CMS Proposal Vastly Expands Medicare Coverage for Opioid Treatment

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took the first steps toward welcoming opioid treatment programs (OTPs) into the Medicare program and expanding Medicare coverage of opioid use disorder (OUD) treatment services provided by both OTPs and physician practices. These steps are a welcome development for providers trying to address the growing opioid epidemic. In its CY 2020 Medicare Physician Fee Schedule proposed rule (2020 MPFS Proposed Rule) published in the federal register today, CMS outlines its bundled payment reimbursement proposal for treating Medicare beneficiaries with OUD in 2020 and its proposed enrollment criteria for OTPs.

While Medicare currently covers certain medications for medication-assisted treatment (MAT), including buprenorphine, buprenorphine-naloxone combination products, and extended-release injectable naltrexone under Part B or Part D, it does not cover methadone or other treatment services provided by an OTP. Medicare also covers individual professional services provided to OUD patients, but not group therapy or other support services often utilized to treat OUD.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-270) enacted October 24, 2018, established Medicare Part B coverage for OUD treatment services furnished by a Medicare-enrolled OTP beginning on or after January 1, 2020 under a bundled payment mechanism. In addition, last year CMS solicited comments about expanding coverage for OUD treatment provided through physician practices. In the 2020 MPFS Proposed Rule, CMS proposes regulatory changes and new Healthcare Common Procedure Coding System (HCPCS) codes to expand Medicare coverage of OUD treatment in both settings.

Comments are due to CMS by 5:00 p.m. EST on September 27, 2019.

Qualifying to Enroll in Medicare as an OTP

CMS is limiting the OTPs eligible for Medicare enrollment and is imposing a number of enrollment requirements to protect against potential fraud, waste and abuse from this expanded coverage. Only OTPs holding current certification in good standing from the Substance Abuse and Mental Health Services Administration (SAMHSA), which requires having accreditation from a SAMHSA-approved accreditation organization and meeting federal opioid treatment standards, may consider enrolling in Medicare. CMS proposes to incorporate the definition of an OTP utilized by SAMHSA (see 42 C.F.R. §8.2) and to not impose any separate conditions of participation in Medicare beyond meeting SAMHSA requirements. CMS believes existing SAMHSA certification and accreditation requirements are “both appropriate and sufficient to ensure the health and safety of individuals being furnished services by OTPs” and creating additional conditions “could create unnecessary regulatory duplication and could be potentially burdensome for OTPs.”

Although the SUPPORT Act classifies OTPs as providers and CMS follows suit, CMS still proposes to utilize a supplier form – CMS-855B – for OTP Medicare enrollment. As proposed, OTPs will be required to submit a list of all physicians and other eligible professionals who are legally authorized to prescribe, order or dispense controlled substances on behalf of the OTP. OTPs also must certify that it meets and will continue to meet the enrollment standards. OTPs will be subject to an application fee for submitting a paper application (currently $586).

For enrollment purposes, CMS proposes to classify OTPs as high risk for fraud, waste and abuse, meaning OTPs will be required to – among other things – submit fingerprints of all 5% or greater owners and be subject to site visits. CMS also proposes to restrict OTP employees and contractors. For example, OTPs will not be able to employ or contract with anyone revoked from Medicare, on the CMS preclusion list (which is currently only shared with Medicare Advantage and Part D plans) or with a current or prior state oversight board adverse action deemed by CMS as detrimental to the best interest of Medicare beneficiaries. OTPs also will not be able to employ or contract with any prescriber or other individual, such as a pharmacist, legally authorized to dispense narcotics who has been convicted of a CMS-deemed detrimental federal or state felony within the preceding 10 years.

The OTP’s Medicare enrollment effective date will be the date that CMS accepts a signed provider agreement rather than the date of any survey or accreditation. As with other Medicare providers, OTPs may appeal an adverse enrollment determination through the Medicare appeals process.

Medicare Covered OTP Services

CMS proposes to define OUD covered services to include the statutory mandated services of Food & Drug Administration (FDA)-approved medications for treatment of OUD (e.g., buprenorphine, naloxone and methadone); dispensing and administration of the medications; substance use counseling; individual and group therapy; and toxicology testing.

CMS also is proposing to utilize its discretionary authority to include the use of telehealth for certain services. More specifically, CMS is proposing to allow OTPs to furnish substance abuse counseling, individual therapy and group therapy services that are included in the bundle via two-way interactive audio-video communication technology, as clinically appropriate. CMS is hoping that the use of communication technology will improve access to care for beneficiaries, particularly those in rural communities and health professional shortage areas. The proposed telehealth expansion is a positive sign that CMS is willing to look for creative, cost effective solutions to ensure patients obtain needed OUD treatment.

Further demonstrating CMS’ commitment to solutions aimed at addressing the opioid epidemic, CMS also seeks commentary regarding other Medicare covered items and services (excluding meals or transportation) that should be added to the definition of OUD treatment services, particularly initial physical examinations, initial assessments, preparation of a treatment plan, and periodic assessment. CMS is also seeking commentary on any drug development efforts in the pipeline not involving opioid agonist and antagonist mechanisms; as well as how medications and biologicals that may be approved in the future by the FDA should be considered.

Medicare Reimbursement for OTP Treatment

In considering how to design the bundled payments, CMS reviewed how OUD services are reimbursed by TRICARE and state Medicaid programs. After taking the various reimbursement models into account, CMS proposes to establish a weekly bundle consisting of a contiguous seven-day period that may start on any day of the week. CMS does not propose any maximum number of weeks during an overall course of treatment as it recognized that patients receiving MAT are often on this treatment regimen for long periods of time. The lack of treatment caps allows providers to develop individualized treatment plans tailored to a specific patient’s need. However, because of anticipated scrutiny for lengthy treatment plans, providers will be expected to thoroughly document the reasons supporting any selected treatment.

As outlined in the chart below, CMS proposes to establish separate bundles and rates based on the type of medication used for treatment, each bundle being inclusive of the bundled services identified above. The bundled rates established by CMS are comprised of a drug component and a non-drug services component. CMS utilized the typical or average maintenance dose to determine the drug costs for each of the proposed bundles, primarily based on the average sales price where that data is available. Regarding the non-drug component of the bundle, CMS prices the bundles assuming one substance-use counseling session, one individual therapy session and one group therapy session per week; and one toxicology test per month. Although CMS recognizes that the intensity of treatment services provided to a patient is often higher in the initial stages as compared to maintenance treatment, CMS has not proposed higher payment rates at the initiation of treatment. Furthermore, CMS proposes to apply a geographic locality adjustment to the non-drug component of the bundled rates and to update the rates annually.

Anticipating that some patients will receive treatment without a drug some weeks (e.g., when a patient receives monthly injections of buprenorphine), CMS proposes to establish a no-drug bundle for OTPs to bill those weeks. Moreover, CMS proposes a separate “drug not otherwise specified” bundle to be used in the future for new FDA-approved opioid agonist and antagonist treatment medications until CMS has the opportunity to consider through rulemaking a new bundled payment for episodes of care utilizing the new drug.

CMS explained that it will consider a weekly bundle to have been provided if the patient receives a majority of the services (i.e., 51% or more) identified in the patient’s treatment plan over the course of a week. If that 51% threshold is not met but at least one of the bundled services was provided, CMS proposes partial week bundled payments. Notably, however, if no drug is provided during the partial episode, CMS will require the no-drug partial code be used for that patient. CMS intends to monitor the use of partial episode codes. CMS seeks comments on both the full and partial episodes bundles, including CMS’ proposed threshold for billing the codes.

*Average Sales Price unless not available, in which case CMS proposes a variety of alternatives.

CMS also proposes an intensity add-on code (GXX19 for each additional 30 minutes of counseling or therapy in a week of MAT, initially priced at $26.60) to address unexpected situations in which a patient requires additional counseling substantially exceeding the amount specified in their treatment plan. CMS clarifies that this code is not intended for use early in treatment when services are expected to be more intense; rather, it is for unanticipated situations, such as a relapse or other unforeseen psychosocial stressors. CMS is aware that basing the add-on code on services not anticipated in the treatment plan may create an incentive for OTPs to document minimal counseling and/or therapy needs. CMS expects, however, that OTPs will ensure treatment plans reflect the full scope of services expected to be furnished during each episode of care and will update treatment plans regularly as the patient progresses through treatment. CMS intends to monitor the use of the intensity add-on code. Providers using the add-on code should expect to receive Medicare contractor audits to verify the code’s appropriate use.

To minimize patient access barriers to OUD treatment services during the opioid crisis, CMS proposes no copayment or cost-sharing at this point; however, the Medicare Part B deductible applies. CMS also plans to establish a new “place of service” code for OTPs to include for OTP service claims. Further, CMS expects OTPs to take reasonable steps to ensure no other providers attempt to submit a claim to Medicare for MAT drugs. In the event duplicate payments are made under Medicare Part B or D, CMS proposes to recoup the duplicative payment from the OTP rather than from, for example, the pharmacy, because CMS believes the OTPs are in the best position to know who furnished the drug – the OTP or a pharmacy.

Office-Based Opioid Treatment Bundles

In a further effort to expand access to opioid treatment services, CMS also proposes to establish bundled rates for treating OUD by physicians and physician practices. As proposed, CMS will utilize two HCPCS codes to describe monthly bundles that include overall management, care coordination, individual and group psychotherapy, and counseling activities for office-based OUD treatment. However, these bundles do not include payment for MAT drugs or toxicology testing; payment for those services will continue through existing mechanisms. CMS believes these bundles will create an avenue for physicians and other health professionals to bill for a bundle of services similar to the new OTP services benefit, outside of an OTP setting. CMS is hoping to incentivize increased provision of counseling and care coordination for patients with OUD in the office setting.

1. GYYY1: (wRVU 7.06) Office-based treatment for OUD, including development of a treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month.
2. GYYY2: (wRVU 6.89) Office-based treatment for OUD, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month.
3. GYYY3: (wRVU 0.82) Office-based treatment for OUD, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (List separately in addition to code for primary procedure).

In valuing the base codes (GYYY1 and GYYY2), CMS assumes two individual psychotherapy sessions per month and four group therapy sessions per month, but recognizes there will be variability from patient to patient and over time. GYYY3 is intended as an add-on code for extraordinary circumstances not contemplated by the bundle, i.e., significantly more care than is in the range of what is typical for the kind of care described by the base codes. Prior to billing one of these bundled codes, CMS expects practitioners would separately furnish a reportable initial visit to establish a treatment relationship, assess and evaluate the patient’s needs, and obtain informed consent. Notably, utilization of these new OUD bundled codes will limit the ability of the same practitioner to bill other psychotherapy codes (e.g., 90832, 90834, 90837 and 90853) during the same month. Only professionals who are appropriately qualified and licensed under applicable state law may provide counseling, therapy and care coordination services. CMS expects the billing practitioner to manage the patient’s overall care and supervise other individuals participating in the patients’ care.

In contrast to receiving services through an OTP, patients receiving OUD services from a physician will be subject to existing deductible and coinsurance requirements under the MPFS.

CMS also proposes to allow any individual therapy, group therapy or counseling to occur via telehealth, and to this end adds these codes to its list of services that may be provided via telehealth. The addition of these codes to the Medicare telehealth list complements changes made by CMS last year to implement provisions of the SUPPORT Act related to removing geographic limitations for Medicare coverage of telehealth services to treatment for individuals diagnosed with substance use disorder (SUD), including permitting a patient’s home to be an appropriate originating site for services.

Conclusion

The 2020 MPFS Proposed Rule begins the implementation of the SUPPORT Act’s coverage expansion for OTPs and demonstrates CMS’ commitment to addressing the opioid epidemic through expanded coverage and creative solutions for providing needed treatment to patients. Providers affected by the 2020 MPFS Proposed Rule should carefully consider its provisions to understand potential enrollment and reimbursement plans. If providers are concerned about any of the proposals, they should consider submitting a comment to CMS to voice these concerns.

If you have any questions regarding the 2020 MPFS Proposed Rule or how to submit comments to CMS, please contact the authors or one of our healthcare attorneys.