services through February 10 of each year (for the upcoming CY) consistent with the deadline for its receipt of code valuation recommendations from the American Medical Association’s (AMA) Relative Value Scale Update Committee (RUC).12
CMS did not receive any requests from the public for additions to the Medicare Telehealth list for CY 2020. CMS believes the vast majority of services that can be appropriately furnished under the PFS as Medicare telehealth services have already been added to the list.13 Nevertheless, CMS did propose adding three new HCPCS G codes describing new bundled services for treatment of opioid use disorders14 that the agency noted are sufficiently similar to services currently on the telehealth list and would therefore be added on a Category 1 basis. These three codes were referred to as HCPCS GYYY1, GYYY2 and GYYY3 in the July 29 proposed PFS revisions, and HCPCS codes G2086,15 G208716 and G208817 in the CY 2020 PFS.
CMS believed the psychotherapy portions of the bundled codes are similar to the psychotherapy codes described by CPT codes 9083218 and 90853,19 which are currently on the telehealth list. CMS noted that it does not need to consider whether the non-face-to-face aspects of these HCPCS-G codes are similar to other telehealth services, as the care coordination aspects of these codes are commonly furnished remotely using telecommunication technology and do not require the patient to be present in-person with the practitioner when furnished.20
As discussed in the CY2019 PFS final rule,21 Section 2001(a) of the SUPPORT Act 22 amended Section 1834(m) of the Social Security Act, adding a new paragraph (7) that removes the geographic limitations for telehealth services23 furnished on or after July 1, 2019 for individuals diagnosed with a substance use disorder (SUD) for the purpose of treating the SUD or a co-occurring mental health disorder. Section 1834(m)(7) of the Social Security Act also allows telehealth services for treatment of a diagnosed SUD or co-occurring mental health disorder to be furnished to individuals at any telehealth originating site (other than a renal dialysis facility) including a patient’s home; however, facility fees would not apply to originating sites from homes.24 CMS believed that adding HCPCS codes G2086, G2087 and G2088 to the telehealth list will complement the existing policies related to flexibilities in treating SUDs.25
Medicare Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs
Section 2005 of the SUPPORT Act added a new Section 1861(jjj) to the Social Security Act, establishing a new Part B benefit category for OUD treatment services26 furnished by an OTP27 beginning on or after January 1, 2020. Section 2005 of the SUPPORT Act also added Section 1834(w) of the Social Security Act, directing the Secretary to pay the OTP an amount equal to 100 percent of a bundled payment for OUD treatment services furnished by the OTP to an individual during an episode of care.28
CMS set forth in the July 29 proposed rule to establish bundled payments for OUD treatment services which would include Food and Drug Administration (FDA)-approved medications for use in the treatment of OUD; the dispensing and administration of such medication; substance abuse counseling; individual and group therapy; and toxicology testing. In calculating the bundled payments, CMS proposed to apply separate payment methodologies for the drug component and the non-drug components. CMS proposed to calculate the full bundled payment rate by combining the drug component and the non-drug components. The agency outlined its proposals for determining the bundled payments for OUD treatment services addressing payment rates for these services under the Medicaid29 and TRICARE programs, duration of the episodes of care for which the bundled payment is made (including partial episodes), methodology for determining bundled payment rates for the drug and non-drug components, site of service, coding, and beneficiary cost sharing.30
CMS received a number of public comments on the proposed approach to calculating the full bundled payment rate. A few commenters supported the proposal to calculate the full bundled payment rate by combining the drug component and non-drug components. Another commenter stated that clinical services, such as individual and group counseling, should be billed separately from the medication. CMS responded, stating that it did not believe the statute supports unbundling the medications from the other OUD treatment services furnished by OTPs. After consideration of the public comments, CMS finalized its proposal to calculate the full bundled payment rate for services furnished by OTPs by combining the drug component with the non-drug components. The agency codified the methodology for determining the bundled payment rates for OUD at Section 410.67(d).31
Duration of the Bundle
CMS posed in the July 29 proposed rule that the duration of an episode of care for OUD treatment services would be a week (i.e., a contiguous seven-day period that may start on any day of the week). CMS also recognized that patients receiving medication assisted treatment (MAT), e.g., methadone, naltrexone and buprenorphine,32 are often on this treatment regimen for an indefinite amount of time, and therefore, did not establish any maximum number of weeks during an overall course of treatment for OUD.33
CMS received a number of public comments on the duration of the bundled payment. Many commenters supported the proposal to define an episode of care as a one-week (contiguous seven-day) period, while several stated that a monthly episode of care may be more appropriate in some circumstances, such as during a maintenance phase of treatment. CMS responded by acknowledging that the clinical needs of patients may differ depending upon their stage of treatment. Nonetheless, CMS finalized its proposal to define an episode of care as a one-week (contiguous seven-day) period at Section 410.67(b). OTPs are already familiar with weekly periods, and as a result CMS believed use of a weekly bundle will be less disruptive since OTPs already have processes in place to bill for weekly episodes.34
CMS further recognized that patients receiving MAT are often on this treatment regimen for an indefinite amount of time and did not impose any limit on the maximum number of weeks during an overall course of treatment for OUD. Accordingly, CMS did not finalize any limit on the number of weeks during an overall course of treatment for OUD.35
Requirements for an Episode
In the July 29 proposed rule CMS noted that the Substance Abuse and Mental Health Services Administration (SAMHSA) requires OTPs to have a treatment plan for each patient that identifies the frequency with which items and services are to be provided (Section 8.12(f)(4)). CMS recognized that there is a range of service intensity depending on the severity of the patient’s OUD and the stage of treatment. Therefore, a “full weekly bundle” may consist of a very different frequency of services for a patient in the initial phase of treatment compared to a patient in the maintenance phase of treatment. However, CMS would still consider the requirements to bill for the full weekly bundle to be met if the patient is receiving the majority of the services identified in his or her treatment at the time. For the purposes of valuation, CMS assumed one substance use counseling session, one individual therapy session and group therapy session per week and one toxicology36 test per month. Given the anticipated changes in service intensity over time based on the individual patient’s needs, CMS explained that it expects treatment plans would be updated to reflect these changes in the patient’s medical record. In cases where the OTP has furnished the majority (51 percent or more) of the services identified in the patient’s treatment plan over the course of a week, CMS proposed that the OTP could bill for a full weekly bundle.37
Several commenters stated that the frequency of services listed in the proposed rule for a typical case would usually only occur during the initial phase of treatment/stabilization. CMS responded that while it identified a set of services for purposes of calculating the payment for the weekly bundle, it is not a requirement for billing the bundled payment that all of those services be furnished in a given episode of care. Rather, CMS finalized a policy under which the threshold to bill for an episode of care would be that at least one service was furnished to the patient during the week that corresponds to the episode of care.38
Partial Episode of Care
As CMS explained in the July 29 proposed rule, there may be instances where a patient does not receive all of the services expected in a given week due to any number of issues. Thus, CMS proposed to establish separate rates for partial episodes that correspond with each of the full weekly bundles. In cases where the OTP has furnished at least one of the items and services but less than 51 percent of the items and services identified in the patient’s current treatment plan over the course of a week, CMS proposed that the OTP could bill for a partial weekly bundle. In cases where the patient does not receive a drug during the partial episode, CMS proposed that the code describing a non-drug partial weekly bundle be used.39
CMS received public comments on its proposal to create separate coding and payment for partial bundles. Many commenters noted that determining the threshold for when to bill the partial episode versus the full episode was impractical, cumbersome and would require more frequent updating of the treatment plan. Commenters also requested clarification on how services would count toward the 51 percent and urged CMS to eliminate the partial bundled payment to simplify billing and reduce confusion that could lead to billing compliance issues.40
Based on the concerns raised by commenters, CMS did not finalize partial episodes as part of the Final CY 2020 PFS. In the interest of combatting the opioid crisis and in the best interest of patients, CMS’s goal is to minimize barriers to OTPs enrolling in Medicare to furnish services to Medicare beneficiaries.41 Thus, for CY 2020, CMS finalized only the proposal to establish full weekly bundled payments at Section 410.67(d)(2). The threshold to bill a full episode will be that at least one service was furnished (whether from either the drug or non-drug component) to the patient during the week that corresponds to the episode of care at Section 410.67(d)(3). CMS will monitor for abuse given this lower threshold for billing for the full weekly bundled payment.42
Non-Drug Episodes of Care
CMS put forward in the July 29 proposed rule a non-drug episode of care to provide a mechanism for OTPs to bill for non-drug services, including substance use counseling, individual and group therapy, and toxicology testing rendered during weeks when a medication is not administered, for instance, in cases where a patient is being treated with injectable buprenorphine or naltrexone on a monthly basis or has a buprenorphine implant. CMS proposed to codify this non-drug episode of care at Section 410.67(d). CMS did not receive any comments on non-drug episodes of care and thereby finalized the policies governing the use of non-drug episodes of care in Section 410.67(d)(1)(iii).
Drug Component of Bundled Payment Rates
CMS recognized in the July 29 proposed rule that the cost of medications used by OTPs to treat OUD varies widely and proposed to base OTP bundled payment rates, in part, on the type of medication43 used for treatment. CMS proposed five categories of bundled payments to reflect those drugs currently approved by the FDA under section 505 of the Federal Food, Drug and Cosmetic Act (FDCA) for use in treatment of OUD. These categories include oral methadone, oral buprenorphine, buprenorphine injection, buprenorphine implant and naltrexone injection. CMS also proposed to create a category of bundled payment describing a drug not otherwise specified to be used for new drugs.44
CMS received public comments related to the proposal to establish categories of OTD bundled payments based upon the type of opioid agonist and antagonist treatment medication used during an episode of care. A few commenters supported the proposal to use five medication categories. One commenter supported the medication categories but cautioned CMS to monitor and evaluate drug pricing and availability to ensure that payments are sufficient to cover the cost of medications. Another commenter stated that the medications should not be bundled and that the bundles, if used, were too broad.
CMS responded that Section 1834(w) of the Social Security Act instructs the Secretary to make a bundled payment for opioid treatment medications furnished by an OTP. CMS, therefore, did not believe the statute supports unbundling the medications from other OUD treatment services provided by OTPs. CMS defined the five medication categories to represent the distinct types of covered OTP medications currently on the market based on primary active ingredient, method of administration, and cost. The agency believed these categories of bundled payments strike a reasonable balance between recognizing the variable costs of these medications and the statutory requirement to make a bundled payment for OTP services.45
Taking all comments into consideration, CMS finalized its proposal to base the OTP bundled payment rates, in part, on the type of medication used for treatment. These five categories reflect those drugs currently approved by the FDA under Section 505 of the FDCA for use in the treatment of OUD. CMS codified this policy of establishing the categories of bundled payments based on the type of opioid agonist and antagonist treatment medication in Section 410.67(d)(1).46
Adjustment to Bundled Payment Rate for Additional Counseling or Therapy Services
In addition to the July 29 proposed items and services included in the bundles, CMS recognized that patients may need to receive counseling and/or therapy more frequently at certain points of their treatment. As a result, CMS offered to adjust the bundled payment rates using an add-on code to account for such instances. The add-on code would reflect each additional 30 minutes of counseling or group or individual therapy47 furnished in a week of MAT and could be billed in conjunction with the codes describing the full episode of care.48
CMS received several comments on the proposed adjustment to the bundled payment rate for additional counseling or therapy services. Many commenters supported the proposal to create the add-on G-code to adjust the bundled payment. Several commenters stated that the number of therapy and counseling services described in the proposed rule usually only occurs during the initial stages of treatment. A few commenters further stated that patients with that level of need in a given week may be referred for more intensive treatment, Intensive Outpatient (IOP)49 treatment.50
After consideration of the public comments, CMS finalized its proposal to establish an add-on code51 to describe an adjustment to the bundled payment when additional counseling or therapy services are furnished. This add-on payment was codified in the regulations at Section 410.67(d)(4)(i)(A). This add-on code may be billed when counseling or therapy services are furnished that substantially exceed the amount specified in the patient’s individualized treatment plan. OTPs will be required to document the medical necessity for these services in the patient’s medical record.52
Telecommunications, Site of Service
CMS proposed on July 29 to allow OTPs to furnish the substance use counseling, individual therapy and group therapy included in the bundle (as described above) via two-way interactive audio-video communication technology (telecommunication), as clinically appropriate, to increase access to care for beneficiaries. The agency did so under the premise that telehealth services furnished by OTPs would be similar to the Medicare telehealth services furnished under Section 1834(m) of the Social Security Act, and the use of two-way interactive audio-video communication technology is required for these Medicare telehealth services under Section 410.78(a)(3). As a result, OTPs in rural communities or federally designated geographic professional shortage areas53 would be able to facilitate treatment through virtual care coming from an urban or other external site.54
CMS noted that Section 1834(m) of the Social Security Act applies only to Medicare telehealth services furnished by a physician or other practitioners. OUD treatment services furnished by an OTP, however, are not considered to be services provided by a physician or other practitioner. As a result, CMS indicated that the restrictions of Section 1834(m) would not apply. CMS further acknowledged that counseling or therapy furnished via communication technology as part of OUD treatment services provided by an OTP must not be separately billed by the practitioner furnishing the counseling or therapy because those services would already be paid through the bundled payment made to the OTP.55
CMS received public comments on the proposal to include substance use counseling and individual and group therapy services furnished using telecommunications technology in the definition of OUD treatment services. Many commenters supported the proposal to allow OTPs to use two-way interactive audio-video communication technology in this capacity. Several commenters noted that this model would vastly expand OTP reach, particularly in underserved areas. A few commenters urged CMS to afford OTPs maximum flexibility in how telehealth is deployed, such as allowing the provision of such services regardless of whether the counselor or patient is physically located at an OTP. One commenter recommended that CMS also allow OTPs to furnish other important medical services including medication dose assessment and interactions, basic primary care and HIV and hepatitis C reduction. A few commenters requested clarification on whether patients participating in individual and/or group counseling could do so from their home or another location of their choosing rather than merely a designated satellite location.56
After consideration of public comments, CMS finalized its proposal to allow OTPs to use two-way interactive audio-video communication technology, as clinically appropriate, in furnishing substance use counseling and individual and group therapy services in Section 410.67(b). In response to requests for clarification regarding where the beneficiary and practitioner can be located at the time of service, CMS noted that Section 2001 of the SUPPORT Act allows telehealth services for treatment of a diagnosed SUD or co-occurring mental health disorder to be furnished to individuals at any telehealth originating site (other than a renal dialysis facility), including a patient’s home. Consistent with this policy, CMS believed it permissible to allow beneficiaries to receive substance use counseling and individual group therapies furnished by an OTP using telecommunications technology in their home or any other telehealth originating site.57
In response to commenters who recommended that CMS allow OTPs to furnish other medical services to beneficiaries via telecommunications, CMS noted that SAMHSA and the Drug Enforcement Administration (DEA) have regulations related to OUD services furnished via telecommunications that CMS would need further time to consider, but CMS may revisit this recommendation in developing its policies for future rulemaking. CMS further noted that no originating site facility fee (HCPCS code Q3014) applies to OUD treatment services, as OTP services are not PFS services. Thus, OTPs are not authorized to bill for the originating site facility fee. 58
Impact of These Changes
The CY 2020 Medical Fee Schedule Final Rule will impact access to care, utilization of services, and costs due to changes directly related to telehealth and the effect of Medicare coverage for OUD treatment services furnished by OTPs. With changes directly related to telehealth, CMS expects its three new codes, HCPCS codes G2068, G2087 and G2088 to have the potential to increase access to care in rural areas, based on recent telehealth utilization of services already on the list, including services similar to the additions. But CMS estimates there will only be a negligible impact on PFS expenditures from these additions. For example, for services already on the list, they are furnished via telehealth, on average, less than 0.1 percent of the time they are reported overall. The restrictions placed on Medicare telehealth by the statute limit the magnitude of utilization. However, CMS believes there is value in allowing physicians and patients the greatest flexibility when appropriate.59
With OUD treatment services furnished by OPTs, it is important to note that SAMHSA currently certifies about 1,700 OTPs. They are located predominately in urban areas, tend to be freestanding facilities and provide a range of services, including MAT. The payor mix for OTPs currently includes Medicaid, private payors, TRICARE and individual pay patients. CMS contends it is difficult to predict how coverage of OTP services will specifically affect the market. CMS anticipates current OTPs may expand access to care for Medicare beneficiaries since they will be able to receive payment from Medicare for services furnished to beneficiaries when they previously were unable to do so. Coverage may also create financial incentives to establish new OTPs. However, since TRICARE, Medicaid and some private payors already pay for OTP services, it is less clear whether the presence of Medicare payment rates will have any effect on current rates for OTP services or on new rates should additional private coverage be established.60
Telehealth models expand access to substance abuse and mental health services, especially in communities with limited provider resources. CMS, in its CY 2020 Medical Fee Schedule Final Rule finalized its proposal to add three new codes for a bundled episode of care for treatment of OUD to the list of services eligible for telehealth reimbursement. It further finalized a bundled payment structure for OUD treatment by OTPs allowing counseling and therapy components to be delivered by interactive video. These actions represent one more step in the government’s attempt to aggressively respond to the ongoing opioid crisis.
- Federal Register, vol. 84, No. 157, Aug. 14, 2019, https://www.govinfo.gov/content/pkg/FR-2019-08-14/pdf/2019-16041.pdf.
- Section 2005. Medicare Coverage of Certain Services Furnished by Opioid Treatment Programs, SUPPORT Act, (a) Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended (1) in subparagraph (FF) by striking at the end “and”; (2) in subparagraph (GG), by inserting at the end “and”; and (3) by adding the following new subparagraph: “(HH) opioid disorder treatment services (as defined in subsection (jjj)),” https://www.congress.gov/115/bills/hr6/BILLS-115hr6enr.pdf.
- Medicare Program, CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule, and Other Changes to Medicare Part B Payment Policies, Fed. Reg. Vol. 84, No. 221, Nov. 15, 2019, https://www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other.
- Finalized CY 2020 Physician Fee Schedule Fact Sheet, Center for Connected Health Policy, Nov. 2019.
- Distant site practitioners who can furnish and get payment for covered telehealth services (subject to state law) are physicians and other healthcare providers, e.g., nurse practitioners (NPs), physician assistants (PAs), nurse-midwives, clinical nurse specialists (CNSs), certified registered nurse anesthetists, clinical psychologists (CPs), clinical social workers (CSWs) and registered dietitians or nutrition professionals. CMS Medicare Learning Network Booklet, Telehealth Services, ICN 901705, Jan. 2019, p.5, https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/TelehealthSrvcsfctsht.pdf.
- Social Security Act Section 1834(m)(1) [42 CFR § 410.78], “The Secretary shall pay for telehealth services that are furnished via a telecommunications system by a physician as defined in section 1861(r) or a practitioner (described in section 1842(b)(18)(c)) to an eligible telehealth individual enrolled under this part notwithstanding that the individual physician or practitioner providing the telehealth service is not at the same site as the beneficiary. (2) Payment Amount- (A) Distant Site- The Secretary shall pay to a physician or practitioner located at a distant site that furnishes a telehealth service to an eligible telehealth individual an amount equal to the amount that such physician or practitioner would have been paid under this title had such service been furnished without the use of a telecommunications system, https://www.ssa.gov/OP_Home/ssact/title18/1834.htm.
- Section 1834(m)(4)(F)(ii) YEARLY UPDATE of the Social Security Act provides that The Secretary shall establish a process that provides, on an annual basis, for the addition or deletion of services (and HCPCS codes), as appropriate, to those specified in clause (i) for authorized payment under paragraph (1). Clause (i) IN GENERAL- The term “telehealth service” means professional consultations, office visits, and office psychiatry services identified as of July 1, 2000, by HCPCS codes 99241-99275, 99201-99215, 90804-90809, and 90862 and subsequently modified by The Secretary, and any additional service specified by the Secretary, https://www.ssa.gov/OP_Home/ssact/title18/1834.htm.
- CY 2019 Medicare telehealth-covered services (i.e. the list of telehealth services) include: telehealth consultations, emergency or initial inpatient; follow-up inpatient; follow-up inpatient telehealth consultations (hospitals and skilled nursing facilities); office or other outpatient visits; subsequent hospital care and nursing facilities services; individual and group kidney disease education services and diabetes self-management training services; behavioral health assessment, intervention and psychotherapy; end-stage renal disease-related services for home dialysis; alcohol and substance abuse assessment and intervention services; telehealth pharmacologic management; smoking cessation services; individual or group medical nutrition therapy; transitional care management services; advanced care planning; psychoanalysis and family psychotherapy; annual wellness visit; and telehealth consultation. Medical Learning Network, Telehealth Services, ICN 901705, Jan. 2019, https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/TelehealthSrvcsfctsht.pdf.
- Section 1834(m)(4)(A). The term distant site means the site at which the physician or practitioner is located at the time the service is provided via a telecommunications system, https://www.ssa.gov/OP_Home/ssact/title18/1834.htm.
- Section 1834(m)(4)(C). The term originating site means only those sites designated in clause (ii) at which the eligible telehealth individual is located at the time the service is furnished via telecommunications system and only if such site is located (I) in an area that is designated as a rural health professional shortage area under Section 332(a)(1)(A) of the Public Health Service Act; (II) in a county that is not included in a Metropolitan Statistical Area; or (III) from an entity that participates in a federal telehealth demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services, https://www.ssa.gov/OP_Home/ssact/title18/1834.htm. See also Federal Register, Vol. 84., No. 221, Nov. 15, 2019, Rules and Regulations, p. 62627, https://www.govinfo.gov/content/pkg/FR-2019-11-15/pdf/2019-24828.pdf.
- Id, at 62628.
- The RUC is an expert panel of physicians which makes recommendations to the government on the resources required to provide a medical service. The expert panel’s assessment takes into account physicians’ time, nurses’ time, supplies and equipment involved in patient care. The RUC is comprised of a volunteer group of 31 physicians and 300 medical advisors that represent each sector of medicine, including primary care physicians and specialists. The RUC regularly reviews medical services to determine whether they are appropriate, undervalued, or overvalued, and volunteers its recommendations to the federal government through CMS for the agency’s consideration. CMS makes all final decisions about what payments should be for each service under the Medicare program. An Introduction to the RUC, American Medical Association, https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/public/rbrvs/introduction-to-the-ruc-updated.pdf.
- Several commenters disagreed with CMS’ July 29, 2019 statement that most eligible services had been already been added to the Medicare telehealth list and suggested that CMS should continue to engage with stakeholders to identify other services that could be furnished via Medicare telehealth or communication technology-based services. A few commenters also provided recommendations for additional services that could be added to the list, as well as suggestions for how CMS could improve the process of requesting that services be added. Commenters reiterated as they have for many years that the statutory restrictions under Section 1834(m) of the Act (rural health professional shortage area Section, 1834(m)(4)(C)(i)(I) and non-Metropolitan Statistical Area originating site restrictions, Section 1834(m)(4)(C)(i)(II)) are too limiting. Many encouraged CMS to utilize its demonstration authority to waive restrictions pursuant to Section 1834(m)(4)(C)(i)(III). CMS responded that it will continue to engage with stakeholders to identify services to add to the Medicare telehealth list, noting the deadline for submitting requests for additions to the list is February 10 of the year prior to the year in which the codes could be added to the Medicare telehealth list and any requests that are received after that date will be considered in the following year’s rulemaking. Federal Register, Vol. 84, No. 221, supra n. 3 at 62629.
- In Section II.H of the CY 2020 PFS proposed rule (84 Fed. Reg. 50518), July 29, 2019, Federal Register, supra n.1, at 50518.
- HCPCS code G2086: Office-based treatment for opioid use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar year, Federal Registrar, supra n.3 at 62628.
- HCPCS code G2087: Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling, at least 60 minutes in a subsequent calendar year, Id, at 62628.
- HCPCS code G2088: Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes, Id. at 62628.
- CPT 90832, Psychotherapy, 30 minutes with patient.
- CPT 90853, Group Psychotherapy (other than a multiple family group).
- Federal Register, Vol. 84, No. 221, supra n.3 at 62628.
- Federal Register, 83 Fed. Reg. 59496, https://www.federalregister.gov/documents/2018/11/23/2018-24170/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions.
- Public Law 1150271, enacted Oct. 24, 2018, HR6-SUPPORT for Patients and Communities Act, https://www.congress.gov/bill/115th-congress/house-bill/6.
- An originating site is the location where a Medicare beneficiary gets physician or practitioner medical services through a telecommunications system. The beneficiary must go to the originating site for the services located in either: a county outside a Metropolitan Statistical Area (MSA), or a rural Health Professional Shortage Area (HPSA) in a rural census tract. The Health Resources and Services Administration (HRSA) defines HPSAs, and the Census Bureau defines MSAs, https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/TelehealthSrvcsfctsht.pdf.
- Congressional Research Service, The SUPPORT For Patients and Communities Act, (P.L.115-271): Medicare Provisions, Updated Jan. 2, 2019, p. 7, https://fas.org/sgp/crs/misc/R45449.pdf.
- Federal Register, Vol. 84, No. 221, supra n.3 at 62629.
- OUD treatment services include opioid agonist and antagonist treatment medications (including oral, injected or implanted versions) approved by the Food and Drug Administration (FDA). There are three drugs currently approved by the FDA for treatment of opioid dependence: buprenorphine, methadone and naltrexone. Covered services include dispensing and administration of such medications, if applicable; substance use counseling by a professional to the extent authorized under state law and to furnish such services; individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under state law); toxicology testing; and other items and services that the Secretary determines are appropriate. Id. at 62631.
- Section 2005 of the SUPPORT Act defines an OTP as an entity meeting the definition of OTP in 42 C.F.R. § 8.2 or any successor regulation (that is, a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication registered under 21 U.S.C. § 823(g)(1)), that meets the additional requirements set forth in subparagraphs (A) through (D) of Section 1861(jjj)(2) of the Act. Specifically, the OTP is enrolled under Section 1866(j) of the Act; has in effect a certification by the Substance Abuse Mental Health Services Administration (SAMHSA) for such program; is accredited by an accrediting body approved by SAMHSA; and meets such additional conditions as the Secretary may find necessary to ensure the health and safety of individuals furnished services. Id. at 62635.
- Id. at 62631.
- Id. at 62638.
- Id. at 62639.
- https://www.govregs.com/regulations/expand/title42_chapterIV_part410_subpartB_section410.67#top. See also Federal Register, Vol. 84, No. 221, supra n. 3 at 62639.
- Medication Assisted Treatment (MAT) is the use of FDA-approved medications, in combination with counseling and behavioral therapies, to provide a “whole patient” approach to the treatment of substance use disorders. SAMHSA, Medication-Assisted Treatment (MAT), https://www.samhsa.gov/medication-assisted-treatment, last updated Sept. 9, 2019.
- Federal Register, Vol. 84, No. 221, supra n.3 at 62640.
- Id. at 62640.
- Id. at 62641.
- SAMHSA requires OTPs to provide drug abuse testing. OTPs must provide adequate testing or analysis for drugs of abuse, including at least eight random drug abuse tests per year, per patient in maintenance treatment, in accordance with generally accepted clinical practice. For patients in short-term detoxification treatment defined in Section 8.2 as detoxification treatment not in excess of 30 days, the OTP shall perform at least one initial drug abuse test. For patients receiving long-term detoxification treatment, the program shall perform initial and monthly random tests on each patient. Id. at 62635.
- Id. at 62641.
- Id. at 62642.
- Medication treatment to support recovery from OUD includes opioid agonist therapy or antagonist therapy. An agonist is a drug that activates certain receptors in the brain. Examples of full agonists are heroin, oxycodone, methadone, hydrocodone, morphine and opium. Partial agonist opioids activate the opioid receptors in the brain, but to a much lesser degree than a full agonist. Buprenorphine is an example of a partial agonist. An antagonist is a drug that blocks opioids by attaching to the opioid receptors without activating them. Antagonists cause no opioid effect and block fully agonist opioids. Examples are naltrexone and naloxone. Current medication examples include: full opioid agonist - methadone, partial opioid agonist - buprenorphine, partial opioid agonist/antagonists - buprenorphine, and opioid antagonist - naltrexone. These medications are FDA approved for OUD and have shown effectiveness in reducing opioid use and harmful opioid-related behaviors when used as part of a comprehensive treatment program. Pharmacological Treatment Medications, https://www.ihs.gov/opioids/recovery/pharmatreatment/.
- CMS anticipates that there will be new FDA-approved opioid agonist and antagonist treatment medications to treat OUD in the future. In the scenario where an OTP furnishes MAT using new FDA-approved opioid agonist or antagonist medication for OUD treatment that is not specified in an existing code, CMS proposed that OTPs would bill for the episode of care using the medication not otherwise specified (NOS) code (HCPCS code G2075). CMS proposed using the typical or average maintenance dose to determine the drug cost for the new bundles. CMS received public comments on the proposals related to new drugs. A few commenters generally supported coverage of new FDA-approved medications for OUD. One commenter noted that a flexible approach to innovative therapies to treat OUD is critical. CMS believes that its proposal to allow providers to bill using a medication NOS code would offer OTPs flexibility to provide patients with quick access to new FDA-approved medications for OUD until CMS has an opportunity to consider through rulemaking establishing a unique bundled payment for episodes of care during which the new drug is furnished. Federal Register, Vol. 84, No. 221, supra n. 3 at 62643.
- Id. at 62642.
- Id. at 62643.
- For example, there could be some weeks when a patient has a relapse or unexpected psychosocial stressors arise that warrant additional reasonable and necessary counseling services that were not foreseen at the time the treatment plan was developed. Id. at 62644-5.
- Id. at 62644.
- HCPCS Code H0015, described as “Alcohol and/or drug services, intensive outpatient (treatment program that operates at least 3 hours/day and at least 3 days/week and is based on an individualized treatment plan), including assessment counseling, crisis intervention and activity therapies or education, https://hcpcs.codes/h-codes/.
- Federal Register, Vol. 84, No. 221, supra n.3 at 62645.
- HCPCS code G2080: Each additional 30 minutes of counseling or group or individual therapy in a week of medication assisted treatment, (provision of the services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure. Id. at 62650.
- Id. at 62645.
- Health Professional Shortage Areas (HPSAs) are designations that indicate healthcare provider shortages in primary care, dental health, or mental health. These shortages may be geographic, (e.g., rural), population or facility based. A geographic area shortage is a shortage of providers for the entire population within a defined geographic area. Population groups shortage is a shortage of providers for a specific population groups(s) within a defined area (e.g., low income, migrant farmworkers, and other groups). Facilities shortages include other facilities (OFAC), correctional facilities, state mental hospitals and automatic facility HPSAs (Auto HPSAs). Auto HPSAs are automatically designated as a HPSA by statute or through regulation without having to apply for a designation. Auto HPSAs include Federally Qualified Health Centers (FQHCs), FQHC Look-A-Likes (LALs), Indian Health Facilities (IHS), IHS and Tribal Hospitals, dual-funded Community Health Centers/Tribal Clinics and CMS-Certified Rural Health Clinics (RHCs) that meet National Health Services Corps (NHSC) site requirements. Aside from Auto HPSAs for federal correctional facilities, state Primary Care Offices (PCOs) must submit applications to designate all HPSAs. HRSA reviews these applications to determine if they meet the eligibility criteria for designation. The main criterion is that the proposed designation meets a threshold ratio for population to providers. Once designated, HRSA scores HPSAs on a scale of 0-25 for primary care and mental health, and 0-26 for dental health, with the higher scores indicating greater need. Health Resources & Services Administration Health Workforce, shortage Designation, Health Professional Shortage Areas (HRSAs), https://bhw.hrsa.gov/shortage-designation/hpsas.
- Federal Register, Vol. 84, No. 221, supra n.3 at 62645.
- Id. at 62646.
- Id. at 62646.
- Id. at 63157.
- Id. at 63158.
Christine Noller, J.D., L.L.M earned her Bachelor of Science in Clinical Dietetics from Michigan State University and her Juris Doctorate (J.D.) and Master of Laws in Taxation (L.L.M.) from the Thomas M. Cooley Law School, specializing in taxation of non-profit organizations and healthcare regulation. She is an Assistant Professor and Health Science Department Chair, and MPH Program Coordinator at Saginaw Valley State University. Her scholarly areas of interest include Telehealth, Community Benefit, Community Health Needs Assessments, Community Health Improvement Programs and Population Health, Patient Safety, Quality and Lean Process Improvement. Her healthcare leadership and administrative experience includes operations and service line management in anesthesia services, wound services, surgical specialists, orthopedics, spine and rehabilitation and occupational health. Ms. Noller practiced law in the area of Workers' Compensation. She is a member of the State Bar of Michigan's Health Care Section. She may be reached at [email protected].